(29 days)
The Naviscan PEMFlex Solo II High Resolution PET Scanner is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.
The Naviscan, Inc. (Naviscan) PEMFlex Solo II High Resolution PET Scanner (Solo II) is a high spatial resolution, small field-of-view PET imaging system specifically developed for close-range, spot, i.e. limited field, imaging. The Solo II is a partial-ring PET scanner, equipped with lutetium-containing gamma-ray detectors, which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. The Solo II is designed to collect gamma rays from a patient's body part with high efficiency. In order to achieve this high efficiency, the detectors should be positioned as close as possible to the body part under examination. Properly configured, the Solo II can display images obtained from other digital imaging modalities for correlative purposes.
The PEMFlex Solo II High Resolution PET Scanner's acceptance criteria and study details are summarized as follows:
1. Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with applicable Standards and predetermined specifications. | Complies with its predetermined specification and applicable Standards. |
| Electrical Safety | Compliance with applicable Standards and predetermined specifications. | Complies with its predetermined specification and applicable Standards. |
| Electromagnetic Compatibility (EMC) | Compliance with applicable Standards and predetermined specifications. | Complies with its predetermined specification and applicable Standards. |
| Performance Testing | Compliance with applicable Standards and predetermined specifications. | Complies with its predetermined specification and applicable Standards. |
| Software Testing | Compliance with predetermined specifications. | Complies with its predetermined specification. |
| Clinical Images | Demonstration of high-resolution image capability and compliance with predetermined specifications. | Three clinical case images demonstrated high resolution capability and compliance with specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Three clinical case images were provided for demonstration purposes.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "clinical case images."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The clinical images were presented to "demonstrate the high resolution image capability."
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The submission focuses on device performance and substantial equivalence to a predicate device, not on human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance evaluation was conducted for various aspects of the device, including Biocompatibility, Electrical Safety, EMC, Performance Testing, and Software Testing. The clinical images were also presented as a standalone demonstration of the device's imaging capability.
7. Type of Ground Truth Used
Based on the nature of the tests:
- For Biocompatibility, Electrical Safety, and EMC, the ground truth was based on adherence to applicable Standards and predetermined specifications.
- For Performance Testing, the ground truth was likely based on technical specifications and performance metrics defined by applicable standards.
- For Software Testing, the ground truth was based on predetermined specifications for the software's design and functionality.
- For Clinical Images, the ground truth for "high resolution image capability" likely refers to the visual quality and diagnostic utility of the images as assessed against expected performance standards for PET scanners, though specific expert review details are not provided.
8. Sample Size for the Training Set
The document does not mention the use of a "training set" in the context of machine learning or AI. This device is a PET scanner, and its performance evaluation focused on hardware and software functionality without indication of an AI component requiring a training set.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this device's evaluation, there is no information on how its ground truth would have been established.
§ 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.