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To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits.

For patients that the clinician desires to monitor or measure airway or circuit pressure.

Home, Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

The Westmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

• 1. Clear housing with a printed pressure scale
• 2. A float with indicator and
• 3. Spring

It functions by reacting to the positive present in the ventilation device. When pressure is in the device the float moves up or down to indicate the pressure of the system. This manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range -0-60 cm H2O. The performance characteristics are that the measured pressures are accurate to:

• • 3 cm H2O up to 60 cm H2O
    It is a single patient, disposable, packaged non-sterile device.

Here's a breakdown of the acceptance criteria and study information for the Disposable Pressure Manometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The predicate device K003497 had different accuracy criteria:

• ± 1 cm H₂O from 0-10 cm H₂O
• ± 2 cm H₂O from 10-40 cm H₂O
• ± 3 cm H₂O above 40 cm H₂O
  The proposed device set its own accuracy criteria, consistent with reference devices (K040991 Ambu, K954486 Mercury Medical) for a wider pressure range.

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

• Sample Size for Test Set: The document states that "All samples met the pass/fail criteria" for Accuracy and Repeatability, Aging, Mechanical, Environmental, and Positional Orientation tests. It also mentions "Samples were dropped," "Samples which had real-time aging and samples in accelerated aging were pressurized," and "Each sample was tested multiple times." However, the exact number of samples (N) used for the test set is not explicitly stated in the provided text.
• Data Provenance: Not specified, but likely from in-house testing by Westmed, Inc. No mention of geographical origin or whether it's retrospective or prospective is made.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. This device is a measurement tool (manometer), and ground truth for its performance is established by comparison to a calibrated standard (digital manometer), not expert interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth for a physical measurement device's accuracy and performance is typically determined against established calibration standards and engineering specifications, not human adjudication.

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

• MRMC Study Done: No. This is a physical medical device (disposable pressure manometer) used for objective measurement, not an AI or diagnostic imaging device that requires human interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, in essence. The documented "Non-Clinical Testing Summary" details the performance of the Westmed DPM device itself, including its accuracy, repeatability, and resilience to aging, mechanical stress, environmental conditions, and positional changes. This testing is performed on the device without a human in the loop, directly measuring its output against a digital manometer.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's accuracy and repeatability was established by comparison with a digital manometer (implicitly, a calibrated standard). The "Summary: Accuracy and Repeatability" section states: "Samples were pressurized across the range and confirmed with the digital manometer."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. Its functionality is based on mechanical principles (spring and float), not learned patterns.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.

The Mercury CPAP device is considered substantially equivalent to its predicate device (Vygon Boussignac CPAP - K013884) based on comparative performance testing. The acceptance criteria are implicit in the comparison to the predicate device's performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "We have performed comparative performance testing, Comparative Flow vs. CPAP Pressure" and "Performance of the pressure relief valve." However, specific sample sizes for these tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies the testing was conducted by or for Mercury Medical, Inc.

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

This information is not applicable or not provided. The study is a comparative performance test of a medical device (CPAP machine) against a predicate device, focusing on physical and performance characteristics like gas flow, pressure, and mechanical features. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the typical sense (e.g., image interpretation by radiologists).

4. Adjudication method for the test set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where disagreements need to be resolved. This study focuses on device performance metrics.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study concerns the physical and performance characteristics of a CPAP device, not an AI or diagnostic imaging system that would involve human readers.

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

No, this is not an AI-driven device, and therefore the concept of "algorithm only" or "human-in-the-loop" performance is not relevant. The testing performed was on the physical device itself.

7. The type of ground truth used

The "ground truth" for this type of device comparison is the established performance characteristics and specifications of the predicate device (Vygon Boussignac CPAP - K013884), as well as engineering standards for CPAP functionality and safety. The Mercury CPAP's performance was compared against these established benchmarks.

8. The sample size for the training set

This information is not applicable. This is a hardware medical device and does not involve machine learning algorithms that require a "training set."

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

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

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