(84 days)
To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): Planar Imaging, Whole Body Imaging, Tomographic imaging (SPECT) for non Positron emitter.
The NuCamma R* nuclear imaging system has a round field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.
The provided text does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets such criteria. It primarily focuses on the 510(k) submission for the NuCamma R* Gamma Camera, demonstrating its substantial equivalence to a predicate device (ISOCAM I).
Here's an analysis of the information that is present, and an explanation of why many of your requested items cannot be fulfilled from the provided text:
Lack of Specific Acceptance Criteria and Performance Study:
The document is a 510(k) submission summary, which primarily aims to establish substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria. This means:
- No specific quantified acceptance criteria are listed. The approval hinges on demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness concerns compared to the predicate device.
- No detailed performance study results are provided. The document mentions a "matrix was constructed comparing the features and intended use of the NuCamma R* with the predicate device," but it doesn't elaborate on the methodology or specific outcomes of this comparison in a way that aligns with a typical performance study against acceptance criteria.
Therefore, the following points cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Information that can be extracted or inferred:
While a detailed performance study isn't available, the document does touch upon the basis for the FDA's decision, which suggests some implicit "acceptance criteria" are being met through substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
As explained, no explicit table is provided. The acceptance, in this context, is primarily based on substantial equivalence to the predicate device (ISOCAM I).
| Acceptance Criteria (Implicitly met via Substantial Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use: Detect location and distribution of gamma ray and positron emitting radionuclides in the body. | NuCamma R* Intended Use: To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the data for analysis. The system only detects and stores data, analysis is done by external software. |
| Technological Characteristics: Similar to predicate. | NuCamma R* Technological Characteristics: Nuclear imaging system with a round field of view. "A matrix was constructed comparing the features and intended use of the NuCamma R* with the predicate device." |
| Safety and Effectiveness: No new safety or effectiveness concerns compared to predicate. | NuCamma R* Safety and Effectiveness: "Deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients." "We conclude that the NuCamma R* is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised." |
| Electrical Safety Standards: Compliance with relevant standards. | Certified to the "same electrical safety standards as the predicate device by a third party organization." |
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation appears to be a technical comparison and safety assessment against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No "ground truth" establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is detailed.
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:
- No. This is not an AI device, and no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a gamma camera, not an algorithm, so "standalone performance" in this context is not what is being assessed as an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided. No explicit ground truth is mentioned regarding clinical performance data. The basis for approval is substantial equivalence to the predicate device, relying on its established safety and effectiveness.
8. The sample size for the training set:
- Not applicable/Not provided. As there is no mention of an algorithm or AI component, there would be no "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set information is available.
§ 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.