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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 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 WatchPAT300 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 PRDIPAHIC. 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 subject WatchPAT300 (WP300) is identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775). The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).

The subject WP300 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Tamper-Proof Bracelet (optional), and Management and Analysis Software (SW).

The subject WP300, like the predicate WP200U and predicate WP300, uses the same offline Management and Analysis Software (SW). The 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 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 WP300 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 provided text describes a 510(k) premarket notification for the WatchPAT300 (WP300) device, focusing on the addition of an arrhythmia detection feature previously cleared in the Watch-PAT200U (WP200U). The key argument for substantial equivalence is that the new software feature does not alter the technological characteristics or principles of operation, and hardware differences do not raise new safety or effectiveness concerns.

However, the document specifically states regarding performance data: "SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". It also mentions that "Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same 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 WP300 signals are equivalent to the WP200U signals."

The document focuses on demonstrating substantial equivalence based on the technological characteristics and intended use being largely the same as predicate devices, with the new arrhythmia feature adopting a previously cleared algorithm. It does not provide specific acceptance criteria or an explicit study proving that the device meets those acceptance criteria through clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the arrhythmia feature in a clinical setting. Instead, the argument relies on the equivalence of signals and the prior clearance of the arrhythmia algorithm in a different device.

Given the information provided in the document:

1. A table of acceptance criteria and the reported device performance:
   The document mentions "The testing and acceptance criteria are the same as those in the predicate devices." However, it does not explicitly list these acceptance criteria or the reported performance data against them for the new arrhythmia feature in the WP300, beyond stating that signals are equivalent to a predicate device. The comparison table (page 6) highlights the identical intended use, user population, environment, and channels, and that the arrhythmia flagging output is "Same as WP200U". This implies that the performance of the arrhythmia feature is expected to be consistent with the WP200U, for which the algorithm was previously cleared.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not explicitly stated for the arrhythmia feature's performance with the WP300. The document indicates "SW verification and validation was performed" and "Bench testing was previously conducted", but details on sample size, data provenance (e.g., countries, retrospective/prospective nature of a clinical test set) are not provided for the arrhythmia performance specifically.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not provided. The document focuses on "SW verification and validation" and "Bench testing," not a clinical performance study with expert interpretation of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not provided. This would typically be relevant for clinical studies establishing ground truth, which is not detailed for the arrhythmia feature's performance in the WP300 submission.

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 MRMC study is mentioned. The arrhythmia feature is described as "informational use only, to flag patients suspected of having arrhythmias," and "aiding the physician to decide if further arrhythmia investigation is needed," rather than a tool for direct improvement of human reader performance or diagnostic efficacy.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document states that "Bench testing was previously conducted... to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms." This implies a standalone evaluation of signal acquisition equivalence. For the arrhythmia algorithm itself, it's integrated software. The performance of the arrhythmia algorithm as cleared in the WP200U would have undergone standalone evaluation at that previous clearance, but specific standalone performance metrics for this particular submission (K222331) are not provided beyond the signal equivalence testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not explicitly stated for the arrhythmia feature's performance in this submission. For prior clearance of the algorithm in the WP200U, a ground truth would have been established (likely clinical diagnosis by experts for arrhythmia detection), but details are absent here for the WP300.

8. The sample size for the training set:
   Not provided.

9. How the ground truth for the training set was established:
   Not provided.

In summary, the provided FDA 510(k) submission primarily leverages the fact that the new arrhythmia software feature was already cleared in a predicate device (WP200U) and that the WP300's hardware can generate equivalent input signals for this algorithm. Therefore, the submission does not detail new clinical performance studies or specific acceptance criteria met for the performance of the arrhythmia feature itself within this specific application. It relies on the substantial equivalence principle, asserting that no new questions of safety or effectiveness are raised.

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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

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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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