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The WatchPAT400 (WP400) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The device is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP400 generates a peripheral arterial tonometry ("PAT"), Respiratory Disturbance Index ("pRDI"), Apnea-Hypopnea index ("pAHI"), Central Apnea-Hypopnea index ("pAHIc"), sleep staging identification (pSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The device's pSTAGES and snoring level and body position provide supplemental information to its pRDI/pAHI/pAHIc. The device's pSTAGES and snoring level and body position are 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.

pAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

The WP400 is a ventilatory effort recorder that utilizes PAT technology. The controller part of the device is worn on the wrist and records the PAT signal and arterial blood oxygen saturation levels by a finger-mounted probe based on an optical plethysmographic method. An actigraph, embedded in the wrist worn controller unit, records wrist motion that is used to determine periods of sleep vs wake. A chest sensor is attached to the patient's chest right under the sternal notch for measuring snoring level, body position states and chest movements. The device is battery powered and connects via Bluetooth to a mobile application.

The WP400 is a re-usable device, with sensors common with the WP300 and wireless connectivity identical to the WP1. With the same core technology, signal acquisition, and signal processing identical across all three WatchPAT devices, the WP400 is a combination of its predecessors: device housing leveraged from the WP300 for its re-usable nature, combined with the ability for wireless communication leveraged from the WP1. Signals recording, processing, and analysis has not changed from the predicate devices.

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The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES and SBP are 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-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U 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), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200U may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (3) external integrated snoring and body position sensor - SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply.

The Watch-PAT200U is identical to the already cleared Watch-PAT200S-3 except for Itamar Medical pulse oximetry which replaces the existing Nonin pulse oximeter.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Eleven (11) healthy adult volunteer subjects.
• Data Provenance: The study was clinical, meaning prospective patient data was collected specifically for this evaluation. It was conducted in CLINIMARK Laboratories, implying a controlled laboratory setting. The country of origin is not explicitly stated for the subjects, but the applicant's address is Caesarea, Israel, and the contact person is in Washington, DC, USA. The study was performed to US FDA guidance.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the test set. However, the ground truth for SpO2 accuracy was established by CO-Oximetry for arterial blood samples, which is a highly accurate and accepted reference method in clinical practice, typically operated by trained medical laboratory professionals.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by direct physical measurement (CO-Oximetry of arterial blood samples) rather than expert interpretation of data.

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

No MRMC comparative effectiveness study was done. The study focused on the standalone accuracy of the device's pulse oximeter component against a reference standard, not its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The clinical study directly evaluated the SpO2 accuracy of the Itamar Medical Pulse Oximetry system (WP200U) against CO-Oximetry, without involving human interpretation of the device's output to establish the primary metric.

7. Type of Ground Truth Used:

The ground truth used was objective physical measurement: CO-Oximetry of arterial blood samples.

8. Sample Size for the Training Set:

The document does not provide information specific to a training set or its sample size. The focus is on the clinical validation of the device's pulse oximetry component, which implies that the algorithm for oxygen saturation calculation was already developed and this study served as a validation "test set."

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

The document does not detail how the ground truth for any potential training set was established. It only describes the ground truth for the clinical validation study as CO-Oximetry. The text mentions a "new algorithm to calculate oxygen saturation" was incorporated into the software, but it doesn't describe the development or training process for this algorithm.

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The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP are 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-PAT200S-3 System (WP200S-3) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 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), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200S-3 may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200S-3 device is worn on the wrist and consists of the following: (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) external integrated snoring and body position sensor - SBP (Optional); (5) electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, actigraph and SBP, (6) the device software; and (7) a power supply.

The Watch-PAT200S-3 is identical to the already cleared Watch-PAT200S-2 with the addition of an optional snoring level and body position sensor and the required electronic and software modification. The integrated sensor (SBP) is an optional external hardware which can be connected to the WP200S-3 device and attached to the patient's chest right under the sternal notch for recording snoring and body position signals.

Here's a breakdown of the acceptance criteria and study information for the Watch-PAT200S-3, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria (e.g., sensitivity, specificity thresholds). Instead, the performance testing demonstrated substantial equivalence to predicate devices and focused on the addition of the SBP sensor. The general "acceptance criteria" can be inferred to be successful completion of the described performance tests to demonstrate safety and efficacy.

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

The document mentions "a clinical study" was performed and that "supportive clinical data" was used. However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the clinical study.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used (e.g., 2+1, 3+1, none) for the test set in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The document does not mention or describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is described as a diagnostic aid that generates indices (PRDI, PAHI, PSTAGES) and provides supplemental information. The focus of the clinical study mentioned was on supporting the snoring level and body position claims.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device (Watch-PAT200S-3) as a diagnostic aid that generates PRDI, PAHI, PSTAGES, and optionally snoring level and body position discrete states, operates in a standalone manner. The clinical study and performance testing would have evaluated the standalone performance of the device's algorithms to support its claims. The document implies an algorithm-only performance assessment where the device's outputs (PRDI, PAHI, etc.) are compared against a ground truth.

7. The Type of Ground Truth Used

The document explicitly states that the clinical study was conducted to support "the claim of measuring snoring level in decibels and body position." While not explicitly stated, it is highly probable that the ground truth for these measurements would have been established by reference devices or expert observation/recording (e.g., simultaneous polysomnography (PSG) recording for body position and sound level meters for snoring, or expert scoring of PSG data). For PRDI/PAHI and sleep staging, the typical ground truth in such studies is concurrently recorded, expertly scored polysomnography (PSG) data.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of any algorithms within the device.

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 (if any was used for algorithm development) was established.

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