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The WatchPAT ONE (WP1) device is a noninvasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 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 WP1 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 WP1's PSTAGES and snoring level and body position provide supplemental information to its PRD/PAHI/PAHIc. The WP1'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 subject WatchPAT ONE (WP1) has the same intended use and indications for use as the cleared predicate WP300 (K222331) and the cleared reference WP1 (K183559). The subject WP1 combines the software arrhythmia feature of the WP300 cleared predicate (K222331) into the WP1 cleared reference (K183559).

The subject WP1 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Management and Analysis Software (SW) and mobile application.

The subject WP1, like the predicate WP300 and reference WP1, uses the same Management and Analysis Software (SW). The arrhythmia feature is to be used for informational use only, to flaq patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed. The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis. The arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices. It provides the sleep physician with additional information to that of the WP1 cleared capabilities of detecting sleep disorders, to be considered in conjunction with the physician's knowledge of patient background, clinical history, symptoms, and other diagnostic information.

The document provided does not contain the specific details required to complete all sections of your request. This is largely due to the nature of a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a full clinical study report with detailed performance metrics, ground truth establishment, or multi-reader multi-case studies.

However, I can extract the following information based on the text provided:

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

The document does not explicitly state "acceptance criteria" with numerical targets or direct "reported device performance" in the context of a clinical study for the newly added arrhythmia feature. It states: "SW Design verification was performed on the subject WP1 device with the SW containing the additional arrhythmia feature. The testing and acceptance criteria are the same as those in the predicate WP300 and reference WP1 devices." This implies that the acceptance criteria for the existing functionalities of the WatchPAT ONE (WP1) were met, and the new arrhythmia feature also adhered to the criteria established for the predicate WP300. Without further information on the WP300's performance from its original 510(k) for the arrhythmia feature, specific numerical acceptance criteria and performance for the arrhythmia detection cannot be provided from this document.

The document emphasizes substantial equivalence to the predicate device WP300 (K222331) and reference device WP1 (K183559). The "performance data" section states: "Bench testing was previously conducted on the reference WP1 (K183559) to show that the acquisition system of the WP1 and WP300 generate equivalent input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP1 signals are equivalent to the WP300 signals."

This suggests that the performance of the arrhythmia detection algorithm in the subject WP1 is assumed to be equivalent to that of the predicate WP300 because the input signals are equivalent and the software algorithm is identical.

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

The document does not specify a separate test set sample size or data provenance for the new arrhythmia feature. It refers to "bench testing" that validated the equivalence of signals between WP1 and WP300. This implies that no new clinical test set was used for the arrhythmia feature's performance validation in this specific 510(k) submission, as the feature itself originated from a previously cleared device (WP300).

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

Not applicable for this submission, as no new clinical test set for the arrhythmia detection was performed or described. The validation focuses on signal equivalence and software transfer from the predicate.

4. Adjudication method for the test set

Not applicable, as no new clinical test set for the arrhythmia detection was performed or described.

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

No such study is mentioned or implied for the new arrhythmia feature. The device's arrhythmia flagging is described as "informational use only" to "flag patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed." It is explicitly stated: "The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis." Therefore, a comparative effectiveness study with human readers improving with AI assistance is outside the scope of this particular submission.

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

The document implies a standalone algorithm performance implicitly by stating the "SW Design verification was performed on the subject WP1 device with the SW containing the additional arrhythmia feature. The testing and acceptance criteria are the same as those in the predicate WP300". The feature "flags" abnormal events for a physician's review, suggesting the algorithm operates in a standalone manner to generate these flags. However, whether a dedicated standalone performance study (beyond software design verification) was done for the arrhythmia feature (as distinct from device equivalence) is not detailed here. The focus is on the equivalence of the acquisition system and the software algorithm to the predicate device, where the arrhythmia feature was initially cleared.

7. The type of ground truth used

The document does not describe the ground truth used for the arrhythmia feature validation in this submission. For the sleep-related breathing disorders, the general method would typically involve comparison to Polysomnography (PSG) as the gold standard, but this document focuses on the arrhythmia feature's integration, not re-validation of the entire device. Since the arrhythmia feature was inherited from the WP300, the ground truth establishment would have been part of the WP300 clearance.

8. The sample size for the training set

Not specified in this document. This submission is for enabling an existing algorithm from a predicate device (WP300) onto a different hardware platform (WP1), not for developing a new algorithm. Therefore, training set information is not relevant to this specific 510(k) summary.

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

Not specified in this document, as it is not a new algorithm development and relies on the ground truth establishment from the predicate device (WP300) for the arrhythmia feature.

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The WatchPAT™ONE (WP1) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 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 WP1 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 snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP1's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP1'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 WatchPAT™ONE (WP1) is a non-invasive home care device intended for use with patients suspected to have sleep related breathing disorders. The WP1 generates a PAT respiratory disturbance index (PRDI), Apnea Hypopnea Index (PAHI), Central Apnea Hypopnea Index (PAHIc), sleep stages (PSTAGES - REM Sleep, Light Sleep, Deep Sleep and Wake) and snoring level and body position discrete states. The WP1 device consists of the following: (1) same unified finger PAT probe that was used in WP300 to measure the PAT and oximeter signals; (2) same Actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) same electronics, except for an antenna added in the WP1's PCB to support BLE communication; (4) same chest sensor (RESBP) to measure snoring level, body position and chest movements; and (5) same zzzPAT Software and algorithm to analyze the data. The subject WP1 is a modified version of the predicate WP300 device (K180775). The proposed modifications mainly include: transition from a reusable device to a single use device; shifting the display and user interface from the device to a mobile application; and shifting of the data storage from main device to a web server.

The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document is a 510(k) premarket notification summary for the WatchPAT™ONE (WP1) device. It focuses on demonstrating substantial equivalence to a predicate device (Watch-PAT 300, K180775), rather than presenting a standalone clinical validation study with detailed performance metrics against specific acceptance criteria.

However, I can extract information related to performance testing and comparison with the predicate device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or correlation coefficients) for the WatchPAT™ONE. Instead, it relies on demonstrating that the new device (WP1) has substantially equivalent performance to its predicate device (WP300) through bench testing and compliance with electrical safety, EMC, and software standards.

What is reported (indirectly, by demonstrating equivalence to predicate):

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

• Sample Size: The document does not specify a sample size for a clinical test set in the traditional sense of a performance study with patients. The "Performance Testing" section mentions "Bench test was conducted to show that the data acquired on the WP1 is identical to the data downloaded by zzzPAT at the physician computer." This implies a comparison focused on the integrity of data transmission and processing rather than a clinical performance evaluation on a patient cohort. No number of patients or recordings is provided for this bench test.
• Data Provenance: Not specified. The document focuses on the mechanical/software changes and equivalence to the predicate, rather than a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. The document describes bench testing and adherence to standards, and states that the "zzzPAT Software and algorithm to analyze the data" remains the same as the predicate device. It does not refer to a study where human experts established ground truth for a test set.

4. Adjudication Method:

• Not Applicable. As no expert-derived ground truth for a test set is discussed, no adjudication method is mentioned.

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

• No. The document does not mention an MRMC study or any study comparing human readers with and without AI assistance. The focus is on device equivalence, not clinical performance enhancement for human readers.

6. Standalone Performance Study:

• No, not explicitly a standalone clinical performance study. The "Performance Testing" section describes bench tests to confirm data acquisition identity and compliance with various standards (electrical safety, EMC, software V&V, biocompatibility). It aims to show the WP1 is substantially equivalent to the predicate device in its fundamental operation and data output, which the predicate device presumably had its own standalone performance demonstrated previously (K180775). The current submission does not include a new standalone clinical study for sensitivity, specificity, etc., for the WP1.

7. Type of Ground Truth Used:

• The document implies that the "ground truth" for its performance testing is the data output from the predicate device (Watch-PAT 300) processed by the zzzPAT software. The bench test establishes that the WP1 acquires data that is "identical" to what the zzzPAT software would process (which is the same software used by the predicate). There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this specific submission's performance evaluation.

8. Sample Size for the Training Set:

• Not Applicable/Not Provided. The document explicitly states that the WP1 uses the "same zzzPAT Software and algorithm to analyze the data" as the predicate device. This suggests that any algorithm training would have been done for the predicate device, not the WP1 itself. The current submission does not describe a training set for the WP1.

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

• Not Applicable/Not Provided. Since no training set for the WP1 is discussed, the method for establishing its ground truth is also not provided. This information would likely be found in the K180775 filing for the predicate device if it involved algorithmic training.

In summary:

The document describes a 510(k) submission for the WatchPAT™ONE (WP1), demonstrating substantial equivalence to its predicate device (Watch-PAT 300). The "acceptance criteria" are primarily based on:

1. Functional equivalence: performing the same functions and producing the same outputs (PRDI, PAHI, etc.) using the same core technology and algorithms (zzzPAT software).
2. Data integrity: ensuring the data acquired by WP1 is "identical" to data handled by the predicate's process.
3. Compliance with relevant standards: electrical safety, EMC, home healthcare environment, biocompatibility of new materials, and software verification/validation.

It does not detail a clinical study with specific acceptance criteria (e.g., sensitivity/specificity targets) for diagnostic performance using a new patient test set with expert-derived ground truth. The performance testing mentioned is focused on verifying that the modified WP1 functions identically to the predicate device in terms of data acquisition and processing.

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