Search Results

The ArthroCare System 15000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare System 15000 consists of a bipolar, high frequency, electrosurgical generator called the Controller, a family of disposable, bipolar, single use Wands and Foot Control.

The provided text is a 510(k) summary for the ArthroCare System 15000, an electrosurgical device. It outlines the device description, predicate devices, and intended use. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy, concordance rates).

The summary states: "The modified ArthroCare System 15000, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to a previously cleared predicate device (K090393), rather than the presentation of a new study with explicit performance acceptance criteria and results.

Therefore, the requested information cannot be extracted from the provided document.

Here's a breakdown of why each point cannot be fulfilled based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document focuses on substantial equivalence to a predicate device, not on specific performance metrics with acceptance criteria.
2. Sample sized used for the test set and the data provenance: No test set information is provided as no new clinical or analytical study with a test set is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no 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. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.
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, as no specific performance study requiring ground truth is detailed.
8. The sample size for the training set: Not applicable, as no algorithmic training is involved.
9. How the ground truth for the training set was established: Not applicable, as no algorithmic training is involved.

Ask a specific question about this device