(90 days)
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
A. Planar Imaging
B. Whole Body Imaging
E. Positron imaging without coincidence
MULTISPECT 2 511keV Collimator
The provided text, K972360, is a 510(k) submission for a device called "MULTISPECT 2 511 keV Collimator" by Siemens Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device rather than rigorously proving performance against pre-defined acceptance criteria through a dedicated study.
Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is NOT present in the provided document.
The document details the administrative aspects of the 510(k) submission, including classification, intended use, establishment information, and the formal approval letter from the FDA. It declares the device to be "substantially equivalent to legally marketed devices," which is the core of a 510(k) process. This means its performance is considered comparable to existing, approved devices, and a separate, detailed performance study with specific acceptance criteria is typically not required for this type of submission.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document is a 510(k) submission demonstrating substantial equivalence, not a performance study against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not provided. No specific test set or data provenance (country of origin, retrospective/prospective) is mentioned, as a formal performance study with a test set is not described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not provided. No experts are mentioned in the context of establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not provided. No test set is described, so no adjudication method is mentioned.
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
Not applicable/Not provided. This device is a collimator (a physical component of a nuclear medicine imaging system), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable/Not provided. This device is a collimator, not a standalone algorithm.
7. The Type of Ground Truth Used
Not provided. Since no specific performance study or test set is described, no ground truth type is mentioned.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is a physical component, not a trainable algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This device is a physical component, not a trainable algorithm.
In summary, the provided document is a 510(k) premarket notification whose purpose is to demonstrate substantial equivalence to a legally marketed predicate device. It does not contain information about a dedicated performance study with specific acceptance criteria, test sets, ground truth establishment, or expert-based evaluations as would be found in a clinical trial or a study for novel device performance.
§ 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.