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The Wireless Vital Signs Monitor Professional (WVSM Pro) series monitors are intended to be used as continuous or spot check monitors and indicated as single or multi-parameter vital signs monitors. There are two monitor configurations WVSM Pro and TVSM (Tactical Vital Signs Monitor):

WVSM Pro is indicated to monitor electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR).

TVSM is indicated to monitor noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI), The monitors use wireless communications to transmit vital signs data to a PC, laptop, or mobile device. Patient population: neonate/infant, pediatric and adult patients.

The monitors may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications.

The monitor is intended to be used by trained healthcare providers.

Wireless Vital Signs Monitor Professional (WVSM Pro) and Tactical Vital Sign Monitor (TVSM) are part of the WVSM Pro Series monitors. The WVSM® Pro series monitors are small, rugged, and highly mobile medical devices intended to be used as an adult, pediatric, and neonate patient vital signs monitor for spot-checking or continuous applications. The monitors are small enough to stay with the patient from point of injury through the triage and treatment process. It is designed as a single or multi-parameter vital signs monitor. The WVSM Pro is capable of acquiring the following physiological parameters: electrocardiogram (ECG) 5- or 12-lead waveforms and heart rate (HR); temperature; noninvasive blood pressure (NIBP); Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI); and capnography including end-tidal CO2 (ETCO2), fractional inspired CO2 (FiCO2) and respiration rate (RR). The TVSM is capable of acquiring the following physiological parameters: noninvasive blood pressure (NIBP) and Pulse Oximetry including functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI). Both models can be used as a standalone device or can transmit data via wireless communications to a PC, laptop, or mobile device (tablet or smartphone).

WVSM Pro series monitors are intended for use in pre-hospital, emergency room, inpatient care facilities, healthcare facilities, emergency medical applications, during transport, outpatient care, and other related healthcare scenarios. The WVSM Pro is intended to be used by trained healthcare providers by prescription only.

The basic principles of operation of the WVSM® Pro Series monitors include:

ECG: 5- or 12-lead waveforms generated via skin electrodes with right-leg drive. Note: The device does NOT include the following functions: Automated Waveform Measurements, Arrhythmia Detection, or Alarms for these functions.

Capnography: Infrared (IR) Spectroscopy is used to detect CO2 concentrations in expired air via mainstream or sidestream methods

Pulse oximetry: The plethysmography waveform from Red and IR LEDs are used to calculate functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVI), and perfusion index (PI)

Temperature: YSI 400 compatible thermistor sensors

Non-invasive blood pressure (NIBP): Oscillometric method

The WVSM® Pro Series patient monitor enclosures are primarily plastic and is not intended to contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact.

This document, K233354, is a 510(k) premarket notification review from the FDA for the Athena GTX, Inc. WVSM Pro (Series) vital signs monitors. It establishes substantial equivalence to a predicate device (ZOLL Power M, K202275) without the need for new clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific performance metrics for the WVSM Pro (Series) monitor. Instead, it states that "performance data were provided in support of substantial equivalence determination" and lists various non-clinical tests and compliance with recognized standards.

The primary "acceptance criterion" for this 510(k) submission appears to be substantial equivalence to the predicate device (ZOLL Power M, K202275) across indications for use, technology, and intended use, without raising new questions of safety and effectiveness.

The document implicitly refers to performance by stating:

• "The device was evaluated and found to be in compliance with the standards identified below" (a list of IEC, ISO, and AAMI standards). These standards contain their own performance requirements and acceptance criteria for vital signs monitoring devices.
• "The device uses OEM modules for parameters that would normally require clinical testing, NIBP and Pulse Oximetry. These modules have had clinical testing performed and have been used in previously cleared devices." This implies that the performance of these modules, for which the predicate also relies on similar technology, is accepted based on prior clearances and clinical data.

Therefore, a table with specific acceptance values and corresponding WVSM Pro performance from this document cannot be constructed directly. The "device performance" is primarily demonstrated through compliance with recognized standards for safety and performance (e.g., IEC 60601 series, ISO 80601 series, AAMI ANSI EC53) and the use of previously validated OEM modules for certain functions.

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

Since no new clinical studies were conducted for the WVSM Pro (Series) device, there is no new test set sample size or data provenance explicitly described for this 510(k) application.

The clinical data that supports the performance of the NIBP and Pulse Oximetry modules, which were incorporated from OEM parts, would have originated from the studies conducted for those original modules. The document does not specify the sample sizes or provenance of these prior studies.

The non-clinical testing (software, safety, usability, cybersecurity) does not typically involve patient "test sets" in the same way clinical trials do.

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

As no new clinical testing was performed on the WVSM Pro (Series) that required establishing a ground truth with human experts, this information is not applicable and not provided in the document. The performance of the OEM modules is presumed to be based on the ground truth established in their original clinical validations.

4. Adjudication Method for the Test Set

Since no new clinical test set requiring human expert adjudication was created for this device, the adjudication method is not applicable and not described.

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

No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not necessary to show substantial equivalence." The device is intended to be used by trained healthcare providers, but its performance is not being compared to human readers or an AI-assisted human workflow in this submission.

6. Standalone Performance Study

No new standalone (algorithm only without human-in-the-loop performance) study was done for the WVSM Pro (Series). The device itself is a vital signs monitor, not typically an AI algorithm in the context of standalone performance a typical AI/CADe device would require.

The document does mention software verification and validation, ensuring the product works as designed, but this is not an "algorithm-only" performance study in the context of diagnostic AI.

7. Type of Ground Truth Used

For the WVSM Pro (Series) submission, the "ground truth" for demonstrating substantial equivalence relies on:

• Compliance with recognized performance standards: These standards (e.g., IEC, ISO, AAMI) establish the gold standard for performance expectations of vital signs monitors.
• Prior clinical validation and clearance of OEM modules: For NIBP and Pulse Oximetry, the ground truth was established during the original clinical testing of the commercially available OEM modules. This would typically involve comparison to reference clinical measurements from calibrated devices. The document does not provide details on the specific type of ground truth used in those prior studies (e.g., invasive arterial line for NIBP, co-oximetry for SpO2).

8. Sample Size for the Training Set

The WVSM Pro (Series) is a vital signs monitor and not described as an AI/Machine Learning device that requires a "training set" in the conventional sense for a standalone algorithm. Therefore, no training set sample size is provided or applicable in this context. The "software verification and validation" refers to traditional software engineering testing.

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

As no training set is described for an AI/ML algorithm within the WVSM Pro (Series), this information is not applicable.

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The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.

The monitor is intended to be used by trained healthcare providers.

The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. The modification to the WVSM includes: Adding an indication for capnography by interfacing with a FDA cleared accessory. Adding the capability to use the device while connected to the AC power adapter instead of only using the device on battery power.

This document provides information about the Athena GTX Wireless Vital Signs Monitor (WVSM) RWC + miniCap, which is a modified version of a previously cleared device. The primary modifications are the addition of capnography functionality and the ability to operate while connected to an AC power adapter.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding performance results for each parameter. Instead, it states that "Key performance specifications are listed in the table in section VI below," which refers to the comparative table between the modified device and the predicate device. This table primarily highlights differences and similarities in technological characteristics.

However, based on the text, the acceptance criterion for this 510(k) submission appears to be demonstrating that the modifications (capnography and AC power mode) do not adversely affect the safety and effectiveness of the device and that the new functionalities (capnography parameters) meet established standards.

The document implicitly refers to compliance with industry standards for safety, EMC (Electromagnetic Compatibility), and essential performance as the main performance metric for the modified device.

Implicit Acceptance Criteria and Reported Performance (Based on the provided text):

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The intended use of the ADMS software application is to:

Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.

Display visual alarm conditions as generated by a connected monitor.

Display of patient information can be real-time or historical record review.

Provide review and trend application data, designed to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.

Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.

ADMS is intended for use in professional healthcare facilities, emergency medical applications, during transport, and other healthcare environments by trained healthcare professionals. ADMS Software is not intended for home use.

Indicated for use for specific patient populations (adult, pediatric, infant/neonate) depends on the indicated labeling of medical device(s) connected to ADMS providing the data.

The Athena GTX Device Management Suite (ADMS) is a software only device that manages patient data from compatible monitoring devices.

The Athena GTX Device Management Suite (ADMS) receives, distributes and displays physiologic waves, parameters and visual alarms at locations other than at the patient, for multiple patients. Data is generate by compatible connected devices and can be real-time or historical review.

The Athena GTX Device Management Suite provides a method of controlling ADMS compatible devices and viewing the device's data on Android devices (smartphones and tablets), iOS devices (smartphones and tablets) and on PCs running Windows OS.

The ADMS software receives data using Wi-Fi (802.11) from any Athena device within range. Whenever a device comes within range of ADMS, it will start receiving data from the device automatically. Commands to devices is transmitted via Wi-Fi (802.11) to the device. Each platform running ADMS can support viewing up to twenty (20) devices at one time.

The Athena GTX Device Management Suite (ADMS) consists of software only applications that do not come into physical contact with patients.

The Athena GTX Device Management Suite (ADMS) is a software-only device. The provided text, an FDA 510(k) summary, details the device's characteristics, comparison to predicate devices, and software verification and validation activities rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, several of the requested sections (sample size, data provenance, expert adjudication, MRMC study, ground truth, training set information) are not directly applicable or available in the provided document.

Here's an overview based on the available information:

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

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and successful software verification and validation. The "reported device performance" is described qualitatively as meeting the intended use and being safe and effective due to these comparisons and testing.

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

This information is not provided in the document. The document refers to "Software verification and validation testing," which typically involves various forms of testing (unit, integration, system, regression) but does not specify a "test set" in the context of clinical or performance data with associated sample sizes or data provenance.

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

This information is not provided in the document. The study described is not a clinical or performance study that would typically involve a ground truth established by medical experts.

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

This information is not provided in the document. As there is no clinical test set described requiring expert ground truth, adjudication methods are irrelevant here.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Study Data [807.92(b)(2)]: None."

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

The document describes the "Athena GTX Device Management Suite (ADMS)" as a "software only device" that "receives, aggregates, processes, distributes and displays physiologic waves, parameters, alarms and events." It also states, "All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making." This indicates that ADMS is designed to operate as a standalone algorithm in terms of data processing and display, but its output is intended for human-in-the-loop evaluation. However, the "standalone performance" in the context of diagnostic accuracy (which is not the primary function of this device) was not explicitly tested or reported in the context of classifying patient conditions. The core function is data management and display.

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

Given that no clinical validation study is described, no ground truth from "expert consensus, pathology, outcomes data" was used. The ground truth for the software verification and validation would be based on expected system behavior and output specifications.

8. The sample size for the training set

This information is not provided in the document. This device is a data management and display software, not an AI/ML algorithm that typically requires a 'training set' in the traditional sense for diagnostic or predictive tasks. The software is developed based on specifications and programming logic.

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

This information is not provided in the document. As mentioned, the concept of a 'training set' for this type of software is not applicable in the context of AI/ML model training described here. The "ground truth" for software development and testing would be defined by the design specifications and functional requirements.

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The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is to be used by trained healthcare providers.

The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry. The WiCap Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WiCap monitor. WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments.

The WiCap Patient Monitor is designed for continuous or spot-check monitoring of EtCO2, FiCO2, respiration rate (RR), SpO2, and pulse rate (PR).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Capnography: The document does not explicitly state the sample size for the capnography accuracy testing or its provenance. However, the accuracy specifications (e.g., "Above 80 breath per minute ± 12%") imply testing across a range of physiological conditions.
• Pulse Oximetry:
  • Sample Size: The number of subjects is not explicitly stated, but it mentions "healthy, non-smoking, light-to-dark-skinned subjects."
  • Data Provenance: The SpO2 accuracy testing was conducted "during induced hypoxia studies... in an independent research laboratory." The location of this laboratory (country of origin) is not specified. The study was prospective in the sense that hypoxia was induced for the purpose of testing.

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

• Capnography: Not mentioned.
• Pulse Oximetry: For SpO2 accuracy testing, the "ground truth" (reference standard) was arterial hemoglobin oxygen (SaO2) values determined from blood samples using a laboratory co-oximeter. This method does not involve human experts establishing ground truth in the traditional sense, but rather a validated clinical measurement device.

4. Adjudication method for the test set:

• Not applicable as the ground truth for the clinical study was established by objective measurements (laboratory co-oximeter for SpO2). For capnography, no specific adjudication method is mentioned.

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, as this device (WiCap Patient Monitor) does not involve human readers interpreting data in the way an imaging AI product would. It directly measures and reports physiological parameters.

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

• Yes, the performance data presented is for the standalone performance of the WiCap Patient Monitor itself. It measures and displays real-time physiological data without requiring human interpretation that would be significantly enhanced or altered by AI assistance in the context of this device type. The clinical accuracy report for the pulse oximeter module and sensor demonstrated its standalone performance.

7. The type of ground truth used:

• Capnography: Not explicitly stated, but typically involves calibrated gas mixtures and/or comparison against a highly accurate reference capnograph.
• Pulse Oximetry: Arterial hemoglobin oxygen (SaO2) values determined from blood samples with a laboratory co-oximeter. This is considered a clinical reference standard.

8. The sample size for the training set:

• The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development for the WiCap Patient Monitor. The device relies on established physiological measurement principles (NDIR infrared spectroscopy for capnography, spectrophotometry for pulse oximetry) rather than a deep learning model that would require a large training dataset. The OEM modules and their underlying algorithms would have been developed and validated by their respective manufacturers, but those specifics are not detailed here for the WiCap device itself.

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

• Not applicable, as no dedicated training set for a machine learning model is mentioned for the WiCap Patient Monitor. The "training" for such devices is typically in the form of engineering design, calibration, and validation against physical and physiological models and clinical reference standards by the OEM module manufacturers.

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The TACVAC™ portable battery powered suction device is intended to provide a battery powered medical suction source to clear bodily fluids and particulate matter from a patient. The primary intended use is to clear the airway by removing bodily fluids (including blood, saliva, mucous, vomitus or other aspirant) and particulate matter (less than 0.100"/2.50mm in diameter). The typical use environment is a pre-hospital in the field setting, transport, hospital and other healthcare applications by trained health care providers (EMTs, nurses, doctors, first responders, etc.). The patient population includes adults.

The TACVAC™ portable battery powered suction device is designed for the same application and intended use as the SSCOR, Inc. Jr® Quickdraw, Model 2400 listed predicate device. The TACVAC™ portable battery powered suction device is capable of the same functions as have been provided by the predicate device referenced above. The TACVAC™ consist of both re-useable and disposable (one-time use components). The device is very light weight (8 ounces) and can be compactly stowed (7.25" x 7.38" x 3.0") by inserting the suction unit inside the bottle to reduce space required to carry the device to the point of injury. To assemble from the stowed condition the valve unit is simply removed (unscrewed from the bottle) and the suction unit is removed. Then the valve unit is replaced back on the bottle and the suction unit is inserted into the valve unit and locked in place by twisting to engage the bayonet fittings. The assembled size is 7.25" x 11.88" x 3.0". A third party suction tip is installed on the suction tubing and then the unit can be turned on/off with the power switch. Once the unit is switched on suction will build in the bottle. Suction is applied at the suction tip by depressing the suction button. The device must be kept upright during use to prevent the overfill float check valve from engaging and shutting off suction to the tip. Once the user has finished using the device on a particular patient the valve unit, bottle and suction tip are discarded. The Suction unit is to be cleaned and disinfected. New batteries are installed as required to ensure full suction and use time. A new valve unit, bottle and suction tip are needed for the next use of the device.

The provided text describes the 510(k) premarket notification for the "TACVAC™ Portable Battery Powered Suction Device." The submission establishes substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating new algorithms or diagnostic tools, is not directly applicable in the context of this 510(k) submission.

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" in the context of demonstrating substantial equivalence to the predicate device. These are primarily related to performance characteristics and safety standards.

Here's a breakdown of the information that can be extracted, framed to address your questions where possible:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence for a 510(k))

Study Information (as inferable from a 510(k) submission focused on substantial equivalence)

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

   • Test Set Sample Size: Not applicable in the traditional sense for this type of submission. Performance was evaluated based on device specifications and compliance with standards, not on a clinical test set of patients or data points. The "tests" mentioned are engineering and performance validation tests on the device itself.
   • Data Provenance: Not applicable. The "data" comes from engineering tests conducted on the TACVAC™ device. No patient data (clinical or retrospective/prospective) is referenced.

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

   • Not applicable. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology reports) is not relevant for this engineering-focused substantial equivalence submission. The "ground truth" here is compliance with established engineering standards and performance specifications, likely verified by engineers and quality control personnel.

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

   • Not applicable. This is typically for clinical data review, not device performance testing against engineering standards.

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:

   • No. This is a medical device (powered suction pump), not an AI/diagnostic software. MRMC studies are not relevant here.

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

   • No. This is a physical medical device; the concept of an "algorithm only" or "human-in-the-loop" performance is not applicable.

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

   • The "ground truth" for this submission are recognized national and international standards for safety and performance for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10079-1) and the performance specifications of the legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a "training set."

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

   • Not applicable.

In summary: The provided document is a 510(k) premarket notification for a medical device (a powered suction pump). Its purpose is to demonstrate that the new device, TACVAC™, is "substantially equivalent" to an already legally marketed predicate device. This is achieved primarily through engineering and performance testing to show compliance with relevant standards and comparable performance characteristics, rather than through clinical studies involving patient data, expert interpretations, or AI algorithm validation. The questions asked are more pertinent to diagnostic AI/software submissions.

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The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or mufti-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.

The monitor is intended to be used by trained healthcare providers.

The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC), Personal Digital Assistant (PDA) or Mobile device.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device compliance:

Based on the provided 510(k) summary, the device in question is the "WVSM Wireless Vital Signs Monitor" with an iOS Mobile App Accessory. This submission is for a device modification, and the focus of the testing appears to be on verifying the compliance of this mobile app accessory with established standards.

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

The document explicitly states: "Testing on the WVSM iOS Mobile App has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device."

However, the provided text does not contain a table detailing specific acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity, or specific numerical targets for physiological measurements like ECG, NIBP, SpO2). It only broadly states that testing verified compliance with standards. It also mentions: "the WVSM with iOS Mobile App-accessory is capable of the same ECG, heart rate, systolic and diastolic blood pressure, functional oxygen saturation, and pulse rate measurements as have been provided by the predicate device referenced above." This implies that the performance of the iOS app accessory meets the established performance of the predicate device.

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

The document does not specify the sample size used for any test set nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for testing.

4. Adjudication method for the test set

The document does not describe any adjudication method used for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a vital signs monitor, not typically an AI-assisted diagnostic tool that would involve human readers interpreting output in the same way as, for example, an imaging AI.

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

The document describes the device as a "Wireless Vital Signs Monitor" to be used by "trained healthcare providers." The iOS Mobile App Accessory is stated to display vital signs, and the device transmits data. It's not a purely standalone algorithm; it's a device that measures and displays vital signs for human interpretation. The testing performed was to ensure the device (including the app accessory) meets performance and safety standards, implying its standalone measurement capabilities are being assessed. However, the document does not explicitly describe a "standalone" algorithm-only performance assessment in the context of, for instance, an AI diagnostic tool. The compliance testing would inherently evaluate the device's ability to accurately measure vital signs independently.

7. The type of ground truth used

Given that the device measures physiological parameters (ECG, NIBP, SpO2), the ground truth for performance testing would typically be established using calibrated reference standards or other gold-standard medical devices for each parameter. For example, a highly accurate blood pressure cuff for NIBP, a reference SpO2 monitor, or a medical-grade ECG machine. The document does not explicitly state the type of ground truth used.

8. The sample size for the training set

The device is a vital signs monitor, not an AI/machine learning device that typically involves a "training set" in the conventional sense. Therefore, the document does not mention a training set sample size. The development likely involved software engineering, hardware calibration, and verification against known physiological signals or simulated data inputs, rather than training on a separate dataset.

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

As there is no mention of a "training set" for an AI/ML algorithm, this information is not applicable and not provided in the document.

In summary, the 510(k) Summary emphasizes compliance with recognized national and international standards for safety and performance of medical devices. However, it lacks specific details on the methodologies, sample sizes, expert involvement, and concrete performance metrics that would typically be found in a detailed study report. The acceptance criteria are broadly described as meeting these standards and achieving performance comparable to the predicate device.

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The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.

The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes, and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.

Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm.

Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application.

Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.

The Athena GTX mini-Medic™ wireless vital signs monitor system is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit time (PWTT). Vital signs are displayed directly on the forehead sensor and transmitted wirelessly to a handheld display unit. Reports and data file saving is done via wireless download to a PC.

Here's an analysis of the provided text regarding the acceptance criteria and study for the mini-Medic™ device:

The provided document, K113165 P1/3, is a 510(k) Summary of Safety and Effectiveness for the Athena GTX mini-Medic™ wireless vital signs monitor. It describes the device, its intended use, and states that testing was completed to verify compliance with standards, concluding that the device is safe, effective, and substantially equivalent to listed predicate devices. However, it does not explicitly detail specific acceptance criteria or the numerical results of studies demonstrating performance against such criteria. The document focuses on regulatory compliance and substantial equivalence, rather than a detailed performance study report with acceptance criteria and their fulfillment.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and detailed study methodologies is not present in the provided text.

Here's what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance Studies

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

• Acceptance Criteria: Not explicitly stated in the provided document. The document indicates that testing was completed "to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device." However, the specific numerical or qualitative acceptance criteria derived from these standards are not detailed.
• Reported Device Performance: Not explicitly reported in numerical or quantitative terms for individual vital signs measurements. The document states that the mini-Medic™ is "capable of the same heart rate, functional oxygen saturation, pulse rate, pulse wave transit time and IR temperature measurements as have been provided by the combination of predicate devices referenced above." This implies performance is comparable to the predicate devices, but no concrete metrics are given.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of an MRMC study. The concept of "human readers improve with AI" does not align with the nature of this device.

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

• Standalone Performance: The core function of the mini-Medic™ is to measure and display vital signs automatically. The 'testing' mentioned in the summary would inherently assess the standalone performance of these measurement capabilities against established standards (e.g., accuracy of SpO2, heart rate, temperature). While not detailed as an "algorithm only" study, the validation of such a device's measurements is by definition a standalone assessment of its sensory and processing capabilities. However, actual performance metrics are not provided.

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

• Type of Ground Truth: Not specified. For physiological monitors, ground truth typically comes from reference gold-standard devices or established clinical methods (e.g., arterial blood gas analysis for SpO2, EKG for heart rate, calibrated thermometers for temperature). The document only states "compliance with recognized national and international standards for safety and performance."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This device is a physiological monitor, not an AI/Machine Learning algorithm that typically requires a distinct "training set" in the same sense as image recognition or predictive models. Its parameters are likely based on established physiological principles and sensor calibration, not learned from a large dataset.

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

• How Ground Truth for Training Set was Established: Not applicable/Not specified, for the reasons stated above.

Summary of what the document does indicate:

• The mini-Medic™ is a standalone physiological monitor designed to measure SpO₂, cardiotachometer (heart rate), skin temperature, and pulse wave transit time (PWTT).
• It is intended for use on patients 18 years and over by trained healthcare providers in various settings (pre-hospital, hospital, emergency medical, transport).
• The manufacturer states that "testing on the mini-Medic™ has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices," and that it is "substantially equivalent" to listed predicate devices in its capabilities.
• The 510(k) clearance by the FDA indicates that the agency found the device to be substantially equivalent to legally marketed predicate devices, implying that its safety and effectiveness profiles are similar.

Conclusion:

The provided 510(k) summary (K113165) gives a high-level overview of the mini-Medic™ device and the regulatory determination of its substantial equivalence. However, it does not contain the detailed data for specific acceptance criteria and study results in the quantitative format requested. Such detailed performance data is typically found in the full 510(k) submission, which is not publicly available in this format, or in associated scientific publications or internal company reports.

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The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor far ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC) or Personal Digital Assistant (PDA).

Here's an analysis of the acceptance criteria and study information for the Athena GTX Wireless Vital Signs Monitor (WVSM), based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with numerical targets. Instead, it broadly states that testing has been completed to verify "compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device." The conclusion is that the WVSM is "safe and effective, and is substantially equivalent to the above listed predicate devices."

Therefore, the implicit acceptance criteria are that the device performs comparably to the predicate devices and meets relevant safety and performance standards for its intended physiological measurements (ECG, NIBP, SpO2), and wireless communication.

A placeholder table is provided below, reflecting the performance claims made in relation to the predicate devices.

Study Details from the Provided Text:

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

   • Sample Size: Not specified in the provided text. The document states "Testing On the WVSM 5.0 has been completed," but does not provide details on the number of subjects, cases, or data points used in the testing.
   • Data Provenance: Not specified. It's unclear if the testing involved human subjects, simulated data, or a combination, and if location data was collected.

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

   • Not applicable/Not specified. The document describes technical testing against recognized standards and comparison to predicate devices, rather than a clinical study requiring expert ground truth establishment in a diagnostic context.

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

   • Not applicable/Not specified. This type of adjudication is relevant for studies where human interpretation or diagnosis is being evaluated against expert consensus. The provided text outlines technical and performance testing against standards.

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 vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

   • Yes, implicitly. The testing described is of the device's performance itself, measuring vital signs and transmitting data, which represents its standalone functionality. However, the exact methodology and results of this "standalone" testing are not detailed beyond "compliance with recognized national and international standards for safety and performance."

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

   • The ground truth would have been established by reference standards or highly accurate clinical measurement devices/calibrated equipment used during the "testing... to verify compliance with recognized national and international standards for safety and performance." For example, for NIBP, a reference invasive blood pressure measurement system or a highly accurate non-invasive system would be used as ground truth. For SpO2, a co-oximeter or other reference method would be used. The document does not specify these reference standards.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is described as a monitor that directly measures physiological parameters, not a machine learning model that requires a training set.

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

   • Not applicable. The device does not explicitly mention using a training set as it would be understood in the context of AI/ML.

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