Biomet Microfixation Twist Drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.

AI/ML Overview

The provided text describes the submission of a medical device (2.1 x 255mm Drill, 22mm Stop) for FDA clearance. It details the performance testing conducted, but it does not represent a study involving AI, human readers, or ground truth establishment in the context of medical image analysis or similar diagnostic applications. Instead, it refers to the physical characteristics and usability of a surgical drill.

Therefore, many of the requested categories (e.g., sample size for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device and the information provided.

However, I can extract the relevant information regarding the device's acceptance criteria and the study performed for its clearance.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Tolerance Analysis: Demonstrated compatibility with neurosurgical stereotactic placement devices through dimensional analysis.	The tolerance analyses showed that the subject device dimensions are compatible with the dimensions of the neurosurgical stereotactic placement devices; thus, the subject drill bit mates effectively.
Summative Usability Validation: Acceptance criteria for usability were met, proving the device can be used safely and effectively with neurosurgical stereotactic instruments.	The acceptance criteria were met and the results demonstrated the subject device can be used safely and effectively with neurosurgical stereotactic instrument.

Study Details (as applicable to a physical surgical instrument)

Sample size used for the test set and the data provenance: Not applicable. For the tolerance analysis, dimensional measurements of the drill were compared against the specified dimensions of neurosurgical stereotactic placement devices. For usability, a group of users (not specified in number) would have participated in the summative usability evaluation.
- Provenance: Not specified, but likely conducted by the manufacturer or a contracted lab.
- Retrospective/Prospective: The usability evaluation would have been prospective, while the tolerance analysis is a form of design verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of establishing "ground truth" as it relates to diagnostic accuracy. For usability testing, healthcare professionals (e.g., neurosurgeons, surgical technicians) would have been involved, but their number and specific qualifications are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device. Usability testing typically involves observing user interactions and collecting feedback against predetermined criteria.
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 study concerns the physical characteristics and usability of a surgical drill, not AI software or diagnostic image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical tool and does not involve an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in a diagnostic sense is not relevant here. The ground for the tolerance analysis was the dimensional specifications for compatibility, and for usability, it was the safe and effective operation of the device by users according to predefined usability criteria.
The sample size for the training set: Not applicable. No training set as this is not a machine learning model.
How the ground truth for the training set was established: Not applicable. No training set.

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. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 15, 2022

Biomet Microfixation % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle. Suite 110 Centennial, Colorado 80112

Re: K223199

Trade/Device Name: 2.1 x 255mm Drill, 22mm Stop 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: October 13, 2022 Received: October 13, 2022

Dear Danielle Besal:

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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2022.11.15, and the time is 11:27:20 -05'00'.

Adam D. Pierce, Ph.D. 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) K223199

Device Name 2.1 x 255mm Drill, 22mm Stop

Indications for Use (Describe)

The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

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}------------------------------------------------

510(k) Summary 2.1 x 255mm Drill, 22mm Stop November 15, 2022

Company:	Biomet Microfixation1520 Tradeport DriveJacksonville, FL 32218
Company Contact:	Jay SharmaJay.Sharma@zimmerbiomet.comPhone: (904) 741-4400
OfficialCorrespondent:	Danielle BesalDanielle.Besal@askmrcglobal.comPhone: (901) 827-8670
510(k) Number:Trade Name:	K2231992.1 x 255mm Drill, 22mm Stop
Predicate Device:	K213072 - 2.1 x 255mm Drill, 22mm Stop
Common Name:	Drills, Burrs, Trephines & Accessories (Simple, Powered)
Classification:	Class II
Regulation Number:	882.4310 Powered simple cranial drills, burrs, trephines, andtheir accessories
Panel:	Neurology
Product Code:	HBE

Device Description:

Indications for Use:

The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Substantial Equivalence:

The subject device is substantially equivalent to the predicate Biomet Microfixation; 2.1 x 255mm Drill, 22mm Stop (K213072). The subject and predicate devices are identical in intended use, technological characteristics, and materials. The addition of compatibility with

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

stereotactic instruments does not raise different questions of safety and effectiveness as they are intended for use with generic instrumentation, such as the subject drill, and this compatibility does not impact the drill's intended use or mechanism of action.

Performance Testing:

Tolerance analysis and summative usability testing were conducted on the subject device and successfully verified and validated compatibility with stereotactic instrument systems.

Test	Test Method Summary	Results
Tolerance Analysis	Dimensional analyses were conducted todetermine if the drill is compatible withthe neurosurgical stereotactic placementdevices.	The tolerance analyses showed that thesubject device dimensions are compatiblewith the dimensions of the neurosurgicalstereotactic placement devices; thus, thesubject drill bit mates effectively.
Summative UsabilityValidation	Summative usability evaluations wereconducted in accordance with IEC 62366-1:2015+A1:2020.	The acceptance criteria were met and theresults demonstrated the subject devicecan be used safely and effectively withneurosurgical stereotactic instrument.

Conclusion:

Based on the summary of design control activities, the subject device is determined to be substantially equivalent to the predicate device.

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).