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Aesculap's Pneumatic Kerrison is intended for removing bone, cartilage and tissue in various surgical disciplines (e.g. neurosurgery and othopaedics).

The Aesculap Pneumatic Kerrison is powered by pneumatic pressure. The power is supplied by compressed air through luer lock connectors. The compressed air is then transferred into the working direction via an angle lever. The movable sheath pusher moves forward and the punching action is carried out in a two step process.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Pneumatic Kerrison:

Based on the provided documents (K062413), the Aesculap Pneumatic Kerrison is a medical device that has undergone a regulatory review for substantial equivalence, not a study evaluating its clinical performance against specific acceptance criteria in the manner you've outlined for AI or diagnostic devices.

The document does not contain the information requested in your numbered points because it's a 510(k) summary for a powered surgical instrument, not a diagnostic or AI-driven device requiring extensive performance studies as you've described.

Here's an explanation of why the requested information is absent and what is available:

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

• No such table is present. The 510(k) process for this type of device focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than meeting specific quantifiable performance metrics like sensitivity, specificity, or accuracy for a new diagnostic claim.
• The document states, "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system." This explicitly means there are no legally mandated performance standards that the device needs to meet for a 510(k) submission.
• Instead of performance criteria, the submission focuses on technological characteristics (operating speeds, power source, attachments, materials) and comparing them to those of 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. There is no "test set" in the context of clinical data for this device as it's not performing a diagnostic task. The "testing" involved here would be mechanical/electrical safety and performance testing to ensure it functions as intended and meets relevant standards (like material specification).

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. There is no "ground truth" establishment in the sense of clinical interpretation for this device. Its function is to physically remove bone, cartilage, and tissue.

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

• Not applicable. No clinical test set or adjudication process 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 instrument, not an AI-assisted diagnostic tool or system designed to improve human reader performance.

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

• Not applicable. This is a physical, human-operated surgical tool, not an algorithm.

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

• Not applicable. There is no "ground truth" in the diagnostic sense for this device.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning and therefore has no "training set."

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

• Not applicable.

What the document does provide regarding "Performance Data":

The only reference to "performance data" is in {1}:

"No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. This device has been evaluated and complies with ASTM F899-95, Standard Specification for Stainless Steel for Surgical Instruments as applicable."

This indicates:

• Acceptance Criteria for Materials: Compliance with ASTM F899-95, Standard Specification for Stainless Steel for Surgical Instruments. This standard dictates the material quality for the instrument's components, ensuring it's biocompatible and durable for surgical use.
• Reported Device Performance (Implicit): By stating compliance with ASTM F899-95, the manufacturer is asserting that the stainless steel used in the device meets the specified properties (e.g., chemical composition, mechanical properties, finish) required for surgical instruments. The document does not provide specific test results or numbers from this evaluation; it simply states compliance.
• Study That Proves the Device Meets Criteria: The statement "This device has been evaluated and complies with ASTM F899-95" refers to material testing (e.g., chemical analysis, tensile strength tests) that would have been performed by the manufacturer to ensure the stainless steel meets the ASTM standard. The details of these tests (sample size, specific results) are not included in the public 510(k) summary.

In summary, the provided K062413 pertains to a traditional surgical instrument and demonstrates substantial equivalence based on technological characteristics and material standards, not clinical performance metrics typical of AI or diagnostic devices.

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The Anspach Powered Kerrison System" (PKS) is indicated for use as an accessory attachment for I he rulisplay of the systems for cutting, shaping and removal of bone, including bones of the skull and spine.

The Anspach PKS is designed to be operated by either pneumatic or electric power but without the forceful, rapid forward stroke of a stationary blade in other powered rongeur systems. The Anspach PKS removes bone using a high speed rotational (85k max. rpm) cutting blade advanced by an operator controlled trigger mechanism. PKS consists of four basic component parts: Pistol Grip Trigger Assembly housing, Straight Nose-Tube Attachment, Shielded Attachments, Cutters.

The provided text describes a medical device, the Anspach Powered Kerrison System (PKS), along with its design, materials, operation, indications, contraindications, cleaning/sterilization, warnings, cautions, and a comparison to predicate devices for demonstrating substantial equivalence. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone performance studies.

The document's primary purpose is to establish substantial equivalence for regulatory clearance (510(k) submission K022907), which relies on comparing the new device to existing legally marketed predicate devices rather than presenting novel performance acceptance criteria or a dedicated study for the new device's performance.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the PKS itself. The acceptance criteria for the 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices, focusing on design, materials, intended use, and safety similarities.
• Reported Device Performance: No quantitative performance data for the PKS (e.g., cutting speed, precision, force exerted) is provided. The description mentions "quick and effectively cut away" bone, but this is qualitative.

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

• Not provided. No test set or associated data is mentioned for proving device performance.

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 provided. No ground truth establishment is described for a test set. This document relies on regulatory review and comparison to existing devices, not a clinical study with expert-adjudicated ground truth.

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

• Not applicable. No test set or adjudication process 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 tool, not an AI-assisted diagnostic tool or system that would typically undergo MRMC studies or involve human readers.

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

• Not applicable. This device is a mechanical surgical tool, not an algorithm. Therefore, standalone performance in the context of AI is not relevant. The device operates with a human surgeon "in the loop."

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

• Not applicable. The document does not describe a study involving a "ground truth" in the context of disease detection or diagnostic accuracy. The "ground truth" for this regulatory submission is essentially that the device is substantially equivalent to predicate devices based on its design, intended use, and operational characteristics, which have established safety and effectiveness.

8. The sample size for the training set

• Not applicable. This device is a mechanical surgical tool. There is no concept of a "training set" as would be used for machine learning or AI models.

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

• Not applicable. As above, no training set or ground truth in that context.

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