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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it can be mounted in a variety of ways (e.g., shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate.

As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula: MAP = 1/3* Systolic + 2/3*Diastolic.

The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.

The provided 510(k) clearance letter and summary discuss the addition of a Mean Arterial Pressure (MAP) feature to the previously cleared Radius VSM and Accessories device. The primary focus of the performance data section is on validating this new MAP feature.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for Blood Pressure (including MAP) is:

"Meets ISO 81060-2 (Mean difference of ≤5 mmHg with a standard deviation of ≤8 mmHg)"

The document directly states that the results of the clinical testing supported the clinical performance of the MAP in accordance with ISO 81060-2. While specific numerical results (e.g., the exact mean difference and standard deviation achieved) are not explicitly provided in the summary table, the clearance implies that these metrics fell within the specified ISO 81060-2 limits for the MAP feature.

Table 1: Acceptance Criteria and Reported Device Performance for MAP Feature (as inferred from the document)

Study Details for MAP Feature Validation

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the numerical sample size (number of subjects/patients) used for the clinical test set. It only mentions "clinical study data."
   • Data Provenance: The document does not specify the country of origin. It indicates it was a "clinical study" and implies it was prospective ("clinical testing is provided to support its performance" for the added feature).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

   • Not applicable as the ground truth was established by an objective reference device, not human experts.

3. Adjudication Method for the Test Set:

   • Not applicable, as the method for ground truth establishment was comparison to a reference device.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The study was a comparison of the device's calculated MAP to invasively measured MAP from a reference device. This is a technical performance validation, not a study assessing human reader improvement with AI assistance.

5. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study. The Radius VSM automatically calculates the MAP based on the NIBP measurements (Systolic and Diastolic Pressure). The clinical testing validated the accuracy of this calculation against a reference standard, without human intervention in the MAP calculation or interpretation for the test itself.

6. The Type of Ground Truth Used:

   • Reference Ground Truth: Invasively measured MAP values from a 510(k) cleared reference device (K171801). This reference device is identified as "IntelliVue Multi-Measurement Module X3." This constitutes a device-based reference standard or instrument-based ground truth.

7. The Sample Size for the Training Set:

   • The document does not provide information about a training set since the MAP feature appears to be a direct calculation using a standard formula (MAP = 1/3* Systolic + 2/3*Diastolic) rather than a machine learning model that requires a training phase. While the device as a whole (Radius VSM) likely had training and validation phases for its other parameters, the specific "addition of a Mean Arterial Pressure (MAP) feature" is described as a software feature that "automates the calculation" using a known formula. Therefore, a separate training set for this specific MAP feature is unlikely to have been required or used in the conventional machine learning sense.

8. How the Ground Truth for the Training Set was Established:

   • As inferred above, a specific training set and ground truth establishment for this isolated MAP calculation feature are not described, given its nature as a direct formulaic calculation.

Summary of Key Information:

The core of this submission revolves around adding a simple, formula-based calculation for MAP. The primary study presented is a clinical validation confirming that the device's computed MAP aligns with a known industry standard (ISO 81060-2) when compared against an invasive reference device. This is a technical performance validation rather than a complex AI-driven diagnostic study.

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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously, and patient posture and activity. VMS allows for the input of non-invasive blood pressure and body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.

The non-invasive Blood Pressure Tracking feature is based on Pulse Arrival Time (PAT), which is obtained utilizing ECG and PPG signals following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.

The Vios Central Station Monitor (CSM) and Central Server (CS) Software (SW) is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSM SW and CS SW receives, stores, manages, and displays patient physiological and waveform data and alarms generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals.

The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station.

The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices.

The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW.

VMS Chest Sensor Adapter Models L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

The provided text describes a 510(k) clearance for the Vios Monitoring System Model 2050, focusing on the addition of a blood pressure tracking feature. Here's an analysis of the acceptance criteria and the study details based solely on the provided document:

Missing Information: It's important to note that the provided FDA 510(k) clearance letter is a summary document and does not contain the detailed clinical study report or the specific acceptance criteria with numerical performance targets. It states that the device meets "all consensus standards requirement" and that "results were within the acceptance criteria," but it does not define those criteria or present detailed performance data in a table format. Therefore, I will have to make assumptions about the typical acceptance criteria for Non-Invasive Blood Pressure (NIBP) devices based on the mentioned standards (ISO 81060-2, IEEE 1708, ISO 81060-3) and then state the general reported outcome from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific numerical acceptance criteria and performance data in the provided document, the table below will broadly reflect typical NIBP acceptance criteria based on the mentioned standards and the general statement of performance from the text.

• Mean difference $\le \text{5 mmHg}$
• Standard deviation $\le \text{8 mmHg}$
  (Requirements per ISO 81060-2) | "The results were within the acceptance criteria, similar to the predicate device." |

Explanation of Assumption: The document explicitly states that "The clinical testing and analysis is performed according to applicable clauses from ISO 81060-2, IEEE 1708, and ISO 81060-3 for validation using reference invasive blood pressure measurement on the radial artery." ISO 81060-2 is the primary standard for non-invasive sphygmomanometers, which outlines specific statistical accuracy requirements (mean difference and standard deviation). Therefore, the acceptance criteria are assumed to be those specified in ISO 81060-2. The document does not provide numerical results for the Vios Monitoring System.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided document. The text mentions "a range of subjects, representative of the intended population."
• Data Provenance: Not explicitly stated. The document indicates a "clinical study" was performed, but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study for validation, it is most likely prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The ground truth was established by "reference invasive blood pressure measurement on the radial artery," which is a direct, objective medical measurement, not typically requiring a panel of experts for interpretation in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the ground truth for blood pressure measurement (invasive arterial line) is an objective, quantitative measurement that does not require expert adjudication in the same manner as subjective or qualitative assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for diagnostic imaging or similar interpretation tasks where human perception and decision-making are aided by AI. For a vital signs monitor, the primary assessment is of the device's accuracy against a known reference, not its ability to assist human readers in interpretation.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Yes, a standalone performance study was done. The clinical testing described for "Blood Pressure Tracking" assesses the algorithm's accuracy in autonomously generating blood pressure values from PAT (Pulse Arrival Time) against an invasive blood pressure reference. This is an assessment of the algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the blood pressure tracking feature was invasive blood pressure measurement on the radial artery. This is considered a gold standard and highly accurate method for blood pressure determination.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set. The descriptions focus on the validation study for the blood pressure tracking feature. It is implied that the algorithm was developed (trained) prior to this validation, but the details of that training are not included in this summary.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established. It only describes the ground truth for the clinical validation study (invasive blood pressure measurement on the radial artery) and the calibration process. The "calibration (initialization)" step uses an "FDA-cleared oscillometric blood pressure monitor" for initial coefficient determination, which is distinct from establishing ground truth for a large-scale training set.

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The Sentec Digital Monitoring System (SDMS) - consisting of monitors, sensors, cables, accessories and disposables for sensor application/maintenance and PC-based software - is indicated for non-invasive patient monitoring of oxygenation and ventilation.

The Sentec Digital Monitoring System is for prescription use only. Devices are non-sterile and non-invasive.

The monitor is not in direct contact with the patient during monitoring. The V-Sign™ Sensor 2, the OxiVenT™ Sensor. the Ear Clip, the Multi-Site Attachment Rings, the Non-Adhesive Wrap, the Staysite™ Adhesive and the Contact Gel are in contact with the intact skin of the patient during monitoring.

Sentec's Digital Monitoring System is intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PC2), oxygen saturation (SpO2) and pulse rate (PR) in adult and pediatric patients as well as for PCO2 and PO2 monitoring in neonatal patients.

The tCOM+ (REF 103164) is a portable, lightweight, stand-alone monitor with a convenient carrying handle and with an integrated calibration and storage facility for the V-Sign™ Sensor 2 or OxiVenT™ Sensor, respectively. It provides continuous and noninvasive PCO2, SpO2 and PR monitoring if used with a V-Sign™ Sensor 2 or PCO2, PO2, SpO2 and PR monitoring if used with a OxiVenT™ Sensor.

Acceptance Criteria and Study for Sentec Digital Monitoring System (SDMS) tCOM+

The Sentec Digital Monitoring System (SDMS) tCOM+ is a transcutaneous blood gas monitoring system intended for the continuous and noninvasive monitoring of cutaneous carbon dioxide partial pressure (PCO2), cutaneous oxygen partial pressure (PO2), oxygen saturation (SpO2), and pulse rate (PR). The tCOM+ is an updated version of the previously cleared Sentec Digital Monitor (SDM), with technological upgrades such as a touchscreen user interface and wireless communication capabilities.

The submission focuses on demonstrating substantial equivalence to its predicate device, the SDM, and updated disposables. The core performance of the device, particularly its measurement modalities, is considered unchanged from the predicate. Therefore, the acceptance criteria and supporting studies primarily revolve around verifying the safety and effectiveness of the new monitor features and updated accessories, and demonstrating that the clinical performance remains consistent with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided documentation does not specify sample sizes for test sets in the context of clinical performance data. The submission explicitly states:

• "No clinical performance data were generated on the tCOM+, because compared to its predicate device, the Sentec Digital Monitor (SDM), it uses the same sensors without software changes impacting algorithm or clinical performance."
• "The introduction of the updated disposables...do not affect the clinical functionality or performance of Sentec's Digital Monitoring System. No further clinical data was required to support safety and performance."

Therefore, there isn't a "test set" of patient data for clinical performance in the context of the tCOM+ submission. The testing done involved non-clinical performance (bench testing, biocompatibility, risk management, software validation, human factors) and compliance with various recognized standards.

For the Human Factors Evaluation testing, while a sample size for participants is typically part of such studies, the document does not disclose this information or the data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Given that "no clinical performance data were generated" for the tCOM+ as the clinical functionality and performance are considered unchanged from the predicate, no experts were used to establish ground truth for a new clinical test set for this submission. The ground truth for the predicate device's performance would have been established during its initial clearance, but that information is not part of this 510(k) summary.

4. Adjudication Method for the Test Set

Since no new clinical test set was generated for the tCOM+, there was no adjudication method employed for clinical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states that no clinical performance data were generated for the tCOM+, as the device's core measurement technology and algorithms are identical to its predicate. Therefore, there is no effect size reported for human readers with or without AI assistance, as AI assistance is not described as a new feature requiring such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

The submission does not specifically describe a standalone (algorithm only) performance study in the context of new clinical data. The device is a monitoring system that interacts with a human user (professional medical personnel or trained lay operators). The core measurement algorithms for PCO2, PO2, SpO2, and PR are stated to be "unchanged" and "identical" to the predicate. The software development and testing focused on verification to requirements and validation to meet specified intended uses, implying the algorithm's performance inherited from the predicate was considered sufficient.

7. The Type of Ground Truth Used

For the non-clinical aspects:

• Mechanical, Electrical, EMC, Safety Standards: Compliance with industry-recognized standards (e.g., IEC 60601 series, ISO 80601-2-61). The "ground truth" here is adherence to the technical specifications and test methodologies defined by these standards.
• Biocompatibility: Compliance with ISO 10993-1:2018. The "ground truth" is established by laboratory testing results against the criteria within this standard.
• Risk Management: Identification and mitigation of hazards, with acceptable residual risks. The "ground truth" is the thoroughness of the risk analysis and the documented resolution of identified risks.
• Software Development: Verification to requirements and validation to intended use. The "ground truth" is the functional correctness and reliability of the software against its specifications.
• Human Factors: Conformance to usability engineering principles as per FDA guidance. The "ground truth" is successful completion of human factors testing.

For clinical performance, the ground truth is assumed to be equivalent to the predicate device's established clinical ground truth, as the core measurement technology, sensors, and algorithms remain unchanged. The original predicate device's clearance would have relied on appropriate clinical data (e.g., comparison to arterial blood gas measurements for PCO2/PO2, or co-oximetry for SpO2), but this is not detailed in the current submission.

8. The Sample Size for the Training Set

The submission does not mention a training set in the context of new algorithm development or machine learning. Since the software changes primarily relate to the user interface and connectivity, and the measurement algorithms are "identical to the configuration listed under K151329" (the predicate), there was no new training required for clinical algorithms.

9. How the Ground Truth for the Training Set Was Established

As no new training set for algorithms was used in this submission, this question is not applicable.

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The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.

The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.

The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.

The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.

The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.

The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.

The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.

A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.

The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.

The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.

The Portrait VSM vital signs monitor is not intended for use during MRI.

"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.

The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA.
In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements:
New hardware platform
Adopted equivalent NIBP design from B105M(K213490)
Adopted equivalent SpO2 design from B105M(K213490)
Compatible with Recorder B1X5-REC
Support Round Advisor in spot check mode
Support automatically screens brightness adjustment.
Improved Early Warning Score
Addtional alarm management enhancement.
Additional cybersecurity enhancement

The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.

As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).

Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.

Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.

Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.

The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc. Portrait VSM vital signs monitor. It describes the device, its intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical testing.

However, the document explicitly states that "the proposed monitor Portrait™ VSM did not require clinical studies to support substantial equivalence." This means there is no detailed clinical study described in this document that proves the device meets specific acceptance criteria based on human-in-the-loop performance or expert-adjudicated ground truth, as would be expected for a complex AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through bench testing, compliance with consensus standards, and verification of hardware/software functionality, electrical safety, usability, and environmental performance.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with the specific elements you've asked for related to clinical performance verification with AI/ML and human readers.

However, I can extract the acceptance criteria (in terms of standards compliance and functional equivalence) and the reported performance from the non-clinical testing described.

Here's what can be extracted and what cannot be provided given the document's content:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Equivalence Claim)

Since no clinical study was required, the "acceptance criteria" for this device's submission are primarily based on demonstrating:

1. Functional Equivalence to legally marketed predicate devices.
2. Compliance with relevant electrical safety, EMC, usability, and performance standards for vital signs monitors.
3. Verification of hardware and software specifications through bench testing.

Therefore, the table below will reflect the claimed equivalence and standards compliance as the "performance" rather than specific accuracy metrics against a clinical ground truth from a reader study.

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The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters.

VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected.

The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions.

The Vos CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,

The Vios Monitoring System (VMS) Model 2050 was evaluated for its arrhythmia detection features, specifically assessing its performance against the ANSI/AAMI EC57:2012 standard and additional database records.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily references compliance with the ANSI/AAMI EC57:2012 standard for cardiac rhythm and ST-segment measurement algorithms. While specific numerical acceptance criteria (e.g., minimum sensitivity, positive predictivity) for each arrhythmia are not explicitly listed in the provided summary, the study's conclusion of meeting "performance requirements as outlined in the consensus standard ANSI/AAMI EC57:2012" implies that the device achieved the performance thresholds defined within that standard for the tested arrhythmias.

2. Sample Size for the Test Set and Data Provenance:

The document states that the device's performance was evaluated using:

• Records from the ANSI/AAMI EC57 standard. This standard often utilizes a combination of standard ECG databases (e.g., MIT-BIH Arrhythmia Database).
• Additional records from LTAF, AAEL, and VFDB databases.

The specific sample sizes (number of patients or ECG recordings) for each arrhythmia or for the combined test set are not provided in the summary. The provenance of LTAF, AAEL, and VFDB databases is not detailed; however, these are generally recognized public databases of ECG recordings used for algorithm testing, often comprising retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document does not state the number of experts used or their specific qualifications for establishing the ground truth of the test set. For publicly available and widely used databases like those mentioned (MIT-BIH, LTAF, AAEL, VFDB), the ground truth labels are typically established by multiple expert cardiologists or electrophysiologists using established criteria, often after multiple review rounds. However, this specific information is not in the provided text.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method used (e.g., 2+1, 3+1). For standard ECG databases, ground truth is usually established via expert consensus, which inherently involves an adjudication process, but the specific mechanics are not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The testing described is focused on the standalone performance of the device's arrhythmia detection algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, a standalone performance evaluation was done. The summary explicitly states: "The non-clinical tests for evaluation of performance of Vios system with the addition of arrhythmia alarms is based on ANSI/AAMI EC57, showing substantial equivalence to the predicate (K180472). The subject device's performance was also evaluated using additional records from LTAF, AAEL, and VFDB database..." This describes the algorithm's performance without direct human intervention as part of the detection process.

7. Type of Ground Truth Used:

The ground truth for the test was established through expert consensus/annotations from well-known ECG databases (ANSI/AAMI EC57, LTAF, AAEL, and VFDB). These databases contain ECG recordings that have been meticulously reviewed and annotated by medical experts (typically cardiologists or electrophysiologists) to identify and label different cardiac events and arrhythmias,
Pathology and outcomes data are not mentioned as sources for ground truth in this context.

8. Sample Size for the Training Set:

The document does not specify the sample size used for the training set of the Vios Monitoring System's arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set Was Established:

The document does not specify how the ground truth for the training set was established. However, it is common practice for such algorithms to be trained on large, expertly annotated ECG datasets, similar to those used for testing (expert consensus/annotations).

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Radius VSM:

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVI as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PV i measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be use with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and Accessories is a wearable, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of monitoring technologies based upon the hospital's and clinician's assessment of what technologies are appropriate. The purpose of this submission is the premarket notification for the introduction of Masimo Radius VSM and Accessories, including its use with the previously cleared Root (K191882) and Masimo Patient SafetyNet (K071047).

The Radius VSM and Accessories system comprises of the Radius VSM Wearable Monitor, Radius VSM ECG Module and Electrodes, and the Radius VSM NiBP Module and Cuff.

The provided text describes the acceptance criteria and study results for the Masimo Radius VSM and Accessories device, focusing specifically on the Non-invasive Blood Pressure (NiBP) feature.

1. Acceptance Criteria and Reported Device Performance (NiBP Feature):

The clinical performance analysis for the NiBP feature supported by the Masimo Radius VSM device had the following acceptance criteria and reported values:

The device met all specified acceptance criteria for the NiBP feature.

2. Sample Size and Data Provenance for the Test Set:

• Sample Size:
  • NiBP Feature: 89 subjects.
  • ECG Waveform Comparison: 31 subjects.
  • Patient Posture, Position, and Activity: 20 subjects.
  • Aggregate Respiration Rate (First Study): 48 subjects.
  • Aggregate Respiration Rate (Second Study): The number of healthy volunteer subjects is not explicitly stated, but it's implied to be a separate group for validation of integration.
• Data Provenance: The document does not explicitly state the country of origin. The studies are described as "clinical studies," implying prospective data collection for the purpose of validating the device. The term "healthy volunteer subjects" used in the fifth study further suggests prospective, controlled data collection.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number or qualifications of experts used to establish ground truth for any of the studies mentioned.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method for the test set data.

5. MRMC Comparative Effectiveness Study:

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human readers improving with AI assistance is made in the provided text. The studies focus on device performance against reference measurements or previously cleared monitors/algorithms, not on human-AI collaboration.

6. Standalone Performance (Algorithm Only):

• For the NiBP feature, the study was conducted to validate the clinical performance of the Radius VSM's NiBP feature against reference blood pressure measurements, implying standalone performance of the algorithm integrated into the device.
• For the ECG waveform comparison, the device's ECG output was compared to an existing FDA-cleared ECG monitor, indicating standalone performance of the device's ECG functionality.
• For the patient posture, position, and activity feature, the testing supported the "correct integration of the algorithm that was previously cleared," suggesting a focus on the device's implementation of an existing standalone algorithm.
• For the Aggregate Respiration Rate, the algorithm's performance was evaluated against manually annotated capnography data, indicating standalone algorithm performance.

7. Type of Ground Truth Used:

• NiBP: Clinical performance was validated through comparison against "reference blood pressure measurements."
• ECG: Comparison against an "FDA cleared ECG monitor."
• Patient Posture, Position, and Activity: Based on the "correct integration of the algorithm that was previously cleared." The original ground truth for this algorithm (K191882) is not detailed here, but the study validates its implementation in the new device.
• Aggregate Respiration Rate: "Reference respiration rate derived from manual annotated capnography data."

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for training sets for any of the algorithms or features. The studies described are validation (test set) studies.

9. How Ground Truth for the Training Set was Established:

As no information regarding training sets is provided, there is no detail on how their ground truth was established. The document focuses on the validation of integrated features, some of which (like PVi, RRa, and position monitoring) leverage previously cleared Masimo technologies, implying that their development and training (if applicable) occurred prior to this submission.

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Indications for Use for CARESCAPE Canvas 1000:

CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas 1000 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.

CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE Canvas 1000 is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas Smart Display:

CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.

CARESCAPE Canvas Smart Display is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and · respiratory (impedance respiration, airway gases (CO2)

CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.

CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas D19:

CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.

CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.

Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.

Indications for Use for F2 Frame; F2-01:

The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.

The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.

The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission.

CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable.

The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately).

For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01).

The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.

Please note that the provided text is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to various standards. It explicitly states that clinical studies were not required to support substantial equivalence. Therefore, some of the requested information regarding clinical studies, human expert involvement, and ground truth establishment from patient data will likely not be present.

Based on the provided text, here's the information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific, quantifiable acceptance criteria alongside reported performance data. Instead, it states that various tests were conducted to demonstrate that the design meets specifications and complies with consensus standards. The performance is generally reported as "meets the specifications," "meets the EMC requirements," "meets the electrical safety requirements," and "fulfilled through compliance."

However, we can infer some "acceptance criteria" based on the standards and tests mentioned:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document implies that the "test set" for performance evaluation was the device itself and its components as described ("CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01)").
  • For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" were involved.
• Data Provenance: The testing described is non-clinical bench testing.
  • For usability testing, the users were located in the US.
  • No direct patient data or retrospective/prospective study data is mentioned beyond the device's inherent functional characteristics being tested according to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in the context of establishing "ground truth" for patient data, as no clinical studies with patient data requiring expert adjudication were conducted or reported to establish substantial equivalence.
• For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" participated. Their specific qualifications (e.g., years of experience, types of healthcare professionals) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical studies with patient data requiring adjudication were conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC study was done, as the document explicitly states: "The subjects of this premarket submission... did not require clinical studies to support substantial equivalence." The device is a patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The performance evaluations mentioned (e.g., for general device functionality, electrical safety, EMC, specific parameter measurements like ECG/arrhythmia detection) represent the device's standalone performance in a bench setting, demonstrating its adherence to established standards and specifications. There is no separate "algorithm only" performance study reported distinctly from integrated device testing. The EK-Pro V14 algorithm, which is part of the device, is noted as "identical" to the predicate, implying its performance characteristics are maintained.

7. The Type of Ground Truth Used

• For the non-clinical bench testing, the "ground truth" was established by conformance to internationally recognized performance and safety standards (e.g., IEC, ISO, AAMI/ANSI) and the engineering specifications of the device/predicate. These standards define the acceptable range of performance for various parameters.
• For usability testing, the "ground truth" was the successful completion of tasks and overall user feedback/satisfaction as assessed by human factors evaluation methods.
• No ground truth from expert consensus on patient data, pathology, or outcomes data was used, as clinical studies were not required.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a patient monitor, not a machine learning or AI model trained on a dataset. The device contains "Platform Software that has been updated from version 3.2 to version 3.3," but this refers to traditional software development and not a machine learning model requiring a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no mention of a "training set" in the context of machine learning. The software development likely followed conventional software engineering practices, with ground truth established through design specifications, requirements, and verification/validation testing.

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The Rad-97 and Accessories is a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital, hospital type facilities, mobile and home environments.

The Rad-97 and Accessories can communicate with network systems for supplemental remote viewing (e.g., at a central station).

The Rad-97 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Rad-97 and Accessories are indicated for the continuous monitoring rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions.

In addition, the Rad-97 and Accessories are indicated to provide the non-invasive spot-checking and continuous monitoring data obtained from the Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices.

The Rad-97 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The optional NomoLine Capnography product family is intended to other medical backboard devices for monitoring of breath rate and CO2. The NomoLine Capnography product family is intended to a patient breathing circuit for monitoring of inspired gases during anesthesia, recovery and respiratory care. The environment is the operating suite, intensive care unit and patient population is adult, pediatric and infant patients.

The optional non-invasive blood pressure (NiBP) module is indicated for the noninvasive measurement of arterial blood pressure. The NiBP module is designed to messure for patient population described in the following table:

Patient Population Approximate Age Range Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older

Devices with Masimo technology are only to be used with Masimo sensors and cables.

The Rad-97 and accessories are indicated for the non-invasive continuous monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions.

PV i may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PV in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

The Rad-97 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate from Pleth (RRp) for adult and pediatric patients during no motion conditions.

The Radical-7 and Accessories are indicated for the non-invasive spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospital-type facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

The Radical-7 and Accessories are indicated for the non-invasive continuous monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospital-type facilities, home environments, and transport within healthcare facilities.

This premarket notification [510(k)] is for the authorization to market the previously cleared Rad-97 (K193626) and Radical-7 (K193242) with an additional indication for spot-checking.

The cleared versions of the subject devices already support both continuous monitoring and spotchecking use through the activation and deactivation of alarms. This submission updates the indications to reflect both uses of the subject devices.

Rad-97: The Rad-97 is a patient monitor capable of providing multiple parameters. The Rad-97 product family provides the integrated ability of noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi), Pleth Variability Index (PVi), carboxyhemoglobin (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), acoustic respiration rate (RRa), Pleth Respiration Rate (RRp), capnography parameters, and noninvasive blood pressure (NiBP) parameters.

Radical-7: The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), Pleth Variability Index (PVi), totalhemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), acoustic respiration rate (RRa), and Pleth Respiration Rate (RRp).

The provided text describes a 510(k) premarket notification for the Masimo Radical-7 Pulse CO-Oximeter and Accessories and the Rad-97 and Accessories. The submission's primary purpose is to update the indications for use to explicitly include "spot-checking" functionality, which the devices already supported by allowing alarm deactivation.

The document asserts that the devices are substantially equivalent to their predicate devices (K193626 for Rad-97 and K193242 for Radical-7) because there are no changes to the device's fundamental technology, principle of operation, or performance specifications. The "spot-checking" capability was already inherent in the devices' design, as users could deactivate continuous monitoring alarms to achieve this function. Therefore, the update is primarily a labeling change to reflect existing functionality.

Based on the provided information, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device is not directly applicable in the way one might expect for a new AI product. This submission is for a traditional medical device (patient monitor/oximeter), and the "study" is demonstrating substantial equivalence to a predicate device, not necessarily proving a new algorithm's performance against specific acceptance criteria for AI.

However, we can infer the "acceptance criteria" not as novel performance thresholds, but as the maintenance of the same performance characteristics as the predicate devices, and the "proof" coming from the assertion that no changes were made to the core technology that would alter these.

Here's an attempt to structure the information according to the requested format, interpreting "acceptance criteria" as maintaining the predicate's performance and "study" as the justification for substantial equivalence.

Acceptance Criteria and Device Performance (Interpreted)

The core "acceptance criteria" in this 510(k) submission are that the subject devices (Rad-97 and Radical-7) maintain substantial equivalence to their predicate devices (Rad-97 K193626 and Radical-7 K193242, respectively) and that the expanded "indications for use" to include "spot-checking" does not introduce new questions of safety or effectiveness. This is because the devices already possessed the capability for spot-checking by deactivating alarms.

The "study" that proves the device meets these criteria is an assertion of no change in fundamental technological characteristics, principles of operation, or performance specifications compared to the predicate devices, supported by software verification and validation that confirm the integrity of the existing as-cleared software.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a traditional device with an expanded indication based on existing functionality, the "acceptance criteria" are implicitly the already cleared performance specifications of the predicate devices. The reported device performance is stated to be identical to these predicate devices. The change is in the stated use (labeling), not in the core performance.

Note: ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
*Applicable with RD SET Disposable sensors.

2. Sample Size for the Test Set and Data Provenance

No new clinical or non-clinical testing was conducted for this submission (K212161) because the changes were limited to labeling to include existing functionality. The predicate devices' performance data implicitly serve as the "test set" and provenance.

• Sample Size for Test Set: Not applicable for this submission as no new testing was performed. The data and sample sizes supporting the original predicate clearances (K193626 and K193242) would have established these performance metrics. The document states that the devices are "the same as the predicate cleared... with exception of the updated indications for spot-checking."
• Data Provenance: Not explicitly stated for new data. The original predicate device data would have come from clinical studies, often including induced hypoxia studies for oximetry, which typically occur in controlled clinical environments (e.g., US, Europe). The studies for the original clearances would have been prospective to generate the performance data.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable for this submission as no new ground truth was established. The performance specifications are based on the device's technical capabilities, validated against reference standards in prior clearances.
• Qualifications of Experts: N/A for this particular submission. For the original clearances, such validation would involve highly trained clinical professionals and laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable for this submission as no new test set requiring adjudication was generated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device where human reader improvement with AI assistance would be measured. This is a traditional physiological monitor.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a medical device that measures physiological parameters. Its performance is inherent in its design and sensor technology, not a detached algorithm output. The "algorithm" here refers to the internal processing of physiological signals, which is proven through the device's accuracy specifications.

7. Type of Ground Truth Used

The ground truth for the device's performance (as established for the predicate devices) would typically be:

• Reference Devices/Methods: In a controlled study, the device's measurements (e.g., SpO2) would be compared against a gold standard reference (e.g., co-oximeter for blood gas analysis).
• Controlled Physiological Conditions: For SpO2 and PR, studies often involve inducing a range of oxygen saturation levels and heart rates in human volunteers under controlled conditions.

8. Sample Size for the Training Set

Not applicable in the context of traditional medical device validation. "Training set" is a concept primarily relevant to machine learning/AI models. The device's internal signal processing algorithms are engineered based on principles of physics and physiology, not "trained" on a dataset in the AI sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.

The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE B650:

The CARESCAPE B650 is not intended for use in a controlled MR environment.

CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.

The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.

Here's a breakdown of what can and cannot be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "Bench testing related to software, hardware and performance" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:

• Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
• Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.

However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.

9. How the ground truth for the training set was established

This information is not provided and is not applicable for the reasons stated in point 8.

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