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The intended use of the "Snap Model 5™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.

The "Snap Model 5™" 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 "Snap Model 5TM" device.

This notification is for a modification to the existing device, the "Digi-Snap™" Testing Device. The modified device is called the "Snap Model 5™4" The modification involves the use of a personal computer with certain options installed instead of the specialized microcomputer and Zip drive system. The oximeter is connected to the unit along with the usual microphone/cannula apparatus and the oximeter sensor is slipped over the patient's finger in the usual manner. The patient turns on the unit, then goes to sleep. Apnea and snoring events are then recorded. After awakening, the patient returns the disk and the equipment to the analysis service center, where the disk is analyzed. If the patient's own personal computer was used, only a disk is returned to the analysis center for evaluation.

The provided text describes a 510(k) premarket notification for the "Snap Model 5TM" device, which is a modification of an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone performance study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring, nor does it present a table of such performance. Instead, it relies on demonstrating substantial equivalence to an existing predicate device ("Digi-Snap™ Testing Device," K984169).

The "Performance testing" section in the Substantial Equivalence Chart simply states "Summarized above," but no performance data or acceptance criteria are actually summarized above or elsewhere in the provided document. The conclusion states: "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device."

2. Sample Size for Test Set and Data Provenance

The document does not specify any sample size for a test set (e.g., number of patients or recordings used for evaluation). It mentions "user testing data" but provides no details on its composition or origin.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth or their qualifications. The evaluation appears to be based on the device's functional equivalence to a previously cleared device.

4. Adjudication Method for Test Set

The document does not describe any adjudication method, as it doesn't detail a study involving expert review or grading of cases.

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

No MRMC comparative effectiveness study is mentioned. The submission is focused on device modification and substantial equivalence, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study

A standalone performance study (algorithm only performance without human-in-the-loop) is not described. The submission focuses on the modified device's functionality and its equivalence to the predicate device, stating that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." However, no numerical results from such testing are provided.

7. Type of Ground Truth Used

Given the absence of a detailed performance study, the document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The implicit "ground truth" for the modified device's performance appears to be the established performance of the predicate device.

8. Sample Size for Training Set

The document does not mention a training set or its sample size. This is consistent with the nature of the submission, which is for a modification to an existing device rather than a de novo submission for a new AI algorithm requiring extensive training data.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of what is indicated:

The submission for the "Snap Model 5TM" is a 510(k) for a modification to an already cleared device ("Digi-Snap™"). The core argument for clearance is substantial equivalence to the predicate device, focusing on changes in hardware (personal computer instead of specialized microcomputer, floppy disk instead of Zip drive) and updates to labeling and instructions. The performance claim is that the modified device is "as safe and effective as the predicate device," based on unspecified "bench and user testing data," but no quantitative performance metrics, test set details, or ground truth methodologies are provided in this document.

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