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The LCCS VC-S RF Cannula is intended for use in RF heat lesion procedures for the relief of pain.

The LCCS VC-S RF Cannula is used in conjunction with the RF electrode for the use in RF heat lesion procedures. The LCCS VC-S RF Cannulas are offered in a variety of lengths, gauges to accommodate various anatomical locations and differences in patients' anatomy. The LCCS VC-S RF Cannula is a stainless steel cannula with an insulated shaft having one exposed tip and one side port located at the end of the cannula to diffuse the anesthesia closer to the lesion site and deliver the RF energy to the tissue. When RF Electrode was inserted into LCCS VC-S RF Cannula and came out from the side port, both active tip and RF Electrode section stuck out of side port can deliver Radio Frequency energy. This RF cannula is provided as a sterile, single use, disposable device. This RF Cannula is offered in a variety of length and Needle outside Dimension to accommodate various anatomical locations and differences in patient anatomy. The LCCS VC-S RF Cannula is consisted of: Protection Sleeve, Needle Tube, Insulating layer, Needle hub, Stylet, Stylet Hub.

The provided text is a 510(k) summary for the LCCS VC-S RF Cannula, which is a medical device. This document focuses on demonstrating the substantial equivalence of the proposed device to existing predicate devices, primarily through a comparison of design features, intended use, technology, and non-clinical testing.

Crucially, this document does not contain information about a clinical study involving human patients or a study comparing the device's performance to specific acceptance criteria related to a machine learning or AI algorithm's performance (e.g., sensitivity, specificity, or AUC). The "acceptance criteria" discussed in this document refer to the device's design specifications and performance against established safety and engineering standards (e.g., sterilization, biocompatibility, mechanical safety), not diagnostic or predictive performance metrics of an AI system.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria for an AI algorithm's performance, a test set, ground truth establishment, MRMC studies, or training sets, as that information is not present in the provided context.

The document's "conclusion" (on page 8) states that the device is considered "as safe, as effective, and performance is substantially equivalent to the predicate devices." This substantial equivalence is based on the comparison table and non-clinical tests, not on a human-in-the-loop or standalone AI study.

To directly answer your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Comparison to Predicate Devices" table (pages 5-6) that lists features like intended use, material, needle gauge, needle tube length, structure, method of sterilization, and biocompatibility. The "reported device performance" is essentially that these features are "identical" or "equivalent" to the predicate devices and that the device complies with certain voluntary standards (e.g., AAMI/ANSI ES 60601-2-2, ISO 7864, ISO 10993-1). There is also a "Summary of Non-Clinical Tests" table (page 7-8) which shows test results for biocompatibility (Cytotoxicity, Acute Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Pyrogen) and concludes "Non-Cytotoxic," "Non-Acute Systemic Toxicity," etc. This is the closest the document comes to defining acceptance criteria and performance, but it's for the physical device, not an AI.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI algorithm is mentioned. The testing refers to non-clinical, biocompatibility, and engineering tests of the device itself.

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 ground truth for an AI algorithm is established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm 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. No AI algorithm or MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm performance is discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for an AI algorithm is mentioned. The "ground truth" for this device's acceptance is its conformity to design specifications, material properties, and safety standards demonstrated through non-clinical testing.

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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