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The EBERLE Shaver System C2 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone conducted by qualified surgeons only.

The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile). All these components are designed, constructed and intended to be operated exclusively as a unit.

This F510(k) summary for the EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification, which largely focuses on demonstrating "substantial equivalence" to previously approved devices rather than presenting the results of a specific clinical performance study with acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from the provided text and what is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

• Not present. The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the shaver system, nor does it report quantitative device performance data against such criteria. The focus is on qualitative statements of safety and equivalence.

Regarding a "study that proves the device meets the acceptance criteria":

The document states, "Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA." This implies that testing was done, but the details of such testing (including acceptance criteria, methodology, and results) are not provided in this summary.

Here's why the other requested points (2-9) cannot be answered based on the provided text:

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

  • Not present. No information about a "test set" or specific study data is provided.

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

  • Not present. This type of information is relevant for studies involving human assessment (e.g., image interpretation), which is not applicable to a surgical shaver system in the context of this 510(k) summary.

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

  • Not present. Not applicable in this context.

• 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 present. Not applicable. MRMC studies are typically for diagnostic AI devices, not surgical instruments.

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

  • Not present. Not applicable, as this is not an AI/algorithm-driven device.

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

  • Not present. No specific "ground truth" as typically understood in diagnostic studies is mentioned. The device's performance relies on its mechanical and functional capabilities.

• 8. The sample size for the training set

  • Not present. Not applicable, as this is not an AI/machine learning device that would require a training set.

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

  • Not present. Not applicable.

Summary of what is stated in the document regarding the device's validation:

• Safety Justification: "The selection of the materials for the EBERLE Shaver System C2 and Blades has been determined through demonstrated appropriate levels of biocompatibility. The materials are similar or identical to those used for predicate devices as well as other brands legally sold in the United States."
• Substantial Equivalence: The primary method of demonstrating safety and effectiveness for this 510(k) submission is by showing substantial equivalence to legally marketed predicate devices (K973195, K030009, K990524, K002523).
• Performance Mention: "Biocompatibility, function, indications and designs have been developed to ensure the safety of this device..." This indicates that functional testing and design verification were performed, but the details of these tests and their specific acceptance criteria are not included in this summary.

Conclusion:

The provided 510(k) summary for the EBERLE Shaver System C2 and Shaver Blades does not contain the detailed information regarding specific acceptance criteria for a performance study or the results of such a study. The document focuses on establishing substantial equivalence to predicate devices, which is the standard pathway for 510(k) clearance for medical devices. Full details of bench testing, biocompatibility reports, and other verification and validation activities would be contained within the complete 510(k) submission, not typically in the public summary.

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