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The intended use of the "Oxi-Snap" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.

The Oxi-SNAP testing system is only intended for short term monitoring such as to record the oximetry level continuously during the night.

The "Oxi-SNAP" system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.

The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.

This notification is for a modification to the existing device, the "Snap Testing Device" the modified device is called the "Oxi-Snap" The modification involves the addition of the ability to record and analyze, (along with snoring sounds) the oxygen saturation level of the patient being monitored. An FDA cleared oximeter (Palco Model K943842) is connected to the currently used DAT tape 305, recorder, and the oxygen saturation is recorded while the patient is under test. Later, during the analysis phase, O2 SAT levels appear on the playback analysis screen, thereby allowing an additional criterion of apnea to be used.

The provided text [K971184](https://510k.innolitics.com/search/K971184) is a 510(k) summary for the "Oxi-Snap" device, which is a modification of an existing device ("Snap Testing Device") to include oxygen saturation level recording and analysis. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove the device meets those criteria in a typical stand-alone performance study format.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring. Instead, it relies on demonstrating that the modified device ("Oxi-Snap") is as safe and effective as its predicate devices, primarily the "Snap Testing Device" (K944524), and incorporates an FDA-cleared oximeter (Palco Model 305, K943842).

The "Performance Testing" section in the Substantial Equivalence Chart for the "Oxi-SNAP" states "Summarized above," referring to the general conclusion of safety and effectiveness presented earlier. For the predicate "SNAP testing device," it refers to "Original submission," implying detailed performance data was provided in its initial filing.

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance metrics directly from this document. The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence and maintaining the safety and effectiveness of the predicate.

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

The document mentions "bench and user testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention using experts to establish ground truth for a test set. This type of study design for determining diagnostic accuracy with expert-derived ground truth is not described in this 510(k) submission, which focuses on substantial equivalence.

4. Adjudication Method for the Test Set

Since no expert-established ground truth study is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on the technical modification of the device and its claimed equivalence to existing devices. Its purpose is not to demonstrate improvement over human readers with or without AI assistance.

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

The "Oxi-Snap" system is described as an "analyser service center" where tapes are analyzed, implying a human-in-the-loop for interpreting the recorded data. However, the core of the submission is about the device's ability to record and present data, not a standalone AI algorithm producing diagnoses. The Palco Model 305 oximeter, which is incorporated, would have undergone standalone performance testing as a prerequisite for its own FDA clearance (K943842). The Oxi-Snap itself is an analysis system that presents data.

7. The Type of Ground Truth Used

The document does not explicitly describe a ground truth used for performance evaluation of "Oxi-Snap" similar to what would be found in a diagnostic accuracy study. The "effectiveness" is primarily assessed by its ability to record and provide additional information (oxygen saturation) in a manner comparable to its predicate and the incorporated cleared oximeter. Polysomnography (PSG) is often considered the gold standard for sleep apnea diagnosis, and the document states the Oxi-SNAP system is "not intended as a substitute for full polysomnography." This suggests that while it screens for apnea, its "ground truth" for screening performance is likely benchmarked against clinical utility as a screening tool, not necessarily against a definitive PSG diagnosis within this specific filing.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is not an AI/machine learning device in the contemporary sense, but rather a modification to a recording and analysis system.

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

Since there is no mention of a training set, no information is provided on how its ground truth would have been established.

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