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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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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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