(64 days)
The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
The MoCo program is an independent, standalone software application developed by Cedars-Sinai Medical Center for the automatic and manual correction of SPECT acquisition motion artifacts from gated and ungated projection datasets. MoCo is the most popular motion correction application in the field of nuclear myocardial perfusion SPECT imaging. The software has the same indication for use and function as the Motion Correction function module of Mirage software (Segami Corporation, K972886), which is currently being used on Digirad 2020tc SPECT Imaging systems.
The provided document describes the Cedars-Sinai Motion Correction (MoCo) Software, a standalone application for correcting patient motion artifacts in SPECT data. However, it does not contain information regarding detailed acceptance criteria, a specific study proving it meets these criteria, or a table comparing acceptance criteria to device performance metrics beyond a general statement of "Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results."
Here's an analysis of the available information, noting what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The submission states that functionality tests were conducted and passed, but it does not specify the quantitative acceptance criteria or the reported performance metrics (e.g., specific accuracy, sensitivity, or specificity values) from these tests.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The document mentions "functionality tests" but does not detail the number of cases or datasets used in these tests. Information on the country of origin of the data or whether it was retrospective or prospective is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not available in the provided document. The method and number of experts for establishing ground truth for any test set are not mentioned.
4. Adjudication Method for the Test Set
Not available in the provided document. No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided document. There is no mention of an MRMC study being conducted, nor any effect size regarding human reader improvement with or without AI assistance.
6. Standalone Algorithm Performance
The document states that the MoCo program is an "independent, standalone software application." The functionality tests described imply a standalone evaluation, where the software's performance against its specifications was assessed. However, specific performance metrics are not given.
7. Type of Ground Truth Used
Not available in the provided document. The document does not specify how the "expected results" for the functionality tests were determined or what type of ground truth (e.g., expert consensus, pathology, outcomes data) was used.
8. Sample Size for the Training Set
Not available in the provided document. The document does not provide any information about a training set or its sample size.
9. How Ground Truth for the Training Set Was Established
Not available in the provided document. Since no training set is mentioned, there is no information on how its ground truth was established.
Summary of available information related to testing:
The document mentions "Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results." This indicates that some form of internal validation was performed to ensure the software performed as designed, but the details of this validation (specific criteria, data used, and quantitative outcomes) are not present in this submission. The submission primarily focuses on the device's classification, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable acceptance criteria.
§ 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.