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510(k) Data Aggregation
(29 days)
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps consist of a seed implant with bioabsorbable caps fitted onto each end of the seed. The seed implant is a welded titanium capsule containing lodine-125 adsorbed onto a nickel/copper coated, gold cored aluminum wire. The bioabsorbable caps are composed of 70% L-lactide and 30% D L-lactide copolymer. 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 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons. The bioabsorbable caps break down over 18-24 months and do not impact the emissions from the lodine-125 seed.
The provided FDA 510(k) summary for the BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps (K140856) focuses on demonstrating substantial equivalence to a predicate device. This type of submission, particularly for a modification of an existing device, relies heavily on non-clinical performance data and material biocompatibility rather than extensive clinical studies or AI algorithm performance evaluations.
Therefore, many of the requested categories related to AI performance metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone AI performance, etc.) are not applicable to this submission. The document explicitly states that the change is the addition of bioabsorbable caps and that the modified device has the "same intended use and fundamental scientific technology as the predicate device."
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Verification of assembly and integrity of bioabsorbable caps with the seed. | Tested via nonclinical functional performance testing, indicating successful verification. |
| Verification of interface of the seed with bioabsorbable caps within brachytherapy implant needles. | Tested via nonclinical functional performance testing, indicating successful verification. | |
| Material Biocompatibility | Meets requirements per ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 for patient contact and duration. | The bioabsorbable caps are made of the same material (70% L-lactide and 30% D L-lactide copolymer) as the SourceLink® Brachytherapy Seeding Spacer Links (K041576), which has met these requirements. |
| Substantial Equivalence | Demonstrates same indications for use and fundamental scientific technological characteristics as the predicate device (BrachySource® Brachytherapy Seed Implants, K093663). | The modification (addition of bioabsorbable caps) is deemed equivalent. Based on design and design control activities, the device is substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission describes non-clinical functional performance testing and material biocompatibility, not a clinical study or AI algorithm evaluation with a "test set" in the traditional sense. The testing was likely conducted in a controlled lab environment.
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. As this is not an AI or diagnostic device requiring expert interpretation of results, there is no mention of experts establishing a "ground truth" for a test set. Evaluation would be based on engineering specifications and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept is relevant for clinical studies or AI performance evaluations involving human readers/adjudicators, which is not the nature of this submission.
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 is not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (brachytherapy seeds), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For functional performance, the "ground truth" would be established engineering specifications and successful operation under defined test conditions.
- For material biocompatibility, the "ground truth" is adherence to recognized international standards (ISO 10993-1:2009) and FDA guidance (G95-1), which likely involves chemical analysis, in-vitro, and in-vivo biocompatibility testing. The fact that the material is the "same as" a previously cleared device (K041576) acts as a form of established "ground truth" for its safety profile.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set."
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