(52 days)
The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual, following external beam or excision of primary tumor.
The I-Seed Model AgX100 is an Iodine 125 brachytherapy source. A silver rod serves as the substrate for the I-125 and as a radiopaque marker and is contained within a titanium tube sealed at both ends with a laser welded dome. The seed is 4.5 mm long and 0.8 mm in diameter.
The provided text describes the regulatory filing (K103319) for a medical device, the I-Seed Model AgX100, which is an Iodine 125 brachytherapy source. However, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven device.
The document primarily focuses on the device's physical characteristics, intended use, comparison to predicate devices, and adherence to established manufacturing and safety standards for medical devices (e.g., ISO standards, 21 CFR 820.30 - Design Controls). It describes "Design Verification" and "Design validation and verification testing" to demonstrate compliance with performance specifications, but these are general statements about the physical device, not related to an AI/ML component.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Details about a test set (sample size, provenance).
- Information on experts used for ground truth establishment.
- Adjudication methods.
- Any mention of a Multi-Reader Multi-Case (MRMC) study.
- Stand-alone algorithm performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The only "acceptance criterion" mentioned is for leak testing of the sealed source, which is "
§ 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.