The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for use by trained medical personnel as an interface coupling device, to permit attachment to and operation of the Medtronic, Midas Rex "Legend" Bone Mill (BM1100) and Disposable Bowl Bone Mill (BM200) with an Anspach motor.

Device Description

The Coupler is a simple attachment; comprised of a cylindrical housing with external locking feature, that when inserted into the bone mill, physically locks the coupler to the bone mill. The coupler is designed to attach and lock onto the Anspach spindle (drive shaft), to permit operation of the bone mill. There are two coupler designs; one for Black Max and one for Micro/Max/xMax and eMax. Attachment is a simple insertion/twist motion, to align cantilever tabs with the Bone Mill "D-lock" feature. A simple twist motion that depresses the two coupler cantilever tabs, unlocking coupler from the bone mill for easy removal.

AI/ML Overview

The provided text describes the Anspach Coupler, a device designed to attach and lock onto an Anspach motor to permit operation of certain Medtronic, Midas Rex bone mills. It does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Instead, the document details the device's design, intended use, and a comparison table for demonstrating substantial equivalence to other Anspach Nosepiece Attachments for regulatory purposes. This is a common approach for Class II medical devices seeking 510(k) clearance, where the focus is often on demonstrating equivalence to a predicate device rather than conducting extensive performance studies with quantitative acceptance criteria in the manner of a new technology.

Therefore, many of the requested categories related to acceptance criteria, study performance, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable to the information provided in this 510(k) summary.

Here's a breakdown of the information that can be extracted and an explanation for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Functionality	Attach and lock onto the Anspach spindle (drive shaft). Permit operation of specific Medtronic, Midas Rex bone mills (BM1100, BM200).	"The coupler is designed to attach and lock onto the Anspach (drive shaft) spindle to permit operation of the Medtronic, Midas Rex 'Legend' Bone Mill (BM1100) and Disposable Bowl (BM200) with an Anspach motor."
Compatibility (Motors)	Use with Pneumatic & Electric motors	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Attachment Method	Tool-Less attachment	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Competitor Device Use	For use with Competitor Device(s)	Y (for Anspach Coupler)
Input Speed	80-85k	80-85k (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Operating Temperature (Max)	120° Max	120° Max (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Material Construction	Stainless steel construction	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Bearing Type	Corrosion resistant bearings	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Cleaning Method	Immersion cleaning	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Sterilization Method	Steam Sterilization, Sterrad sterilization	Y (for Anspach Coupler and Other Anspach Nosepiece Attachments)
Serviceability	Not user/third-party serviceable; Anspach serviceable.	N (User Service/Repair), Y (Anspach Service/Repair) (for Anspach Coupler and Other Anspach Nosepiece Attachments)

2. Sample size used for the test set and the data provenance:

Not Applicable. The document does not describe a formal "test set" with a specific sample size in the context of performance metrics that would typically apply to software or diagnostic devices. The evaluation here is based on design specifications and a comparison to predicate devices, not empirical performance data from a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As there is no "test set" in the context of performance metrics for this device, there are no experts establishing ground truth for such a set. The "ground truth" for this filing is based on engineering design, material science, and the functional requirements for mechanical compatibility and safe operation as outlined by Anspach and reviewed by the FDA.

4. Adjudication method for the test set:

Not Applicable. No test set or corresponding adjudication method is detailed.

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 mechanical attachment for surgical drills, not an AI-powered diagnostic or assistive tool for human readers.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is based on engineering specifications and functional requirements for a mechanical device, verified through design, material selection, and internal testing (though specific testing details are not provided in this summary). It's also implicitly based on the established safety and effectiveness of the predicate devices (other Anspach Nosepiece Attachments and the bone mills it interfaces with). The FDA's substantial equivalence determination relies on assurance that the new device shares fundamental characteristics and functions without raising new questions of safety or effectiveness.

8. The sample size for the training set:

Not Applicable. The concept of a "training set" is relevant for machine learning or AI models, which this device is not.

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

Not Applicable. This device does not involve a training set as it's not an AI/ML product.

Summary

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K050628

2005 APR 7

Page 13 of 14
Page 1 of 2

Exhibit 16-01

510(k) SUMMARY: -

CLASSIFICATION NAME: Powered simple cranial drills, burrs trephines and their accessories

COMMON/USUAL NAMES: Nosepiece attachment; nose-tube; Coupler, Adaptor, etc.

CLASSIFICATION: US Class II / EU Class IIa

APPLIED (PERFORMANCE) STANDARDS:

There are no known standards established for powered, simple cranial drills, burrs, trephines, There are no known standards established for powerou, standards for bone mills of
and their accessories at this time. There are no known performal accepted standards for and their accessories at this tiffe. There aile no knowledge and accepted standards for
adaptors for powering devices for bone mills. Appropriate international accepted and adaptors for powering devices for bone mills. " Repreprise in Systems are applied.

SUMMARY:

The Coupler is a simple attachment; comprised of a cylindrical housing with external locking The Coupler is a simple attachment, complised or a vysically locks the coupler to the bone mill. The bone mill. The bone mill. The bone mill. The bone mill. feature, that when Inserted fints the bone mint the Anspach drive shaft, to permit
coupler is designed to attach and lock onto the Anspack (dive shaft) coupler is designed to attach and 100x spindle (drive shaft).

There are two coupler designs; one for Black Max and one for Micro/Max/xMax and eMax.

Attachment is a simple insertion/twist motion, to align cantilever tabs with the Bone Mill "D-lock" Attachment is a simple insertion.wist motion that depresses the two coupler cantilever tabs, unlocking coupler from the bone mil for easy removal.

IDENTIFIED ADDITIONAL RISKS:

Locking tab damage or excessive/premature wear:

Appropriate design considerations (materials, design, etc.) for such wear are incorporated and Approphate design ochelabrations (includermined design requirements.

Bone mill design change to inhibit use of the Anspach motor/coupler assembly:

Thought possible, it would be highly unlikely as it would require a similar design revision to all Thought poosibled Midas Rex Motors and/or bone mills.

INDICATIONS / CONTRAINDICATIONS:

The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for The Anspach Surgical Dill, Specially Nosepted Italy, Novice, to permit attachment to and use by trained medical personnel as an intentional Mill (BM1100) and Disposable Bowl
operation of the Medtronic, Midas Rex "Legend" (1934) and Disposable Bowl operation of the Medifonic, Midas Rex "Esgeria "Dono Mill (Entrol)
(BM200) with an Anspach motor. It is contraindicated for use by untrained personnel or as a (DMZOO) with an ment for any other competitive device.

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K050628

Page 14 of 14

Page 2 of 2

CLEANING/STERILIZATION/MAINTENANCE:

The Anspach Coupler is distributed clean, non-sterilized and is intended to be a re-usable The Anspach Coupler is distinuted to be subjected to gross bio-contact and with soiled gloves could cause external bio-contamination. Valiated cleaning, disinfection,
with soiled gloves could cause external bio-contaminations are crowind use manuals with soiled gloves could cause extential pro-condininations are provided in product use manuals
sterilization, and routine maintenance recommendations are lee JIEUN that acco sterilization, and routine maintenance recommendations are provide in that accompany in each product.

The Anspach Coupler is not serviceable by user or third parties but remains fully serviceable The Anspach Coupler is not service/repair activities can invalidate warranty.

WARNINGS and CAUTIONS:

Generic Wamings and Cautions for use of Anspach motor systems, attachments and cutters Generic Warnings and Cautons in use of Anser and effective use of any Anspach product, it is are specified on product insents. For sale and enconvers since surgical techniques using
strongly suggested that specialized training be undertaken since surgical technique strongly suggested that specialized training bookures. Improper surgical technique
Anspach products are highly specialized and complex procedures. Improper surging and Anspach products are highly specialized and common proceath to a user or patient and or improper use of Anspach products and/or other equipment.

SUBSTANTIAL EQUIVALENCE:

The Anspach coupler is substantially equivalent to other Anspach Attachments in that it is The Anspach coupler is substantially equivaline to other may has and support a bone cutting/ processing device (cutter, saw, perforator, chuck system, etc.).

	AnspachCoupler	Other AnspachNosepiece Attachments
Use w/Pneumatic & Electric motors	Y	Y
Tool-Less attachment	Y	Y
For use with Competitor Device(s)	Y	-
Straight Nosepieces:		N
Saggital Saw:		Y
Chuck System:		Y
Speed Reducers:		Y
Input Speed	80-85k	80-85k
Operating temperature (Max)	120° Max	120° Max
Stainless steel construction	Y	Y
Corrosion resistant bearings	Y	Y
Immersion cleaning	Y	Y
Steam Sterilization	Y	Y
Sterrad sterilization	Y	Y
User Service/Repair	N	N
Anspach Service/Repair	Y	Y
	End Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal bars representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.

Public Health Service

2009 APR 7

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William G. Conety IMI: William O: Sollow,
Director, Regulatory Affairs and Quality Assurance Anspach Companies 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K050628

Trade/Device Name: Adaptor/ Coupler Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: HBE Product Code: II Dated: March 7, 2005 Received: March 11, 2005

Dear Mr. Conety:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave decembined the acress to recess to vices marketed in interstate for use stated in the encrosule) to regally mancted provice Americal Device Ameralments, or to commerce prior to May 28, 1970, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMAN devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ions and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, secject to the girls annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Fiel networks of the same of the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existing major regulations affecting your device . EDA if may be subject to such additional concreter - Einemage 21, Parts 800 to 898. In addition, FDA can be lound in the Code of I cuefar Regulations, Ferran Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualier of a successful other requirements of the Act
that FDA has made a determination that your device complies with on any that FDA has made a decemination that Jour seee a agencies. You must or any Federal statutes and regulations daminders as of not limited to: registration and listing (21 let comply with all the Act s requirements, mercessed manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalations (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 – Mr. William G. Conety

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the same of a line of a list as the tisk assivelence of your device This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of fyour premarket notification. The FDA miding of Substantal organ 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
rs the regulation of 1010 - 1010 - Also, also - Also, plass note the regula If you desire specific advice for your de vice on our an accesses not the regulation entitled, the regulation entitled, the contact the Office of Compliance at (240) 270 - 1200) Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to premarkst nonlied.com (1) it it from the Division of Small
other general information on your responsibilities under the Act from wwbar (800) 638other general information on your responsibility in the 2014 fires number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at iss toll-free number (800) Manufacturers, International and Consulter Assistance arovedrh/industry/support/index.html.

Sincerely yours,

E.O.T.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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<050628

510(k) Number: K 050628

Page 1 of 1

Device Name: Adaptor/Coupler

INDICATIONS FOR USE:

The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for The Anspach Surgical Drill, Specialty Noseplex of Arabton Ocalphia dapt to and use by trained medical personnel as an interrace couping device, to pornit and and and and and and of the manager of the may of (BM200) with an Anspach motor.

Prescription Use: _ (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: _ (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)

(21-01)

Carral, Restorative

K050628

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).