(121 days)
For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.
The provided text describes the 510(k) Premarket Notification for the AnyScan-S SPECT Imaging System. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate comparison) | Reported Device Performance (AnyScan-S) |
|---|---|
| Performance of predicate devices (Symbia-E - Siemens [K072567]) based on NEMA Standard test protocols (implied baseline for performance in SPECT systems) | Met or exceeded that of predicate devices (using NEMA NU1 phantoms, under NEMA Standard test protocols). |
| Tomographic image quality comparable to reference predicate devices for clinical images | Tomographic image quality was at least equal to images produced by reference predicate devices (in human subjects). |
| Applicable electrical safety standards and defined acceptance criteria | Met applicable electrical safety standards and defined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Clinical images were obtained using the AnyScan-S in human subjects." However, it does not specify the exact number of human subjects or the sample size of the clinical images used for the test set.
- Data Provenance: The document implies that the clinical images were obtained from human subjects directly during the testing of the AnyScan-S device, suggesting a prospective nature for this specific part of the evaluation. The country of origin of the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method used for the test set.
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
This document describes a SPECT Imaging System, which is a medical imaging device. It does not involve an AI component or human-in-the-loop performance evaluation, therefore, an MRMC comparative effectiveness study regarding AI assistance would not be applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone SPECT imaging system. The performance testing described (NEMA phantoms, clinical image quality) reflects the standalone performance of the device's imaging capabilities without human intervention in image acquisition or processing beyond standard operational procedures. There is no explicit "algorithm only" component mentioned as distinct from the device's overall function.
7. The Type of Ground Truth Used
- For the NEMA phantom testing, the "ground truth" is established by the physical properties and known measurements of the NEMA NU1 phantoms, according to NEMA Standard test protocols.
- For clinical images in human subjects, the document states "Tomographic image quality was at least equal to images produced by reference predicate devices." This implies a comparison to a clinical standard established by existing, legally marketed predicate devices, rather than a singular, independently established "ground truth" like pathology or outcomes data specifically for this study. The implication is that if the images are "at least equal," they meet the clinically acceptable standard.
8. The Sample Size for the Training Set
The document does not mention a training set for an algorithm, as the device is a hardware imaging system and not primarily an AI algorithm. Its performance is based on the physical characteristics and design of the SPECT system.
9. How the Ground Truth for the Training Set Was Established
As no training set for an algorithm is mentioned or implied, this question is not applicable.
§ 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.