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

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K062413

Pneumatic Kerrision

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B. 510(k) SUMMARY (as required by 21 CFR 807.92)

Aesculap Pneumatic Kerrison August 16, 2006

Nije 2 1 2006 Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 CONTACT: Kathy A. Racosky 800-258-1946 (phone) 610-791-6882 (fax) kathv.racosky@aesculap.com COMMON NAME: Powered rongeur CLASSIFICATION NAME: Rongeur, Powered REGULATION NUMBER: 882.4845 PRODUCT CODE: HAD

SUBSTANTIAL EQUIVALENCE

Aesculap®. Inc. believes that the Pneumatic Kerrison is substantially equivalent to:

Aesculap Hilan Motor System by Aesculap Inc. (K980686) .
Aesculap manual Kerrisons by Aesculap Inc. (Class I device) .
Anspach Powered Kerrison System (PKS) by The Anspach Effort, Inc . (K022907)

DEVICE DESCRIPTION

INDICATIONS FOR USE

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

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Pneumatic Kerrisons are offered in similar operating speeds, power source, and attachments as the predicate devices. The material used for the Aesculap Pneumatic Kerrison is the same or similar as that used to manufacture the predicate devices.

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{1}------------------------------------------------

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PERFORMANCE DATA

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.

{2}------------------------------------------------

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. % Ms. Kathy A. Racosky Regulatory Affairs Associatc 3773 Corporate Parkway Center Valley, Pennsylvania 18034

NOV 2 1 2006

Re: K062413

Trade/Device Name: Pneumatic Kerrison Regulation Number: 21 CFR 882.4845 Regulation Name: Powered rongeur Regulatory Class: II Product Code: HAD Dated: October 16, 2006 Received: October 17, 2006

Dear Ms. Racosky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

{3}------------------------------------------------

Page 2 - Ms. Kathy A. Racosky

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation -Center for Devices and Radiological Health

Enclosure

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A. INDICATIONS FOR USE STATEMENT

510(k) Number: K062413

Device Name:

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) No

Regulation Number and Section

§ 882.4845 Powered rongeur.

(a)
Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).