(244 days)
AOS Marker Seeds are used to provide reference positions around a proposed treatment site in order to re-apply a radionuclide source into the body or to the surface of the body for multiple sessions of radiation therapy.
AOS Marker Seeds are small, cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems.
Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the AOS Marker Seeds:
Analysis:
This 510(k) submission for the "AOS Marker Seeds" does not contain a traditional performance study comparing the device against specific acceptance criteria for a new, independent claim. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (also "AOS Marker Seeds," but preamendment and non-sterile).
Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this 510(k) is a comparison to a predicate, not a de novo performance evaluation with objective acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as performance criteria for a new claim) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Design Equivalence: The new device should have the same design as the predicate. | Met: Both the new and predicate device share the same design. |
| Material Equivalence: The new device should be constructed of the same materials as the predicate. | Met: Both the new and predicate device are constructed of the same materials. |
| Single Use: The new device should be single use only. | Met: Both the new and predicate device are Single Use Only. |
| Sterility: (Implicit improvement/difference) | Met: New device is sterile. (Predicate was non-sterile). |
| Visibility with radiography imaging systems: (Implicit requirement for intended use) | Met (by statement of intended use and material): AOS Marker Seeds are small cylindrical pieces of 24k gold or silver, which are easily visible with radiography imaging systems. (This is a statement of fact and intended functionality, not a measured performance metric in this submission). |
| Safety and Efficacy: The new device should be equivalent in safety and efficacy to the predicate. | Met: "The Conclusion drawn from the above is that the Marker Seeds are equivalent in safety and efficacy to their 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)
- Sample Size: Not Applicable / Not Provided. This submission does not include a performance study with a test set of data. The equivalence is based on design and material comparison.
- Data Provenance: Not Applicable / Not Provided.
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 / Not Provided. No ground truth establishment was conducted as part of a performance study in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication of a test set was performed.
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, an MRMC study was not done. This device is a passive marker seed, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device based on its preamendment history and previous FDA clearance.
8. The sample size for the training set
- Not Applicable / Not Provided. This submission does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set was used.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.