(203 days)
The VCAR option to the VISION FX-80 Gamma Camera and Power Station produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians. The system is intended for whole body nuclear imaging.
The VCAR option to the VISION FX-80 Gamma Camera and Power Station (FX-80&PS/VCAR) is an accessory upgrade to the previously cleared FX-80 Gamma Camera (K935273) and Power Station (K912753). This accessory enables the system to perform electronic collimation for positron emission tomography (PET) of radioisotopes within the human body. The FX-80&PS/VCAR utilizes proprietary coincidence detection electronics and software to perform electronic collimation of gamma rays emitted from decay of radioisotopes in a patient. This process is called "Coincident Photon Emission Computed Tomography" (CPECT). The FX-80&PS/VCAR allows the operator to acquire coincidence imaging data by controlling the detector electronics and processors in coincidence imaging mode. The FX-80&PS/VCAR also includes the control, processing, and display screens to perform reconstruction of 2-D and 3-D information from the acquired datasets.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with the requested level of detail. The information is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with specific performance metrics and patient data.
Here's a breakdown of what can be extracted and what information is missing based on your questions:
1. A table of acceptance criteria and the reported device performance
The document states: "Major performance parameters have been measured using industry-standard test methods to determine that the device meets its system performance specifications and performs in a fashion similar to predicate devices." However, specific numerical acceptance criteria and the corresponding reported device performance values are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The summary mentions "system testing and validation" but does not detail the nature of the test set (e.g., patient data, phantom data), its size, or its origin.
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)
This information is not available. The document mentions that the device "produces images which depict the anatomical distribution of radioisotopes within the human body, for interpretation by medical clinicians," but does not describe any human expert review process for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available.
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
This type of study is not mentioned in the provided text. The device is described as an "accessory upgrade" that enables CPECT, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The document suggests that the device performs imaging and reconstruction as a standalone system (algorithm only without human-in-the-loop performance for image generation), given that it "produces images which depict the anatomical distribution of radioisotopes." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not provided. The focus is on the technical capability to generate images for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a gamma camera system for nuclear imaging), the "ground truth" for its basic performance would likely involve phantom studies (measuring spatial resolution, sensitivity, uniformity with known radioisotope distributions) and comparison to established imaging techniques (e.g., existing PET systems). However, the document does not explicitly state the type of ground truth used. It implies that the images are for "interpretation by medical clinicians," suggesting a reliance on clinical judgment as the ultimate benchmark, but doesn't detail how this was assessed during testing.
8. The sample size for the training set
This information is not available. The document describes "proprietary coincidence detection electronics and software" and states the device was "developed and validated in accordance with the Company's product and software development procedures," but does not mention specific training sets or machine learning aspects that would typically involve a training set as understood today.
9. How the ground truth for the training set was established
This information is not available, as a "training set" in the context of modern AI/ML development is not explicitly discussed.
In summary: The provided 510(k) summary focuses on the technological characteristics and substantial equivalence to predicate devices for a gamma camera accessory enabling CPECT. It asserts that "system testing and validation demonstrates that the system meets its published specifications, performs as well as or better than the currently marketed product, and is safe and effective for its intended use." However, it does not provide the granular details of acceptance criteria, specific performance metrics, study designs, sample sizes, or ground truth methodologies that your questions are looking for. This is typical for a 510(k) summary from 1997, where the emphasis was on engineering validation and equivalence rather than extensive clinical efficacy trials with detailed statistical reporting of performance against ground truth as might be expected for an AI/ML-driven device today.
§ 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.