(247 days)
The AOS Orion Ir-192 Source Cable is a sealed 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. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.
The AOS Orion Ir-192 Source Cable (Model No. CSO0012-192) is a nominal 12 Curie Iridium-192 source cable for use in the Nucletron microSelectron HDR Version 2 (Model No. 105.99) and the Nucletron microSelectron V3 (Model No. 106.990) Remote Afterloaders.
Here’s an analysis of the provided text, focusing on the acceptance criteria and the study (performance test) that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Devices) | Reported Device Performance (AOS Orion Ir-192 Source Cable) |
|---|---|
| Mechanical Compatibility: Must be compatible with Nucletron microSelectron HDR V2 and V3 Remote Afterloaders | Successfully completed various tests demonstrating worst-case scenarios, confirming compatibility with Nucletron microSelectron V2 and V3 HDR Remote Afterloaders. |
| ISO 2919 and ISO 9978 Compliance: Meet standards for sealed radioactive sources. | The device has been tested and meets acceptance criteria outlined in ISO 2919 and ISO 9978 standards. |
| Cable Strength: ≥ 200 Newtons | ≥ 200 Newtons |
| Weld Strength: Able to withstand 15 Newtons for 3 minutes | Able to withstand 15 Newtons for 3 minutes |
| Range of Motion: Radius of ≥ 15mm (predicate) | Radius of ≥ 12mm |
| Tested Transfer Cycles: 100,000 cycles | 100,000 cycles |
| Certified Cycles: 25,000 cycles | 25,000 cycles |
| Recommended Cycles: 5,000 cycles | 5,000 cycles |
Note on Range of Motion: While the predicate requires a radius of ≥ 15mm, the new device reports ≥ 12mm. The document states that the new cable design "provides the same strength and flexibility as the 2 piece predicate cable," implying that the different radius is considered an acceptable, equivalent performance characteristic due to the design change.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of individual units. The performance tests refer to "series of tests" and "the Orion Cable" (singular), suggesting that a sufficient number of cables were tested to demonstrate compliance with the specified criteria. Specific numbers for units tested are not provided.
- Data Provenance: The document does not specify the country of origin for the test data nor explicitly state whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these would typically be internal, prospective performance tests conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a physical medical device like an Ir-192 source cable is established by objective, measurable engineering and performance standards (e.g., ISO, tensile strength tests, cycle tests), not by expert consensus on clinical data or images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data (e.g., medical images) where there can be inter-reader variability. For objective performance tests of a physical device, the results are typically directly measured against a predetermined standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images or data. The AOS Orion Ir-192 Source Cable is a physical brachytherapy source, and its performance is assessed through engineering and physical property tests, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. Standalone performance (algorithm-only) applies to software algorithms (like AI) that perform a task without immediate human intervention. The device in question is a physical medical device, not a software algorithm. Its "standalone" performance is simply its inherent physical and mechanical properties.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on objective engineering and material standards, specifically:
- ISO 2919 and ISO 9978: International standards for sealed radioactive sources.
- Predicate device performance: The performance characteristics of the legally marketed predicate devices (MicroSelectron HDR Version 2 and MicroSelectron V3) serve as a benchmark for equivalence. This includes specific numerical values for dimensions, strength, and cycle testing.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. This device is a physical product, and its development and testing do not involve a training set in the AI sense. Its design is based on engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
§ 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.