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The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis. The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.

The EZsleep Sleep Quality Recorder is a small battery powered device designed to be simple and easy to use by a patient who suffers from sleep disorder. It is self-contained, with integrated microcontroller and LED displays and all necessary interface electronics for performing recording functions. The device has a storage function in which the recorded signals can be transmitted through a USB port to a computer for data analysis. The proposed device is intended for adults who suffer from sleep disorders such as abnormal pauses in breathing (apnea), or instances of abnormally low breathing during sleep (hypopnea). This device is not intended to substitute for a hospital device for diagnosis of sleep disorders. This device is also not intended for recording and transmission of user's heart rate signal simultaneously. Users with implanted pacemaker are not recommended to use this device.

This 510(k) premarket notification for the EZsleep Sleep Quality Recorder does not contain the detailed information typically found in a study report that directly establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards.

Here's an analysis based on the provided document, addressing your specific points where information is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a performance table in the format usually associated with clinical or analytical validation studies. Instead, it relies on general performance claims and adherence to standards.

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

The document does not specify a sample size for a test set in the context of a clinical performance study. The "Performance Summary" primarily refers to bench tests for electrical safety, EMC, and biocompatibility. These types of tests typically involve a limited number of device units or specific materials rather than patient data.

Data Provenance: Not applicable based on the type of tests described.

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

This information is not provided in the document. The filing describes safety and engineering tests, not a clinical study involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As explained above, the document details engineering and safety tests, not clinical evaluations that typically employ adjudication methods.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) submission. The device is a "Sleep Quality Recorder" which records heart rate signals. The recorded data is intended for "sleep quality analysis using the software, Sleep Quality Apnea Examination System, which was already cleared by US FDA, as K070855." This implies the EZsleep device is a data acquisition tool, and its primary function being evaluated here is accurate signal recording and safe operation, not diagnostic efficacy compared to human readers.

6. Standalone Performance Study

A standalone performance study, in the sense of an algorithm-only diagnostic performance without human-in-the-loop, is not described for the EZsleep device itself. The EZsleep is a recorder. Its "performance" in this context is about accurately recording signals and meeting safety/EMC standards, not about making diagnostic interpretations. The document explicitly states the recorded data is for analysis by another cleared software (K070855), implying that diagnostic interpretation is handled by that separate system, not the EZsleep recorder in standalone mode.

7. Type of Ground Truth Used

For the bench tests mentioned:

• Electrical Safety & EMC: Ground truth would be defined by the specifications in IEC 60601-1 and IEC 60601-1-2. The "truth" is whether the device's electrical characteristics and electromagnetic compatibility fall within the limits set by these standards. This is generally determined by calibrated test equipment.
• Biocompatibility: Ground truth is established by ISO 10993 guidelines, which define acceptable levels of biological response to materials. Testing would involve observing biological reactions (e.g., irritation) to the device's materials.

No human expert consensus, pathology, or outcomes data is referenced for establishing ground truth for the EZsleep recorder's performance in this document.

8. Sample Size for the Training Set

The document does not mention a training set as this filing describes a hardware device (recorder) and its associated bench tests, not an AI/ML algorithm that would typically require a training set.

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

Since no training set for an AI/ML algorithm is mentioned, this point is not applicable.

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