(88 days)
The “ISOCAM II” manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. Same as ISOCAM II.
The ISOCAM II (Dual Head Gamma Camera) is a Single Photon Emission Computed Tomography (SPECT) gamma camera. This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification. The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.
Here's a breakdown of the acceptance criteria and the study information based on the provided text for the ISOCAM II with MCAT™:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISOCAM II with MCAT™) | Reported Device Performance (ISOCAM II with MCAT™) | Baseline Performance (ISOCAM II) |
|---|---|---|---|
| System Sensitivity | ≥ 1000 cpm/μCi/min | 1000 cpm/μCi/min (implied by "better sensitive measurements" and meeting the "≥" criteria) | 190 cpm/μCi/min (with LEHR collimator) |
| Image Resolution (0-20 cm) | 5-8 mm FWHM | 5-8 mm FWHM | 3.7-12.3 mm FWHM |
Note: The document explicitly states "better sensitivity and resolution measurements change the effectiveness of the ISOCAM II system." It then lists the specific values for the MCAT™ version, implying these are the performance goals and achievements.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a specific test set in terms of patient data or clinical trials for performance evaluation. The "study" described appears to be a technical comparison and verification of the device's physical and technical characteristics against a predicate device (the ISOCAM II without MCAT™).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. Given the nature of the evaluation (technical performance metrics for a gamma camera), it's unlikely that traditional "ground truth" established by clinical experts in the context of diagnostic accuracy was involved in the same way it would be for AI algorithms. The performance metrics (sensitivity and resolution) are typically measured using physical phantoms and established scientific methodologies.
4. Adjudication Method
This information is not applicable to the type of evaluation described. There's no mention of a human-in-the-loop diagnostic task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted, or at least not described in this submission. The focus is on the technical specifications of the imaging equipment itself, not on comparing diagnostic outcomes with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the device is a gamma camera, not an AI algorithm. The performance metrics listed are inherent to the machine's imaging capabilities.
7. Type of Ground Truth Used
The ground truth used for evaluating the performance metrics (sensitivity and resolution) would be based on physical measurements using standardized phantoms and radioactive sources. This is a common practice in imaging device evaluation to objectively quantify their technical capabilities. There are no mentions of expert consensus, pathology, or outcomes data being used for this specific evaluation.
8. Sample Size for the Training Set
This information is not applicable as the device is a gamma camera and not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 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.