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Where the clinician decides to monitor cardiac arthythmia 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 ST/AR cardiotach is to monitor a neonatal, pediatic, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediation of adult patient ECG's for heart rate and ventricular arthythmias, and produce events/alarms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.

The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.

Note: The ST algorithm does not analyze ventricularly paced or ventricular ectopic beats.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatic and adult patients with and without symptoms of arrhythmia. OT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.

EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

RLS ECG is intended for monitoring multiple leads of ECG of adults.

RLS ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult patients including arrhythmia, ST segment changes, and QT/QTc, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The modification is a software-based change that adds the following features:
· Support derived 12-lead ECG (RLS ECG) from a 6-electrode lead set.
· Provide enhanced AF and Irregular HR alarms detection
· Provide enhanced QT and ST analysis and alarms.

The provided text is a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release K.0. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a study proving the device meets said criteria in the format requested.

Here's an analysis of what is and is not provided, based on your request:

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

• Not provided. The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test.results showed substantial equivalence. The results demonstrate that ST/AR Release K.O meets all defined reliability requirements and performance claims."
• This statement indicates that acceptance criteria (pass/fail criteria) were established and met, but it does not specify what those criteria were (e.g., sensitivity, specificity, accuracy targets) nor does it report the device's performance against those criteria with specific metrics.

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

• Not provided. The document mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not detail the sample sizes for these tests or the nature of the data (e.g., patient population, 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)

• Not provided. The document does not describe the establishment of a "ground truth" using experts for performance evaluation. The testing described focuses on functional equivalence to predicate devices and adherence to existing specifications.

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

• Not provided. There is no mention of an adjudication process for the test set.

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

• Not provided. This document describes a software update for a physiological monitor with expanded features (e.g., derived 12-lead ECG, enhanced AF/Irregular HR alarms, enhanced QT/ST analysis). It is not focused on an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study to assess human reader improvement. The focus appears to be on the algorithm's performance itself, rather than its impact on human interpretation.

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

• Implied, but not explicitly detailed. The statement "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate" suggests that the algorithm itself was tested for performance against established specifications. However, specific metrics (like sensitivity, specificity, accuracy) are not provided in this summary. The testing appears to be focused on whether the new features function as intended and meet the specifications set for the predicate device.

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

• Not explicitly stated how ground truth was established, if at all, for performance claims. The document uses the term "specifications cleared for the predicate device" as the basis for pass/fail criteria. This suggests that the ground truth for evaluation would be derived from comparisons to the expected outputs or performance of the cleared predicate devices, rather than an independent clinical ground truth like pathology or expert consensus on new data.

8. The sample size for the training set

• Not provided. Training sets are typically associated with machine learning or AI development. While the device includes "algorithms" (e.g., ST/AR arrhythmia analysis algorithm, ST/AR ST analysis algorithm), this document does not provide details of their development processes that would include training sets. Given the submission date (2010), these algorithms likely rely on more traditional signal processing and rule-based methods rather than large-scale machine learning requiring explicit "training sets" in the modern sense.

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

• Not applicable / Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned.

In summary, this 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It confirms that testing was conducted and specifications were met, but it does not provide the detailed performance metrics, study designs, or ground truth establishment methods typically requested for a deeper understanding of a device's clinical performance and validation against specific acceptance criteria. The "study" mentioned is a general "Verification, validation, and testing" activity, not a specific clinical trial with reported outcomes.

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