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510(k) Data Aggregation
(127 days)
The ISOAID Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IsoAid Palladium Brachytherapy Seeds:
Based on the provided documents, it's evident that this 510(k) submission is for a medical device (IsoAid Palladium Brachytherapy Seeds) and not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like AI performance, human readers with/without AI assistance, standalone algorithm performance, training set, and AI-specific ground truth methods are not applicable.
The approval for this device is based on substantial equivalence to a predicate device, the TheraSeed Palladium-103 Model 200 Implant, rather than a clinical study proving its performance against acceptance criteria in the context of an AI/ML diagnostic or prognostic tool.
Here's a breakdown of the requested information based on the provided text, focusing on what is applicable to a substantial equivalence submission for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (IsoAid Palladium Brachytherapy Seeds) | Basis for Acceptance |
|---|---|---|---|
| Indications for Use | Brachytherapy for localized tumors | Brachytherapy for localized tumors | "Same" as predicate (Substantial Equivalence) |
| Capsule | Titanium | Titanium | "Same" as predicate (Substantial Equivalence) |
| Capsule Sealing Method | Laser Weld | Laser Weld | "Same" as predicate (Substantial Equivalence) |
| Half-Life | 17.0 days | 17.0 days | "Same" as predicate (Substantial Equivalence) |
| Length | 4.5 mm | 4.5 mm | "Same" as predicate (Substantial Equivalence) |
| Outside Diameter | 0.8 mm | 0.8 mm | "Same" as predicate (Substantial Equivalence) |
| Application Method | Through an 18 gauge needle | Through an 18 gauge needle | "Same" as predicate (Substantial Equivalence) |
| Apparent Activity | 0.10 to 5.0 mCi | 0.10 to 5.0 mCi | "Same" as predicate (Substantial Equivalence) |
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, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm requiring a test set for performance evaluation. The "study" is a comparison to a predicate device.
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 a substantial equivalence submission for a physical device, not an AI/ML algorithm. The "ground truth" for this submission are the established specifications and safety profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used here is the performance and safety profile of the legally marketed predicate device (TheraSeed Palladium-103 Model 200 Implant) as accepted by the FDA. The submission demonstrates that the new device has identical specifications and intended use as the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of the Study (Substantial Equivalence):
The "study" or evidence provided to the FDA for the IsoAid Palladium Brachytherapy Seeds is a comparison against a legally marketed predicate device, the TheraSeed Palladium-103 Model 200 Implant (K010283). The applicant asserts that the IsoAid device has identical specifications and intended use to the predicate device. The comparative data (presented in the table) directly shows that critical parameters such as material (titanium capsule), manufacturing method (laser weld), physical dimensions (length, diameter), radioactive properties (half-life, apparent activity), and application method are all the "same" as the predicate.
The acceptance criteria are effectively the specifications and previously accepted safety/efficacy profile of the predicate device. The IsoAid device "meets" these criteria by being demonstrably identical across all relevant engineering and performance characteristics. The FDA's issuance of a substantial equivalence determination signifies that they agreed the new device is as safe and effective as the predicate device, without requiring new clinical trials due to the direct equivalence.
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