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EasyCare Tx is intended to be used with ResMed compatible therapy devices via the Tx Link. EasyCare Tx provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely. EasyCare Tx is intended to be used in a clinical environment. The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed compatible therapy devices. The Tx Link relays real-time signals measured by the ResMed compatible therapy device to a polysomnograph (PSG). The Tx Link is intended to be used in a clinical environment.

ResMed's EasyCare Tx System enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control room within the hospital and sleep lab clinical setting. The EasyCare Tx System includes: EasyCare Tx, a software application that executes on the end-user's PC and interfaces with the accessory Tx Link to view and set various flow generator parameters and settings; and Tx Link, a hardware accessory that connects to a flow generator and interfaces to a remote PC via an Ethernet connection. The Tx Link also provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).

The provided text describes the EasyCare Tx System, a software application and hardware accessory designed to monitor and adjust settings of ResMed compatible therapy devices in a clinical environment. While the document mentions "predetermined acceptance criteria" and that all tests confirmed the product met these criteria, it does not explicitly detail the specific acceptance criteria or the study that quantitatively proves the device meets them.

The document states:

• "Design and Verification activities were performed on the EasyCare Tx System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria."
• "Performance testing of EasyCare Tx has been conducted using End-to-End bench testing methodology to demonstrate that the modified EasyCare Tx performs to design input specifications."
• "EasyCare Tx met the predetermined pass/fail criteria as defined in the EasyCare Tx System Verification Report!"

However, the "predetermined pass/fail criteria" or "predetermined acceptance criteria" are not listed or described in the provided text.

Based on the available information, here is a summary of what can and cannot be answered regarding acceptance criteria and the study that proves the device meets them:

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

The document lacks specific, quantifiable acceptance criteria (e.g., accuracy percentages, latency thresholds, reliability metrics). It only states that the device successfully met these unspecified criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "End-to-End bench testing methodology." This implies a simulated or lab-based environment rather than patient data. No sample size for a test set (e.g., number of patients, number of data points) is provided, nor is the data provenance (country of origin, retrospective/prospective).

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)

No information is provided regarding experts, ground truth establishment, or their qualifications. Given the nature of the "End-to-End bench testing," it's likely that ground truth would be based on expected system outputs or specifications rather than expert interpretation of complex clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No information is provided regarding an adjudication method.

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 document explicitly states: "Clinical testing was not deemed necessary as indentified in the Risk Analysis, as EasyCare Tx only obtains patient and machine information from therapeutic devices; clinical trials have already been performed on the therapeutic devices and their algorithms. Accordingly, no clinical testing is required!"

Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance can be reported from this document. The device is a system for monitoring and adjusting existing therapy devices, not an AI for interpretation.

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

The performance testing was "End-to-End bench testing methodology." This would inherently be a standalone test of the software and hardware system against design specifications, without a human-in-the-loop component for the evaluation of its core functions (monitoring and adjusting settings).

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

The ground truth for the "End-to-End bench testing" would be the design input specifications for the device's performance. The device is designed to accurately display real-time data and implement setting changes, implying that "ground truth" refers to the expected, correct display values and successful application of settings. It would not typically involve expert consensus, pathology, or outcomes data in the context of this device's function.

8. The sample size for the training set

No information regarding a training set is provided. The device is a system for data transfer and control, not a machine learning algorithm that typically requires a training set.

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

Not applicable as there is no mention of a training set or machine learning.

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The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The Watch-PAT200S-3 System (WP200S-3) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea – hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200S-3 may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200S-3 device is worn on the wrist and consists of the following: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger, for measuring blood oxygen saturation; (3) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (4) external integrated snoring and body position sensor - SBP (Optional); (5) electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, actigraph and SBP, (6) the device software; and (7) a power supply.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

The document does not provide information on how the ground truth for the training set (if any was used for algorithm development) was established.

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The EasyCare Tx System comprises of the Titration Software, EasyCare Tx, and the Connection Module accessory, Tx Link.

Indication for Use

EasyCare Tx is intended to be used with ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol via the Tx Link. EasyCare Tx provides real time data and treatment settings display, and can also provide CPAP or Bilevel device setting changes remotely.

EasyCare Tx is intended to be used in a clinical environment.

The Tx Link is intended to provide connectivity between ResMed EasyCare Tx software and ResMed continuous positive airway pressure (CPAP) or Bilevel devices that incorporate ResMed's proprietary communication protocol. The Tx Link relays real-time signals measured by the CPAP or Bilevel device to a polysomnograph (PSG).

The Tx Link is intended to be used in a clinical environment.

ResMed's EasyCare Tx System enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control room within the sleep lab clinical setting.

The EasyCare Tx System includes:

• EasyCare Tx, a software application that executes on the end-user's PC and interfaces with the . accessory Tx Link to view and set various flow generator parameters and settings; and
• Tx Link, a hardware accessory that connects to a flow generator incorporating ResMed's proprietary D communication protocol, and interfaces to a remote PC via an Ethernet connection. The Tx Link also provides analog flow generator signals to third party Polysomnograph (PSG) systems, such as Embla (K971813).

The EasyCare Tx System is a software and hardware system designed for clinicians to monitor and adjust settings of ResMed CPAP or Bilevel devices in a sleep lab clinical setting. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding specific studies, sample sizes, and expert adjudication to prove performance against acceptance criteria is not typically found in this type of submission.

Here's a breakdown of the available information and what cannot be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary explicitly states: "Design and Verification activities were performed on the EasyCare Tx System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria." However, it does not provide a table detailing those specific acceptance criteria nor the quantitative performance metrics achieved for each criterion. The submission focuses on substantial equivalence based on similar intended use, operating principle, technology, and manufacturing process to the predicate devices (TxControl K072615 and ResControl II K040944).

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

This information is not provided in the 510(k) summary. The submission does not detail specific studies with test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for proving device performance against acceptance criteria.

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

This information is not provided in the 510(k) summary. As no explicit studies for establishing clinical performance against ground truth are detailed, there is no mention of experts or their qualifications for establishing such ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the absence of detailed performance studies, there is no mention of an adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or, at least, not reported in this 510(k) summary. The device's primary function is to facilitate clinicians' interaction with a CPAP/Bilevel device, rather than to make interpretations or diagnoses from data that would typically require MRMC studies.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop performance) was not detailed as a separate clinical study in this 510(k) summary. The system integrates software and hardware to enable human clinicians to monitor and adjust device settings. While components would undergo verification (e.g., software functionality, hardware connectivity), a "standalone" clinical performance study in the sense of an AI algorithm making independent decisions is not applicable here given the device's intended use.

7. Type of Ground Truth Used

The 510(k) summary does not specify a type of ground truth used, as it doesn't describe clinical studies with endpoints requiring a "ground truth" (e.g., expert consensus, pathology, or outcomes data). The "verification activities" mentioned are likely related to engineering and system functionality, ensuring the device accurately displays data and transmits setting changes as intended, rather than clinical diagnostic accuracy.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The EasyCare Tx System is a control and monitoring system, not a device that employs machine learning or AI models requiring a training set in the typical sense.

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

This information is not provided in the 510(k) summary, as it's not applicable to this type of device and submission.

Summary based on the provided document:

The 510(k) summary for the EasyCare Tx System indicates that "Design and Verification activities were performed... All tests confirmed the product met the predetermined acceptance criteria." However, it does not elaborate on these criteria, the specific studies performed, sample sizes, expert involvement, or adjudication methods beyond that statement. The submission primarily relies on demonstrating substantial equivalence to its predicate devices based on similar intended use, operating principle, technologies, and manufacturing processes, rather than presenting de novo clinical performance data against new acceptance criteria.

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The TxControl™ is a software application intended to be used by clinicians with ResMed flow generators that incorporate ResMed's proprietary communication protocol. TxControl provides real-time data display directly from the flow generator or via ResControl II™.

TxControl can also provide flow generator setting changes, remotely within a clinical environment.

ResMed's TxControl™ is a PC-based software application that enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control raom within the sleep lab clinical setting.

TxControl is also designed to transfer data from a CPAP or bilevel flow generator to a polysomnograph (PSG) display system such as Somnologica (K971813) when used in conjunction with a ResControl II device The performance and functional characteristics of the TxControl includes similar user friendly features of the predicate device, ResControl II (K040944).

This document provides a summary of the 510(k) premarket notification for TxControl, a software application developed by ResMed Ltd. However, it does not contain specific details about acceptance criteria or a study proving the device meets those criteria with numerical performance metrics. The document primarily focuses on establishing substantial equivalence to a predicate device (ResControl II) and lists general design and verification activities.

Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I answer questions related to sample size for test sets, data provenance, ground truth establishment, expert involvement, MRMC studies, or standalone performance directly from the provided text.

The document states: "Design and Verification activities were performed on the TxControl as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." This is a general statement and does not include the details of those tests or acceptance criteria.

Based only on the provided text, the following information can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "All tests confirmed the product met the predetermined acceptance criteria." However, no specific acceptance criteria or performance numbers are provided in the text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   This information is not present in the provided text.

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):
   This information is not present in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not present in the provided text.

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:
   This information is not present in the provided text. The device is described as a software application for clinicians to display data and adjust settings, not an AI or diagnostic tool that would typically involve MRMC studies for improved human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document focuses on the software's functionality in a clinical environment with clinicians. It states TxControl "enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings." This implies a human-in-the-loop scenario. No standalone algorithm performance without human involvement is mentioned or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   This information is not present in the provided text. Given the device's function (real-time data display and setting changes for flow generators), "ground truth" in a diagnostic sense may not be directly applicable as it's not performing a diagnostic task. The "tests" mentioned likely relate to software functionality and accuracy of data display/setting implementation rather than diagnostic accuracy.

8. The sample size for the training set:
   This information is not present in the provided text.

9. How the ground truth for the training set was established:
   This information is not present in the provided text.

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The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.

The performance and functional characteristics of the ResControll II system includes all the user friendly features of the predicate device. UCU. ResControl II is designed to transfer data from a CPAP or birevel Flow Generator to a polysomnograph display system such as Sommitigica (K971813). ResControl 11 also provides parameter setting of Flow Generators within the hospital or sleep lab facilities.

The provided 510(k) summary for ResControl™ II (K040944) focuses on establishing substantial equivalence to a predicate device (ResMed UCU, K961783) through similar intended use, operating principles, technologies, and manufacturing processes. It states that "Design and Verification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria."

However, this submission does not contain specific details about the acceptance criteria nor the study that proves the device meets them. It asserts that such testing was done, but gives no quantitative data, sample sizes, or methods used to establish performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, with specific notes where information is missing:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not provided.
• Data Provenance: Not provided.

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 applicable as no specific test set or ground truth establishment method is described for device performance. The submission discusses compliance with guidance documents and risk/product requirements for design and verification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no specific test set or adjudication method for performance evaluation is 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 MRMC comparative effectiveness study is mentioned. This device is a measurement and control device, not one involving AI for image interpretation or diagnosis.

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

• The device functions as a data display, relay, manometer, and parameter setting tool for clinicians using flow generators. The concept of "standalone algorithm only" performance as typically applied to diagnostic AI is not directly relevant here. However, the submission implies that the device's functional performance (displaying data, relaying data, acting as a manometer, setting parameters) was verified to meet its specified requirements. No specific standalone performance metrics are provided.

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

• N/A. The "ground truth" for a device of this nature would likely refer to engineering specifications, accuracy of measurements against calibrated standards, and successful execution of its intended functions. No details on how this "ground truth" was established are provided.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.

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

• Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.

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