(90 days)
The ArthroCare® Coblator IQ™ Perc-D® SpineWand® is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
The Wands are bipolar, single use, high frequency electrosurgical devices. The Coblator IQ Perc-D SpineWands include the following Wands: Coblator IQ DC SpineWand, Coblator IQ DLR SpineWand, and the Coblator IQ DLG SpineWand.
This 510(k) premarket notification (K000353) is for the ArthroCare® Coblator IQTM Perc-D® SpineWand®. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics or clinical outcomes.
Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. The key points are:
- Substantial Equivalence: The document states that "This Special 510(k) proposes modifications to the performance specifications and labeling of the ArthroCare Coblator IQ™ Perc-D® SpineWand". It further clarifies that "The indications for use, materials, technology, sterilization, and principle of operation of the SpineWands remain the same as in the predicate device."
- Safety and Effectiveness: It asserts that "The proposed modifications to the SpineWands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices."
Therefore, the request for acceptance criteria and a study proving device performance using metrics like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance cannot be fulfilled from the provided text. The FDA's letter (pages 2-4) confirms the substantial equivalence determination but does not delve into specific performance study results.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than new performance criteria.
- Sample size used for the test set and the data provenance: Not provided. No specific test set data is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment related to a test set is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 provided. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so an MRMC study is not applicable here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is an electrosurgical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 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.