(34 days)
The Watch-PAT200S-2 (WP200S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-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 WP200S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP200S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP200S-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 WATCH-Pat200-2 System (WP200S-2) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP200S-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. a, based on Peripheral Arterial Tonometry (PAT); a non-invasive technology.
The WP200S-2 System is a compact version of the WP100S-2 System, both consist 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 finger-mounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, optopneumatic sensor.
The provided FDA 510(k) document for the Itamar Medical Ltd Watch PAT200S-2 System does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy).
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (Watch-Pat100S-2, K080427) and a device with identical hardware (Watch-Pat200i, K081037). The “Performance Data & Substantial Equivalence” section explicitly states:
"The WP200S-2 System is substantially equivalent in all aspects, including technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available WP100S-2 System, cleared under K080427 and in respect of its hardware is also substantially equivalent to the WP200i System cleared under K081037."
Therefore, the acceptance criteria are implicitly those that defined the substantial equivalence of the predicate devices, and the "study" is largely a comparison to these predicates and engineering verification/validation rather than a new clinical performance study with defined acceptance thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As a new clinical study with specific performance acceptance criteria for the WP200S-2 was not conducted or reported in this document, such a table cannot be directly generated from the provided text. The "acceptance criteria" for the WP200S-2's clearance were its substantial equivalence to the WP100S-2 (for all aspects, including performance and software) and WP200i (for hardware).
The document mentions that the WP200i/WP200S-2 hardware was subjected to:
- Electrical and electromagnetic testing
- Electronics design verification test
- Performance testing demonstrating the accuracy of the captured signals and device's reproducibility
And the software underwent:
- Comprehensive software verification and validation activities to ensure it meets all software requirement specifications.
Essentially, the reported performance is that it performs equivalently to the predicate devices. No specific numerical metrics (e.g., accuracy, sensitivity, specificity for RDI/AHI, or sleep staging against a gold standard) are provided for the WP200S-2 itself from a new clinical study in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in this document. The submission relies on the performance data of the predicate devices and engineering tests for the new device.
- Data Provenance: Not explicitly stated for any clinical data specifically related to the WP200S-2 or its predicates in this document. The K080427 and K081037 submissions for the predicate devices would contain this information.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided document, as a new clinical study with a defined test set for performance evaluation against a ground truth was not detailed.
4. Adjudication Method for the Test Set
This information is not available in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study for human readers with and without AI assistance is not mentioned in this document. The device is a diagnostic aid, and the primary focus of this 510(k) is substantial equivalence based on prior device clearances.
- Effect Size: Not applicable, as no such study was reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? A standalone clinical performance study with specific metrics (e.g., sensitivity, specificity, accuracy against a gold standard like polysomnography) for the WP200S-2 itself is not detailed in this document. The document states: "Performance testing demonstrating the accuracy of the captured signals and device's reproducibility" was done for the hardware, and "comprehensive software verification and validation activities" were conducted. These are engineering and software tests, not typically clinical performance studies against a medical ground truth (like physician diagnosis or pathology). The substantial equivalence claim implies that its standalone performance is similar to its predicates, but no new study data is presented here.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified in this document as a new clinical performance study against a specific ground truth for RDI/AHI or sleep staging was not detailed for the WP200S-2. For devices detecting sleep disorders, the typical gold standard ground truth is Polysomnography (PSG) readings interpreted by a sleep specialist. The substantial equivalence claim implies that the predicate devices demonstrated acceptable performance against such a standard.
8. Sample Size for the Training Set
- Training Set Sample Size: This information is not available in the document. The document refers to the device's software as being the same as the WP100S-2, which implies that any "training" (if an AI/ML component was used, which is not explicitly stated but implied by "diagnostic aid" and algorithm-based indices) would have occurred during the development of the predicate's software.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: This information is not available in the document. As stated above, any ground truth used for developing the algorithms (if applicable) would have been established during the development of the predicate device's software.
§ 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).