(30 days)
The 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.
This document describes a Special 510(k) submission for the ArthroCare Perc-D SpineWand, proposing modifications in dimensional and performance limits, materials, and labeling. The submission asserts that these changes are not substantial and do not significantly affect safety or efficacy. Therefore, a comprehensive study to establish new acceptance criteria and prove device performance against them, as if it were a novel device, was not conducted or required. The information provided focuses on demonstrating substantial equivalence to a previously cleared device.
Here's an analysis based on the provided text, addressing the requested points:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, no specific quantitative acceptance criteria or objective performance metrics are reported for the modified Perc-D SpineWand. The submission is a "Special 510(k)" which indicates that the changes are minor and primarily relate to dimensional and performance limits, materials, and labeling, asserting that these do not significantly affect safety or efficacy. The "Substantial Equivalence" section states: "The modified Perc-D Wands, as described in this submission, are substantially equivalent to the predicate device...The proposed modification in dimensional and to the producer, specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
Therefore, no direct table of acceptance criteria and associated performance results is available in this document. The "acceptance criteria" here are implicitly met by demonstrating that the modifications do not alter the fundamental safety and effectiveness profile established for the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No new test set or clinical data is mentioned for this Special 510(k) submission. The submission relies on the substantial equivalence to the predicate device (K010811), which was cleared on May 30, 2001.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set or clinical data requiring expert ground truth establishment for a diagnostic or AI device is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set or clinical data requiring adjudication is 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 an electrosurgical tool, not an AI-assisted diagnostic or imaging interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth establishment is described for this submission. The "ground truth" for the device's efficacy and safety would have been established during the clearance of the predicate device (K010811) through appropriate non-clinical testing and potentially clinical data, as required for that submission.
8. The sample size for the training set
Not applicable. This device is an electrosurgical tool and does not involve AI/machine learning models requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.