Anspach micro saw attachments are indicated for use with eMax electrical and Black Max, MicroMax pneumatic drill systems for surgical cutting, shaping and removal of bone, including bones of the spine and cranium.

Device Description

Keyless driver connects to surgical motor (or eMax Console - electric driver) and holds the micro saw head.. It reduces motor speed and drives the attached saw blade.
There designs: Black Max, MicroMaxleMax and "stand alone" electric driver certified to:

UL 2901-1: Second Addition, Rev. 10/24/97 .
CSA-C22.2 No. 601.1- M90, including General Instruction No. 1 .
EN60601-1. Issue 2. (including A1. A2. A11-13) .
Drivers are non-invasive and non-patient contact; contain no materials or substances which could be transferred to patient. Drivers cannot internally transfer materials or substances from motor. Drivers are reusable and can be cleaned with soap/water or isopropyl alcohol and can withstand temperatures of up to 278°(F) for up to 30 min. (static).
Micro saw head attaches to keyless driver without tools. Head converts motor rotational drive to sagittal, oscillating or reciprocating motions. Heads may be surgically invasive. Unintentional contact may occur due to proximity of blade and tissues of surgical site. Heads are constructed of biocompatible materials and contain no substances which could be transferred to patient. Like drivers, heads cannot internally transfer substances from motor. Heads are reusable and can be cleaned with soap-water or isopropy! alcohol and can withstand temperatures up to 278°(F) for up to 30 min. (static).
Saw blades are pre-sterilized, single-use, disposable bone cutting blades. Saw blades are sterilized to an appropriate SAL as specified by recognized standards for sterilization.

AI/ML Overview

The provided document is a 510(k) summary for "Advanced Micro Saw Attachments." It describes the design, materials, operation, risk assessment, and indications for use of the device, and then establishes substantial equivalence to a predicate device.

However, the document does not contain any information regarding specific acceptance criteria for a device's performance that would require a study to prove it meets those criteria. Instead, it focuses on the device's design specifications and how they compare to an older model to establish substantial equivalence for regulatory purposes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and establishment methods, training set size) are not applicable to this document as it doesn't describe a performance study with such metrics.

Below is a response attempting to answer the relevant questions based on the provided text, while clearly indicating where information is not available.

Acceptance Criteria and Device Performance Study for Advanced Micro Saw Attachments

The provided 510(k) summary for the "Advanced Micro Saw Attachments" primarily focuses on establishing substantial equivalence to a predicate device based on design, operational characteristics, and intended use. It does not present specific quantitative acceptance criteria related to a device's functional performance (e.g., precision, speed, cutting efficiency) that would be evaluated through a clinical or performance study with defined metrics like sensitivity, specificity, or reader agreement.

The "Substantial Equivalence" table outlines design and feature comparisons rather than performance metrics with thresholds for acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative performance acceptance criteria in the typical sense (e.g., accuracy, reliability metrics) that would be measured in an evaluation study. Instead, it compares specific design and functional features to a predicate device to demonstrate substantial equivalence.

Acceptance Criterion (Feature Comparison to Predicate)	Reported Device Performance (NEW Micro Saw)
Use w/Electric motor	Y (Yes)
Use w/Pneumatic motor	Y (Yes), vs. N for OLD Micro Saw
Stand alone keyless driver	Y (Yes), vs. N for OLD Micro Saw
Tool-less attachment	Y (Yes)
90° degree head	Y (Yes)
180° degree head	Y (Yes)
20° angled head	Y (Yes), vs. N for OLD Micro Saw
Stainless steel construction	Y (Yes)
Corrosion resistant bearings	Y (Yes), vs. N for OLD Micro Saw
Immersion cleaning**	Y (Yes), vs. N for OLD Micro Saw
4 Min flash sterilization **	Y (Yes), vs. N for OLD Micro Saw
Pre-sterilized blades (SAL)	Y (Yes)
Speed reduction*	Achieved with internal gear reduction mechanism (NEW), vs. power reduction only (OLD)
Max speed, Degree of ark, Stroke length, Operating temp.(Max)	[PROPRIETARY INFORMATION]

* OLD: Speed reduction achieved only by power reduction. NEW: Speed reduction achieved with internal gear reduction mechanism.
* Excluding saw blades which are single use and disposable.

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

Not Applicable. The document does not describe a performance study with a test set of data or samples for evaluating typical device performance metrics. The comparison is based on design features.

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

Not Applicable. No test set or ground truth establishment by experts is described in this regulatory submission for a performance study.

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

Not Applicable. No test set or adjudication method is 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 document pertains to surgical micro saw attachments, not AI-based diagnostic or assistive devices that would typically undergo MRMC studies with human readers.

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

Not Applicable. This is a mechanical surgical device, not an algorithm, so "standalone" performance in the context of AI or software is irrelevant here.

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

Not Applicable. The submission focuses on substantial equivalence based on design characteristics and compliance with electrical safety standards (UL, CSA, EN). There is no "ground truth" as would be defined for a diagnostic or predictive device's performance study.

8. The sample size for the training set

Not Applicable. This is a mechanical device, and the submission does not describe any machine learning or AI components that would require a "training set."

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

Not Applicable. As there is no training set mentioned or implied, the method of establishing ground truth for it is also not applicable.

Summary

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K040076, 1 of 2

MAR 1 5 2004

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510{k} SUMMARY: -- Advanced Micro Saw Attachments

CLASSIFICATION : US Class II

PERFORMANCE STANDARDS:

No known performance standards.

DESIGN, MATERIALS AND OPERATION CHARACTERISTICS;

Keyless driver connects to surgical motor (or eMax Console - electric driver) and holds the micro saw head.. It reduces motor speed and drives the attached saw blade.

There designs: Black Max, MicroMaxleMax and "stand alone" electric driver certified to:

UL 2901-1: Second Addition, Rev. 10/24/97 .
CSA-C22.2 No. 601.1- M90, including General Instruction No. 1 .
EN60601-1. Issue 2. (including A1. A2. A11-13) .

Drivers are non-invasive and non-patient contact; contain no materials or substances which could be transferred to patient. Drivers cannot internally transfer materials or substances from motor. Drivers are reusable and can be cleaned with soap/water or isopropyl alcohol and can withstand temperatures of up to 278°(F) for up to 30 min. (static).

Micro saw head attaches to keyless driver without tools. Head converts motor rotational drive to sagittal, oscillating or reciprocating motions. Heads may be surgically invasive. Unintentional contact may occur due to proximity of blade and tissues of surgical site. Heads are constructed of biocompatible materials and contain no substances which could be transferred to patient. Like drivers, heads cannot internally transfer substances from motor. Heads are reusable and can be cleaned with soap-water or isopropy! alcohol and can withstand temperatures up to 278°(F) for up to 30 min. (static).

Saw blades are pre-sterilized, single-use, disposable bone cutting blades. Saw blades are sterilized to an appropriate SAL as specified by recognized standards for sterilization.

RISK ASSESSMENT:

Risk assessment has been accomplished for the micro saws. All identified risks and hazards associated with use of the micro saws were capable of being reduced to acceptable levels through design, process and/or labeling activities.

INDICATIONS / CONTRAINDICATIONS:

There are no specific indications or contraindications for use of micro saw attachments. Generally, micro saw attachments are indicated for use only by qualified and trained surgeons. with Anspach surgical drill motor systems, for surgical cutting, shaping and removal of bone, including bones of the spine and cranium.

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K040076 2

CLEANING/STERILIZATION/MAINTENANCE

Cleaning, sterilization and maintenance instructions are provided in product use manuals available to all purchasers and Instructions (directions) For Use (IFU/DFU) that accompany each product. Unauthorized repairs and maintenance can be grounds for termination of warranty benefits.

WARNINGS and CAUTIONS:

Generic Warnings for use of Anspach products are specified in manuals and on product inserts. For safe and effective use of any Anspach product, specialized training is required as surgical techniques are highly specialized procedures. Improper surgical technique or improper use of product can cause injury or death to a user or patient and damage to product.

SUBSTANTIAL EQUIVALENCE:

Advanced micro saw attachments are substantially equivalent to Anspach Micro Saws.

	OLD Micro Saw			NEW Micro Saw
	Sagittal	Reciprocating	Oscillating	Sagittal	Reciprocating	Oscillating
Use w/Electric motor	Y	Y	Y	Y	Y	Y
Use w/Pneumatic motor	N	N	N	Y	Y	Y
Stand alone keyless driver	N	N	N	Y	Y	Y
Tool-less attachment	Y	Y	Y	Y	Y	Y
90° degree head	N	N	Y	N	N	Y
180° degree head	Y	N	N	Y	N	H
20° angled headShaft diameter	N	N	N	Y	N	N
Speed reduction*
Maximum speed
Degree of arkStroke length	[PROPRIETARY INFORMATION]
Operating temp.(Max)
Stainless steel construction	Y	Y	Y	Y	Y	Y
Corrosion resistant bearings	N	N	N	Y	Y	Y
Immersion cleaning**	N	N	N	Y	Y	Y
4 Min flash sterilization **	N	N	N	Y	Y	Y
Pre-sterilized blades (SAL)	Y	Y	Y	Y	Y	Y

★ OLD: Speed reduction achieved only by power reduction. NEW: Speed reduction achieved with internal gear reduction mechanism.

** Excluding saw blades which are single use and disposable.
__ End Summary _______________________________________________________________________________________________________________________________________________________________

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

MAR 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William G. Conety Director, Regulatory Affairs and Ouality Assurance Anspach Companies 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K040076

Trade/Device Name: Advanced Micro Saw Attachments -Sagittal. Oscillating and Reciprocating Regulation Number: 21 CFR 882.4310, 21 CFR 882.4360 Regulation Name: Powered simple cranial drills, burrs, trephines and their accessories; Electric cranial drill motor Regulatory Class: II Product Code: HBE, HEC Dated: January 12, 2004 Received: January 16, 2004

Dear Mr. Conety:

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 complics 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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) 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost
C.C.

Celia M. Witton, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: ΚΟΥΟΌ 7 6

Page 1 of 1

Device Name: Advanced Micro Saw Attachments - Sagittal, Oscillating and Reciprocating

INDICATIONS FOR USE:

DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K040076

Prescription Use: V OR Over-the-Counter Use:

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).