Search Results

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 ST/AR cardiotach is to monitor a neonatal, pediatric, 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 arthythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias 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.

The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT 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.

The modification is a software-based change that adds QT/QTc interval monitoring features.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria. Instead, it is a 510(k) summary and an FDA clearance letter for the Philips ST/AR ST and Arrhythmia Software, Release H.0.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a detailed performance study with specific acceptance criteria and results.

However, based on the limited information available, here's what can be extracted:

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

The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It also says, "The results demonstrate that ST/AR Release H.0 meets all defined reliability requirements and performance claims."

Since the specific "specifications cleared for the predicate device" are not provided, a table of acceptance criteria and reported performance cannot be fully constructed. The performance is generally stated as "substantial equivalence" and meeting "all defined reliability requirements and performance claims," without quantifiable metrics.

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

This information is not provided in the given 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 provided in the given text.

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

This information is not provided in the given 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

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's standalone performance in relation to predicate devices.

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

Yes, based on the description, the testing appears to be a standalone evaluation of the device's performance. The text mentions "system level tests, performance tests, and safety testing from hazard analysis." This type of testing typically focuses on the algorithm's direct output and adherence to specifications without explicitly involving human-in-the-loop scenarios for comparison.

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

This information is not provided in the given text. The reference to "specifications cleared for the predicate device" suggests that performance was measured against established standards, but the basis of those standards (e.g., expert annotations on specific datasets) is not detailed.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

Summary of the Study (as described in the document):

The study referenced is a set of "Verification, validation, and testing activities" aiming to establish the performance, functionality, and reliability characteristics of the new Philips ST/AR ST and Arrhythmia Software, Release H.0, with respect to its predicate devices.

• Test Types: System level tests, performance tests, and safety testing from hazard analysis.
• Acceptance Criteria Basis: Pass/Fail criteria were based on specifications cleared for the predicate device.
• Outcome: Test results reportedly showed substantial equivalence to the predicate device and demonstrated that ST/AR Release H.0 meets all defined reliability requirements and performance claims.

The document serves as a regulatory filing for substantial equivalence, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate, rather than providing a detailed scientific study with specific acceptance metrics and comprehensive dataset information. Therefore, many of the requested details about sample sizes, expert qualifications, and ground truth establishment are not present in this type of regulatory submission.

Ask a specific question about this device