(356 days)
The Kelowna GYN Templates are interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
The Kelowna GYN and Crook Prostate Templates are applicator accessories for 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 applicators act to guide the radioactive source to the correct location or locations for treatment.
The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients.
The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
The Kelowna GYN and Crook Prostate Templates are CT compatible.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
The provided document details a 510(k) premarket notification for the "Kelowna GYN and Crook Prostate Templates," which are applicator accessories for brachytherapy. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance and Results |
|---|---|---|
| Biocompatibility | Meet standards for medical devices in contact with breached surfaces and prolonged contact duration (ISO 10993-1). | Cytotoxicity, Sensitization, Irritation, System Toxicity, Subacute Toxicity, and Implantation tests were conducted. The components are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d) according to ISO 10993-1. (Implied: All tests passed). |
| Sterilization | Effectiveness of cleaning, disinfection, and sterilization procedures; device performance and safety/effectiveness after repeated sterilization cycles. | Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles; Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles were performed. (Implied: All tests passed and demonstrated effectiveness and suitability). |
| Mechanical/Acoustic | Compatibility with CT imaging; adherence to applicator design specifications. | CT Compatibility Tests and Analysis; Verification and Validation Testing for Applicator Design Specifications were conducted. (Implied: Demonstrated CT compatibility and adherence to specifications). |
| General Comparison to Predicate | Must perform comparably to the predicate device (GammaMed Plus High Dose Rate Remote Afterloading System, K983436) for its intended use and indications. | The non-clinical tests support the safety and effectiveness, and validation/verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use. The device shares the same intended use (brachytherapy for cancer) and compatible afterloader series as the predicate. Different designs and materials (PEEK, Titanium vs. PPSU, Stainless Steel) are used but are considered biocompatible and suitable. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the individual non-clinical tests (biocompatibility, sterilization, mechanical) beyond stating that "testing was conducted" or "components were subjected." It is common for these types of tests to use a statistically adequate number of samples as per the relevant standards, but the specific numbers are not disclosed.
The data provenance is retrospective non-clinical bench testing and analysis, as indicated by the "Non-Clinical Tests" section. There is no mention of human subject data or data from a specific country of origin, as the testing relates to the device's physical and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the document. The "ground truth" for non-clinical performance data like biocompatibility, sterilization efficacy, and mechanical properties is typically established by adherence to international standards (e.g., ISO 10993, AAMI TIRs) and validated by laboratory testing following established protocols. The expertise lies in the execution and interpretation of these standardized tests by qualified laboratory personnel, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical studies or image-based evaluations where multiple human readers assess data and discrepancies need to be resolved. For non-clinical bench testing, the results are objectively measured against defined criteria within the test protocols.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes physical medical devices (applicators for brachytherapy) and their non-clinical performance. It does not involve AI, software, or human interpretation of images or data that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for these non-clinical tests is based on:
- Established International Standards: For biocompatibility (ISO 10993 series), sterilization (AAMI and ISO standards), and mechanical properties (internal design specifications validated through testing).
- Objective Measurements: Laboratory test results measured against predefined acceptance limits set by these standards and engineering specifications.
There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense, as this is a pre-market notification for a physical device demonstrating substantial equivalence through bench testing.
8. The sample size for the training set
This information is not applicable or provided. There is no "training set" as this device does not involve machine learning or artificial intelligence.
9. How the ground truth for the training set was established
This information is not applicable or provided. As there is no training set, there is no ground truth established for one.
§ 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.