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The OxyMinder Pro is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. This device can be used in the hospital and subacute settings. The monitor is not intended as a life supporting device or for diagnostics.

The OxyMinder Pro is an oxygen and pressure monitor capable of measuring the oxygen concentration from 18 to 100% (cleared under K213948) and pressure from 0 to 60 cmH2O (subject of this submission) that for convenience can be mechanically mounted on to the cleared blender.

The pressure is measured via a disposable pressure tubing that connects from the monitor to an adapter placed in the patient circuit. This sampling line is identical to that cleared in predicate Maxtec K221734. We have only updated the labeling to reflect the name of the sponsor.

As indicated the oxygen monitoring portion has been previously cleared, K213948. It utilizes a cleared oxygen sensor which outputs a voltage to determine the concentration of oxygen. The OxyMinder Pro calibrates at ambient air (21%) and 100% oxygen. The OxyMinder Pro is software controlled. Again, the oxygen monitoring feature and functions are unchanged and previously cleared under reference K213948.

The new pressure monitoring feature utilizes a pressure sensor which measures the pressure within a patient circuit. There is a disposable pressure tubing that connects between the patient circuit and the pressure sensor.

This document, K251245, describes the 510(k) clearance for the OxyMinder Pro, an oxygen and pressure monitor. It uses the Maxtec MaxO2ME+p (K221734) as its predicate device for the combined oxygen and pressure monitoring features, and the Bio-Med Devices OxyMinder (K213948) as a reference for the oxygen monitoring aspects, which were previously cleared.

The core of the submission focuses on the new pressure monitoring feature, as the oxygen monitoring component is largely based on a previously cleared device (OxyMinder, K213948). The acceptance criteria and testing detailed largely pertain to the performance of the device's measurement capabilities and adherence to relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance specifications of the OxyMinder Pro and compares them to the predicate and reference devices. These specifications serve as the acceptance criteria for the device's functionality. The "Reported Device Performance" is implied by the similarity claims and the statement that "The test results met the applicable standards".

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

The document states that "Bench testing was performed" and lists various types of tests (Shelf-life / Aging, Software Verification and Validation, Safety and ElectroMagnetic Compatibility, etc.). It claims that "The test results met the applicable standards". However, the sample size for the test set is not explicitly stated.

The data provenance is not explicitly mentioned as country of origin, nor is it specified if the testing was retrospective or prospective. Given it's bench testing for a device clearance, it is implicitly prospective testing within a laboratory/manufacturing environment.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable or not provided for this specific 510(k) submission. Medical device performance testing, especially for devices like oxygen and pressure monitors, relies on calibrated instruments and established physical and electrical standards to determine "ground truth" (e.g., a calibrated gas mixture for oxygen concentration, a pressure calibrator for pressure measurements), not human expert consensus.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1 used in clinical trials or image interpretation studies) is not applicable here. The "ground truth" for the device's performance (e.g., accuracy of oxygen or pressure readings) is established through comparison to validated and calibrated measurement standards, not through human interpretation that would require adjudication.

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

An MRMC study is not applicable and was not done for the OxyMinder Pro. MRMC studies are typically used to assess human reader performance, often in diagnostic imaging, with and without AI assistance. The OxyMinder Pro is a direct measurement device; its performance is based on its physical and electrical accuracy, not on human interpretation or an AI algorithm assisting human interpretation.

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

The OxyMinder Pro itself is a standalone device. Its performance, as described by its measurement accuracy, resolution, response time, etc., is its standalone performance without a human-in-the-loop influencing the measurement itself. The device is intended to present data to a human for monitoring, but its core function (measurement) is standalone. The testing conducted, as per the "Non-Clinical Testing Summary," assesses the device's inherent performance.

7. Type of Ground Truth Used

The ground truth for the performance testing is established using calibrated instruments and reference standards. For oxygen measurements, this would involve calibrated gas mixtures with known oxygen concentrations. For pressure measurements, this would involve calibrated pressure sources or transducers with known pressure values. It is based on physical and engineering measurements against established standards, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The OxyMinder Pro uses an oxygen sensor (galvanic cell) and a pressure transducer. While it is "software controlled," it does not appear to employ machine learning or AI algorithms that would require a "training set" in the conventional sense (i.e., a dataset used to train a model). The software is likely for control, data processing, display, and alarm functions, using fixed algorithms based on physical principles, not learning from data. Therefore, a training set sample size is not applicable.

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

As there is no indication of a training set in the context of machine learning, this question is not applicable. The device's operation is based on pre-programmed algorithms and calibrated sensor outputs.

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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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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 Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.

The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting.

The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions.

Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing.

The Smart Check O2 is for prescription use only.

Key Components:

• Handheld analyzer unit
• Removable battery door
• Replaceable sample tube
• Two Alkaline AA cells

The provided FDA 510(k) Clearance Letter for the Smart Check O2 device does not contain the specific details of a study proving the device meets acceptance criteria, nor does it present acceptance criteria in a structured table format with reported performance. The document focuses on demonstrating substantial equivalence to a predicate device, and the "Non-Clinical Performance Data" section primarily lists compliance with consensus standards, rather than presenting test results against performance specifications.

Therefore, for the purpose of answering your request, I will extract relevant performance specifications from the "Substantial Equivalence Comparison Table" and present them as "Acceptance Criteria" and "Reported Device Performance." Please note that these are derived from the comparison table and are not explicitly stated as "acceptance criteria" within the provided text.

Here's an attempt to reconstruct the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

As the document does not explicitly present acceptance criteria or detailed study results in a table, the following table is constructed from the performance specifications listed in the "Substantial Equivalence Comparison Table" where the Subject Device (K250002) performance characteristics are taken as the "Reported Device Performance" and are implicitly assumed to have met an internal "Acceptance Criteria" derived from either design requirements or predicate device performance.

The provided document describes a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to a predicate device. It does not describe a clinical study involving human subjects or interpretation of medical images. Instead, it details the technical performance of a medical device (an oxygen gas analyzer) used for servicing other medical equipment (oxygen concentrators).

Therefore, many of the requested items related to clinical studies, expert consensus, and human reader performance are not applicable to this type of device submission as described in the provided text.

Based on the information given, here's what can be inferred for the other requested points:

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

• Sample Size: Not explicitly stated. The document refers to "non-clinical tests" and demonstrates compliance with standards. Testing would involve a number of units of the Smart Check O2 device under various conditions.
• Data Provenance: Not explicitly stated. Given it's a device performance test, the data would likely be generated in a lab setting by the manufacturer, Life Spark Medical. It would be prospective data collected during device testing and verification.

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

• Not applicable. This device measures physical parameters (oxygen purity, flow, pressure, pulse volume). The 'ground truth' is established by calibrated reference standards and test equipment, not by human experts interpreting clinical data.

4. Adjudication Method for the Test Set

• Not applicable. Since the ground truth for device performance is based on measurements against calibrated physical standards, there is no human interpretation or adjudication process as would be seen in, for example, a radiology study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Human Assistance

• Not applicable. This is not an AI-powered diagnostic device that assists human readers. It's a measurement tool.

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

• Yes, implicitly. The performance metrics (accuracy, range, resolution, response time, etc.) are characteristics of the device itself (its internal sensors and algorithms) without human intervention in the measurement process, beyond initiating the test. The "Substantial Equivalence Comparison Table" lists these standalone performance characteristics.

7. The Type of Ground Truth Used

• The ground truth for the performance metrics (oxygen purity, flow, pressure, pulse volume) would be established by calibrated reference standards and test equipment (e.g., precise gas mixtures for oxygen purity, calibrated flow meters, and pressure gauges).

8. The Sample Size for the Training Set

• Not applicable/Not stated. This document describes a physical measurement device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data for model training. The device's underlying technology is ultrasonic time-of-flight measurements, which is a physics-based method, not a data-driven learning algorithm.

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

• Not applicable. As a non-AI/ML device, the concept of a training set and its ground truth is not relevant here. The device's accuracy relies on its design, component quality, and calibration procedures.

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NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO).

The NOxBOXi Nitric Oxide Delivery System includes:

• The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
• Continuous monitoring and alarms for NO, O2, and NO2.
• The integrated NOxMixer which provides a backup NO delivery capability that is intended to deliver a continuous flow of NO, mixed with O₂, for iNO therapy and provides a continuous treatment option during transit and transfer conditions within hospitals.

The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling (currently neonates). Refer to this material prior to use.

The NOxBOXi Nitric Oxide Delivery System (NOxBOXi) simultaneously delivers Nitric Oxide (NO) medical gas, while monitoring Nitric Oxide, Nitrogen Dioxide (NO2), and Oxygen (O2) levels in the inspiratory limb of a ventilator for patients undergoing inhaled Nitric Oxide Therapy.

The system is designed for use by healthcare professionals to administer treatment to patients undergoing inhaled Nitric Oxide (iNO) therapy. The NOxBOXi will deliver nitric oxide in a synchronous manner to a single patient.

An integrated component to the NOxBOXi, the NOxMixer is intended to deliver a continuous flow of Nitric Oxide from the NOxBOXi, mixed in line with O₂ for use in iNO therapy. The NOxMixer will be used in conjunction with manually bagging a patient.

The NOxBOXi includes the NOxBOXi Head Unit, a NOxFLOW sample line, two NO feed hoses, two regulators (connector type dependent on the gas supplier), a test circuit, NO, O2, and NO2 monitors, power supply, drainage syringe, Operating Manual & Technical Guide.

This submission is for the introduction of new compatible ventilators including the addition of pediatric categories for existing ventilators, an additional optional software mode which disables the "Vent Flow Idle" alarm to reduce this alarm which may not be necessary and is considered a "nuisance" alarm in certain situations. Alarm initiations are still recorded in the log file. Additionally, language choices other than English have been disabled for this mode. There are no changes to the indications for use of the product, patient population of neonates, and there are no significant design changes.

The provided text is a 510(k) summary for the NOxBOXi Nitric Oxide Delivery System, focusing on changes to compatible ventilators and an optional software mode. It does not present a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-enabled devices, which often involve performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Instead, this document describes a modification to an already cleared medical device (NOxBOXi Nitric Oxide Delivery System). The "study" here refers to non-clinical performance testing to demonstrate that these changes do not alter the substantial equivalence of the modified device to its predicate. The acceptance criteria are therefore related to the safety and performance parameters of the delivery system itself, rather than diagnostic or analytical accuracy of an AI model.

Therefore, many of the requested points related to AI/ML study design (like sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for an algorithm) are not applicable to this document's content.

However, I can extract information related to the device's technical specifications and the testing performed for this submission.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the existing performance characteristics of the predicate device (K231823) and regulatory standards. The reported "performance" for this submission is that the device, with the new ventilator compatibility and software mode, continues to meet these original performance specifications and does not raise new questions of safety or effectiveness.

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

• Test Set Description: The "test set" here refers to the specific modifications being evaluated: the compatibility with additional ventilators and an optional software mode.
• Sample Size: Not quantified in terms of a "sample size" of patients or images, as this is a hardware/software modification submission. The testing involves specific ventilator models and configurations, and the software mode itself.
• Data Provenance: Not applicable in the context of clinical data or patient-derived data for an AI/ML model. The testing is non-clinical, likely bench testing, and usability testing.

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

• Not applicable in the context of this 510(k) summary. Ground truth as typically understood for AI/ML diagnostic devices (e.g., expert radiological reads) is not established here. The "truth" is based on the engineering specifications and performance of the device under various conditions and its compliance with regulatory standards.

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

• Not applicable. This relates to clinical endpoint adjudication, which is not described.

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:

• No. This is not an AI-enabled diagnostic device.

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

• No. This is a medical device for gas delivery and monitoring, not a standalone algorithm.

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

• The "ground truth" for this device's performance, as demonstrated in this submission, is based on:
  • Engineering specifications and design requirements.
  • Validated test methods conforming to international standards (e.g., ISO, IEC).
  • Compliance with FDA guidance documents related to nitric oxide delivery apparatus and software.
  • Bench testing results for parameters like accuracy, flow rates, alarm functionality, and gas purity.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML model with a training set.

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

• Not applicable. This document does not describe an AI/ML model with a training set.

Summary of the study conducted:

The "study" or testing performed for this 510(k) submission was non-clinical performance testing and usability testing. The purpose was to demonstrate that adding compatibility with new ventilators (including pediatric categories for existing ones) and an optional software mode does not adversely impact the safety or effectiveness of the NOxBOXi Nitric Oxide Delivery System, and that it remains substantially equivalent to its predicate device (K231823). The testing focused on validating that the changes did not introduce new safety concerns or alter the specified performance characteristics of the device. This involved testing against international standards and FDA guidance relevant to medical devices, particularly those for nitric oxide delivery systems. No clinical testing was required for this specific submission given the nature of the changes.

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The iX series Patient Monitors including iX10, iX12, iX15 are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults and pediatics (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), cardiac output (C.O.), and Anaesthesia gas (AG).

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

The NIBP monitoring supports iCUFS algorithm and iFAST algorithm is intended for adult, pediatric and neonatal patients. The iFAST algorithm is intended for adult and pediatic 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 iX series Patient Monitors including iX10, iX12, iX15 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.

This document describes the premarket notification (510(k)) for the Edan Instruments, Inc. Patient Monitor (iX10, iX12, iX15) and its equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device were generally established by compliance with various international standards for medical electrical equipment and specific performance characteristics. The reported device performance indicates that the device meets these standards and its specified accuracy.

For the Quick Temp Module (T2A), the provided text details specific clinical study results. Other parameters were tested for compliance with relevant standards through non-clinical testing.

2. Sample Size for Test Set and Data Provenance

For the Quick Temp Module (T2A) Predict Mode clinical accuracy study:

• Sample Size: 142 valid cases for sublingual and axillary temperature measurements.
• Data Provenance: Clinical investigation (prospective study). No country of origin is explicitly stated, but the company is based in China.

For other parameters, specific sample sizes for non-clinical (bench) testing are not provided, but the document states "Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards."

3. Number of Experts and their Qualifications for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study of the Quick Temp Module (T2A). It only mentions that the study compared the new module against the "direct mode of F3000 Temp Module of M3A Vital signs monitor," implying the predicate device served as a reference for accuracy.

For other non-clinical tests, the ground truth is implicitly defined by the specifications and performance requirements outlined in the referenced international standards.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical study or any other test sets.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is a patient monitor, and its performance evaluation typically focuses on the accuracy and reliability of its physiological parameter measurements, not on improving human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance was evaluated for the components of the device. The non-clinical data section describes extensive functional and system-level testing to validate the performance against relevant consensus standards. This includes specific tests for algorithms like cardiac rhythm and ST segment measurement. The clinical study for the Quick Temp Module (T2A) also assesses the standalone performance of that specific module.

7. Type of Ground Truth Used

• For the Quick Temp Module (T2A) clinical study: The ground truth was established by comparison to a reference device's direct temperature measurement mode ("direct mode of F3000 Temp Module of M3A Vital signs monitor"). This is a form of reference standard comparison (using a predicate device as the reference).
• For other parameters (e.g., ECG, NIBP, SpO2, CO2, AG): The ground truth for non-clinical testing is implicitly based on the specifications and performance requirements outlined in the referenced international consensus standards (e.g., IEC 60601 series, ISO 80601 series, AAMI standards).

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a patient monitoring device and not a machine learning algorithm as typically understood in the context of large-scale image-based diagnostics. The "algorithms" mentioned (e.g., arrhythmia detection, NIBP algorithms) are likely engineered signal processing algorithms rather than deep learning models requiring large training datasets.

9. How Ground Truth for Training Set was Established

Not applicable, as no training set for a machine learning model is described in the provided text. The algorithms for the patient monitor's functions are developed and validated against established physiological principles and engineering standards.

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The Maxtec MaxBlend 2+p is intended to provide a continuous air/oxygen gas mixture and to continuously monitor the concentration of oxygen and pressure being delivered to infant, pediatric, and adult patients. It is a restricted medical device intended for use by qualified, trained personnel, under the direction of a physician, in professional healthcare settings, i.e., hospital, subacute, and nursing-care facilities where the delivery and monitoring of air/oxygen mixtures is required. This is not intended as a life-supporting device or life sustaining device.

The Maxtec MaxBlend 2+p is an oxygen delivery device which incorporates an air/oxygen blender, battery powered oxygen and pressure monitor, and an adjustable flowmeter, all in a single assembly. The integral air/oxygen blender provides precise mixing of medical grade air and oxygen. The flowmeter provides control of the flow rate delivered. The oxygen monitor measures the oxygen concentration from the blender's gas flow, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also allows the user to monitor pressure simultaneously using adjustable high and low alarm limits.

The document describes the Maxtec MaxBlend 2+p, a medical device combining an air/oxygen blender, oxygen monitor, pressure monitor, and flowmeter. The 510(k) submission seeks substantial equivalence to existing predicate devices (Maxtec MaxBlend 2 - K161718 and MaxO2ME+p - K221734), particularly highlighting the addition of a pressure monitoring feature.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for several performance aspects are implicitly derived from the comparative tables (Table 1 and 2) where the subject device's specifications are listed and compared to the predicate devices. The "Reported Device Performance" for the subject device is simply its stated characteristics, which are claimed to meet or be identical to the predicate device specifications, thereby meeting the acceptance criteria based on substantial equivalence.

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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 MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

The MaxO2 ME+p device is an oxygen monitor with integrated pressure monitoring. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document compares the MaxO2 ME+p (proposed device) to two predicate devices: Maxtec - MaxO2 ME (K153659) for oxygen monitoring and Caradyne - Criterion 40 (K992101) for pressure monitoring.

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

• The document does not specify a sample size for a test set in terms of clinical data or patient samples.
• The study primarily relies on non-clinical testing (bench testing and adherence to standards) to demonstrate performance.
• No human clinical testing or animal testing was performed.
• The data provenance is not applicable as it's not a study involving patient data.

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

• This information is not provided in the document. Given that the testing was non-clinical (adherence to standards and bench testing), the "ground truth" would be established by the requirements of those standards and the accuracy of reference measurement equipment. Experts involved would be in engineering, quality assurance, and regulatory affairs, but specific numbers and qualifications are not detailed.

4. Adjudication method for the test set:

• An adjudication method is not applicable as there was no study involving human readers or interpretation of results that would require consensus among experts. The testing involved verifying the device's performance against defined technical specifications and industry standards.

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:

• No MRMC comparative effectiveness study was done. This device is an oxygen and pressure monitor, not an AI-powered diagnostic imaging device or a system designed to assist human readers in interpretation. Therefore, this type of study is not relevant to the MaxO2 ME+p.

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

• This question is not directly applicable in the context of this device. The MaxO2 ME+p is a standalone physical device (monitor) that measures oxygen concentration and pressure. Its performance is evaluated through non-clinical bench testing against established standards and specifications, not through an "algorithm only" performance study in the way it might be for a diagnostic AI. The device's functioning is its standalone performance without human input beyond its operation.

7. The type of ground truth used:

• The "ground truth" for the performance evaluation was established by technical specifications, measurements from calibrated reference equipment, and compliance with recognized industry standards. These include:
  • AAMI ANSI ES 60601-1: Medical electrical equipment safety and essential performance.
  • IEC 60601-1-2: Electromagnetic Disturbances.
  • AIM Standard 7351731: Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
  • IEC 60601-1-8: Alarm systems.
  • ISO 80601-2-55: Respiratory gas monitors.
  • ISO 10993-5, -10, -11, -18: Biocompatibility.
  • ISO 18562-2, -3: Particulate material and VOCs.

8. The sample size for the training set:

• This information is not applicable. This device is a hardware monitor, not a machine learning or AI algorithm that requires a training set of data.

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

• This information is not applicable, as there is no training set for this type of device.

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The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, alarming and storing of multiple physiological parameters These parameters include ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.

All parameters can be monitored on single adult, pediatric, and neonatal patients except:

• · BIS monitoring is intended for adult and pediatric patients only;
• · C.O. monitoring is restricted to adult patients only;
  · Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• · When using COMEM SpO2, the monitor is intended to be used on adult patients only.
• · NIBP measurement continual mode is not applicable to neonates.

The monitors are to be used in general healthes by clinical physicians or appropriate medical staff under the direction of physicians.

The monitors are not intended for helicopter transport, hospital ambulance, or home use.

The monitors do not measure, display, or trend changes in the ST segment.

The monitors do not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient.
All parameters can be monitored on single adult, pediatric, and neonatal patients except:
BIS monitoring is intended for adult patients only; C.O. monitoring is restricted to adult patients only; Arrhythmia analysis is intended for use with adult patients only and is not intended and shall not be used on pediatric and neonatal population. When using COMEM SpO2, the monitor is intended to be used on adult patients only. NIBP measurement continual mode is not applicable to neonates. Both models are designed with:
Same system framework and components
Same hardware design principle
Same software platform
Same parameters measurement subsystems (including parameters modules and accessories)
The only difference between NC10 and NC12 is the display size.

The acceptance criteria and supporting study details for the Multi-Parameter Patient Monitor (NC10 and NC12) are provided below, based on the given FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific "acceptance criteria" for each physiological parameter in a tabular format with corresponding "reported device performance." Instead, it compares the subject device's specifications to those of the predicate device, stating that the subject device's performance aligns with or is a subset of the predicate's performance, and that the device meets relevant consensus standards. The "Comparison" column in the provided tables indicates "Same" for most parameters, implying that the subject device's performance is equivalent to the established performance of the predicate device. For the "Comen SpO2" feature, where there's a difference, the document states, "The SpO2 accuracy met ISO 80601-2-61 and was validated by the clinical study," indicating that its performance meets the standard.

Here's a condensed representation of the key performance specifications for the subject device (NC10 and NC12), which also serve as implied acceptance criteria given the "Same" comparison to the predicate:

The document implies that the "reported device performance" for the subject device meets or is equivalent to these specified ranges and accuracies through bench testing and clinical studies, confirming compliance with relevant standards.

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

• Sample Size for Test Set: The document does not specify exact numerical sample sizes for each clinical test. It mentions that clinical accuracy of NIBP, SpO2, and respiratory rate were validated for the intended patient population.
  • For SpO2 accuracy, it states the validation was done "using the method outlined in ISO 80601-2-61:2017 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013." These standards typically require a certain number of subjects (often healthy volunteers) with induced hypoxemia for desaturation studies to demonstrate accuracy across the specified range. However, the exact number is not provided in this summary.
  • For NIBP accuracy, it states validation was "according to ISO 81060-2 which contains the requirements for clinical accuracy and the protocols for investigating the NIBP determination clinical accuracy." This standard also prescribes specific subject enrollment criteria and measurement methods.
  • For Respiratory Rate (RR) accuracy, it was validated "by clinical testing to compare the measurement of the subject device and that of a clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." The sample size for this is not detailed.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the studies were retrospective or prospective, though clinical validation studies for device clearance are typically prospective. It does say "All clinical accuracy validation studies were conducted in accordance with standard ISO 14155:2020," which governs clinical investigation of medical devices, generally implying prospective collection.

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

The document does not provide details on the number or qualifications of experts used for establishing ground truth, as it is a multi-parameter patient monitor.

• For SpO2, the ground truth would typically be established by a CO-oximeter reading during a controlled desaturation study, as per ISO 80601-2-61. This is a highly objective measurement.
• For NIBP, ground truth is typically established by direct intra-arterial blood pressure measurements, not by expert consensus.
• For Respiratory Rate, the ground truth was "clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography." This implies clinically trained personnel, but their specific qualifications or number are not provided.
• For Arrhythmia Analysis, and other subjective physiological monitoring parameters, the ground truth source is not explicitly mentioned but typically relies on expert interpretation of ECG waveforms or other data.

4. Adjudication Method for the Test Set

The document does not detail any adjudication methods (e.g., 2+1, 3+1) for the test set, as most of the parameters are quantitative measurements compared against an objective reference standard rather than subjective interpretations requiring adjudication.

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

This document describes a multi-parameter patient monitor, which is a measurement device, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device and was not conducted. The study aims to demonstrate that the device's measurements are accurate and equivalent to predicate devices, not to show an improvement in human reader performance.

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

The entire device, including its algorithms for parameter measurement and arrhythmia detection, operates in a "standalone" fashion to generate the values and alarms displayed to the clinician. The performance validated (e.g., accuracy of SpO2, NIBP, RR, arrhythmia detection) is the inherent performance of the device's algorithms and hardware. While a human uses the device and interprets its output, the core measurements are algorithm-driven.

7. The Type of Ground Truth Used

• SpO2: CO-oximetry in a controlled desaturation study (objective, gold-standard reference for SpO2 saturation).
• NIBP: Direct intra-arterial blood pressure measurements (objective, gold-standard).
• Respiratory Rate: Clinician-scored capnography device, manually scored end-tidal CO2 (EtCO2) capnography. (This suggests an expert-derived observation from an objective measurement, or comparison to another well-established measurement device).
• ECG/Arrhythmia Detection and other parameters: The document implies comparison to established methods and compliance with relevant ISO standards, which would typically involve highly accurate reference measurements and possibly expert review of waveforms for specific event detection.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. This is common for device clearances that focus on performance validation rather than machine learning algorithm development where distinct training and test sets are crucial. The device's algorithms are likely based on established physiological principles and signal processing, rather than deep learning from a massive training dataset.

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

As no specific training set is mentioned in the filing summary for this device, information regarding the establishment of its ground truth is not applicable or provided. The device's performance is demonstrated through its adherence to established international standards and clinical testing against reference methods.

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