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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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PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

The PowerNeb is a pneumatic, single-patient use device used to enhance secretion clearance, deliver aerosol, and recruit lung volumes. PowerNeb uses a fixed venture against a user-set orifice to create a continuous high frequency oscillation (CHFO) waveform at 180-220 breaths per minute (BPM). The PowerNeb can also deliver a continuous expiratory pressure (CPEP) when switched to CPEP mode. This device is pneumatic in operation and does not incorporate any electronic parts or software. This device is non-sterile, and is not intended to be sterilized by the user. The PowerNeb is packaged with a a small-volume nebulizer/mouthpiece, and a disposable manometer, each of which has been previously 510k cleared.

Here's an analysis of the provided text regarding the PowerNebTM device, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission typically does not include detailed clinical study results or acceptance criteria in the same way a PMA (Pre-Market Approval) or a full clinical trial publication would. The focus here is on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. Therefore, direct "acceptance criteria" and "study proving device meets acceptance criteria" as might be found in a clinical trial report are not explicitly stated in this document.

The "Performance Testing" mentioned is comparative testing against predicate devices and particle size testing for the nebulizer component, not a full-scale clinical trial with predefined end-point acceptance criteria in the traditional sense.

Acceptance Criteria and Device Performance

Since explicit acceptance criteria for a "study proving the device meets the acceptance criteria" are not detailed in this 510(k) summary, the table below will instead reflect the comparative features to predicate devices, which serve as the implicit "acceptance" for substantial equivalence. The "Acceptance Criteria" column will list critical features where the proposed device is expected to be comparable or equivalent to its predicates. The "Reported Device Performance" will detail how the PowerNeb® aligns with these features.

Study Details (Based on the 510(k) Summary)

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

   • Test Set Size: Not specified. The document mentions "comparative testing against the predicate devices" and "testing of particle sizes from the small-volume nebulizer," but does not provide details on the number of devices tested or the specific test protocols.
   • Data Provenance: Not specified. It's likely these were internal laboratory or bench tests conducted by the manufacturer, Comedica, Inc. (Dallas, TX, USA). The document does not indicate the country of origin of data or whether it was retrospective or prospective.

2. 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. This was a 510(k) submission for a noncontinuous ventilator, not an imaging or diagnostic device requiring expert interpretation for ground truth. Performance would be assessed through objective measurements against engineering specifications and predicate device performance.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This document describes performance testing of a mechanical device.

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 device is a noncontinuous ventilator and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.

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

   • Yes, in the sense that the device's performance was assessed independently. The document states, "Performance testing includes comparative testing against the predicate devices, as well as testing of particle sizes from the small-volume nebulizer both with and without the PowerNeb, to determine any effects of the PowerNeb on the nebulizer's performance." This implies bench testing of the device's functional attributes. The device itself is described as "pneumatic in operation and does not incorporate any electronic parts or software," so there is no "algorithm" in the modern AI sense.

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

   • For this type of device, "ground truth" would be established by:
     • Objective engineering measurements: Such as pressure measurements (cmH2O), flow rates, frequency (bpm), and particle size distribution for nebulization.
     • Comparison to predicate device specifications/performance: Demonstrating that the PowerNeb® operates within expected parameters analogous to the legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

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

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