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The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hernostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.

This submission is a 510(k) Pre-market Notification for a medical device called the ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe). The purpose of this type of submission is to demonstrate that the new device is substantially equivalent to existing legally marketed predicate devices. It typically does not involve new clinical studies to prove effectiveness or establish acceptance criteria based on performance. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed predicate devices.

Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as it's a 510(k) summary focused on substantial equivalence.

Based on the content, here's what can be inferred or stated about the requested information:

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

• Not Applicable. The 510(k) summary does not define specific performance-based acceptance criteria for this new device in the way a clinical trial would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices in areas like intended use, materials, design, and operating principles. Performance is assessed in comparison to these predicates, not against novel, pre-defined quantitative thresholds in this document.

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 test set or associated data provenance is described for proving new performance claims. The 510(k) submission primarily relies on comparisons to known predicate devices and non-clinical testing (which is not detailed here).

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 expert-established ground truth for a test set is described.

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

• Not Applicable. No test set or adjudication method is described.

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 a surgical probe, not an AI software/diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

• Not Applicable. This device is a surgical probe, not an algorithm.

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

• Not Applicable. No new ground truth is established or used for the purpose of this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is relevant to this submission.

Summary of the 510(k) Conclusion:

The 510(k) summary concludes that the ORATEC® Ablator™-S Probe is substantially equivalent to the predicate devices listed:

• ORATEC Electrosurgical Probes (K965007 and K992408)
• ORATEC Bipolar Ablation Suction Probes (K991218)
• ArthroCare Ablation Probes (K943450, K961747, and K962321)

This substantial equivalence determination is the primary "proof" for a 510(k) submission, indicating that the device is as safe and effective as existing devices on the market, rather than meeting specific performance criteria demonstrated through a de novo study.

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