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The ArthroCare® Coblator IQ™ 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. The Coblator IQ Perc-D SpineWands include the following Wands: Coblator IQ DC SpineWand, Coblator IQ DLR SpineWand, and the Coblator IQ DLG SpineWand.

This 510(k) premarket notification (K000353) is for the ArthroCare® Coblator IQTM Perc-D® SpineWand®. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics or clinical outcomes.

Instead, this document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. The key points are:

• Substantial Equivalence: The document states that "This Special 510(k) proposes modifications to the performance specifications and labeling of the ArthroCare Coblator IQ™ Perc-D® SpineWand". It further clarifies that "The indications for use, materials, technology, sterilization, and principle of operation of the SpineWands remain the same as in the predicate device."
• Safety and Effectiveness: It asserts that "The proposed modifications to the SpineWands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices."

Therefore, the request for acceptance criteria and a study proving device performance using metrics like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance cannot be fulfilled from the provided text. The FDA's letter (pages 2-4) confirms the substantial equivalence determination but does not delve into specific performance study results.

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

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than new performance criteria.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment related to a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 provided. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so an MRMC study is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is an electrosurgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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The Wands are intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurological procedures.

The Wands are bipolar, single use, high frequency electrosurgical devices.

This 510(k) submission (K091228) for the ArthroCare® SpineWand® is a Special 510(k) and primarily focuses on modifications to the dimensional specifications, materials, and packaging. The key statement regarding performance is: "The indications for use, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)."

Therefore, this submission does not contain a new study demonstrating the device meets acceptance criteria. Instead, it relies on the safety and effectiveness established for the predicate devices. The information provided is insufficient to answer the detailed questions regarding a new performance study.

Here's a breakdown of why this submission doesn't provide the requested information and what it would look like if it did:

Why the requested information is not available in this document:

• Type of Submission: This is a "Special 510(k)". Special 510(k)s are for modifications to a manufacturer's own legally marketed device where the modifications do not require scientific review of clinical data, such as minor design changes or material changes that do not significantly alter the fundamental scientific technology or intended use.
• Reliance on Predicate: The submission explicitly states that "The indications for use, technology, sterilization, principle of operation, and performance specifications of the Wands remain the same as in the predicate cleared 510(k)." This means ArthroCare is not presenting new performance data for this specific submission. They are asserting that the modifications made do not impact the previously established performance.
• Lack of New Performance Study: The document does not describe any new testing, such as clinical trials, bench testing (beyond that related to the minor modifications), or analytical studies, to establish new performance metrics for the modified device.

What to look for if a new performance study were present (and why it's not here):

If this 510(k) were a traditional 510(k) or involved significant changes requiring new performance data, it would typically include a section titled "Performance Data," "Summary of Non-Clinical Testing," or "Summary of Clinical Testing." This section would then detail a study or studies designed to demonstrate the device's efficacy and safety against predefined acceptance criteria.

To answer your questions as best as possible, based only on the provided text, and acknowledging the absence of a new performance study:

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

   • Acceptance Criteria: Not explicitly stated for this submission as no new performance study was conducted. The implied acceptance criterion is that the modified device's performance is equivalent to the predicate devices.
   • Reported Device Performance: Not reported for this specific submission as no new performance study was conducted. The document states, "The proposed modifications to the Wands are not substantial changes, and do not significantly affect the safety or efficacy of the predicate devices."

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 new test set or data provenance mentioned as no new performance study was conducted.

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 mentioned as no new performance study was conducted.

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

   • Not applicable. No new test set mentioned as no new performance study was conducted.

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 diagnostic/imaging device. Therefore, an MRMC study is completely irrelevant. No such study was performed or mentioned.

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

   • Not applicable. This device is an electrosurgical tool, not an algorithm. No standalone performance study was done or mentioned.

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

   • Not applicable. No new ground truth mentioned as no new performance study was conducted.

8. The sample size for the training set

   • Not applicable. No training set mentioned as no new performance study was conducted.

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

   • Not applicable. No training set mentioned as no new performance study was conducted.

In summary: This 510(k) document is for a minor modification and explicitly states that the performance specifications remain the same as the predicate. Therefore, it does not contain the details of a new study proving the device meets acceptance criteria, as no such new study was required or performed for this particular submission. To find such details, one would need to refer to the predicate 510(k)s (K072089, K011634, K001588) or earlier submissions for the ArthroCare SpineWand line.

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