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The VORTRAN GO2VENT with PEEP Valve is to be used by properly trained personnel to deliver emergency, shortterm, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above.

The device consists of a modulator (an exhalation valve that opens at PIP and closes at PEEP), a mechanical manometer, a resistor (which is referred to as the PEEP Valve) attached within the exhalation path for elevating the PEEP further than can be set with the modulator, a patient connector tee to supply gas flow, entrain additional air, and connect to a face mask or a tube inserted into a patient's airway, and two associated accessories. It is intended to be used by properly trained personnel in any environment in which emergency ventilation is required.

The VORTRAN GO₂VENT with PEEP Valve provides short-term, constant flow, pressure-cycled ventilatory support in either pressure control or pressure support mode. In pressure support mode, the rate dial of the VORTRAN GO₂VENT with PEEP Valve is set so that the baseline pressure is set above the set PEEP. This allows the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. In pressure control mode, the device will automatically cycle between PIP and PEEP when connected to a patient's airway.

The working mechanism of the VORTRAN GO₂VENT with PEEP Valve consists of a moving diaphragm that opens the exhalation path when the pressure reaches PIP and closes when the pressure reaches PEEP. Without the PEEP Valve, PEEP will be approximately 20% of the set PIP. With the PEEP Valve attached, the PEEP will be increased from this value up to 24 cm-H₂O depending on the patient's compliance and the VORTRAN GO₂VENT with PEEP Valve's settings. The PEEP Valve is attached within the exhalation path by connecting it between the modulator and the patient connector tee. The pressure at which the diaphragm opens and closes against the valve is controlled by the amount of spring force acting against the diaphragm's movement. The spring force is adjusted by manually turning a threaded knob that varies the amount of spring compression.

The device is constructed of a variety of plastics such as K-Resin, HDPE, polycarbonate, and silicone, as well as copper beryllium springs. The VORTRAN GO₂VENT with PEEP Valve is an external communicating device with limited and prolonged tissue contact duration (up to 30 days) via the breathing gas pathway.

The associated accessories were included with the cleared predicate device (K162968) and include:

• . Elbow flex hose for connecting the patient connector tee to a face mask or a tube inserted into a patient's airway
• Oxygen tubing for connecting the patient connector tee to a gas supply

The provided text describes the 510(k) premarket notification for the VORTRAN GO2VENT with PEEP Valve. It includes information on performance testing which addresses acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the sample size used for the mechanical performance testing. It also does not provide details on the data provenance, such as country of origin or whether the studies were retrospective or prospective.

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 applicable and not provided in the document. The device is a medical device, and its performance is evaluated against engineering and biological standards, not through expert-labeled data like in AI/imaging studies.

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

This information is not applicable and not provided in the document for the reasons stated above.

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

This information is not applicable. The device is a powered emergency ventilator, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.

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

This information is not applicable for the reasons stated above.

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

For biocompatibility, the "ground truth" was regulatory guidance and recognized ISO standards. For mechanical testing, the "ground truth" was compliance with internationally recognized ISO standards for lung ventilators and connectors.

8. The sample size for the training set

This information is not applicable as this is a medical device approval, not an AI/machine learning model.

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

This information is not applicable as this is a medical device approval, not an AI/machine learning model. The relevant "ground truth" for compliance was established through recognized international standards.

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The VORTRAN® APM-Plus is used to measure airway pressure for patients utilizing positive pressure devices where monitoring is desired.

The VORTRAN® APM-Plus is a battery (2 x AA) operated, microprocessor controlled, portable, self-contained device designed for monitoring a positive airway-pressure device such as a resuscitator or CPAP. The VORTRAN® APM-Plus is housed in a plastic enclosure. It connects to the positive-pressure device under monitor via pneumatic pressure tubing and receives the pressure signals using its solid-state pressure transducer. The pressure signals are used to calculate the related characteristics which are displayed on the LCD screen. The values are used to trigger alarms that alert the user of any abnormal pressure conditions. The software algorithm constantly monitors the data and if/when the pressure characteristics are outside of the user-set limits, an alarm will be activated. The alarms are both visual and audible. For ease of use, the VORTRAN® APM-Pus software provides two modes of operations: Resuscitator Mode and PAP Mode. When the device is turned on, the user can select one of the two modes. In each mode, the pressure data shown is suitable for the device under monitoring.

The VORTRAN® APM-Plus is an airway pressure monitor. The provided text outlines the device's technical specifications and comparison to predicate devices, but it explicitly states "Clinical Studies None" under the "Performance Data" section (Page 11).

Therefore, based on the provided text, a study proving the device meets acceptance criteria through clinical performance data, a multi-reader multi-case (MRMC) study, or a standalone algorithm-only study was not conducted or provided as part of this 510(k) submission.

The performance data provided for the VORTRAN® APM-Plus focuses on:

• Biocompatibility Testing: Comparing patient-contacting materials to a cleared reference device (K103639).
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8.
• Software Verification and Validation Testing: Development in accordance with FDA guidelines and IEC 62304.
• Risk Management: Compliance with ISO 14971.
• Shelf Life: An accelerated shelf life test showing a simulated age of 1 year.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and performance based on clinical study data, human reader performance, or standalone algorithm performance from the given document.

The tables of "Performance Specifications" (starting on page 8) list the device's stated ranges and accuracies, essentially defining its intended performance characteristics or "acceptance criteria" from a technical specification standpoint rather than from a clinical study outcome.

However, if we interpret "acceptance criteria and reported device performance" as the technical specifications and their stated values, we can construct the following table based on the "Performance Specifications" section (pages 8-9):

Technical Acceptance Criteria and Reported Device Performance (Based on Stated Specifications)

Since "Clinical Studies None" is stated, the following information cannot be extracted from the provided document:

1. Sample sizes used for the test set and data provenance: Not applicable as no clinical test set was described.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for clinical performance. The software verification and validation would have tested the algorithm's functionality against its specified requirements, but not in a clinical "standalone" performance study.
6. The type of ground truth used: Not applicable for clinical performance. Ground truth for technical specifications would be derived from laboratory calibration and testing.
7. The sample size for the training set: Not applicable as a clinical training set is not described. This device is an airway pressure monitor, not typically an AI/ML device that requires a "training set" in the conventional sense for clinical performance. Its software capabilities are described as "microprocessor controlled" and for "calculating related characteristics" and triggering alarms (Page 4).
8. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) clearance for the VORTRAN® APM-Plus was based on substantial equivalence to predicate devices and adherence to relevant electrical safety, software, and quality system standards, without the need for clinical performance studies.

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The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.

The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.

The provided text describes the VORTRAN® Cuff Inflator (VCI) and its substantial equivalence determination by the FDA. However, it does not detail a study that defines acceptance criteria and then proves the device meets those criteria in the way typically seen for AI/ML-driven medical devices (e.g., involving AI model performance metrics like sensitivity, specificity, AUC).

This document is a 510(k) summary for a mechanical device, a cuff inflator, not an AI/ML-driven device. Therefore, many of the requested criteria in your prompt (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone AI performance) are not applicable to the information provided in this document.

The "Performance Data" section (Section VIII) states: "Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill."

Based solely on the provided document, here's an attempt to answer your questions, acknowledging the limitations for a non-AI/ML device:

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

The document provides "Pressure Accuracy and Range" as key performance characteristics. While not explicitly stated as "acceptance criteria" with pass/fail thresholds in the provided text, these are the performance targets the new device aims to match or be equivalent to.

Note: The document states for "Pressure Range": "(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness." This indicates the 0-60 cm-H2O range was deemed acceptable relative to the predicate/reference devices.

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

• Sample Size: Not specified in the document. The performance testing is described generally ("Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks.").
• Data Provenance: Not specified. Given it's a technical performance test, it's likely lab-based and conducted by the manufacturer.
• Retrospective/Prospective: Not applicable in the context of device performance testing in this document.

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)

• Not applicable/Not specified. The ground truth for manometer accuracy, inflation/deflation function, and leak absence would be established by calibrated instruments and engineering measurements, not human expert consensus, for a mechanical device.

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

• Not applicable. This is not a human-reader study requiring adjudication.

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 study was done, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device. Its performance is its standalone performance. There is no "algorithm" in the AI sense.

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

• For the performance characteristics mentioned (manometer accuracy, inflation/deflation, leaks), the ground truth would be established by calibrated reference standards and engineering measurements. For example, manometer accuracy would be verified against a highly accurate master pressure gauge.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not applicable.

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This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.

The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient). The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.

The VORTRAN® GO2VENT™ is a powered emergency ventilator. The device was found substantially equivalent to its predicate device (VORTRAN® Automatic Resuscitator (VAR-Plus), K041473) based on non-clinical performance data and material biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

The device's acceptance criteria are based on compliance with the following standards:

• ASTM Designation: F 920 - 93 (Reapproved 1999): "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."
• ISO 10651-5: "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators."

The table below summarizes some key operational characteristics of the device and how they compare to the predicate, demonstrating that the new device meets the same specifications:

In addition, specific modifications were tested:

• MR Conditional: The new beryllium-copper springs were tested according to ASTM F2052 and verified as MR Conditional for a static magnetic field of 3-Tesla or less, and a spatial gradient magnetic field of 10,000-gauss/cm or less.
• New Entrainment Connectors: All testing data showed that the change in the knobs for FiO2 delivery did not degrade performance and the device delivers the required specifications.
• New Beryllium-Copper Springs: Tested for performance and fatigue.

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

The document concerns non-clinical performance testing only. There is no specific "test set" sample size in terms of clinical data or patient cases mentioned. The testing was conducted on the device itself and its components. The data provenance is from non-clinical laboratory testing performed by the manufacturer and a third-party (Shellock MR Testing for MR Conditional verification). The data is retrospective in the sense of comparing the new device against previously documented performance of the predicate device and established standards.

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

Not applicable, as this was a non-clinical device performance and material compatibility study, not an expert-driven ground truth establishment for a diagnostic or AI algorithm.

4. Adjudication method for the test set:

Not applicable, as this was non-clinical device performance testing against established standards and predicate device specifications, not a clinical trial requiring adjudication of patient outcomes or interpretations.

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 device; it is a powered emergency ventilator. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an algorithm, but a medical device.

7. The type of ground truth used:

The ground truth for the device's performance is compliance with established engineering and medical device standards (ASTM F 920-93 and ISO 10651-5) and the performance specifications of the predicate device. Material compatibility was assessed against materials used in previously cleared devices.

8. The sample size for the training set:

Not applicable, as this is hardware medical device. There is no "training set" in the context of machine learning.

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

Not applicable, no training set or ground truth in the context of machine learning.

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The VORTRAN Manometer is a single patient use device intended to provide visual indication of a patient's airway pressure during ventilation from 0 to 60 cm-H2O. It may be attached to the manometer port on ventilation devices such as resuscitators, resuscitation bags, hyperinflation bags, CPAP Masks or CPAP Circuits.

The VORTRAN Pressure Manometer provides pressure readings from a breathing circuit in the range of 0 to 60 cm-H2O. The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O; ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O; and ±5 cm-H2O for pressures above 40 cm-H2O. The manometer design requirements include: the pressure range of 0 to 60 cm-H2O, connection to a breathing circuit via a 22 mm male-female adaptor, and having a life expectancy as a single patient multiple use device. It accommodates connections through the option of a 22 mm tee or 15 mm port. The manometer includes a translucent enclosure that allows the pressure indicator needle to be seen from all sides.

The manometer label has three color zones of green, yellow, and red to give enhanced visual support during ventilation. The color coded scale indicates the following: green is 0 to 20 cm-H2O; yellow is 20 to 40 cm-H2O, and red is for pressures above 40 cm-H2O. The color coded scale is only for visual support and the correct ventilation pressure must be determined by the medical professional.

The provided document describes the VORTRAN Manometer, an airway pressure monitor, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail a clinical trial or performance evaluation with statistical metrics such as sensitivity, specificity, or AUC, as would be typical for such devices.

The document primarily focuses on:

• Device Description: The VORTRAN Manometer provides visual indication of airway pressure from 0 to 60 cm-H2O.
• Technological Characteristics Comparison: A comparison of the VORTRAN Manometer's technology (pressure barrier, counter force, method of translating in-line air pressure, indicator mechanism, indicator movement, pressure limits, display increments, color coding, operating & storage temp) against several predicate devices.
• Performance Data: The performance data section explicitly states "Animal Study: None" and "Clinical Studies: None." It only mentions "The VORTRAN Manometer will indicate airway pressure with an indicator needle..." and describes its mechanical operation.
• Biocompatibility Testing: References to material compatibility with previously cleared devices.
• Compliance with Performance Standards: Adherence to ISO 5356-1 for conical connectors.

Therefore, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be extracted from this document. This typically indicates a 510(k) pathway for a traditional medical device, not an AI/ML-powered device. The "performance data" section in this document refers to bench testing of the mechanical performance, not a clinical trial or AI model validation.

However, based on the information provided, I can construct a partial response:

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

   Acceptance Criteria	Reported Device Performance
   Functionality:
   Visual indication of airway pressure	Met: The VORTRAN Manometer is intended to provide visual indication of a patient's airway pressure. The indicator needle shows PIP and PEEP in cm-H2O, associated with a linear rack and pinion gear tied to a moveable diaphragm. (Performance Data section)
   Pressure range from 0 to 60 cm-H2O	Met: The device provides pressure readings from 0 to 60 cm-H2O. (Device Description, Performance Data section)
   Accuracy:
   ±2 cm-H2O for 0 to 20 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±2 cm-H2O for a low pressure range from 0 to 20 cm-H2O. (Device Description section)
   ±3 cm-H2O for 20 to 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±3 cm-H2O for a pressure range of 20 to 40 cm-H2O. (Device Description section)
   ±5 cm-H2O for pressures above 40 cm-H2O	Met: The pressure readouts are approximate with an accuracy of ±5 cm-H2O for pressures above 40 cm-H2O. (Device Description section)
   Connectivity:
   Connection to breathing circuit via 22mm male-female adapter	Met: Connection to a breathing circuit via a 22 mm male-female adaptor, and accommodates connections through the option of a 22 mm tee or 15 mm port. Also, connected via a "Tee" 15 mm/22 mm ID/OD or "Vertical" plastics connector. (Device Description, Clinical Application sections)
   Biocompatibility:	Met: The device uses materials (Polycarbonate, Acetal, Silicon) for components with indirect patient contact that are the same as predicate devices previously cleared by FDA. (Biocompatibility Testing section)
   Mechanical Standard Compliance:	Met: Compliance with ISO 5356-1 Anaesthetic and respiratory equipment -- Conical connectors - Part 1: Cones and sockets. (Compliance with Performance Standards section)

   Note: The "acceptance criteria" here are derived directly from the device's specified performance characteristics and design requirements mentioned in the document, as no explicit "acceptance criteria table" for a study was provided. The "reported device performance" are the statements made in the document regarding the device's characteristics.

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

   • No information provided regarding a test set sample size or data provenance. The document explicitly states "Clinical Studies: None" and "Animal Study: None." The performance data section describes the mechanical operation and accuracy specifications, likely derived from bench testing, not a clinical test set. Data provenance is not mentioned.

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):

   • Not applicable. There was no clinical test set for which expert ground truth would be established. The accuracy claims are based on engineering specifications and likely bench testing/calibration.

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

   • Not applicable. No test set requiring expert adjudication was 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:

   • Not applicable. This device is a mechanical manometer, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or mentioned.

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

   • Not applicable. This is a mechanical device, not an algorithm.

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

   • For the accuracy claims, the ground truth would typically be established by validated calibration standards and highly accurate reference pressure measurement equipment during bench testing. This is not explicitly stated in the document but is implied by the nature of the device (a manometer).

8. The sample size for the training set:

   • Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.

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

   • Not applicable. This device is a mechanical manometer; it does not involve machine learning or a training set.

In summary, the provided document pertains to a traditional, mechanical medical device (manometer) undergoing a 510(k) clearance process based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, rather than a clinical study involving human subjects or an AI/ML algorithm validation study. Therefore, much of the requested information, which is relevant for AI/ML powered devices, is not available or applicable.

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The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).

The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via the connection tubing for monitoring cycling conditions of resuscitators such as the VORTRAN® Automatic Resuscitator.

1. Table of Acceptance Criteria and Reported Device Performance:

   The provided document describes the VORTRAN Airway Pressure Monitor (VAPM) and states that "The VAPM passed all required tests and demonstrated that it meets all predetermined acceptance criteria for applicable standards." However, the document does not explicitly list the specific numerical acceptance criteria for each measured parameter (e.g., accuracy for Peak Inspiratory Pressure, PEEP, Respiratory Rate, etc.) nor does it provide a table of the device's reported performance against these criteria.

   Instead, it lists the performance standards with which the VAPM complies:

   • IEC/UL-60601-1: General Requirements for Safety
   • IEC 60601-1-8: Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
   • IEC 60601-1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests

   Without specific performance criteria (e.g., "PIP accuracy ±X cm-H2O") and corresponding reported performance, a table cannot be fully generated from this document. The document only offers a general statement of compliance.

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

   • Sample Size: This information is not provided in the document.
   • Data Provenance: This information is not provided in the document.

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

   • This information is not provided in the document. As this is a medical device for monitoring physiological parameters, the "ground truth" would typically come from calibrated reference instruments or established methodologies rather than expert consensus on interpretive data like images.

4. Adjudication Method for the Test Set:

   • Not applicable as the document does not describe a test set requiring adjudication in the context of interpretation (e.g., image reading). Testing for this device would involve comparing its measurements against reference standards.

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

   • No, an MRMC comparative effectiveness study was not done. The device is an objective measurement tool, not an interpretive AI system that assists human readers.
   • The document states "Clinical Tests: None."

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

   • The relevant "standalone performance" for this type of device would be its accuracy and reliability in measuring airway pressure and related parameters. While the document states "The VAPM passed all required tests," detailed information about the specific standalone performance study (e.g., protocols, results of accuracy tests for PIP, PEEP, respiratory rate, alarm activation thresholds, and timing) is not provided. The document indicates compliance with international performance standards, implying such tests were conducted.

7. Type of Ground Truth Used:

   • The document implies that the ground truth for validation would be derived from calibrated reference standards or established measurement methodologies for airway pressure and respiratory parameters as per the IEC/UL standards it complies with. Specific details are not given, but for devices measuring physical quantities, this is the standard approach (e.g., a highly accurate pressure transducer for pressure measurements, a timer for rate measurements, etc.).

8. Sample Size for the Training Set:

   • Not applicable. This device is a hardware-based monitor, not an AI/ML algorithm that requires a "training set" in the conventional sense.

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

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

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The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

The VAR-Monitor is a battery (9 VDC) operated device that is mounted onto the VAR to monitor cycling conditions during operation.

The provided text describes a 510(k) summary for the "VAR with VAR-Monitor™" device, which is a powered emergency ventilator.

Here's an analysis based on the given information:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the VAR with VAR-Monitor is its compliance with ASTM F 920-93 (Reapproved 1999), "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans."

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

The document states "Clinical Tests: None" and does not refer to a "test set" in the context of clinical data. The evaluation appears to be based on engineering tests against the ASTM standard and comparison to predicate devices, rather than a clinical study with patients or a specific dataset. Therefore, there is no mention of sample size or data provenance in this context.

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

As "Clinical Tests: None" is stated, there is no indication of a test set requiring ground truth established by experts. The evaluation primarily relies on compliance with the ASTM standard and comparison to predicate devices.

4. Adjudication Method for the Test Set

Given that no clinical test set is described, there is no mention of an adjudication method.

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

No. The document explicitly states "Clinical Tests: None." This type of study would fall under clinical testing.

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

The device is a physical medical device (ventilator) with a monitor, not an algorithm in the typical AI sense. The performance evaluation focuses on the mechanical and alarm functions of the device itself, which are inherently "standalone" in their operation rather than involving a human-in-the-loop for interpreting algorithm outputs.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is primarily derived from:

• Engineering Standards: Compliance with ASTM F 920-93 (Reapproved 1999) for performance and safety.
• Operational Characteristics: Whether the device successfully detects a non-cycling condition and triggers alarms within the specified time.
• Predicate Device Comparison: The established safety and effectiveness of the existing predicate devices (RespirTech PRO, RespirTech PRO O₂C, VAR-Plus Model PCM).

There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for a specific clinical dataset.

8. The Sample Size for the Training Set

The document does not describe the development of an AI algorithm or a "training set." The device is a ventilator with an alarm monitor, evaluated against engineering standards and substantial equivalence to predicate devices, not through machine learning.

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

Not applicable, as there is no mention of a training set or AI algorithm.

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The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.

The VORTRAN Automatic Resuscitator (Model VAR-Plus) provides constant flow pressure cycled ventilatory support. The primary working mechanism of the VAR-PLUS is the Modulator which is an exhalation valve that opens at a set PIP (Peak Inspiratory Pressure) pressure and closes at a lower PEEP (Positive End Expiratory Pressure) pressure. During inhalation, exhalation will not start until the peak pressure is reached. During exhalation, inhalation will not begin until the pressure drops to PEEP. The rest of the VAR-PLUS consists of the Patient Connector Tee used to supply a flow of gas, entrain additional air, and provide a redundant pop-off valve

The provided document is a 510(k) summary for the VORTRAN Automatic Resuscitator (VAR-Plus), a Class II medical device. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain information about clinical studies measuring specific performance metrics against acceptance criteria.

The document explicitly states "Clinical Tests: None" and "Adverse S & E: None." Instead, the submission relies on in vitro testing and comparison to existing standards and predicate devices to demonstrate substantial equivalence.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered:

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

The document does not provide a table of acceptance criteria with corresponding device performance metrics. It refers to two standards/guidances that define performance and safety requirements:

• "FDA Draft Emergency Resuscitator Equivalency Guidance" 14 April 1993 868.5925 Powered Emergency Ventilator (Resuscitator) BTL
• "Standard Specification for Minimum Performance and Safety requirements for Resuscitators Intended for Use with Humans", ASTM Designation: F 920 - 93 (Reapproved 1999) An American National Standard.

However, the specific acceptance criteria from these documents and the VAR-Plus's reported performance against them are not detailed in this 510(k) summary. It only states that the device "meets" these standards. The device's operational characteristics are described qualitatively:

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

Not applicable, as no clinical tests were performed. The "in vitro testing" mentioned is not detailed in terms of sample size or methodology.

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)

Not applicable, as no clinical tests requiring expert-established ground truth were performed.

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

Not applicable, as no clinical tests requiring adjudication were performed.

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 mechanical resuscitator, not an AI or diagnostic imaging device that would typically undergo MRMC studies with human readers.

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

The device itself is a standalone mechanical resuscitator. However, "standalone performance" in the context of typical AI/diagnostic device evaluation refers to the algorithm's performance without human intervention, which is not relevant here. The device's performance, as a mechanical product, was evaluated through in vitro testing against standards.

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

Not applicable for clinical studies. The "ground truth" for the in vitro testing would be the specifications and requirements outlined in the referenced FDA Guidance and ASTM Standard. Compliance was likely verified through physical measurements and observations during bench testing.

8. The sample size for the training set

Not applicable, as this is a mechanical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable, as this is a mechanical device, not an AI/machine learning algorithm.

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