(56 days)
The T-Wave Alternans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing.
The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs.
The provided text describes the T-Wave Alternans (TWA) Algorithm Option, a software algorithm for electrocardiographs. However, the document (K023380) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data.
Therefore, much of the requested information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not available within this document. The document primarily focuses on regulatory compliance and the intended use of the device.
Here's an attempt to answer the questions based on the available information, with clear indications of what is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (The document states "The results of these measures demonstrate T-Wave Alternans (TWA) Algorithm Option is as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System." This is a general statement of equivalency, not specific performance metrics against defined criteria.) |
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 for the test set: Not provided.
- Data provenance: Not provided. (The document mentions "Verification and Validation" but does not detail the specific datasets used for these activities.)
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 provided.
- Qualifications of experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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 done: Not provided. The document focuses on the algorithm's performance itself and its equivalency to a predicate device, not on its impact on human reader performance.
- Effect size of human reader improvement with AI: Not applicable, as an MRMC study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: The document implies standalone testing in that it describes the algorithm as a "software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographs" and states "Verification and Validation" were performed. However, specific details of a formal standalone performance study with metrics are not explicitly provided. The comparison is often implicitly against the performance of the predicate device's existing algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not provided.
8. The sample size for the training set
- Sample size for the training set: Not provided. The document focuses on regulatory approval, not on the developmental aspects like training data for the algorithm.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not provided.
Summary of available information:
The 510(k) summary (K023380) primarily indicates that the device underwent standard quality assurance measures, including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Code inspections
- Verification and Validation
These measures were deemed sufficient to demonstrate that the T-Wave Alternans (TWA) Algorithm Option is "as safe, as effective, and performs as well as the predicate software option offered with device, CASE 8000 Exercise Testing System." The document does not disclose the detailed methodologies, datasets, or specific performance metrics from these verification and validation activities.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).