AOS Marker Seeds (SMG0242-025)

• K Number: K233626
• Device Name: AOS Marker Seeds (SMG0242-025)
• Manufacturer: Alpha-Omega Services, Inc.
• Date Cleared: 2024-07-02 ( 232 days)
• Product Code: JAQ
• Regulation Number: 892.5700
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K062825

Intended Use

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

Device Description

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

AI/ML Overview

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.

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.