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. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.

AI/ML Overview

The provided text describes a medical device, the Aesculap ELAN 4 Tools, and its regulatory submission to the FDA. The submission asserts substantial equivalence to predicate devices based on various tests and comparisons. However, the document does not contain information about the performance of a device based on AI/ML.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details for an AI/ML device:

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

The document presents a table of bench tests and their results, which could be considered analogous to acceptance criteria and performance for a mechanical device.
The acceptance criterion for each test is implicitly "Pass," meaning the device performed as intended or within acceptable design limits (e.g., "Design not suitable, suitable for speeds up to 100,000 rpm" for the rotating performance test).
The reported performance for all listed bench tests (Rotating performance test for burrs and disc, Functional testing of the tool adaptation with small blade, Measurement of oscillation frequency and fatigue test (small blade), Measurement of oscillation frequency and fatigue test (large blade), Measurement of temperature) is "Pass."

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

The document (K172709) describes the testing of electromechanical surgical tools, not an AI/ML device. Therefore, the concepts of "test set" and "data provenance" in the context of AI/ML are not applicable here.
For the bench tests, the sample sizes are not explicitly stated, but these would typically involve a small number of physical samples for mechanical testing, not a large dataset for algorithm evaluation.

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)

This information is not applicable. The device is a surgical tool, and its performance is evaluated against engineering specifications and physical measurements, not against expert interpretation of data.

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

This information is not applicable. Adjudication methods are relevant for human interpretation of data, often in clinical studies with expert reviewers, which is not the case for this mechanical device.

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

This information is not applicable. MRMC studies are used for evaluating AI performance in clinical settings where human readers interpret medical images or data. The Aesculap ELAN 4 Tools are mechanical surgical devices.

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

This information is not applicable. There is no algorithm mentioned for this device; it is a physical tool.

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

For the bench tests described, the "ground truth" is based on engineering specifications, physical measurements, and established industry standards (e.g., ISO standards for biocompatibility and sterilization). The "Pass" results indicate adherence to these predefined criteria and expected performance.

8. The sample size for the training set

This information is not applicable. The device is a mechanical tool, not an AI/ML model, so there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it.

In summary, the provided document describes the regulatory clearance for a mechanical surgical device and its supporting non-clinical (bench) testing, not an AI/ML-driven medical device. Therefore, most of the requested information pertaining to AI/ML device evaluation is not present in the text.

Summary

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

Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2018

Aesculap, Inc. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K172709

Trade/Device Name: 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: September 7, 2017 Received: September 8, 2017

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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

(http://www.fda.gov/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 C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K172709

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 Tools October 15, 2018

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:	HBE

SUBSTANTIAL EQUIVALENCE

The ELAN 4 Tools are substantially equivalent to the primary predicate, Anspach Dissection Tools (K113476) and the reference predicate, Aesculap ELAN 4 Electro Motor System (K152960).

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, Anspach Dissection Tools (K113476) and the reference predicate ELAN 4 Electro Motor System (K152960). 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, intended use, and materials. The subject device has the exact same indications as the reference predicate. A comparison table summarizing these characteristics can be found below.

The ELAN 4 Tools offers similar components when compared to the primary predicate. Anspach Dissection Tools (K113475). The only difference is the subject device is also offered in a blade type design. Bench testing determined that the blade design does not raise new questions of safety and effectiveness. Similar to the devices that are subject to this submission, the reference predicate, ELAN 4 Electro Motor System (K152960) also has the same indications for use.

	Aesculap Inc.ELAN 4 Tools	Anspach Dissection Tool	Aesculap, Inc.ELAN 4 Electro MotorSystem
K#	K172709	K113476 - Primary	K152960
Indications	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.	The ELAN 4 ElectroMotor System is intendedfor high speed cutting,sawing, and drilling ofbone in the fields ofSpine, ENT, Neuro, andMaxillofacial Surgery.
Regulation number	882.4310	882.4310	882.4310
Product Code	HBE	HBE	HBE
Regulatory Panel	Neurology	Neurology	Neurology
Tools
Burrs & drills
--Size	0.6 mm to 9 mm	0.5 mm to 24.5 mm	N/A
--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	N/A
Blades	Sagittal & reciprocating	N/A	N/A
Materials	Stainless Steel	Stainless Steel, diamond	N/A
Attachment mechanism	Yes	Yes	N/A
Sterile Single Use	Yes	Yes	N/A
Sterilization	GAMMA irradiation	unknown	N/A

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.

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

Page 3 of 4

Biocompatibility testing within this submission includes Cytotoxicity and Hemolysis testing. The biocompatibility test results yielded a non-toxic response. Other biocompatibility endpoints were leveraged through a risk assessment.

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.

Packaging is validated per ISO 11607. 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 forburrs and disc	Design not suitable, suitablefor speeds up to 100,000 rpm	Pass
Functional testing of the tooladaptation with small blade	Distal tool adaptation andburr release mechanism,locks during use	Pass
Measurement of oscillationfrequency and fatigue test(small blade)	Downforce oscillation outputfrequencies 0 to 20,000 rpmat the distal tool adaptation.	Pass
Measurement of oscillationfrequency and fatigue test(large blade)	Distal tool adaptation andburr release mechanism,locks during use. Downforceoscillation output frequencies0 to 20,000 rpm at the distaltool adaptation.	Pass
Measurement of temperature	With constant pressure andregular irrigation, evaluatedbone temperature increaseafter milling, drilling orcutting	Pass

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

CONCLUSION:

Page 4 of 4

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).