(15 days)
The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.
The MyoLIGHT system is a dedicated Gamma Camera for nuclear cardiology, highperformance dual-head nuclear medicine imaging system. It is based on the following legally marketed device: CARDIOSPECT D90 - K021823. Modifications include reduced gantry size, adapted patient table, detectors moving in an enclosed space on a fixed radius and set at 90 degrees, integrated patient table, integrated acquisition station and operator console, and built-in cardiac gating circuitry.
This document is a 510(k) summary for the GE Medical Systems F.I. Haifa MyoLIGHT device, a dedicated Gamma Camera for nuclear cardiology.
1. Acceptance Criteria and Reported Device Performance:
The document states that the MyoLIGHT device is a modification of a legally marketed predicate device, CARDIOSPECT D90 (K021823). The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to CARDIOSPECT D90 (K021823) in terms of safety and effectiveness | "Bench and images data show that the MyoLIGHT images are similar to the CARDIOSPECT D90 (K021823) images." |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench and images data" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not specify an adjudication method.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable as this is not an AI-assisted device in the context of the provided document. The study focuses on demonstrating equivalence of the MyoLIGHT system to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone performance evaluation (algorithm only) was not explicitly detailed as such. The "Bench and images data" likely refers to technical performance assessment of the system, not an algorithm's performance independent of human interaction for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of ground truth used. The statement "Bench and images data show that the MyoLIGHT images are similar to the CARDIOSPECT D90 (K021823) images" suggests a comparison against the imaging characteristics or output of the predicate device, rather than a clinical ground truth like pathology.
8. The sample size for the training set:
There is no mention of a training set as this device is not described as involving a learning algorithm. The study focuses on comparing a modified device to a predicate.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.