(249 days)
For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical , laparoscopic or thoracoscopic surgical procedures.
The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-held sensor probes, a counting unit, and a cable interconnecting the two.
The provided text is a 510(k) summary for the "Modified GAMMA GUIDANCE SYSTEM." It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or a study proving the device meets those criteria.
Generally, a 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria in the same way a PMA (Premarket Approval) would. The FDA letter confirms the substantial equivalence finding based on the information provided in the 510(k) submission, which would have included performance data, but that data is not detailed in the summary.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be stated based on the given document:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the text. The document states the device is substantially equivalent to a predicate device (GAMMA GUIDANCE SYSTEM, K961321), implying its performance is comparable. However, specific acceptance criteria or quantitative performance metrics for the "Modified GAMMA GUIDANCE SYSTEM" are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the text.
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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the text.
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 guidance system, a medical instrument for detecting and quantifying radiation, not an AI-assisted diagnostic imaging system that would involve human "readers" or an "AI vs. without AI assistance" comparison in the typical MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (probe, counting unit, cable), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in the text. (This would typically relate to the "predicate device" information, which is also not detailed enough here.)
8. The sample size for the training set:
- Not applicable/Not provided. This device is a physical instrument, not a machine learning model that undergoes "training."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This device is a physical instrument, not a machine learning model that relies on establishing ground truth for a "training set."
§ 892.1320 Nuclear uptake probe.
(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.