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The EBERLE Shaver System Accessories are designed to use with the EBERLE Shaver System for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.

The Eberle Shaver System Accessories are manufactured by EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG in Germany. They are developed for surgical use in the field of arthroscopy and should only be used by trained personnel in designated institutions.

The Eberle Single Use Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector consist of POM, the tubes consists of stainless steel. The Blades are provided in a sterile packaging and are intended for single use (not autoclave- reusable).

The Eberle Hand Piece with Switch has three buttons to select the direction of rotation. It consists of Stainless Steel and Aluminum.

The Eberle Drill- and the Saw- Hand Piece also consist of Stainless Steel and Aluminum. The Drill has two buttons to select the direction of rotation and the Saw hast a operator lever.

All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System C2.

The provided document is a 510(k) Summary of Safety and Effectiveness for the EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System Accessories. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or available in this document. The document primarily attests to safety and substantial equivalence based on material selection, design, and adherence to various electrical, sterilization, and biocompatibility standards.

Here's an analysis based on the information provided and what is typically expected for a 510(k) submission of this nature:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of specific performance acceptance criteria in terms of clinical or technical metrics for the shaver system accessories and their corresponding tested performance. Instead, it refers to compliance with various safety and material standards.

2. Sample size used for the test set and the data provenance

The document refers to compliance with standards, implying that testing was conducted as required by those standards. However, it does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any specific performance tests of the device in a clinical or simulated clinical setting. This type of detail is generally not included in a 510(k) Summary for non-complex, predicate-based devices like surgical accessories.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set in the context of device performance, especially for AI or diagnostic devices. The acceptance is based on compliance with engineering and safety standards, and functional equivalence to predicate devices, verified through bench testing and material conformity, not expert evaluation of output.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. No adjudication method would be detailed for a submission of this type.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those incorporating AI, to assess the impact of the AI on human performance. The EBERLE Shaver System Accessories are surgical tools, not diagnostic aids.

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

This information is not applicable. There is no AI algorithm being evaluated for standalone performance described in this document.

7. The type of ground truth used

The "ground truth" for this device's acceptance is primarily:

• Compliance with established engineering, electrical safety, biocompatibility, and sterilization standards. These standards define the "truth" for safety and materials.
• Functional equivalence to legally marketed predicate devices. The predicate devices serve as the "ground truth" for acceptable design and performance profile in the intended use.
• Material properties and design specifications for the components.

8. The sample size for the training set

This information is not applicable. This is not an AI or machine learning device, so there is no "training set."

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

This information is not applicable for the same reasons as point 8.

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