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The Smith & Nephew ElectroBlade Adaptor, when used in conjunction with The Smith & Nephew ElectroBlade® Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft tissue. The Smith & Nephew ElectroBlade® Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

The Smith & Nephew ElectroBlade® Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument. The Smith & Nephew ElectroBlade® Adaptor is a transformer that converts the power output of the generator into a higher current / lower voltage output.

The provided text describes the Smith & Nephew ElectroBlade® Resector and Adaptor, but it primarily focuses on its substantial equivalence to predicate devices based on safety standards, not on a study to prove performance against specific clinical acceptance criteria. Therefore, most of the requested information cannot be extracted from the given document.

Here's what can be inferred and what cannot:

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

The document does not provide specific performance acceptance criteria related to clinical outcomes (e.g., resection time, hemostasis effectiveness quantified in a clinical setting). Instead, it lists compliance with established safety and electrical standards as the "summary performance data."

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

This information is not provided in the document. The document refers to compliance with standards, not performance in a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Clinical ground truth experts (e.g., radiologists) are not relevant to the compliance with electrosurgical device standards discussed here.

4. Adjudication method for the test set

This information is not provided. Adjudication methods are not applicable here as no clinical test set 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

This information is not provided. This device is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

This information is not provided and is not applicable. The device is a surgical tool, not an algorithm.

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

The "ground truth" for the device's acceptability in this context is its compliance with pre-defined national and international safety and performance standards for electrosurgical and medical devices. No clinical outcomes data, pathology, or expert consensus on clinical performance are mentioned.

8. The sample size for the training set

This information is not provided. There is no "training set" in the context of device compliance with safety and electrical standards.

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

This information is not provided and is not applicable.

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