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AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

This document is a 510(k) premarket notification for the AOS Marker Seeds (SMG0242-025), which are 24k gold, 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site.

Based on the provided text, the device is considered substantially equivalent to a legally marketed predicate device (K062825, AOS Marker Seeds). The core of this submission is the claim of identity to the predicate device, rather than new performance data.

Therefore, most of the requested information regarding acceptance criteria and study proving device performance (like accuracy metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this specific 510(k) submission.

Here's how the provided information addresses your questions:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of performance metrics for a new device. The "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device. This means the new device must have the same technological characteristics and indications for use as the predicate, or any differences must not raise new questions of safety and effectiveness.
• Reported Device Performance: No new performance data is reported as the device is deemed "identical to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. No new testing was performed; the device is asserting substantial equivalence based on its identity to a previously cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No new testing was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No new testing 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:

• Not Applicable. This device is a physical marker seed, not an AI or imaging diagnostic tool. It does not involve human readers or AI assistance in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. No new performance study was conducted. The "ground truth" for this submission relies on the established safety and effectiveness of the identical predicate device.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning/AI device, so there is no training set in that context.

9. How the ground truth for the training set was established:

• Not Applicable. As per point 8.

Summary from the document that supports the above responses:

• "Nonclinical testing was not performed as device is identical to the predicate device." (Page 4)
• "Clinical testing was not performed as device is identical to the predicate device." (Page 4)
• "Nonclinical and clinical testing were not performed as device is identical to the predicate device." (Page 5)
• "Indications for use have been rephrased for clarity but are the same as the predicate device." (Page 4)
• "All other technological characteristics are the same as the predicated device." (Page 4 - referring to the only differences being the discontinued silver version and the change from sterile factory shipment to end-user sterilization).

In conclusion, this 510(k) submission is based on the concept of substantial equivalence, where the new device is considered "identical" to a previously cleared predicate. Therefore, no new performance data or studies (clinical or non-clinical in terms of performance metrics) were required or presented.

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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

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.

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