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The Flexible Fixation Device for gynecological applicators is intended for cancer treatment of the vagmal stump. cervix, uterus, endometrium or rectum using HDR or PDR Brachytherapy.

The Flexible Fixation Device for Gynecological Applicators is an accessory used to hold an applicator in place, to prevent movement of the applicator during the imaging (standard radiograph, CT and/or MR technique) and treatment process for HDR and PDR brachytherapy.

The key performance characteristics of the device are as follows:

Fixation rings for cylinders of various diameters (20 mm - 40 mm); and fixation straps (500 mm/150 mm, 1050 mm /350 mm, 1700 mm/500 mm)

• CT compatible -
• -MR safe
• -Fixation rings are sterilizable and released for 250 reuses
• -Fixation plate rings are sterilizable and released for 50 reuses
• -The fixation straps are qualified for 50 textile laundering cycles
• -Suitable for patient contact—on intact skin—for a period of less than 30 day

Fixation straps are fixed in slots of the fixation plate and around the waist of the fixation ring is attached onto an applicator which then is inserted into the patient. The flexible fixation plate is attached over the applicator and clamped in the fixation ring. The applicator is connected to an afterloader. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue. The applicator guides the radioactive source to the correct location or locations for treatment.

The fixation rings for cylinders of ø 20, 23-, 26-, 30-, 35-, and 40-mm diameter, in combination with the flexible fixation plate, provide a mount for the respective cylinder applicator. The flexible fixation plate for gynecological applicators has a smaller and a larger teardrop-shaped holes for the different fixation rings. It also provides several slots for the fixation straps. The fixation straps of different lengths (500 mm/150 mm, 1050 mm/350 mm/500 mm) can be fixed at the fixation plate through the slots of the plate using hook-and-loop fasteners. Multiple straps in suitable lengths can be combined and fixated around the patient's waist and if necessary, additionally around the shoulders.

The provided text describes the regulatory clearance of a medical device, the "Flexible Fixation Device for Gynecological Applicators," and its substantial equivalence to a predicate device. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness. The document focuses on non-clinical testing and regulatory compliance.

Here's an analysis of what is and is not in the document based on your request:

1. A table of acceptance criteria and the reported device performance

• Not provided in the document. The document lists "key performance characteristics" of the device, but these are descriptive features (e.g., fixation ring diameters, CT compatibility, MR safety, sterilization reuses, laundering cycles, patient contact duration), not quantifiable performance metrics with acceptance criteria and reported values in the way one would find for an AI/diagnostic device's accuracy. The "Summary of Performance Testing" section lists types of tests conducted (biocompatibility, cleaning/disinfection/sterilization, human factors validation, mechanical/acoustic testing), but does not provide specific acceptance criteria or quantitative results.

2. Sample size used for the test set and the data provenance

• Not applicable/Not provided. This device is a physical accessory, not a diagnostic algorithm that processes data or images. Therefore, there's no "test set" in the context of diagnostic performance, nor data provenance in terms of country of origin or retrospective/prospective data collection. The "tests" mentioned are for physical device characteristics and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. As above, there's no diagnostic "test set" requiring expert ground truth establishment.

4. Adjudication method for the test set

• Not applicable/Not provided. No diagnostic performance test set is described.

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. This device is a physical fixation device, not an AI software or assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm.

7. The type of ground truth used

• Not applicable/Not provided. Since there's no diagnostic performance being evaluated, there's no "ground truth" in that sense. The "ground truth" for the non-clinical tests would be defined by the standards and specifications that the device must meet (e.g., successful sterilization, structural integrity after mechanical stress).

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

Summary of available information:

The document describes a "Flexible Fixation Device for Gynecological Applicators," an accessory for brachytherapy. The submission is a Traditional 510(k), indicating the manufacturer believes the device is substantially equivalent to a legally marketed predicate device.

The "Summary of Performance Testing (Non-Clinical Testing)" section states that the following tests were conducted to demonstrate safety and effectiveness:

• Biocompatibility Testing: Complied with ISO 10993-1 and applicable parts.
• Cleaning, Disinfection and Sterilization Testing: Demonstrated effective sterilization and specified number of reuses/laundering cycles.
• Human factors validation study: Conducted according to IEC 62366 to verify device performs as intended for users, uses, and environments.
• Mechanical and Acoustic Testing: Formal design verification and validation testing demonstrating the device performs as intended, in accordance with FDA Quality System Regulation, ISO 13485, and ISO 14971.

The device also utilized several harmonized consensus standards for its design and evaluation (listed in the document).

Conclusion:

Based on the provided text, the device is a physical medical accessory, and the regulatory filing focuses on demonstrating its physical performance, safety (e.g., biocompatibility, sterilization, mechanical integrity), and substantial equivalence to a predicate device through non-clinical testing. It does not involve diagnostic accuracy, AI, or human-in-the-loop performance, which are the typical contexts for the robust performance criteria and study details requested in your prompt. Therefore, most of the requested information is not applicable or present in this specific document.

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