(58 days)
The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment. Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The ASSISTO® Universal Applicator Clamping Device is a self-retaining device that consists of a stainless steel tubular, articulated arm connected to a vertical stand. The arm is freely adjustable within the articulating radius. A screw clamp mounted on the distal end of the device serves to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy. Two accessories, a stainless steel clamp socket and a base plate manufactured of thermoplastic and stainless steel, are provided to table-mount the device during clinical use. The ASSISTO® Universal Applicator Clamping Device and the clamp socket are reusable and provided non-sterile for cleaning and sterilization by the user before use. The non-sterile, reusable base plate is intended for cleaning and disinfection by the user before use.
The provided text describes a 510(k) premarket notification for the ASSISTO® Universal Applicator Clamping Device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human subjects.
Therefore, many of the requested points regarding diagnostic performance studies (sample size, expert qualifications, ground truth, MRMC studies, standalone performance) are not applicable to this submission, as the device is an accessory for brachytherapy and its performance is evaluated based on engineering and functional testing.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Securely hold Varian Medical Systems applicator holding devices. | Verification of the device's capacity to securely hold the Varian Medical Systems applicator holding devices. (Stated that "Acceptance criteria were met for all tests performed.") |
| Device reprocessing procedures (e.g., cleaning, sterilization) are effective and validated. | Validation testing of the recommended end user device reprocessing procedures. (Stated that "Acceptance criteria were met for all tests performed.") The device is non-sterile and reusable, requiring cleaning and sterilization by the user. The base plate is non-sterile, reusable, and intended for cleaning and disinfection by the user. The validation testing would confirm the adequacy of the instructions for these processes. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as this is not a clinical study involving human cases or diagnostic imaging. The "test set" here refers to the number of Varian Medical Systems applicator holding devices used for verification, and potentially the number of reprocessing cycles for validation. These numbers are not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The tests are engineering verification and validation tests, likely performed in a lab setting by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, located in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The ground truth for engineering performance measures (like securely holding an object or effective reprocessing) is established through technical specifications, engineering principles, and validated testing protocols, not by expert medical opinion on clinical cases.
4. Adjudication method for the test set
- Not applicable. There's no clinical "ground truth" to adjudicate. Test results are likely objectively measured against predefined engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The ASSISTO® is a physical accessory for brachytherapy.
6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done
- Not applicable. The device is a physical mechanical accessory, not an AI algorithm. Its function is to physically hold other devices.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on engineering specifications and functional requirements. For example, the ability to physically secure an applicator holding device without slippage or failure, and the effectiveness of specified cleaning/sterilization protocols.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI algorithm.
§ 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.