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The P-M O2 Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O2 Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.

The Passy-Muir O2 Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube

This 510(k) summary describes a device that is an accessory to an existing medical device, rather than a standalone diagnostic or therapeutic device. As such, it does not involve the typical clinical study or performance metrics that would require the detailed breakdown of acceptance criteria, sample sizes, and ground truth establishment you've requested.

The submission focuses on demonstrating substantial equivalence to existing devices, primarily by showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where applicable and explaining why others are not present:

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This submission is for a Class II medical device accessory, the Passy-Muir Oxygen (O2) Adapter. The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices, focusing on safety and functional characteristics typical for O2 delivery accessories. No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance are explicitly stated in the document, nor would they be expected for this type of device. The "study" proving the device meets criteria is primarily a comparison to predicate devices and an assessment of its operational principles.

1. Table of Acceptance Criteria and the Reported Device Performance

As mentioned, explicit quantitative acceptance criteria are not provided for this type of accessory. The "reported device performance" is described through its functional design and how it operates similarly to existing devices.

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

• Sample Size for the Test Set: Not applicable. No clinical "test set" of patients or data was used in the assessment of this device, given its nature as an accessory relying on the established safety and effectiveness of its predicate devices and its simple mechanical function.
• Data Provenance: Not applicable. The submission relies on a comparison to existing, legally marketed devices and general knowledge about oxygen delivery systems. No specific patient data or clinical trial data is presented.

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

• Number of Experts & Qualifications: Not applicable. There was no "test set" requiring ground truth establishment by experts in a clinical context. The assessment is based on engineering principles and comparison to predicate devices, evaluated by the FDA's reviewers.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring clinical adjudication was involved.

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

• MRMC Study: No. Such a study is completely irrelevant for an oxygen adapter. This type of study is typically used for diagnostic imaging devices to assess how AI impacts the performance of human interpreters.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No. This device is a mechanical accessory, not an algorithm or an AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for this submission revolves around the known functional principles of oxygen delivery accessories and the established safety and effectiveness profiles of predicate devices. The truth is established through engineering design, material compatibility, and comparison to existing products.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical accessory, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

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