(89 days)
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
The TAC-2 hardware consists of two sliding line source emitter block/collimator assemblies. Each assembly extends transaxially across the face of each detector of a DST series gamma camera oriented 180°. When in use each emitter block exposes the collimator in the opposing assembly. The assemblies travel in synchrony along the axial direction.
The provided text primarily focuses on the 510(k) summary for the TAC-2 device, its intended use, and substantial equivalence to predicate devices. It lacks the detailed information required to comprehensively answer the request regarding acceptance criteria and a study proving device performance against those criteria.
However, based on the limited information, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a quantitative manner. The closest statement regarding performance is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "Images produced were of the same quality as those provided by the manufacturers of the predicate devices." |
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 provided in the document. The text only mentions "Clinical and non-clinical studies were conducted."
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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 information is not provided in the document. Given the device's nature (attenuation correction for gamma cameras), it's unlikely to be an AI-driven device in the modern sense that would involve human reader improvement with AI assistance. The focus is on image quality enhancement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an accessory that produces images to enhance emission images by correcting for photon attenuation. Its performance would be evaluated on the quality of these corrected images, which is a form of standalone performance in terms of image processing. The statement "Images produced were of the same quality as those provided by the manufacturers of the predicate devices" implies a standalone evaluation against a benchmark. However, details of this evaluation are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "images that depict the anatomy of a patient" and "correcting for photon attenuation effects of the patient's anatomy." The implied ground truth would be the actual patient anatomy and the actual amount of attenuation, likely assessed through comparison with established imaging techniques or potentially physical phantoms for quantifiable metrics. However, the specific method for establishing ground truth is not provided.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of Study Information Provided:
- Study Purpose: Clinical and non-clinical studies were conducted to evaluate the TAC-2 attenuation correction device.
- Device Under Test: TAC-2 attenuation correction device with a DST-XL with the VCAR option.
- Outcome: "Images produced were of the same quality as those provided by the manufacturers of the predicate devices."
- Comparison: Implied comparison to images from predicate devices (90KPS TAC SMV and 90 KPS MCD-AC ADAC Laboratories).
Key Missing Information for a Comprehensive Answer:
The document is a 510(k) summary, which often provides high-level information for substantial equivalence. It lacks the detailed methodology, specific quantitative acceptance criteria, statistical analysis, and comprehensive results typically found in full study reports required to answer all sections of your request comprehensively.
§ 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.