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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. TheWP200U 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"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U'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 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 wrist: (3) external integrated snoring and body position sensor – SBP/RESBP (optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP/RESBP; (5) the device software; and (6) a power supply.

The subject WP200U introduces the RESBP sensor - an additional Snoring and Body Position (SBP) integrated sensor which also includes chest movement signal.

Another change in the subject WP200U is the introduction of new sleep disorder parameter - central apnea/hypopnea index (pAHIc).

The provided document gives information about the Watch-PAT200U device, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a structured table or provide detailed information about a study that proves the device meets specific acceptance criteria in the format requested.

The document discusses a clinical study conducted to evaluate the WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration, but it only briefly mentions "Test results demonstrated substantially equivalent performance" without detailing specific performance metrics or acceptance thresholds.

Given the limitations of the provided text, I will construct the answer based on the information that is available, and explicitly state where information is missing or not provided in the requested format.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with specific performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it states that "Test results demonstrated substantially equivalent performance" for the clinical study. This implies that the performance was deemed comparable to the predicate device or a clinical gold standard, but the numerical targets for such equivalence are not given.

Therefore, a table as requested cannot be fully constructed.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: 72 subjects
• Data Provenance: The document states "72 subjects were evaluated in an overnight sleep study". It does not explicitly mention the country of origin or whether it was retrospective or prospective, but the description of an "overnight sleep study" suggests a prospective collection of data for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the comparison was made against "polysomnographic (PSG) manual scoring."

• Number of experts: Not specified.
• Qualifications of experts: While it implicitly refers to qualified professionals performing PSG manual scoring (likely sleep physicians or trained sleep technologists), their specific qualifications (e.g., years of experience, board certification) are not detailed.

4. Adjudication method for the test set

The document mentions "polysomnographic (PSG) manual scoring" as the reference standard but does not specify any adjudication method (e.g., 2+1, 3+1, none) for disagreements among scorers, implying either a single scorer or an established standard procedure.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any evaluation of human readers with or without AI assistance. The study described focuses on the standalone performance of the Watch-PAT200U device against PSG.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done. The clinical study evaluated the "WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration" by comparing its output directly to polysomnographic manual scoring. This indicates testing of the device's algorithms without human intervention in the diagnostic process.

7. The type of ground truth used

The ground truth used was polysomnographic (PSG) manual scoring. PSG is considered the gold standard for diagnosing sleep disorders.

8. The sample size for the training set

The document does not provide information regarding the sample size used for the training set or development of the device's algorithms. It only describes the clinical study for evaluation/validation.

9. How the ground truth for the training set was established

Since information about a training set is not provided, how its ground truth was established is also not available in the document.

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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, 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 WP200U is indicated for use in patients 12 years of age or greater.

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 provided text describes the Watch-PAT200U (WP200U) device and outlines its substantial equivalence to a predicate device, primarily focusing on the expansion of its intended use to include an adolescent population (12 to 17 years old). The document highlights performance data and clinical studies used to support this expanded indication.

Here's an attempt to extract the requested information, understanding that certain details like specific acceptance criteria numerical values for RDI/AHI or the number of experts for polysomnography scoring are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document implies that the device is acceptable if its performance in the adolescent population is comparable to its already cleared performance in adults, and demonstrates accuracy suitable for a "diagnostic aid." The specific numerical thresholds for "high correlation" or "reasonable agreement" are not explicitly defined as acceptance criteria but are demonstrated by the reported study results.

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

• Test Set Sample Size: "Data from adolescence patients (12 to 17 years old) was pooled from 3 prospective clinical studies sponsored by Itamar of a broader age range population." The precise number of adolescent patients (12-17 years old) is not explicitly stated from the total 'broader age range population' in these 3 prospective studies. However, a separate published study mentioned prior to the main clinical studies analyzed 17 children with OSA (age range 5 to 17 years old), but this appears to be a separate smaller study contributing to the literature review, not the primary "test set" for the current submission.
• Data Provenance: Prospective clinical studies sponsored by Itamar. The country of origin is not specified, but Itamar Medical, Ltd. is based in Caesarea, Israel.

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

The ground truth for the test set was established by Polysomnography (PSG) manual scoring. The document states: "The purpose of the studies was to compare the efficacy of the WP to the manual scoring of the PSG for aiding in the diagnosis of SDB."

• Number of Experts: Not specified.
• Qualifications of Experts: The document refers to "manual scoring of the PSG," which implies scoring by trained polysomnography technologists or sleep medicine physicians, but their specific qualifications (e.g., years of experience, certifications) are not detailed.

4. Adjudication Method for the Test Set

The document states "manual scoring of the PSG," but it does not specify an adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in PSG scoring if multiple scorers were involved.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly described in the provided text. The study focused on the standalone performance of the device (WP200U) against PSG as the gold standard.

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

Yes, a standalone performance study was conducted. The clinical studies described compared the WP200U's output (PRDI, PAHI, and sleep stages) directly against the manual scoring of simultaneous in-lab polysomnography (PSG). This assesses the algorithm's performance without direct human intervention in the device's diagnostic output generation or interpretation, beyond the initial use setup.

7. Type of Ground Truth Used

The primary ground truth used was expert-scored Polysomnography (PSG). The studies compared the WP200U's sleep indices and sleep stages with those "generated by the manual scoring of the PSG."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The clinical study details describe a "test set" used for evaluating the device's performance in adolescent patients. Given that no modifications were made to the algorithm (the "PAT technology or the algorithm for the detection of sleep related breathing disorders" was identical to the predicate K133859), it's highly probable that the training of the algorithm occurred much earlier, prior to the K133859 submission, and is not detailed here. This submission focuses on validating the existing algorithm for an expanded age group.

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

This information is not provided in the document. As mentioned above, the algorithm itself was part of the predicate device (K133859) and its training data and ground truth establishment would have been detailed in that prior submission. The current document focuses on validating the existing algorithm for a new patient population.

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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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