(122 days)
The ProxiScan™ is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScan™ may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used.
The ProxiScan™ is an imaging device consisting of the imaging system: detector module, high-voltage power supply and computer. The detector module and highvoltage power supply are integrated into a small handheld enclosure, which works in conjunction with an external low-voltage power supply and a computer for data acquisition and processing.
Here's an analysis of the provided text regarding the ProxiScan™ device, focusing on acceptance criteria and study details.
Please note: The provided document is a 510(k) summary and FDA clearance letter. These types of documents typically summarize the results of testing rather than providing the full, detailed study reports. Therefore, some specific details commonly requested about study design (like exact sample sizes for test sets, detailed ground truth establishment for training, or MRMC study specifics) are often abbreviated or not explicitly stated in this format. My answers will reflect what is discernible from the provided text.
Acceptance Criteria and Device Performance
The document states that "All specifications were met" for both non-clinical and functional testing. While the specific numerical performance targets (i.e., the acceptance criteria) are not explicitly laid out with numerical thresholds in the provided text, the reported device performance is that it successfully met all of these unstated specifications.
Here's a table based on the information provided:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Testing | All specifications for appropriate performance were met. |
| Electrical Safety | Complied with IEC-60601-1 requirements. |
| Biocompatibility | Complied with ISO-10993 standard. |
| Functional Testing | All specifications were met for: |
| System Energy Linearity | Specifications met |
| Intrinsic Energy Resolution | Specifications met |
| Spatial Resolution | Specifications met |
| Contrast Evaluation | Specifications met |
| Uniformity | Specifications met |
| Count Rate Characteristics | Specifications met |
| Sensitivity | Specifications met |
Study Details
Based on the provided K093706 510(k) summary:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document refers to "appropriate performance testing" and "functional testing" without detailing the number of samples or cases used for each test.
- Data Provenance: Not explicitly stated. The tests are described as performance and functional tests, which typically involve phantom studies, bench testing, and engineering validations, rather than patient data in the context usually implied by "test set" for AI/clinical studies. Given it's a gamma camera, these tests likely involve phantoms or controlled radioactive sources.
- Retrospective or Prospective: Not applicable as the tests described are primarily engineering and performance characterization, not clinical studies with patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. The "ground truth" for the tests described (e.g., energy linearity, spatial resolution) would be established by the device's design specifications and by quantitative measurements using calibrated equipment and known standards (e.g., specific radioactive sources, phantom designs). It does not involve expert readers establishing ground truth for images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where human judgment is used to establish ground truth from patient data, particularly in complex or ambiguous cases. The described tests are objective performance measurements.
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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:
- No. The ProxiScan™ is a medical imaging device (a handheld gamma camera), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or reported for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, the primary testing described is "standalone" performance of the device itself. The functional and non-clinical tests evaluate the device's intrinsic characteristics (e.g., resolution, uniformity, sensitivity) independent of a human operator's interpretation decisions. However, this is not an "algorithm-only" standalone performance in the context of AI, as the device's output is an image for human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the reported tests refers to established engineering standards, physical properties of radioactive sources and phantoms, and predefined performance specifications. For example, for "system energy linearity," the ground truth is the known energy of a radionuclide and the device's measured response. For "spatial resolution," it would be a known physical dimension in a phantom.
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The sample size for the training set:
- Not applicable. This is a medical imaging device, not a machine learning or AI algorithm in the context typically implying a "training set." The device's software processes signals from CZT detectors to display images; this processing is based on engineering design and calibration, not machine learning training data.
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How the ground truth for the training set was established:
- Not applicable, for the same reasons as point 7.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).