The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).

AI/ML Overview

Based on the provided text, the device in question is Aesculap ELAN 4 Tools, which are instruments for high-speed cutting, sawing, and drilling of bone. This document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo clinical efficacy or performance of a novel AI/software medical device.

Therefore, the information required for explaining acceptance criteria and a study proving device performance, particularly related to AI performance metrics, clinical studies, reader studies, and large datasets for training/testing, is not present in this document. The document details testing related to the physical device's characteristics and safety.

Here's what can be extracted and why other sections cannot be completed:

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance (for test set):

Since this is a physical medical device (drills, burrs, trephines) and not an AI/software device, the "acceptance criteria" and "reported device performance" in an AI context (e.g., AUC, sensitivity, specificity, F1-score) are not applicable. The performance evaluated here relates to the mechanical function and biocompatibility of the tools.

Acceptance Criteria (Bench Testing)	Reported Device Performance
Design suitable for speeds up to 80,000 rpm for 2 minutes (Rotating performance test for rotating tools)	Pass
With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting (Measurement of temperature)	Pass
Biocompatibility in accordance with ISO 10991-1 (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Pyrogen testing)	All testing met acceptance criterion
Endotoxin testing in accordance with ISO 10993-5	Met acceptance criterion
Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006 and ISO 11137-2:2006 (Gamma irradiation)	Validated
Packaging validation per ISO 11607	Validated
Shelf life (5 years) validated per ASTM F1980 (Accelerated aging data)	Supported

Sample Size and Data Provenance:

For Rotating performance test and Measurement of temperature: The document does not specify the sample size used for these bench tests (e.g., how many tools were tested). The data provenance is implied to be from the manufacturer's internal testing.
For Biocompatibility, Sterilization, Packaging, and Shelf-life testing: These typically involve standardized protocols where the "sample size" refers to the number of units tested to achieve statistical confidence for validation. Specific numbers are not provided in this summary but are part of the underlying validation reports. The data provenance is internal lab testing by the manufacturer or their contractors.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the studies described are bench tests and biocompatibility tests for a physical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., radiologist reads).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for the same reason as above.

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 diagnostic or assistance system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical device testing:

Bench Testing (Rotating performance, Temperature Measurement): Ground truth is based on engineering specifications and physical measurements, demonstrating the device performs as designed under specified conditions.
Biocompatibility, Sterilization, Packaging, Shelf-life: Ground truth is established by adherence to recognized international standards (ISO, ASTM) and achieving specified pass/fail criteria (e.g., no cytotoxicity, acceptable endotoxin levels, sterility assurance level).

8. The sample size for the training set & 9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the same sense as an AI model's training phase.

In summary: The provided document is a 510(k) clearance letter and summary for a conventional surgical instrument. The "acceptance criteria" and "study" described pertain to the manufacturing, material science, and mechanical performance of the physical tools, and their biological safety (biocompatibility and sterilization). It does not involve any AI, software, or diagnostic imaging components, thus many of the requested fields are not relevant to this specific submission.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 9, 2019

Aesculap, Inc. Kathy A. Racosky Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034

Re: K183203

Trade/Device Name: Aesculap ELAN 4 Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: July 11, 2019 Received: November 19, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew Krueger, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K183203 Device Name Aesculap ELAN 4 Tools

Indications for Use (Describe)

Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery

Type of Use (Select one or both, as applicable):

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Page 1 of 4

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

	Aesculap ELAN 4 ToolsJuly 17, 2019
COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculapimplants.com
TRADE NAME:	ELAN 4 Tools
COMMON NAME:	Drills, Burrs, Trephines & Accessories (Simple, Powered)
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Powered simple cranial drills, burrs, trephines and theiraccessories
REGULATION NUMBER:	882.4310
PRODUCT CODE:	HRE

SUBSTANTIAL EQUIVALENCE

The ELAN 4 Tools are substantially equivalent to the primary predicate, ELAN 4 Tools (K172709) and predicate Anspach Dissection Tools (K113476).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

{4}------------------------------------------------

Page 2 of 4

TECHNOLOGICAL CHARACTERISTICS (compared to predicate)

The ELAN 4 Tools are substantially equivalent to the predicate, ELAN 4 Tools (K172709) and the reference predicate Anspach Dissection Tools (K113476). The subject device is shown to be substantially equivalent and has the same performance characteristics to its primary predicate device through comparison in design, principles of operation and indications for use. The subject device has the same sizes and manufacturing materials as the reference predicate. A comparison table summarizing these characteristics can be found below.

The ELAN 4 Tools offer similar components when compared to the primary predicate, ELAN 4 Tools (K172709). The proposed device has some differences from the primary predicate device. The subject device ranges in sizes from 0.5 mm to 8 mm versus 0.6 mm to 9 mm for the predicate device. The subject device is manufactured from stainless steel with some tools containing a layer of diamond chips whereas the predicate is made from stainless steel. Similar to the devices that are subject to this submission, the predicate. Anspach Dissection Tool (K113476) are manufactured from the same materials; stainless steel with some tools containing a layer of diamond chips and range in the same sizes as the subject device offers.

K#	Aesculap Inc.ELAN 4 Tools	Aesculap Inc.ELAN 4 Tools	Anspach Dissection Tool
	Proposed device	K172709 - Primary	K113476
Indications	The ELAN Tools areintended for high speedcutting, sawing, anddrilling of bone in thefields of Spine, ENT,Neuro, and MaxillofacialSurgery.	The ELAN Tools areintended for high speedcutting, sawing, anddrilling of bone in thefields of Spine, ENT,Neuro, and MaxillofacialSurgery.	Dissection tools areintended for cutting andshaping bone includingspine and cranium.
Regulation number	882.4310	882.4310	882.4310
Product Code	HBE	HBE	HBE
Regulatory Panel	Neurology	Neurology	Neurology
Tools
Burrs & drills
--Size	0.5 mm to 8 mm	0.6 mm to 9 mm	0.5 mm to 24.5 mm
--Type	fluted, ball, conical, oval,barrel, acorn, pin, twist,drills, cutters, and discs	fluted, ball, conical, oval,barrel, acorn, pin, twist,drills, cutters, and discs	fluted, ball, conical, oval,barrel, acorn, pin, twist,drills, cutters, and discs
Materials	Stainless steel & diamond	Stainless steel	Stainless steel, diamond,carbide
Attachment mechanism	Yes	Yes	Yes
Sterile Single Use	Yes	Yes	Yes
Sterilization	GAMMA irradiation	GAMMA irradiation	unknown

{5}------------------------------------------------

PERFORMANCE DATA

Biocompatibility Testing

Biocompatibility testing in accordance to ISO 10991-1 and Use of International Standard ISO 10993-1. "Biological evaluation of medical devices –1 Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff has been performed to demonstrate that the ELAN 4 Tools are substantially equivalent to other predicate devices.

Biocompatibility testing within this submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, and Pyrogen testing. In addition, endotoxin testing was conducted with all testing meeting the acceptance criterion.

Sterilization Validation

Product sterilization is validated in accordance with the ANSI/AAMI/ISO 11137-1:2006 -Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006 - Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose.

The ELAN 4 Tools are packaged and sterilized by gamma irradiation.

Packaging is validated per ISO 11607. Testing per ASTM F1980 validated the 5 year shelf life. Accelerated aging data (5 years) for ELAN 4 Tools has been generated to support this submission.

Bacterial Endotoxin testing per Endotoxin ISO 10993-5 met the acceptance criterion.

Bench Testing

The following bench testing was performed to demonstrate that the ELAN 4 Tools perform as intended and are substantially equivalent to the predicate devices.

Test	Test Summary	Results
Rotating performance test forrotating tools	Design suitable for speeds upto 80,000 rpm for 2 minutes	Pass
Measurement of temperature	With constant pressure andregular irrigation, evaluatedbone temperature increaseafter milling, drilling orcutting	Pass

{6}------------------------------------------------

Page 4 of 4

CONCLUSION:

The biocompatibility and bench testing results along with a comparison between the technology, materials and intended use for the ELAN 4 Tools and the predicate devices demonstrate that the ELAN 4 Tools are as safe, as effective, and perform as well as the predicate devices. The biocompatibility and bench testing results and technological comparison demonstrates that the ELAN 4 Tools are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).