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Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Phasor™ GREEN Drill is composed of 2 items: (1) a re-sterilizable, non-rechargeable battery-operated Phasor Green Driver (made of plastic housing, capable of drilling up to 10 total holes in one or more patients) in conjunction with (2) a separately packaged, single-use Phasor Green Drill Bit Assembly comprised of a steel bit (of 6.35-mm or less), plastic adapter, and polybag secured using latex-free bands. The device is for drilling cranial or orthopedic bone, by prescription only and used by qualified users, with (1) Drill Driver (provided non-sterile) for sterilization using vaporized hydrogen peroxide (VHP)prior to use at user facility and (2) Drill Bit Assembly provided gamma-sterilized for single-use respectively.

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The Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child users in hospitals, hospital facilities and home healthcare environments.

The Pulse Oximeter model BM20, can display the SpO2 and PR, plethysmogram wave and other indication parameters, such as pulse battery power status and the PI. The model BM20 Pulse Oximeter include the mainboard, display and lithium battery. It has small size, light weight, easy to carry. It adopts low power consumption design, and has the function of battery capacity display.

The pulse oximeter, model BM20, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults, pediatric and adolescent patients in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios. This medical device can be reused. Not for continuously monitoring.

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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

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

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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

This is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

4. 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 sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

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

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

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

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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The monitors are intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatrics (including neonates). The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), and cardiac output (C.O.).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm. The iCUFS algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatric patients (≥3 years of age). Both measurement algorithms are also intended for use with pregnant women, including pre-eclamptic patients. NIBP MAP is not applicable to pregnant women.

The Spot Temp with T2A module can only measure temperature of adult and pediatric (> 1 year of age) patients.

The monitors are not intended for MRI environments.

The cardiac output (C.O.) is only intended for adult patients.

The CX&UX series Patient Monitor including CX10/CX12/CX15/UX10/UX12/UX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate.

Minor differences from the predicate device are limited to some modifications of monitoring parameter specifications. These updates do not change the fundamental scientific technology of the cleared predicate device and thus do not raise any questions about the safety and effectiveness of the subject device.

The provided FDA 510(k) clearance letter details the device's technical specifications and comparisons to predicate devices, along with the non-clinical performance data and adherence to various IEC and ISO standards. However, it explicitly states: "Clinical data: The subject device did not require new clinical studies to support substantial equivalence."

This means that the submission for this Patient Monitor device (CX10, CX12, CX15, UX10, UX12, UX15) relies on demonstrating substantial equivalence to a legally marketed predicate device (Edan Instruments, Inc., Patient Monitor Model iX10, iX12, iX15, K232962) through non-clinical performance testing and software verification/validation, rather than new clinical trials or studies involving human patients.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria through clinical performance (e.g., sample size for test set, expert involvement, MRMC studies, ground truth establishment for test/training sets, effect size of human reader improvement with AI) cannot be extracted from this document, as such clinical studies were explicitly not required for this 510(k) submission.

The document focuses on demonstrating that the new device's technical specifications and performance are similar to the predicate device, and that it complies with relevant safety and performance standards through bench testing.

Here's what can be extracted from the provided text regarding acceptance criteria and the type of study performed, specifically focusing on the non-clinical aspects:

Device: Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The acceptance criteria for this device are implicitly tied to its performance meeting the standards and accuracy specifications of the predicate device and relevant international standards. Since no new clinical studies were conducted, the "proof" comes from non-clinical bench testing and software validation.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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

• Sample Size: Not applicable in terms of human subjects or patient data test sets, as "new clinical studies" were not required. The "test set" refers to bench testing and functional system-level validation. The specific number of test cycles or a detailed breakdown of test cases for bench testing is not provided in this summary.
• Data Provenance: The data primarily originates from Edan Instruments Inc. (Shenzhen, Guangdong, China) through internal engineering and quality assurance processes for non-clinical bench testing and software validation. It is not patient data, so concepts like "retrospective or prospective" do not apply.

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

• Not applicable for clinical ground truth: Since no clinical studies were performed requiring human interpretation or diagnosis for a test set, no medical experts (e.g., radiologists) were used to establish ground truth in this context.
• Internal experts: Bench testing and software validation would have involved engineers and quality assurance professionals, whose qualifications are implicit in the quality system (21 CFR Part 820) but not specified in detail here.

4. Adjudication Method for the Test Set:

• Not applicable: Adjudication methods (e.g., 2+1, 3+1) are relevant for clinical studies involving multiple readers. This was not a clinical study. Bench testing relies on established technical specifications and standard compliance.

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

• No: No MRMC study was performed as no new clinical studies were required or conducted. Therefore, there's no effect size of human readers improving with AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

• Yes (for the technical components): The "performance testing-Bench" effectively represents a standalone evaluation of the device's functional components (ECG, NIBP, SpO2, etc.) and software against defined technical specifications and standards. The "software verification and validation testing" also represents a standalone evaluation of the algorithm and software functions. The specific algorithms (e.g., iCUFS, iFAST for NIBP, arrhythmia analysis logic) are tested independently for their accuracy against known inputs or reference standards as part of bench testing.

7. The Type of Ground Truth Used:

• Technical/Reference Standards: For the bench testing, the "ground truth" would be derived from:
  • Reference standards/simulators: Calibrated medical equipment, physiological simulators, and test signals (e.g., known ECG waveforms, simulated blood pressure readings, temperature standards) are used to provide the "true" values against which the device's measurements are compared.
  • Defined specifications: The device's internal design specifications and the requirements of the referenced IEC/ISO standards serve as the "ground truth" for compliance testing.
• Not clinical ground truth: No expert consensus, pathology, or outcomes data from real patients were used for establishing ground truth for this submission.

8. The Sample Size for the Training Set:

• Not applicable: The device is a patient monitor, not a machine learning/AI algorithm that typically undergoes a distinct "training" phase with a large dataset. Its functionality is based on established physiological measurement principles and programmed algorithms. Any internal calibration or algorithm refinement would be part of the product development process, not a dedicated "training set" in the AI/ML sense.

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

• Not applicable: As there was no "training set" in the context of an AI/ML model, the concept of establishing ground truth for it does not apply to this 510(k) submission.

In summary, this 510(k) clearance relies on demonstrating that the new Patient Monitor is substantially equivalent to a previously cleared predicate device, primarily through robust non-clinical bench testing and software validation, proving compliance with established medical device standards and functional specifications. No new clinical studies with patient data were required or conducted for this specific submission.

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• HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter and Swan-Ganz Jr catheter indications for use statements for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >=18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

• HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

  • When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >=40 kg.
  • When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >=3 kg.
  • When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

  Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere ClearSight Module: The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller or Smart Pressure Controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

• Indication for Acumen IQ Plus and VitaWave Plus finger cuffs: The Acumen IQ Plus and VitaWave Plus finger cuff adult indicated for patients over 18 years of age to continuously blood pressure and associated hemodynamic parameters when used with a compatible Edwards monitoring platform.

• Smart Pressure Controller: The Smart Pressure Controller is intended for use with an Edwards compatible noninvasive monitoring system - composed of compatible monitor, pressure source (pump), compatible Edwards finger cuff(s) and pressure controller - for continuous noninvasive measurement of blood pressure and associated hemodynamic parameters. Refer to the operator's manual of the compatible Edwards monitor being used for specific information on the intended use environment and patient population.

• Intended Use: The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The Viewfinder remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as faults, alerts and notifications generated by the HemoSphere advanced monitoring platform. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, Swan-Ganz Jr catheters, FloTrac sensors, FloTrac Jr sensors, Acumen IQ sensors, TruWave disposable pressure transducers, ForeSight/ForeSight Jr sensors, Acumen IQ fluid meter, and ClearSight/ClearSight Jr/Acumen IQ/Acumen IQ Plus/VitaWave/VitaWave Plus finger cuffs

The HemoSphere Advanced Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."

This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.

Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The text primarily focuses on:

• Substantial equivalence to predicate devices.
• Indications for Use for various HemoSphere configurations and modules.
• Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
• General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."

Based on the provided document, here's what can and cannot be stated:

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

Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error < Z") or reported performance values are publicly disclosed in this summary for any parameter, including HPI or AFM. For measured and derived parameters (like CO, MAP, etc.), it states they were tested using bench simulation, and "All tests passed," implying they met internal accuracy specifications for physical measurements, but these are not detailed.

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

Cannot be provided from the given text. The document mentions "bench simulation" for measured and derived parameters, but does not provide sample sizes for these, or the type/provenance of data for testing the HPI or AFM algorithms.

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)

Cannot be provided from the given text. The document doesn't describe the process of establishing ground truth for the algorithms, nor does it mention the number or qualifications of experts involved in such a process.

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

Cannot be provided from the given text. There is no mention of adjudication methods for any test sets.

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

Cannot be provided from the given text. The document does not describe any MRMC studies or human-in-the-loop performance evaluation regarding the HPI or AFM features. The HPI and AFM features are described as providing "physiological insight" and "suggestions," not as tools requiring reader interpretation in a comparative effectiveness study as typically seen with imaging AI.

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

Likely yes, based on the nature of the algorithms, but no specific performance metrics are provided. The HPI and AFM features are stated to provide "quantitative information" and "suggestions." The text indicates "System Verification (Non-Clinical Performance)" and "Software Verification" were performed, suggesting standalone evaluation against internal specifications, but no detailed results are provided. The HPI algorithm itself was "previously cleared in K230057," implying its standalone performance would have been evaluated during that prior clearance, but those details are not in this document.

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

Cannot be definitively stated from the given text. For the HPI feature, which predicts future hypotensive events, ground truth would typically involve actual patient outcomes (e.g., observed hypotensive events). For AFM, which suggests response to fluid therapy, ground truth might involve observed physiological responses to fluid boluses. However, the document does not specify how these ground truths were established for the purpose of testing the algorithms.

8. The sample size for the training set

Cannot be provided from the given text. The document does not mention details about the training data for the algorithms.

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

Cannot be provided from the given text. The document does not mention details about the training data or its ground truth establishment.

Summary of Device Features Mentioned in Relation to Performance/Testing (General):

• HemoSphere Advanced Monitor and various modules/accessories: The document primarily describes this as a monitoring platform for various hemodynamic parameters (CO, SvO2, MAP, etc.). Performance for these measured and derived parameters was tested via "bench simulation," and "All tests passed," implying they met internal benchmarks for accuracy and reliability.
• Acumen Hypotension Prediction Index (HPI) software feature: This feature provides "physiological insight into a patient's likelihood of future hypotensive events." It was integrated from a previously cleared device (K230057). The document states "There are no changes to the Acumen HPI algorithm from what was cleared in K230057." This implies that the acceptance criteria and supporting studies for the HPI algorithm itself would be found in the K230057 clearance documentation, not typically resubmitted in detail for integration into another platform unless the integration process significantly altered its functionality or intended use.
• Acumen Assisted Fluid Management (AFM) software feature: This feature provides "physiological insight into a patient's estimated response to fluid therapy" and "suggestions." It also mentions "Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions." This language suggests it's a supportive, advisory tool, rather than a diagnostic one requiring strict accuracy metrics in the same way. No performance specifics for AFM are given.
• Usability Study: Conducted to ensure primary operating functions and critical tasks can be performed without patient or user harm. Determined that "intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm." This is an acceptance criterion for human factors, but not for algorithmic performance.
• Electrical Safety and EMC, Software Verification: All tests passed. These are general product safety and quality criteria, not specific to the performance of the predictive algorithms.

To obtain the detailed performance data, acceptance criteria, sample sizes, and ground truth information for the HPI or AFM algorithms, one would typically need to refer to the original 510(k) submission for the HPI algorithm (K230057) and potentially separate documentation for the AFM feature, which are not included in this general clearance letter for the HemoSphere platform update.

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The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensor in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and < 40 kg.

When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.

The ΔcHb, ΔO2Hb, ΔHHb provided as part of the Masimo O3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔO2Hb), deoxygenated hemoglobin (ΔHHb), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensors in adults, pediatrics, and neonates.

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the O3 Module, O3 Sensors (e.g., O3 Adult, O3 Pediatric, O3 Infant/Neonatal sensors), and a Host/Backboard Device (e.g., Root).

The Masimo O3 Regional Oximeter System provides the following measurements and calculated features:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Δbase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
• Delta SpO2 (ΔSpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (ΔHHb): Index associated with the relative change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the relative change in the oxygenated hemoglobin.
• Delta cHb (ΔcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.

The provided FDA 510(k) clearance letter and summary for the Masimo O3 Regional Oximeter (K243324) states that the submission is for an expansion of indications for existing "delta features" (ΔO2Hb, ΔHHb, ΔcHb) of the device. This means the core rSO2 measurement accuracy was not re-evaluated, as it was previously cleared under the predicate (K214072) and no changes were made to the device's fundamental operation.

Therefore, the acceptance criteria and study detailed below focus specifically on the expansion of trending ability of the delta features to new patient populations (pediatric and neonates) and non-cerebral sites.

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter (K243324)

Based on the provided document, the acceptance criteria and study focus on confirming the trending ability of the delta features (ΔO2Hb, ΔHHb, ΔcHb) for expanded indications. The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range) for these delta features, unlike the rSO2 accuracy (ARMS) specifications which are quantitative. Instead, it speaks of "strong correlation" and "equivalent performance."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Non-cerebral trending study: Data from 25 subjects.
• Pediatric/Neonatal trending study: Data from 29 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Clinical studies for 510(k) submissions are typically prospective, but this is not confirmed here.

3. Number of Experts and Qualifications for Ground Truth

• The document describes studies for "trending ability" of physiological parameters (hemoglobin changes). For such physiological measurements, the ground truth is typically established by direct physiological measurement or well-established reference methods, not by expert panel review of images or clinical assessments. Therefore, the concept of "experts establishing ground truth" in the manner of diagnostic imaging studies (e.g., radiologists) is not applicable here. The ground truth would be the actual physiological changes occurring in the subjects, measured by a gold standard method (though not explicitly detailed in the summary).

4. Adjudication Method for the Test Set

• Given that the studies are evaluating the trending ability of physiological measurements against an assumed physiological ground truth (not expert interpretations), an "adjudication method" in the sense of reconciling multiple expert opinions (e.g., 2+1, 3+1) is not applicable.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images or data with and without AI assistance to measure improvement in reader performance. The Masimo O3 Regional Oximeter is a physiological monitoring device that provides direct measurements, and the current submission is about expanding the trending indications of those measurements, not assisting human interpretation of complex medical cases.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The studies described evaluate the device's ability to trend delta features. This is a direct measurement of the device's algorithm performance in a clinical setting against physiological changes. The device itself produces these measurements, so the performance reported is inherently "algorithm only" in terms of its output, even though it's measured on human subjects.

7. Type of Ground Truth Used

• The ground truth for studies of physiological monitoring devices like oximeters is typically actual physiological values measured concurrently by a highly accurate or gold-standard reference method. For regional oximetry and hemoglobin changes, this might involve induced changes in oxygenation/perfusion and simultaneous measurement with a more invasive or laboratory-based technique, though the summary does not detail the specific reference method used for these "delta features" studies. It is implied to be a quantitative, objective physiological ground truth, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.

8. Sample Size for the Training Set

• The document does not provide information on the training set sample size. This submission is for an expanded indication based on clinical study data, not a new algorithm development submission where training data sets are typically detailed. It is assumed the algorithms for the delta features were trained/developed prior to the predicate device clearance (K214072) or during earlier development cycles, and the current submission is about validating their performance for new uses.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for any potential training set was established. As this submission pertains to an expanded indication for existing features, the focus is on clinical validation of those features in new contexts rather than the de novo development process.

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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 RTM Vital Signs RTMsense is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and general wards, to monitor breathing in adult (at least 22 years old) patients.

RTMsense is a non-invasive system that graphically displays respiratory function against time and reports respiratory rate.

RTMsense measurements are used as an adjunct to other clinical information sources.

The RTMsense Respiratory Monitoring System is a single use wearable device consisting of a wearable trachea sound sensor (TSS) and software that continuously measures a patient's respiratory rate by analyzing the sounds of air flow within the proximal trachea during inhalation and exhalation. The acoustic signal is transmitted wirelessly to a Lenovo Tablet, and the respiratory measurement values are displayed on the tablet after analysis of the acoustic data by a proprietary software algorithm.

The RTMsense software application has three parts: firmware on the TSS, a web-based application on the Lenovo tablet, and a cloud-based proprietary software algorithm. The TSS securely transmits acoustic data wirelessly to the local, Bluetooth low energy enabled Lenovo tablet. The tablet uses a web-based application to securely transmit the acoustic data to the cloud for analysis in RTM's proprietary cloud-based algorithm. The web application retrieves the processed data from the algorithm to display respiratory rate on the tablet.

The device will be used by healthcare professionals in healthcare facilities such as post-operative care or general wards. The RTMsense respiratory measurements are used as an adjunct to other clinical information sources.

The TSS is held in place by a flexible wearable carrier adhered to the patient's proximal trachea with commercially available medical grade adhesive. The TSS contains the audio sensor, onboard processing, wireless communications technology, and Lithium-ion coin cell rechargeable battery. A custom charger is provided to charge the battery.

The provided FDA 510(k) clearance letter and summary for the RTM Sense (A-0001) device details several aspects of its performance and validation. However, it does not explicitly provide a table of acceptance criteria for specific metrics, instead focusing on overall "passing" of predefined performance criteria. The information regarding ground truth establishment for the training set, number and qualifications of experts, and adjudication methods is also limited.

Based on the provided text, here's an attempt to reconstruct the information:

Overview of RTM Sense (A-0001) Performance Study

The RTM Sense (A-0001) is a non-invasive respiratory monitoring system that continuously measures a patient's respiratory rate by analyzing tracheal sounds. The device, intended for use by healthcare professionals in healthcare facilities, underwent non-clinical and clinical performance testing to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

While explicit acceptance criteria are not presented in a table format within the document, the "Clinical Performance Testing" section describes primary endpoints that serve as de facto acceptance criteria. The results indicate that the device met these criteria.

Note: The acceptance criteria are inferred from the "Primary endpoints assessed were accuracy ≤ 1 BPM and mean accuracy error < 5%."

2. Sample Size and Data Provenance for Test Set

• Total Sample Size: Combined, the studies included 44 subjects and over 150 breath samples.
  • Study #1: 31 subjects and 124 breath samples.
  • Study #2: 13 subjects and 65 breath samples.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that the studies were prospective comparative studies.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set. Ground truth was established by "Manually scored End-Tidal CO2 breath counts from the capnometer." This suggests a direct technical measurement rather than expert consensus requiring adjudication.

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

No MRMC study was conducted or reported. The study design focused on comparing the device's measurements directly against a gold standard (capnometer), not on how AI assistance improves human reader performance. Therefore, no effect size for human reader improvement with AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Clinical Performance Testing" directly evaluates the RTMsense device's (which includes its proprietary software algorithm) accuracy against a gold standard respiratory measurement (Hamilton C-1 Ventilator with integrated Capnostat 5 capnometer). The reported results (accuracy, bias, % error) are based on the algorithm's performance in calculating respiratory rate from acoustic signals.

7. Type of Ground Truth Used

The ground truth used for the clinical performance testing was technical measurement/outcomes data. Specifically, "Manually scored End-Tidal CO2 breath counts from the capnometer" from a Hamilton C-1 Ventilator with integrated Capnostat 5 capnometer were used as the gold standard reference.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only describes the clinical validation (test set) data.

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

The document does not describe how the ground truth for the training set was established. It only refers to "RTM's proprietary cloud-based algorithm" that processes acoustic data and "Software Verification / Validation Testing" which states "Integration and algorithm testing was conducted to verify the software meets its requirements and accurately reports respiration rate." This implies internal validation of the algorithm, but details about the training data and its ground truth establishment are absent.

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