(186 days)
The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.
The Mould Applicator Set is an applicator for intraoperative, interstitial, intraluminal or surface brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The Mould Applicator Set can be steam sterilized with common parameters using Pre-vacuum sterilization. The mould probes Ø 2.8mm (GM11002280), which are part of the set, have a maximum implantation time of up to 24 hours. According to ISO 10993-1 they are categorised as medical devices, external communicating with tissue/bone communicating and a limited contact duration (A). They can be steam sterilized and used 25 times. The mould probes Ø 1.8mm (GM11002290) have a maximum implantation time of up to 7 days. According to ISO 10993-1 they are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient.
The provided document is a 510(k) Premarket Notification for a medical device called "Mould Applicator Set" manufactured by Varian Medical Systems, Inc. The document primarily focuses on establishing substantial equivalence to a predicate device (GammamedPlus HDR Afterloading System).
Based on the content, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the tests performed within a section titled "Non Clinical Tests Bench Testing." The acceptance criteria are implied by statements such as "demonstrate that..." and "conformance to applicable requirements and specifications." The reported performance is the positive conclusion that all tests met these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correct functioning with specified afterloader | Conformance to applicable requirements and specifications |
| Withstanding specified number of use cycles | Conformance to applicable requirements and specifications |
| Enabling radioactive source location with required accuracy | Conformance to applicable requirements and specifications |
| Construction from materials not significantly affected by radiation | Conformance to applicable requirements and specifications |
| Effective sterilization | Conformance to applicable requirements and specifications |
| Safe and effective use/sterilization for specified number of times | Conformance to applicable requirements and specifications |
| Adequate positional accuracy of the source | Conformance to applicable requirements and specifications |
| Biocompatibility as per ISO 10993 standards | Conformance to applicable requirements and specifications |
| Safe and effective use in CT environments | Conformance to applicable requirements and specifications |
| Safe use in MRI environments under specified conditions | Conformance to applicable requirements and specifications |
| Usability meeting IEC 62366:2007 requirements | Conformance to applicable requirements and specifications |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical tests have been included in this pre-market submission." Therefore, there is no sample size for a test set of patient data, nor is there any provenance information for such data. The testing mentioned (bench testing) would have used physical samples of the device components. The number of such samples is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since no clinical studies were performed, there was no expert review of patient data to establish ground truth in the context of diagnostic or treatment efficacy. The "experts" involved would have been the engineers and testers performing the bench tests, verifying compliance with technical standards and design specifications. Their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used. The bench testing would involve direct measurement and verification against predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted. The document states, "No clinical tests have been included in this pre-market submission." Therefore, there is no information about the effect size of AI improving human readers' performance, as the device is a physical applicator and not an AI-assisted diagnostic or treatment planning tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The device is a physical "Mould Applicator Set" for brachytherapy, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device itself is designed to perform its function (guiding a radioactive source) without continuous human intervention during the source guidance, but it is always used by a human operator within a clinical workflow.
7. Type of Ground Truth Used:
For the non-clinical bench tests, the ground truth was based on engineering specifications, design requirements, and recognized industry standards (e.g., ISO 10993 for biocompatibility, IEC 62366 for usability, and internal Varian standards for accuracy and durability).
8. Sample Size for the Training Set:
Not applicable. The "Mould Applicator Set" is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as point 8.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.