(77 days)
The T-Wave Alternans (TWA) Algorithm Option is intended for use in a hospital, doctor's office or clinic environment by competent healthcare professionals for recording ST-T wave morphology fluctuations for patients who are undergoing cardiovascular disease testing.
T-Wave Alternans (TWA) Algorithm Option is a software algorithm that runs on GE Medical Systems Information Technologies' electrocardiographic equipment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the T-Wave Alternans (TWA) Algorithm Option:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for the T-Wave Alternans (TWA) Algorithm Option. Instead, it relies on substantial equivalence to a predicate device and a general statement of performance.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly defined in the document. The primary criterion is "as safe, as effective, and performs as well as the predicate software option." | "Tests results are identical. It is the same software as predicate device." |
| Implicit: Accuracy and resolution of 1-microvolt for measuring T-wave alternans. | "The algorithm performs the measurement of this variation at an accuracy and resolution of 1-microvolt." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions an "independent, published study" but does not provide details about its specific test set or data provenance. The primary justification is that the device is "the same software as predicate device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- How Ground Truth was Established: Not specified for the predicate device's original testing, which this submission relies upon. The current device "provides only the measurements of the ST-T-waves" and states "No interpretation is generated," implying that the ground truth for TWA measurements would likely be based on comparison to an established gold standard for TWA detection (e.g., highly accurate spectral analysis or expert visual assessment using specific criteria) rather than expert interpretation of a TWA diagnosis itself.
4. Adjudication Method for the Test Set
Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this document. The submission relies on equivalence to a predicate device and an "independent, published study" without detailing its methodology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, indirectly. The TWA Algorithm Option is described as a "software algorithm" that performs "measurements of the fluctuations of the ST-T-waves." It explicitly states that "No interpretation is generated" by the algorithm. This indicates that its performance is assessed as a standalone measurement tool, providing data for healthcare professionals to interpret. The stated performance is related to its measurement capability (1-microvolt accuracy and resolution).
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the original predicate device's validation. Given that the algorithm performs "measurements of this variation at an accuracy and resolution of 1-microvolt," the ground truth likely involved a highly precise method for determining actual T-wave alternans magnitude, possibly through:
- Expert Consensus: Experts meticulously reviewing ECGs for TWA patterns and their characteristics using established criteria.
- Validated Reference Method: Another, more established and precise method for quantifying TWA (e.g., a highly accurate
spectral analysis-based system or specialized signal processing techniques). - The "independent, published study" mentioned might contain further details on this, but it is not provided in this submission.
8. The Sample Size for the Training Set
Not specified. The document states that the new device "employs identical technology as the predicate device" and that "Tests results are identical. It is the same software as predicate device." This suggests that the training was done for the predicate device, but no details are provided here.
9. How the Ground Truth for the Training Set Was Established
Not specified. As with the test set, this information would pertain to the predicate device's development and is not detailed in this 510(k) summary.
§ 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).