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510(k) Data Aggregation
(57 days)
BRACHYTHERAPY STRAND DEVICE
The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor.
The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:
- Localized
- Unresectable
- Low to Moderate Radiosensitivity
The tumors may be of the following type:
- Superficial
- Intrathoracic
- Intra-abdominal
- Lung, Pancreas, Prostate, Head and Neck
- Residual following external beam radiation or excision of primary tumor
- Recurrent
The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel
The provided text is a 510(k) Premarket Notification for the BEBIG Brachytherapy Strand Device. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than conducting a performance study with defined acceptance criteria and device performance evaluation as one might find for a diagnostic AI/ML device.
Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in this regulatory document.
However, I can extract the comparison to predicate device table which serves a similar purpose in this context: to show that the new device is comparable to existing, legally marketed devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in the format typically seen for a diagnostic or AI/ML device's performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison of characteristics.
| Characteristic | BEBIG Brachytherapy Strand Device (Reported Performance/Description) | Predicate Device (RAPID Strand) |
|---|---|---|
| Premarket Notification | Subject of this 510(k) (K040339) | K030594 |
| Sealed source | BEBIG brachytherapy I-125 source cleared by K021343 and TheraSeed® cleared by K010283 | OncoSeed cleared by K914281 |
| Seeding Spacer | Absorbable Seeding Spacer made from medical grade Poly-(glycolide-co-L-lactide) 90:10 and moulded under class 10,000 cleanroom conditions. | Commercially available absorbable Seeding Spacer made from Poly(glycolide-co-L-lactide) 90:10, cleared by K013964 |
| Seed carrier | Coated VICRYL Polyglactin 910 (Poly(glycolide-co-L-lactide) 90:10) Synthetic absorbable suture, cleared by K022269, thermally stiffened. | (No specific information provided for RAPID Strand, implying similarity or that the specific material was not a differentiator in this context) |
| Sterilization | Gamma sterilization (also used for Vicryl Rapide Suture, cleared by K944110) | EtO sterilization |
| Packaging | Strands preloaded in implantation needle. | Strands housed in plastic spacing jig. |
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 is a medical device for brachytherapy, and the submission is for substantial equivalence based on material and design comparison, not a clinical performance study with a test set of data.
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. Ground truth for a test set is not established for this type of regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication is not relevant for this type of regulatory 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 a physical medical device, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.
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. Ground truth, in the context of a performance study for AI/ML or diagnostic devices, is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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