(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):
A. Planar Imaging
B. Whole Body Imaging
C. Tomographic imaging (SPECT) for non Positron emitter
The NuCamma Rx nuclear imaging system has a rectangular 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.
This document is a 510(k) Premarket Notification for the NuCamma Rx gamma camera system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through novel testing.
Therefore, many of the requested elements (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and training set details) are not typically found in a 510(k) submission that relies on equivalence to a predicate device. The information provided mainly covers the device's intended use and a qualitative comparison to the predicate.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with quantitative performance metrics for the NuCamma Rx itself. Instead, it claims substantial equivalence to a predicate device based on its intended use and general safety/effectiveness. The key "performance" aspect is its ability to perform certain imaging techniques within a specified energy range.
| Acceptance Criteria (Inferred from "Intended Use" and "Determination of Substantial Equivalence") | Reported Device Performance (as stated or inferred) |
|---|---|
| Intended Use: To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store data for analysis. | NuCamma Rx: Detects the location and distribution of radionuclides in the body; stores data for transmission/retrieval by existing commercially available data analysis software. (Does not include internal data analysis capability, distinguishing it from the predicate in this specific functional aspect, but not in its fundamental detection capability). |
| Imaging Techniques: Must perform Planar Imaging, Whole Body Imaging, and Tomographic imaging (SPECT) for non-Positron emitters. | NuCamma Rx: Performs Planar Imaging (✓), Whole Body Imaging (✓), and Tomographic imaging (SPECT) for non-Positron emitters (✓). Does not perform Positron imaging by coincidence or without coincidence (✗). |
| Energy Range: Must operate within a specified energy range for imaging. | NuCamma Rx: Operates within an energy range of 50 - 400 keV for Planar, Whole Body, and SPECT imaging. |
| Safety and Effectiveness: Must be safe and effective, and meet electrical safety standards. | NuCamma Rx: Deemed safe and effective, and certified to the same electrical safety standards as the predicate device by a third-party organization. |
| Substantial Equivalence: Must be substantially equivalent to the ISOCAM I gamma camera. | NuCamma Rx: A matrix comparing features and intended use demonstrated substantial equivalence to the predicate device, raising no new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission for NuCamma Rx relies on demonstrating substantial equivalence to a predicate device (ISOCAM I gamma camera) rather than conducting a new clinical performance study with a test set of patient data. Therefore, there is no mention of a specific sample size, data provenance, or whether the study was retrospective or prospective.
3. 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. As stated above, no new clinical performance study on a test set was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used for a new clinical performance study.
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
Not applicable. This device is a gamma camera system, not an AI-assisted diagnostic tool. There is no mention of AI or MRMC studies in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a gamma camera, not an algorithm, and the submission does not describe standalone performance testing in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new clinical performance study with defined ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to a predicate device already on the market.
8. The sample size for the training set
Not applicable. No algorithm training was performed or described for this device.
9. How the ground truth for the training set was established
Not applicable. No algorithm training was performed or described for this device.
Summary of the document's approach:
The core of this 510(k) submission is to demonstrate that the NuCamma Rx is "substantially equivalent" to a previously cleared predicate device (ISOCAM I gamma camera). This approach means the manufacturer doesn't need to perform extensive new clinical studies to prove safety and effectiveness from scratch. Instead, they compared the NuCamma Rx's intended use, technological characteristics, and safety certifications to the predicate device.
The "study that proves the device meets the acceptance criteria" in this context is the qualitative comparison (a "matrix was constructed comparing the features and intended use") and the certification to electrical safety standards, all aimed at establishing substantial equivalence to the predicate device. The FDA's letter confirms that, based on this comparison, the device is deemed substantially equivalent.
§ 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.