(44 days)
The Smith & Nephew Vulcan Articular Cartilage Probe is indicated for arthroscopic chondroplasty procedures in the knee, shoulder, wrist, hip, etc.
The Smith & Nephew Vulcan Articular Cartilage Probe is a single-use, monopolar radiofrequency probe which incorporates a pivoting ceramic head with an embedded RF electrode; protective sheath; and integrated cable. It requires a split ground pad and it is designed for use only with the Smith & Nephew Vulcan Generator.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Smith & Nephew Vulcan Articular Cartilage Probe.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biological Safety | In compliance with ISO 10993-1 |
| Electromagnetic Compatibility | In compliance with ANSI/AAMI HF-18 |
| Electrical Safety | In compliance with IEC 60601-2-2 |
| Sterilization | Will be in compliance with applicable sterilization standards at the time of commercialization |
| Performance Characteristics (compared to predicate device) | Bench testing confirms substantial equivalence in performance characteristics. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily references bench testing for performance characteristics and compliance with standards. It does not explicitly state a "test set" in terms of patient data or sample size in the clinical sense. The data provenance is not specified beyond "bench testing," which implies laboratory-based studies rather than human or animal studies, and thus no country of origin is relevant for this type of test. The study appears to be prospective in nature, as it's testing a new device against established standards and a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are focused on technical compliance (biological, electrical, electromagnetic safety, and performance equivalence via bench testing) rather than clinical efficacy or diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a test set requiring adjudication in a clinical context is not 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 monpolor electrosurgical probe, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies involving AI assistance for human readers are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument. "Standalone" performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance studies:
- Biological Safety: Ground truth is established by the criteria within ISO 10993-1.
- Electromagnetic Compatibility: Ground truth is established by the criteria within ANSI/AAMI HF-18.
- Electrical Safety: Ground truth is established by the criteria within IEC 60601-2-2.
- Performance Characteristics: Ground truth for substantial equivalence is based on the performance of the legally marketed predicate device, the Smith & Nephew Vulcan TAC C II Probe, as determined through bench testing.
8. The sample size for the training set
Not applicable. This device is a medical instrument and does not involve an AI algorithm with a 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.
§ 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.