(293 days)
A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.
The source is made of a stainless steel capsule with an outer diameter of approximately 1.1mm. A hole is drilled through the center of the capsule to a depth of the ir 192 seed. The closed end of the capsule is welded to a 1.1 mm diameter 7 X 7 stranded stainless steel cable. On the opposite end, a solid connector is welded in the same manner to the free end of the cable A Ir 192 seed is inserted into the open end of the capsule. The Ir 192 seed is secured by welding the open end of the capsule. The post-weld length of capsule is approximately 4.5 mm in length and overall length of the finished source cable assembly is approximately 2000 mm. These physical specifications are the source for the Nucletron Microselection HDR device.
The provided text is a 510(k) summary for the "Alpha-Omega Services, Inc., 10 Curie Iridium 192 Source, Model CSN0010-192". This document does not describe a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Nucletron Microselection Source, K864210) based on comparisons of:
- Indications for Use: Both devices are high specific activity radionuclide brachytherapy sources for placement onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy, and are active sources for a Nucletron Microselection Device.
- Physical Size and Materials: The subject device has identical dimensions (1.1 mm diameter, 2000 mm ± 5% length) and uses the same materials (Stainless steel 316LVM, 7X7 Stranded cable type, IR-192 Seed 3.5 mm) as the predicate device. The only difference noted is the "Seal Method" (Laser/Tig Welding for the subject device vs. Laser Welding for the predicate device).
- Radioisotope and Activity: Both use IR-192 with a radioactive half-life of 75 days and apparent activity levels of 9-13 Ci at the time of shipping.
- Tested Transfer Cycles: The subject device was tested for 50,000 transfer cycles, exceeding the predicate device's 20,000 tested cycles and both devices' recommended 5,000 cycles.
Given that this is a 510(k) submission based on substantial equivalence to a predicate device, and not a de novo clearance or PMA submission, a standalone clinical study with detailed acceptance criteria and performance metrics for the new device (as would be typical for an AI/software device) is not presented or required in this document. The "acceptance criteria" here are essentially the demonstration of equivalence to the predicate.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth types for test/training sets, training set size) are not applicable or cannot be extracted from this specific document, as they pertain to clinical or performance studies of a different nature than what is presented.
Here's the information that can be extracted, adhering to the spirit of the request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on Predicate Equivalence) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy, and acting as the active source for a Nucletron Microselection Device. (Identical to predicate) | Indications for Use: A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device. (Substantially equivalent) |
| Physical Dimensions: Diameter 1.1 mm, Length 2000 mm ± 5% (Identical to predicate) | Physical Dimensions: Diameter 1.1 mm, Length 2000 mm ± 5% (Identical) |
| Cable Type: 7X7 Stranded (Identical to predicate) | Cable Type: 7X7 Stranded (Identical) |
| Material: Stainless steel 316LVM (Identical to predicate) | Material: Stainless steel 316LVM (Identical) |
| Radioisotope: IR-192 Seed 3.5 mm (Identical to predicate) | Radioisotope: IR-192 Seed 3.5 mm (Identical) |
| Radioactive Half-life: 75 days (Identical to predicate) | Radioactive Half-life: 75 days (Identical) |
| Apparent Activity Levels: 9-13 Ci at time of shipping (Identical to predicate) | Apparent Activity Levels: 9-13 Ci at time of shipping (Identical) |
| Transfer Cycles (Tested): At least 20,000 (Based on predicate's tested cycles) | Transfer Cycles (Tested): 50,000 (Exceeds predicate) |
| Recommended Cycles: 5,000 (Identical to predicate) | Recommended Cycles: 5,000 (Identical) |
| Seal Method: Laser Welding (Based on predicate) | Seal Method: Laser/Tig Welding (Slight difference, but deemed equivalent as part of the overall substantial equivalence determination. The document implies this difference does not impact safety or effectiveness.) |
| External Radiation Levels: Dose rates for a 10 curie source at specified distances (e.g., 48,000,000 mr/hr at 1 cm, 76,800 mr/hr at 25 cm, 19,200 mr/hr at 50 cm, 4,800 mr/hr at 100 cm). (Implicitly, the subject device is expected to produce these same levels given identical radioisotope and activity). | External Radiation Levels: The document states "The following are radiation dose rates for a 10 curie source" and lists the same values as implicitly expected from an equivalent device. It explicitly states, "These values are for health physics ONLY and not for clinical use," indicating their role in safety and handling, not clinical performance. This implies the subject device exhibits these characteristics. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device (a brachytherapy source) and a 510(k) submission based on substantial equivalence, not a performance study of an AI/software device with test sets and data provenance in the typical sense. Equivalence is primarily based on design specifications and performance characteristics derived from physical testing (like transfer cycles) and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. See point 2. Ground truth establishment by experts for a test set is not part of this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 2.
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. See point 2. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. See point 2. This device is a physical brachytherapy source, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of physical medical device, "ground truth" (in the context of clinical or diagnostic performance) is not applicable. The equivalence is established against the known and accepted characteristics and performance of the predicate device. For "tested transfer cycles," the ground truth is the physical measurement of cycles completed before failure or degradation.
8. The sample size for the training set
Not applicable. See point 2. No training set is involved.
9. How the ground truth for the training set was established
Not applicable. See point 2. No training set is involved.
§ 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.