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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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DynaDx Sleep Quality is intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.

Sleep Quality is a software system, which can probe the dynamical interactions between heart rate and respiratory variability during sleep by using a single lead Electrocardiogram (ECG) recording. It is designed to support FDA approved Holter Monitor devices on the market. Sleep Quality system takes text format ECG recording as input. It requires that supported Holter devices are able to export their recording into ASCII data format. Most of the commencially available Holter Monitors devices have this capability. ECG recording data is first collected by a standard Holter devices na subject's sleep, is converted into ASCII data format, and is then analyzed by the Sleep Quality system. By recognizing episodes of Sleep Disordered Breathing (SDB), the software indicates that apneic events have occurred and estimated the Apnea-Hypopnea Index (AH). To detect SDB, the algorithm derives both RR Interval and ECG-Derived Respiratory (EDR) information from the ECG recording.

The DynaDx Sleep Quality device is intended as a screening tool for sleep apnea in adult patients, determining the need for further clinical diagnosis and evaluation by polysomnography. The ECG recordings can be obtained in various settings (home, hospital, clinic) from subjects with at least 4 hours of sleep and predominantly sinus rhythm in their ECG.

The acceptance criteria for the DynaDx Sleep Quality device and its reported performance are presented below, along with a comparison to its predicate device, Lifescreen Apnea.

1. Table of Acceptance Criteria and Reported Device Performance

The DynaDx Sleep Quality device demonstrated performance metrics (Sensitivity, Specificity, Accuracy, Positive Predictivity) that met or exceeded those of the predicate device, Lifescreen Apnea, for both per-subject and per-minute analyses.

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

The document does not explicitly state the sample size used for the test set specifically or data provenance (e.g., country of origin, retrospective/prospective). It does, however, provide "Sleep Length for Test" as 26,100 minutes for both the submission device and the predicate device, suggesting a total duration of ECG recordings used for evaluation. This value alone does not specify the number of individual patients.

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

This information is not provided in the submitted text.

4. Adjudication Method for the Test Set

This information is not provided in the submitted text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on the standalone performance of the algorithm without human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The reported performance metrics (Sensitivity, Specificity, Accuracy, Positive Predictivity) for "DynaDx Sleep Quality (Submission Device)" reflect the performance of the algorithm itself in detecting apneic events and estimating the Apnea-Hypopnea Index (AHI) from ECG recordings. This is evident from the fact that it's a software system analyzing ECG data to produce these metrics.

7. Type of Ground Truth Used

The document states that the device is intended "to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score." This strongly implies that the ground truth for evaluating the device's performance (i.e., whether a patient needs clinical diagnosis and evaluation by polysomnography, or the occurrence of apneic events and AHI) would be established by polysomnography (PSG). PSG is the gold standard for diagnosing sleep disordered breathing, including sleep apnea.

8. Sample Size for the Training Set

This information is not provided in the submitted text. The document focuses on the performance of the device rather than the specifics of its training.

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

This information is not provided in the submitted text. However, similar to the test set, it is highly probable that if a training set were used, its ground truth would also be established by polysomnography.

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