(323 days)
The UroMed Brachytherapy Iodine-125 Sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
UroMed I-125 Sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5mm long and 0.8mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by a laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The marker will be composed of gold alloy or iridium.
Iodine seeds have a half-life of 59.6 days and are available in a range of activity levels. The UroMed I-125 Sources are provided non-sterile and must be sterilized prior to use.
The provided text describes the UroMed Brachytherapy Iodine-125 Sources, a medical device. However, it does not contain information about acceptance criteria for device performance, the results of a study demonstrating these criteria are met, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details in the context of device performance metrics like sensitivity, specificity, or accuracy.
Instead, the document focuses on:
- Regulatory information: 510(k) summary, device classification, predicate devices.
- Intended Use and Indications for Use: What the device is for.
- Device Description: Physical characteristics (size, material, radioactive component).
- Summary of Standards Achieved: This section lists compliance with various regulatory and industry standards for manufacturing, quality systems, biological evaluation, material specifications, and leak testing. These are a form of acceptance criteria (i.e., the device must meet these standards to be cleared), but they are not presented as performance metrics in the typical sense of a clinical or analytical study.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the study, sample sizes, experts, adjudication, MRMC, standalone performance, or ground truth, as that information is not present in the provided text.
The closest information related to "acceptance criteria" is the list of standards the device complies with, which are prerequisites for regulatory clearance. These are general manufacturing, safety, and material standards, not performance metrics derived from a study.
Information that could be extracted and partially answers some points (though not in the requested format):
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (from "Summary of Standards Achieved"):
- FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practice.
- ISO 46001: Quality System
- ISO 10993-1: 1992 (E), "Biological Evaluation of Medical Devices".
- ASTM Standard for Titanium: F136-96e; Titanium alloy ASTM Grade 5 6AI-4V ELI Electro low interstitial elements.
- ANSI Standards for Brachytherapy: N44.1 - 1973: "Integrity and Testing Specifications for Selected Brachytherapy Sources."
- N44.2 - 1973: "Leak Testing Radioactive Brachytherapy Sources."
- ISO 9978: 1992(E), "Radiation protection - Sealed radioactive sources - Leakage test Methods".
- AAMI document, "Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices".
- Reported Device Performance: The document states, "Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness." This is a general statement of compliance, not specific performance data.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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, as this is a physical brachytherapy source, not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. This would relate to performance studies, which are not detailed.
8. The sample size for the training set: Not applicable (not an AI device, no 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.