(28 days)
The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. The ENTec EVac Plasma Wand is indicated for ablation, coagulation, and hemostasis of soft tissue in tonsillectomy and adenoidectomy procedures.
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
The provided text describes a Special 510(k) submission for a modification to the ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™. This typically means the device is being compared to its own previously cleared versions, and the focus is on demonstrating that the modifications do not significantly affect safety or efficacy. Therefore, the "study" referenced would be the justification for how these modifications maintain substantial equivalence, rather than a clinical trial proving new performance criteria.
Based on the provided text, the acceptance criteria and study information are significantly different from what would be expected for a typical AI/ML device submission that requires performance metrics. This is a 510(k) submission for an electrosurgical device, and the criteria are related to maintaining substantial equivalence after material and performance specification modifications, not to establishing performance for diagnostic accuracy or similar AI model outputs.
Here's an interpretation based solely on the provided document, acknowledging that it addresses a different type of device and regulatory pathway than what the prompt's questions typically imply:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "The proposed modification in performance specifications and materials are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This implies the "acceptance criteria" are that the modified device's performance remains congruent with or within the established safety and efficacy profile of the predicate devices. No specific quantitative performance metrics are provided for the modified device itself, nor are there explicit "acceptance criteria" tables in the manner of diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Modifications do not substantially change the device. | The modifications are to "performance specifications and materials." The indications for use, technology, principle of operation, dimensional specifications, packaging, labeling, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s. |
| Modifications do not significantly affect the safety or efficacy of the devices. | The submission asserts that the modified Wands are "substantially equivalent to the predicate devices" and that the changes "do not significantly affect the safety or efficacy of the devices." No new safety or efficacy data from studies are presented. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document as it's not a study testing a new device feature or performance. The submission is about modifications to an already cleared device. Clinical studies with test sets are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The regulatory review in a Special 510(k) focuses on the impact of device modifications on established safety and efficacy, not on clinical performance metrics evaluated by experts against a ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable and not provided. This is not a study assessing human reader performance with or without AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not provided. The device is an electrosurgical wand, not an algorithm.
7. Type of Ground Truth Used
This information is not applicable and not provided. The "ground truth" here is the established safety and efficacy profile of the predicate device, and the submission argues that the modifications do not alter this.
8. Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of an electrosurgical device modification.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this Special 510(k) submission for the ArthroCare ArthroWands® ENTec® EVac™ Plasma Wand™ is a comparison to predicate devices (K011083 and K011279). The manufacturer submitted documentation to demonstrate that modifications made to the device's performance specifications and materials are not substantial and do not significantly affect the device's safety or efficacy. The core argument for acceptance is substantial equivalence to the previously cleared predicate devices, meaning the modified device continues to meet the established safety and performance characteristics of its predecessors. This is a documentation-based justification rather than a new clinical study.
§ 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.