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The EndoPATx device is a non-invasive device intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive hyperemia procedure.

The EndoPATx has been shown to be predictive of coronary artery Endothelial Dysfunction in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

The EndoPATx device is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

The EndoPATx is a non-invasive system for assessing vascular endothelial function. It is based on the use of Peripheral Arterial Tone (PAT) technology which measures post-ischemic vascular response following arm blood flow occlusion.

It is intended for use as a diagnostic aid in the detection of presence coronary artery Endothelial Dysfunction using a reactive hyperemia procedure in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

It is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

The provided FDA 510(k) summary for the EndoPATx device does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically presented for clinical performance studies of AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EndoPAT2000) through functional, safety, and performance testing, emphasizing that the underlying technology and algorithms are identical, with the EndoPATx being a "modern replica" with updated hardware and user interface.

Therefore, many of the requested elements (sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance details, and specific acceptance criteria with reported performance) are not explicitly described in this document. This is common for 510(k) submissions where the device builds directly upon a previously cleared predicate and primarily involves hardware or usability updates, rather than a new clinical algorithm requiring extensive de novo validation.

However, based on the information provided, I can construct a response addressing what is present and noting what is absent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Given that the EndoPATx device is seeking clearance through substantial equivalence to its predicate device (EndoPAT2000) and states that "The principles of operation of the EndoPATx are identical to those of the predicate... Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices," the acceptance criteria are implicitly tied to demonstrating that the changes in the EndoPATx do not negatively affect the performance or introduce new questions of safety or effectiveness compared to the already cleared predicate.

The "performance data" provided relates to this equivalency, rather than establishing de novo clinical performance metrics against a defined ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The overall conclusion is that "The testing above demonstrated that the EndoPATx is substantially equivalent to its predicate and the proposed modifications do not raise any different questions of safety or effectiveness."

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation with patient data. The equivalency testing mentioned ("PAT signal acquisition input/output equivalency tests; Scoring equivalency tests") refers to technical tests comparing the new device's output to the predicate's, likely using simulated or previously collected signals rather than a new clinical test set with human subjects.

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely relates to internal technical validation data rather than a new clinical dataset from patients. Given the predicate's established use, it's implied that the original predicate's performance was proven with clinical data, and this submission leverages that.
• Retrospective or Prospective: Not stated for this equivalency testing; however, if it involved patient data, it would likely be retrospective given the nature of demonstrating equivalence to an existing device.

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

Not applicable/Not specified. The ground truth for direct clinical performance is not explicitly established or re-established for this 510(k) submission, as the device is leveraging substantial equivalence. The claim is that the device's technical performance for PAT signal acquisition and scoring is equivalent to the predicate, which presumably had its own clinical validation and ground truth established during its initial clearance (K032519).

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a human-reviewed "test set" requiring adjudication in this 510(k) summary for the new device's clearance.

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

Not applicable. An MRMC study was not conducted for this 510(k) submission. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which isn't the focus when demonstrating substantial equivalence of a device with identical algorithms to its predicate.

6. Standalone (Algorithm Only) Performance

The EndoPATx relies on the same core analysis algorithms as its predicate, EndoPAT2000. The document states: "Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices."
Therefore, its "standalone" performance is considered to be identical to that of the predicate. The document does not provide new standalone performance metrics for the EndoPATx, but implies it has the same standalone performance as the predicate due to identical algorithms.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for the equivalency testing. For the original EndoPAT2000, the "ground truth" for "coronary artery endothelial dysfunction" would typically be established via a gold standard clinical procedure, such as coronary artery angiography (as mentioned in the Indications for Use, "who lack angiographic evidence of obstructive coronary artery disease" implies correlation to angiographic findings for patient selection). However, for this 510(k), the "ground truth" for the equivalency study is implicitly the output of the predicate device (EndoPAT2000) for PAT signal acquisition and scoring, as the objective is to show the new device produces the same results.

8. Sample Size for the Training Set

Not applicable/Not specified. This 510(k) is for a device which uses established, identical algorithms as its predicate. There is no mention of a new "training set" for an AI/ML algorithm in this submission. The algorithms are already developed and proven via the predicate.

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

Not applicable/Not specified. As there is no new training set mentioned, the establishment of ground truth for a training set is not pertinent to this submission.

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The WatchPAT™200U (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"), 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/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 (pRDI), apnea - hypopnea index (pAHI), central apnea - hypAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.

The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) Tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.

The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.

Beside the introduction of the new arrhythmia information, the SW provides identical output information as that previously provided for the predicate.

The additional arrhythmia information presented by the modified WP200U device follows the AASM (American Academy of Sleep Medicine) guidelines to provide the sleep physician with information regarding cardiac events occurred during the night. The WP200U arrhythmia feature is to be used for informational use only, to flag 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 WP200U's arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices.

The new analysis provides the sleep physician with additional information to that of the WP200U 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.

Here's a breakdown of the acceptance criteria and the study details for the Watch-PAT200U (WP200U) device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a detailed, quantitative table within the provided document. However, the document describes the clinical testing performed to evaluate the device's ability to identify cardiac arrhythmias (Atrial Fibrillation and Premature beats). The reported performance is generally stated as "acceptable performance" against a "Gold Standard."

Given the information, we can infer the acceptance criteria would be related to the accuracy of arrhythmia detection. The table below represents the available information and how performance against these implied criteria is reported:

Study Details that Prove the Device Meets Acceptance Criteria

1. Sample Size used for the test set and the data provenance:

   • Sample Size: One hundred and fifty-seven (157) subjects.
   • Data Provenance: The document does not explicitly state the country of origin. It indicates that subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG in a sleep lab. This suggests it was likely a prospective study.

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

   • Number of Experts: Not explicitly stated, but the ground truth was established by "cardiologist-scored ECG channel." This implies at least one cardiologist, and potentially multiple for consensus, reviewed the ECG data.
   • Qualifications of Experts: "Cardiologist-scored." Specific years of experience are not mentioned, but a cardiologist is a highly qualified medical professional specializing in heart conditions.

3. Adjudication method for the test set:

   • The document does not explicitly describe a specific adjudication method like "2+1" or "3+1." It simply states "cardiologist-scored ECG channel" was the "Gold Standard," implying their scoring was accepted as the truth.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study focuses on the standalone performance of the device's arrhythmia detection algorithm against a gold standard, not on how human readers (physicians) might improve with AI assistance.

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

   • Yes, a standalone study was done. The clinical performance testing evaluated "the capability of WP200U to identify arrhythmic events," directly comparing the device's outputs to the "Gold Standard" cardiologist-scored ECG data. This is a standalone assessment of the algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Expert Consensus/Diagnosis: The ground truth for arrhythmia detection was established by a "cardiologist-scored ECG channel of a polysomnography (PSG)." This falls under expert diagnosis from a recognized "Gold Standard" method.

7. The sample size for the training set:

   • The document does not provide the sample size for the training set. It only describes the clinical testing performed to evaluate the device, which would typically be a test set after training and development.

8. 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, as it doesn't mention specifics about the training process or dataset.

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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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The Watch-PAT300 (WP300) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP300'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-PAT300 System (WP300) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 is a diagnostic aid for the detection of sleep related breathing disorders (RDI, AHI and AHIc) and sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. The WP300 can be connected to an external integrated sensor snoring and body position (SBP/RESBP) for recording snoring, body position and chest movement (in RESBP sensor only) data.

The WP300 device consists of the following: (1) Same unified finger PAT probe that was used in WP200U is used to measure the PAT and oximeter signals; (2) an embedded actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist: (3) Electronics, which include a microprocessor that records the information supplied by the uPAT finger probe, actigraph and chest movement; (4) snoring and body position sensor (SBP/RESBP sensors same sensors as in the WP200U) and (5) the device software.

The subject WP300 is an improved version of the predicate WP200U device (K161579) and introducing hardware changes to its components and new external design. The modifications made in order to upgrade the hardware (HW) components of the device, reduce the size of the WP200U device, improve the data download speed of the device, modify the materials in the wrist strap and update the device appearance. None of these changes alter the fundamental operation of the device or its principles of operation. Moreover, the modified system, the WP300 maintains the full capabilities of the cleared WP200U (K161579) and provides the user with the same output information, i.e. pRDI, pAHI, pAHIc, pSTAGES, snoring and body position, remain the same.

The provided document describes the Watch-PAT300 (WP300) device and its substantial equivalence to a predicate device. This device is a non-invasive home care device for detecting sleep-related breathing disorders, sleep staging, snoring level, and body position.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate WP200U device, rather than defining new acceptance criteria for the WP300. The performance testing section mentions only one specific performance metric for which acceptance criteria are explicitly stated: SpO2 accuracy.

Other aspects of performance for pRDI, pAHI, pAHIc, and pSTAGES are implied to be equivalent to the predicate device because the underlying algorithms and PAT technology remain unchanged.

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

For the SpO2 accuracy study:

• Sample Size: Eleven healthy adult volunteer subjects.
• Data Provenance: Not explicitly stated, but the study was performed in CLINIMARK Laboratories. Further details (e.g., country of origin, retrospective/prospective) are not provided in this document. Given it involved healthy adult volunteers in a laboratory setting, it was a prospective study.

For the substantial equivalence of the main algorithms (pRDI, pAHI, pAHIc, pSTAGES):

• There is no specific new clinical study with a defined test set sample size mentioned for these parameters. The claim is based on the fact that "There were no modifications to the PAT technology or the algorithms for the detection of sleep related breathing disorders and sleep staging." and "The modified acquisition system was designed and verified to give the same input signals to the algorithm as the predicate WP200U." This implies reliance on the performance data of the predicate device (WP200U).

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

• SpO2 Accuracy Study: The ground truth for SpO2 accuracy was established by arterial blood samples assessed by CO-Oximetry, which is an objective measurement. No human experts were involved in establishing this specific ground truth.
• Other Parameters (pRDI, pAHI, pAHIc, pSTAGES): As no new clinical study for these parameters on the WP300 is described, there's no information on experts for a new test set's ground truth. For the predicate device, such an evaluation would typically involve polysomnography (PSG) scored by board-certified sleep physicians/technicians, but this document does not detail the predicate's ground truth method.

4. Adjudication Method for the Test Set:

• SpO2 Accuracy Study: Adjudication methods are not applicable here, as ground truth was established by CO-Oximetry, an objective measurement.
• Other Parameters: Not applicable, as no new test set is described.

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

• No MRMC comparative effectiveness study is mentioned in this document. The submission is focused on demonstrating substantial equivalence of a modified device (WP300) to its predicate (WP200U), primarily through hardware modifications not affecting core algorithms.

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

• The documentation suggests that the core algorithms (for pRDI, pAHI, pAHIc, pSTAGES) themselves were not re-evaluated in a standalone study for the WP300, as they were unchanged from the predicate.
• The SpO2 accuracy study evaluates the device's sensor performance, which is a standalone measurement of the device's capability to measure blood oxygen saturation, rather than an "algorithm only" study in the context of diagnostic interpretation.

7. Type of Ground Truth Used:

• SpO2 Accuracy Study: Objective measurement using arterial blood samples assessed by CO-Oximetry. This is a direct physiological measurement establishing a "gold standard" for blood oxygen saturation.
• Other Parameters (pRDI, pAHI, pAHIc, pSTAGES): Not explicitly stated for WP300, as the algorithms are unchanged from the predicate. Typically, for sleep disorder diagnosis, the ground truth would be established by Polysomnography (PSG), scored according to recognized criteria (e.g., AASM guidelines).

8. Sample Size for the Training Set:

• The document does not describe the training set size for the WP300's algorithms, as the algorithms were not modified. The algorithms for pRDI, pAHI, pAHIc, and pSTAGES are stated to be the same as those in the predicate WP200U. Therefore, the training for these algorithms would have been performed prior to the predicate's clearance.

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

• Not described in this document, as the algorithms were adopted from the predicate device without modification.

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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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