(19 days)
I3RAD 1351 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.
The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.
The provided text describes a 510(k) premarket notification for the International Isotopes Inc. I3RAD 125I Seed, a radionuclide brachytherapy source.
This submission does NOT contain the details of a study that establishes acceptance criteria or reports device performance based on objective metrics.
Instead, the documentation focuses on demonstrating substantial equivalence to previously marketed devices. The core of the argument is that the I3RAD 125I Seed is technologically similar to its predicates (EndoSeed, Amersham Model 6711, Mentor IoGOLD) and thus, is expected to be equally safe and effective.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided document. The acceptance criteria seem to be implicit in demonstrating "safety and efficacy" and "substantial equivalence" to predicate devices, which implies meeting the performance standards already established for those devices.
- Reported Device Performance: No specific quantitative performance data (e.g., radiation output accuracy, seed integrity under specific conditions) derived from a study of the I3RAD 125I Seed are reported in this summary. The summary states: "The I3RAD 125 Seed has been tested for safety and biocompatibility by standard tests used for radionuclide devices and found to safe and effective and substantially equivalent to other predicate devices." This is a qualitative statement of compliance, not a report of specific performance values against defined acceptance criteria.
| Acceptance Criteria (Inferred) | Reported Device Performance (Qualitative) |
|---|---|
| Safety | "safe" |
| Efficacy | "effective" |
| Biocompatibility | Met "standard tests" |
| Substantial Equivalence | "substantially equivalent to other predicate devices" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "standard tests," but no sample sizes for these tests are provided.
- Data Provenance: Not specified. It's unclear if the testing was performed internally by International Isotopes, Inc. or by an external laboratory, or where it occurred. The nature of "standard tests" for radionuclide devices would typically involve physical and radiological measurements rather than clinical data in this context.
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)
- This information is not applicable and not provided. The "ground truth" concept relating to expert consensus or clinical outcomes is typically relevant for diagnostic AI/software devices. For a physical medical device like a brachytherapy seed, the "ground truth" would be established through physical and radiological measurements and engineering specifications, often against international or national standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. Adjudication methods are typically relevant for human-interpretable data (e.g., images) where multiple experts might disagree on findings.
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 device is a brachytherapy seed, not an AI software or a device that involves human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a brachytherapy seed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- As discussed in point 3, the concept of "ground truth" in the cognitive sense (like expert consensus on an image or pathology for a diagnosis) doesn't directly apply here. For this type of physical device, the "ground truth" is established by physical and radiological measurement standards (e.g., measurements of activity, dose rate, physical dimensions, material composition, biocompatibility testing standards). The review process by the FDA, including their determination of "substantial equivalence," implies that these standards were met.
8. The sample size for the training set
- Not applicable. This device is a physical brachytherapy seed, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.