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510(k) Data Aggregation
(172 days)
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(166 days)
125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.
Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
The provided text describes the Prostec 125I Brachytherapy Seed and its substantial equivalence to a predicate device, rather than a study with detailed acceptance criteria and performance metrics in the typical sense of a clinical trial or algorithm validation. This submission is for a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device.
However, I can extract the "acceptance criteria" as implied by the comparison to the predicate device and the reported "device performance" as stated in the document.
Here's an interpretation based on the provided text, recognizing that this is a technical equivalence comparison, not a performance study in the context of diagnostic algorithms or clinical outcomes:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Prostec 125I Brachytherapy Seeds) |
|---|---|
| Intended Use: For permanent interstitial implantation in selected localized tumors, as a source of nuclear radiation for therapy. | Matches predicate intended use. |
| Material-Capsule: Titanium | Titanium |
| Material-Radioisotope: 125I | 125I |
| Material-Substrate: Dowex® | Dowex® |
| Physical Dimensions - Length: 4.5 mm | 4.5 mm |
| Physical Dimensions - Outside Diameter: 0.8 mm | 0.8 mm |
| Key Radiological Characteristics - Half-life: 59.4 days | 59.4 days |
| Key Radiological Characteristics - Principal Energy Levels (keV): 27.4, 31.4, and 35.5 | 27.4, 31.4, and 35.5 |
| Key Radiological Characteristics - Point-source approximation anisotropy constant (φan): 0.95 (predicate) | 0.96 (Prostec) - considered equivalent |
| Key Radiological Characteristics - Dose rate Constant (cGy/hr/U, 1999 NIST): 1.04 (predicate) | 1.05 (Prostec) - considered equivalent |
| Key Radiological Characteristics - Residual Activity: < 0.2 µCi after 2 years | < 0.2 µCi after 2 years |
| Manufacturing - Capsule Sealing Method: Weld | Laser Weld - considered equivalent |
| Manufacturing - Delivered Non-sterile: Yes | Yes |
| Manufacturing - Packaging: Glass vial in lead container placed in a shipping carton | Glass vial in lead container placed in a shipping carton |
| Application Methods: Through an 18 gauge needle, attachable to common applicators | Through an 18 gauge needle, attachable to common applicators including Mick applicator with Prostec Cartridge. - considered equivalent |
| Quality Standards: Compliance with ISO 2919-1980(e), ISO/TR 4826-1979(E) | Complies with these standards. |
| Biocompatibility Standards: Meets ASTM F 1472 -- 93, ASTM F 67 95 | Meets these standards. |
| Radiographic Marker: Presence of a radiographic marker. | Gold Alloy (Predicate had none, but this is an enhancement not a deviation from safety/effectiveness). |
Note: The activity level differs (0.1 to 5.0 mCi for Prostec vs. 5.0 to 40 mCi for predicate). This is presented as a characteristic difference, not an 'acceptance criterion' that Prostec failed, likely because the range still falls within therapeutic use and possibly reflects different clinical needs or manufacturing capabilities. The key is that the type of seed and its fundamental physical and radioactive properties are equivalent.
2. Sample size used for the test set and the data provenance
This is not a traditional "test set" study. The evaluation is based on comparison of physical characteristics, dimensional measurements, and anisotropy of the Prostec device against the predicate device specifications and recognized standards.
- Sample Size: Not explicitly stated in terms of a "test set" of devices for statistical analysis. It implies that these characteristics were measured on the Prostec device and compared to the established specifications of the predicate device.
- Data Provenance: The data comes from the manufacturer (Prostec LLC) performing measurements and comparisons to established specifications of the predicate device and international/national standards. This is not a retrospective or prospective patient data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is the technical specifications of the predicate device and recognized industry standards (ISO, ASTM). The submission itself implies internal expertise at Prostec LLC and the FDA's regulatory team as evaluators, but not experts establishing ground truth for a clinical dataset.
4. Adjudication method for the test set
Not applicable. There was no "test set" requiring adjudication by clinicians for a diagnosis or outcome. The comparison is against established technical benchmarks.
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 medical device for brachytherapy (a physical treatment), not a diagnostic algorithm or AI-assisted system. No human readers or AI were involved in this type of substantial equivalence comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence relied on:
- Predicate device specifications: The known and legally marketed characteristics of the Amersham/Medi+Physics Model 6702 seeds.
- Recognized consensus standards: ISO 2919-1980(e), ISO/TR 4826-1979(E), ASTM F 1472 -- 93, ASTM F 67 95.
- Published scientific literature: Referencing Hilaris, Holt, and St. Germain regarding the use of 125I radioactive seeds for interstitial implant.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a machine learning model. The foundational "truth" for the device's design and manufacturing comes from established physics, materials science, and medical needs as embodied in existing successful predicate devices and industry standards.
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