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

The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: 1. A flexible nipple for attachment to a sampling / pressure port. 2. Clear housing with a printed pressure scale 3. A float with indicator 4. Spring. When positive pressure is present in the ventilation device, the 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. Besmed intends offer three (3) models / styles of their disposable pressure manometer. They are identical in design, function and materials. The differences are: Pressure range. 0 0 60 cm H2O 0 40 cm H2O · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design Note the accuracy and performances are identical . Indicator strip . O All models have the pressure range embossed on the housing o A color strip / indicator may also be included to indicate the pressure. It is a single patient, disposable, packaged non-sterile device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific numerical sample size for the test set used for accuracy or other performance testing. It simply refers to "a number of tests."

• Data Provenance: The document does not specify the country of origin of the data. It implies the testing was conducted by or for Besmed Health Business Corp., which is located in New Taipei City, Taiwan. The studies were likely prospective as they were conducted to demonstrate the device's performance against defined criteria.

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

This information is not provided in the document. For a device like a pressure manometer, the "ground truth" for accuracy testing would typically be established by a highly accurate reference pressure measurement system or calibrated standard, not by human experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As the "ground truth" for pressure measurements is established by a reference instrument, an adjudication method involving human experts is not relevant for this type of objective performance testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a measurement tool, not an interpretive one.

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

This device does not contain an algorithm in the sense of AI. It is a mechanical device. The performance testing described ("Accuracy of pressure across the full pressure range") essentially is a standalone performance evaluation of the device's ability to measure pressure. There is no human-in-the-loop component for the measurement itself, only for the observation and interpretation of the displayed pressure by the clinician.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the accuracy testing, the ground truth was based on a reference pressure standard. The document states, "Accuracy of pressure across the full pressure range to meet the pass / fail criteria." This implies the device's readings were compared against a known, precise pressure source.

8. The Sample Size for the Training Set

This information is not applicable. This device is a mechanical manometer, not an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for a mechanical device.

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