(98 days)
The Watch-PAT100S-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
The WP100S-2 is not indicated for children less than 17 years old.
The WATCH-PAT100S-2 System (WP100S-2) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT); a non-invasive technology.
The WP100S -2 device consists of: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger, for measuring blood oxygen saturation; (3) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (4) Electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, and actigraph; (5) the device software; and (6) a power supply.
The device is worn on the wrist, and continuously measures the relative state of the vasomotor activity in the distal part of the finger, by a fingermounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, opto-pneumatic sensor.
Acceptance Criteria and Device Performance Study for Watch-PAT100S-2 (K080427)
The Watch-PAT100S-2 (WP100S-2) is a non-invasive home care device intended as a diagnostic aid for detecting sleep-related breathing disorders and sleep staging. The device generates a Peripheral Arterial Tonometry (PAT) Respiratory Disturbance Index (PRDI), Apnea-Hypopnea Index (PAHI), and PAT sleep staging identification (PSTAGES).
1. Acceptance Criteria and Reported Device Performance
The provided document describes a clinical study conducted to validate the accuracy of the WP100S-2. While explicit, quantified acceptance criteria for specific metrics are not directly stated in the excerpt, the study aims to establish accuracy against gold-standard Polysomnography (PSG) and predicate devices. The "reported device performance" is the conclusion that the study results establish the accuracy of the WP100S-2 for both Sleep Staging identification and Sleep Apnea Indices (PRDI and PAHI). The substantial equivalence claim is based on performance testing results.
Given the information, a table summarizing the acceptance criteria and performance would look like this:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Accuracy in Sleep Staging Identification (against gold-standard PSG and predicate BioSleep) | Clinical study results established the accuracy of the WP100S-2 System in Sleep Staging identification. |
| Accuracy in Sleep Apnea Indices (PRDI and PAHI) (against gold-standard PSG and predicate WP100S) | Clinical study results established the accuracy of the WP100S-2 System in Sleep Apnea Indices (PRDI and PAHI). |
| Substantial Equivalence | The device is substantially equivalent to its predicates without raising new issues of safety or effectiveness. |
| Software Performance | Software validation testing verified that the WP100S-2 System performs according to its specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "A clinical study was conducted to validate the accuracy of the WP100S-2 System." However, the exact sample size used for the test set is not specified within the provided text.
Regarding data provenance, the document does not explicitly state the country of origin of the data. The study is described as a "clinical study," which implies it was prospective, as it was conducted to validate the accuracy of the device.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, there is no reported effect size for how much human readers improve with AI vs. without AI assistance. The study described focuses on the device's standalone accuracy against gold standards.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical study was conducted "to validate the accuracy of the WP100S-2 System in sleep staging identification and detection of respiratory related sleep disorders" against gold-standard PSG and predicate devices. This implies evaluating the algorithm's performance without human intervention as a primary outcome.
7. Type of Ground Truth Used
The type of ground truth used for the clinical study was:
- Gold-standard PSG (Polysomnography): This is explicitly stated as the primary benchmark for validation of both sleep staging and respiratory related sleep disorders.
- Predicate devices: The BioSleep for sleep staging identification and the WP100S for respiratory disturbance index were also used for comparison.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. The text primarily focuses on the validation study.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. It only mentions a clinical study for validation and software verification and validation activities.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).