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The ArthroCare Cavity SpineWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in percutaneous, intraoperative or spinal procedures including the creation of a cavity in malignant lesions in a vertebral body.

The ArthroCare Cavity SpineWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in spinal procedures.

This 510(k) summary (K063172) is for the ArthroCare® Cavity SpineWands®. It describes a new indication for use, stating that the device is substantially equivalent to previously cleared predicate devices and does not present new acceptance criteria or a new study proving the device meets new acceptance criteria. Instead, it relies on the previously established safety and efficacy of the predicate devices.

Therefore, many of the requested details, such as a table of acceptance criteria, sample sizes for test and training sets, and details of ground truth establishment, are not applicable or available in this document. This submission focuses on demonstrating substantial equivalence for an expanded intended use based on existing technology and performance.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Not applicable. This 510(k) is for a new indication for an existing device. It does not present new performance data against specific acceptance criteria. The submission relies on the substantial equivalence to predicate devices, implying that the device's performance for the new indication is considered safe and effective based on the predicate's established performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new test set data is presented for this 510(k) submission. The device is being cleared for an expanded indication based on its existing technology and substantial equivalence to predicate devices.

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 ground truth establishment for a test set is reported in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set or adjudication method is reported.

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 device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (electrosurgical tool), not an algorithm. Standalone performance as typically described for software or AI is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new ground truth is established or reported in this submission for the purpose of demonstrating performance for new acceptance criteria. The safety and effectiveness are established through substantial equivalence to predicate devices, which would have undergone their own testing and validation with relevant "ground truth" (e.g., surgical outcomes, tissue effects) at the time of their clearance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth.

Summary of the 510(k) Content:

The K063172 submission for the ArthroCare® Cavity SpineWands® is a re-indication 510(k). The core of this submission is to demonstrate substantial equivalence to predicate devices (ArthroCare® Wands and RITA System) for a new, expanded indication: "creation of a cavity in malignant lesions in a vertebral body."

The document explicitly states:

• "This 510(k) proposes a new indication and labeling for the ArthroCare Cavity SpineWands."
• "The technology, principle of operation, materials, and sterilization parameters of the ArthroCare Cavity SpineWands remain the same as those Wands cleared in the ArthroCare predicate 510(k)s."
• "The ArthroCare Cavity SpineWands, as described in this 510(k), are substantially equivalent to the predicate devices. The new proposed indication and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."

Therefore, this 510(k) does not introduce new performance acceptance criteria or a study that proves the device meets new acceptance criteria. Instead, it leverages the pre-existing safety and efficacy data, and the established regulatory clearance, of the predicate devices for the expanded use.

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