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Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The intended use of the STAR cardiotach is to monitor a neonatal, pediatric, or adult patient's heart rate and produce events/alarms for one of one of on paced and non-paced patients.

The intended use of the STAR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient's heart rate and ventricular and other arrhythmia events/alarms for one of two following both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient of all possible ECG leads. The ST analysis produce events/alarms for ST segment elevation or depression and repatients.

The modification is a software-based change that provides ST analysis for conventional 12-lead, MCL/V ST derivation, and single-lead QRS detection with adjustable QRS detection threshold capabilities.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.0. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, much of the specific information requested, such as a table of acceptance criteria with reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, details of comparative effectiveness studies (MRMC), detailed standalone performance data, and detailed information about training set ground truth and size, is not explicitly available in the provided text.

However, I can extract and infer some information:

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

   • Acceptance Criteria: "Pass/Fail criteria were based on the specifications cleared for the predicate device."
   • Reported Device Performance: "Test results showed substantial equivalence. The results demonstrate that ST/AR Release E meets all reliability requirements and performance claims."
   • Inference: The document does not provide a specific table of quantitative acceptance criteria or detailed performance metrics (e.g., sensitivity, specificity, accuracy for ST segment detection or arrhythmia). It only states that the device met the "specifications cleared for the predicate device" and passed testing.

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified.

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)

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified.
   • Inference: The document does not mention the use of human experts to establish ground truth for testing. Testing involved "system level tests, performance tests, and safety testing from hazard analysis."

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

   • Not specified. (Likely "none" as no human adjudication is mentioned for establishing ground truth.)

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

   • MRMC Study: Not mentioned.
   • Effect Size: Not applicable as no such study is described.
   • Inference: This device is software for monitoring, not described as an AI assistance tool for human readers in a diagnostic setting.

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

   • Standalone Performance: Implied. The document states "performance tests" were conducted and that the "ST/AR Release E meets all reliability requirements and performance claims." This refers to the software's inherent performance. However, specific performance metrics are not given.

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

   • Type of Ground Truth: Not explicitly stated. Given the nature of cardiac arrhythmia and ST segment monitoring, ground truth would typically come from well-characterized ECG databases or expert-annotated ECG recordings, but the document does not specify this. "Pass/Fail criteria were based on the specifications cleared for the predicate device," suggesting the predicate's established performance served as a benchmark for what constituted acceptable behavior.

8. The sample size for the training set

   • Not applicable/Not specified. This document pertains to a software release that is a modification of an existing device, and the focus is on verification and validation against predicate specifications, not on a new algorithm developed through machine learning training.

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

   • Not applicable/Not specified. This information is not relevant to the type of submission described (a software modification to an existing cleared device, primarily demonstrating substantial equivalence).

Summary of what is available from the text:

The provided 510(k) summary focuses on demonstrating that a new software release (Philips ST/AR ST and Arrhythmia Software, Release E.0) is substantially equivalent to a previously cleared predicate device. It states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." The "Pass/Fail criteria were based on the specifications cleared for the predicate device," and the test results showed "substantial equivalence," indicating the device "meets all reliability requirements and performance claims." However, it does not provide detailed quantitative acceptance criteria, specific performance metrics (e.g., sensitivity, specificity), sample sizes for test data, details about data provenance, expert involvement, or adjudication methods. The study appears to be a validation against an existing cleared standard/predicate, rather than a de novo clinical study with new ground truth established by experts.

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