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Nasal-Aire is intended for use as an accessory to respiratory ventilators. Ventilation is indicated for patients who require mechanical assistance with breathing.

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.

The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit

Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use.

The Nasal-Aire accessory and associated tubing is intended for use in delivering ventilation to patients. The device consists of a hollow silicone elastomer under nose strip with molded nasal insert sleeves made from silicone elastomer. The under nose strip is fitted bilaterally with 3/8" Tygon® tubing which serves as conduits for ventilation. The tubing is joined to form a single ventilation conduit by a silicone elastomer "Y" coupling. The system is completed by the "Y" coupling connected to an adapter for connection to the main ventilators supply line. When the device is worn by the patient the under nose strip is positioned across the patient's upper lip and the silicone nasal inserts are inserted in the patient's nares. The tubing drapes over the patient's ears in the manner of standard nasal cannulae used for administering oxygen with the "Y" coupling positioned in front of the patient.

This document describes the Nasal-Aire™ ventilator accessory and its clearance through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. It does not contain an acceptance criteria table with reported device performance in the way one would typically see for an AI/ML device or a device requiring specific performance metrics against a defined standard.

Instead, the performance evaluation for this medical device focuses on safety and functionality sufficient to demonstrate equivalence for its intended use as a ventilator accessory.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of a 1999 510(k) summary for a ventilator accessory.

Acceptance Criteria and Study for Nasal-Aire™ Ventilator Accessory

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "A limited clinical study was conducted using the device to assess unintended leakage of respiratory gases during clinical use. In vivo tests with healthy subjects..." The exact number of healthy subjects is not specified.
• Data Provenance: The study was "in vivo" (on living subjects). The location or country of origin is not specified, but it's likely in the USA given the FDA application. The study appears to be prospective as it involved testing the device on subjects.

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

• Not Applicable. This type of device evaluation (for a physical medical accessory) does not typically involve expert consensus for "ground truth" in the same way an AI/ML diagnostic device would. Performance was directly measured (e.g., leakage).

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no "ground truth" established by experts or human readers to adjudicate, this concept does not apply to this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• No. An MRMC study is relevant for diagnostic or interpretive devices involving human readers. This is a ventilator accessory, and its effectiveness was evaluated based on physical performance parameters like leakage and biocompatibility.

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

• Not Applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used:

• For the leakage study, the "ground truth" was the direct measurement of unintended leakage during ventilation.
• For biocompatibility, the "ground truth" was compliance with established material safety standards (FDA Blue Book Memorandum G95-1 and ANSI/AAMI/ISO Standard 10993 (Part 1)).

8. The sample size for the training set:

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

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

• Not Applicable. This device does not use machine learning or AI, so there is no training set or ground truth for it.

Summary Context:

This 510(k) summary (from 1999) describes a physical medical device. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended (minimal leakage, comfortable fit), uses safe and compatible materials, and is substantially equivalent to a legally marketed predicate device (The Monarch® Mini Mask). The studies mentioned are primarily focused on physical performance and material safety, not on diagnostic accuracy or AI performance.

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