(86 days)
These devices are designed for general surgical use, including orthopedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissue. Arthroscopic surgery may include the following: Knee, Shoulder, Ankle, Elbow, and Wrist.
SterilMed's reprocessed RF Arthroscopy Probes are radio frequency electrosurgical devices that are designed for arthroscopic surgical procedures and are used with a conductive irrigant. They consist of connector pins, a handle, an insulated cannula, a return electrode, an electrode tip with single or multiple electrodes, and come in straight or angled designs.
The provided text describes a 510(k) summary for SterilMed's Reprocessed RF Arthroscopy Probes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding performance, sample sizes, expert involvement, and ground truth generation for a clinical study is not detailed in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Representative samples underwent bench testing to demonstrate appropriate functional characteristics. |
| Cleaning Validation | Process validation testing was done to validate the cleaning procedures. |
| Sterilization Validation | Process validation testing was done to validate the sterilization procedures. |
| Packaging Validation | Process validation testing was done to validate the devices' packaging. |
| Manufacturing Process Quality | The manufacturing process includes visual and functional testing of all products produced. |
2. Sample size used for the test set and the data provenance
The document mentions "Representative samples" for bench testing and "all products produced" for manufacturing process testing. It does not specify a distinct "test set" sample size for proving acceptance criteria in a clinical context, nor does it provide information on data provenance (country of origin, retrospective/prospective). This is because the device focuses on reprocessing existing devices, and the testing described is primarily for manufacturing and reprocessing validation, not clinical performance for a novel device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes bench testing and process validation, not a study where expert-established ground truth would be required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a process requiring adjudication.
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 is not an AI-powered diagnostic device, and thus, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device is a reprocessed physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed device is implied to be its functional equivalency to new, legally marketed predicate devices, and the safety and effectiveness of its reprocessing. This is assessed through:
- Bench testing: Against performance specifications derived from the predicate devices.
- Process validation: To ensure cleaning, sterilization, and packaging meet established standards.
- Visual and functional testing: During manufacturing.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study:
The study described is not a clinical trial or performance study against specific diagnostic or treatment outcomes. Instead, it is a validation study for a reprocessed medical device. The primary goal was to demonstrate substantial equivalence to original, legally marketed devices.
The study involved:
- Bench testing: On "representative samples" to confirm functional characteristics.
- Process validation: To ensure the efficacy of cleaning, sterilization, and packaging procedures.
- Manufacturing quality checks: Including visual and functional testing of "all products produced."
The conclusion of the study was that the reprocessed RF Arthroscopy Probes are substantially equivalent to the predicate devices based on "functional design, materials, indications for use, and principles of operation." The FDA concurred with this finding, allowing the device to be marketed.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.