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The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The 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. CAUTION: US Federal law restricts this device to sale by or on the order of a physician, Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the "Digi-Snap™" device.

This notification is for a modification to the existing device, the "Oxi-Snap™" Testing Device. The modified device is called the "Digi-Snap. TM" The modification involves the use of a 100 MB "Zip" drive in place of the DAT tape recorder. This eliminates one A/D-D/A conversion because the snoring sounds are digitized at the first opportunity, in the unit at the patient's bedside.

The provided text does not contain any specific acceptance criteria or performance metrics for the "Digi-Snap TM" device. The submission is for a modification to an existing device, focusing on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed performance outcomes against predefined criteria.

The document primarily describes:

• Device Identification: The "Digi-Snap TM" device, its classification, and common name.
• Predicate Device: "Oxi-Snap TM" Testing Device (K971184).
• Intended Use: Screening patients for apnea and snoring, providing quantitative and qualitative analysis, short-term monitoring, not a substitute for full polysomnography.
• Description of Modification: Replacement of a DAT tape recorder with a 100 MB "Zip" drive for digital recording.
• Substantial Equivalence Chart: Compares characteristics of the modified device to the predicate device, highlighting changes in recording device, channels acquired, user equipment, and energy source.
• Conclusion: The device is deemed as safe and effective as the predicate device based on "bench and user testing data," achieving substantial equivalence.
• FDA Clearance Letter: Confirms substantial equivalence finding.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's an attempt to answer based on the available information, explicitly stating when data is not provided:

Acceptance Criteria and Device Performance Study Information for "Digi-Snap TM"

The provided 510(k) submission for the "Digi-Snap TM" device focuses on demonstrating substantial equivalence to a predicate device ("Oxi-Snap TM," K971184) due to a modification (replacing a DAT tape recorder with a Zip drive). It emphasizes that the modified device is "as safe and effective" as the predicate based on "bench and user testing." However, no specific quantitative acceptance criteria or detailed performance results from a clinical study are provided in this document to directly populate the requested table or answer most detailed questions about device performance against such criteria.

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or corresponding reported device performance metrics are provided in the document. The submission states that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." This is a qualitative statement of equivalence rather than a report on specific performance metrics against defined criteria.

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

• Test Set Sample Size: Not provided. The document mentions "bench and user testing" but gives no details on the number of subjects or cases included in these tests.
• Data Provenance: Not specified, but given the context of US regulatory submission by a US company (Glenview, IL), it can be inferred that testing would likely have taken place in the US. The document does not specify if the data was retrospective or prospective.

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

Not provided. Details about how "user testing" was conducted, who assessed the results, or the qualifications of any involved experts are absent.

4. Adjudication Method for the Test Set

Not provided.

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

Not indicated. The document focuses on device modification and equivalence, without suggesting a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone Performance Study

The submission indicates "bench and user testing," but no specific standalone performance study report with detailed metrics (e.g., sensitivity, specificity for apnea detection) is included in the provided text. The focus is on demonstrating that the modified component (Zip drive for recording) does not compromise the overall safety and effectiveness established by the predicate device.

7. Type of Ground Truth Used

Not explicitly stated. Given the device's purpose (screening for apnea and snoring), the "user testing" likely involved comparisons to established methods of diagnosing these conditions (e.g., polysomnography or other clinical assessments), but this is not detailed in the document.

8. Sample Size for the Training Set

Not applicable. This device is a recording and analysis system, not an AI/machine learning algorithm that typically requires a training set. The modification described is a hardware change (recording medium).

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

Not applicable (as it's not an AI/ML device with a training set).

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