(20 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 is a 510(k) summary for modifications to an existing device, the ArthroCare® PercD™ SpineWand™. It is not a detailed study report that would typically contain specific acceptance criteria and performance data for a new device's efficacy.
Based on the provided text, the device is cleared based on demonstrating substantial equivalence to a predicate device (ArthroCare PercD SpineWand K020621). This means the submission argues that the modified device's performance is assumed to meet the same acceptance criteria as the predicate device because the changes are not substantial.
Therefore, many of the requested elements for a detailed study proving acceptance criteria are not present in this type of submission.
Here's a breakdown of what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as such for this submission. The acceptance criterion for this 510(k) is demonstrating "substantial equivalence" to the predicate device. This implies that the modified device should perform comparably to the predicate device in terms of safety and efficacy.
- Reported Device Performance: No specific numerical performance data is presented in this summary for the modified device, as the submission focuses on asserting that "The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable/not provided. This submission is for modifications to an already cleared device, relying on the substantial equivalence principle rather than new performance testing data to establish initial safety and efficacy.
- Data Provenance: Not applicable/not provided.
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. As no new clinical study data is presented to assess performance against new acceptance criteria, there's no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new test set requiring adjudication is mentioned.
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-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (electrosurgical wand), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for this submission. The "ground truth" for this 510(k) is the established safety and efficacy of the predicate device (K020621). The modified device is asserted to be substantially equivalent to that.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 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.