(39 days)
The Radialis PET Camera 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 Radialis PET Camera is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Camera is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Camera is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient's body part with high efficiency.
The Radialis PET Camera 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.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it lists various performance aspects that were tested and states that the device "complies with its predetermined specifications and with applicable standards." The "Reported Device Performance" is generally descriptive rather than numerical.
| Performance Aspect | Acceptance Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Radiation | Compliance with applicable standards | Tested and found compliant |
| Resolution | Meets predetermined specifications | Tested and found compliant; images demonstrate high-resolution |
| Spatial Linearity | Meets predetermined specifications | Tested and found compliant |
| System Sensitivity | Meets predetermined specifications | Tested and found compliant |
| Flood Field Uniformity | Meets predetermined specifications | Tested and found compliant |
| Coincidence | Meets predetermined specifications | Tested and found compliant |
| Scatter | Meets predetermined specifications | Tested and found compliant |
| Imaging Workflow | Meets predetermined specifications | Tested and found compliant |
| Notifications | Meets predetermined specifications | Tested and found compliant |
| Cleaning | Meets predetermined specifications | Tested and found compliant |
| Lifecycle | Meets predetermined specifications | Tested and found compliant |
| Biocompatibility | Compliance with applicable standards | Patient contact material tested and found compliant |
| Electrical Safety / Electromagnetic Compatibility | Compliance with AAMI / ANSI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 | Undergone testing and found compliant |
| Software Testing | Compliance with IEC 62304 and FDA Guidance | Designed and developed according to robust SDLC, rigorously verified and validated |
2. Sample Size for the Test Set and Data Provenance
The non-clinical testing included an imaging study with:
- Sample Size for Test Set: Three (3) patients.
- Data Provenance: Not specified, but the submission is from a Canadian company (Radialis Inc. Suite 2300B, 290 Munro Street Thunder Bay, Ontario P7A 7T1 Canada), so the data could be from Canada. The study type is presumably prospective in nature for these three patients to acquire images for demonstration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text states "Three (3) patients were imaged with the Radialis PET Camera and the images were provided. The images demonstrate the high-resolution image capability of the Radialis PET Camera." There is no mention of experts reviewing these images to establish a ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the limited description of clinical imaging (only 3 patients for demonstration), it's unlikely a formal adjudication process was described for these images.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission focuses on the technical performance and substantial equivalence of the device itself, not on human reader performance with or without AI assistance. The device in question is a PET Camera, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The Radialis PET Camera is a hardware device (an Emission Computed Tomography System), not an algorithm that performs standalone analysis. Therefore, a standalone algorithm performance study as typically defined for AI/ML devices was not done. The "performance testing" described refers to the functional performance of the hardware and its associated software for image acquisition and processing.
7. The Type of Ground Truth Used
For the very limited "clinical images" set (3 patients), the type of ground truth used is not explicitly stated. However, the purpose was to "demonstrate the high-resolution image capability." This suggests the images were likely reviewed based on visual assessment of image quality, potentially against expected physiological distribution of radiopharmaceuticals, rather than a definitive "ground truth" for a diagnostic task (e.g., pathology, outcomes).
For the broader performance testing (Resolution, Sensitivity, etc.), the "ground truth" would be established by physical phantom measurements and documented engineering specifications conforming to NEMA NU 4:2008 and other relevant standards.
8. The Sample Size for the Training Set
This device appears to be a traditional medical imaging device (PET Camera) and not an AI/ML device that requires a "training set" in the context of machine learning. The section on "Software Testing" refers to robust software development processes, verification, and validation, but this pertains to the software functionality of the imaging system, not an AI model trained on a dataset. Therefore, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a training set, 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.