(28 days)
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal, and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual ournors following completion of a course of external radiation therapy and for recurrent tumors.
BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter.
lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The tifanium wall of the BrachySource Seed Implant absorbs the electrons.
This document is a 510(k) Summary for a medical device (BrachySource® Brachytherapy Seed Implants). It describes a traditional medical device (brachytherapy seeds for radiation therapy), not an AI/ML-based device. Therefore, the concepts of acceptance criteria for AI performance, clinical study design for AI, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details as requested in the prompt are not applicable to this document.
The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing.
Here's a breakdown of the specific aspects requested, as they relate to this non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same intended use as predicate device | The subject device has the same intended use. |
| Same general design as predicate device | The subject device has the same general design. |
| Same fundamental scientific technology as predicate device | The subject device has the same fundamental scientific technology. |
| Meets performance requirements for safety and effectiveness (demonstrated via bench testing) | "The appropriate bench testing to determine substantial equivalence was completed." (Specific performance metrics are not detailed in this summary) |
| Physical characteristics (dimensions, materials) | Nominally 4.5mm long by 0.8mm in diameter, welded titanium capsule, lodine-125 absorbed onto nickel/copper coated, gold cored aluminum wire. |
| Radioactive properties (half-life, emissions) | Half-life of 59.6 days, decays by electron capture with emission of 27.4 and 31 keV x-rays and a 35.5 keV gamma. |
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. This document describes a physical medical device (brachytherapy seeds) and its 510(k) submission. The evaluation was based on "bench testing" to demonstrate substantial equivalence to a predicate device, not on a "test set" of clinical data in the context of an AI/ML study.
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. See point 2. Ground truth is not established by experts for a physical device's performance in this context. The core evaluation is engineering/physics-based bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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 relates to AI-assisted diagnosis/interpretation, which is not relevant to brachytherapy seeds.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical device, the "ground truth" for its performance would be established by physical measurements and engineering specifications (e.g., verifying dimensions, material composition, radioactivity levels, radiation spectrum, dose profile, etc., against manufacturing specifications and safety standards) during the bench testing. This is not clinical ground truth.
8. The sample size for the training set
- Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model to train.
§ 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.