The Anspach eG1 High Speed System, which consists of a control console, handpiece, and various attachments, is an electrically powered surgical drill that handles a range of surgical procedures ranging from power-demanding applications to delicate dissection.

AI/ML Overview

This submission is for a 510(k) premarket notification for a Class II medical device, the Anspach eG1 High Speed Electric System, an electrically powered surgical drill. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove safety and effectiveness. Therefore, the information typically found in acceptance criteria documentation for novel devices (e.g., studies with test sets, ground truth establishment, MRMC studies) is generally not present in such FDA documents.

Based on the provided text, here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Derived from Substantial Equivalence to Predicate): The device must perform as intended, utilizing similar materials, features, and functions as the predicate device (Anspach eMax Drill System, K011444), and raise no new safety or effectiveness issues.

Reported Device Performance:

Performance Aspect	Claimed Performance
Functional	"The Anspach eG1 High Speed Electric System and attachments perform as intended."
Safety	"Raises no new safety or effectiveness issues."
Materials	"Designed utilizing the same materials... as the predicate devices."
Features/Functions	"Contains features and functions which are similar to the predicate devices."
Intended Use	"Intended for cutting and shaping bone including spine and cranium." (Same as predicate implied by substantial equivalence)

Study Information

For a 510(k) submission, the "study" is primarily a "Design Verification" and "Performance Testing" against the design requirements, not a clinical study on human subjects or an AI algorithm performance study.

2. Sample size used for the test set and the data provenance: Not applicable. This submission describes physical and functional testing of the device itself, not an algorithm using a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic or AI/ML algorithm evaluation (e.g., radiologist consensus) is not relevant here. The "ground truth" for the device's functional integrity would be engineering specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The testing described is design verification, likely performed by engineers, not subjective human assessment needing adjudication.

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 is not an AI/ML device or a diagnostic imaging device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device would be engineering specifications, functional requirements, and performance standards. Testing would be against these predefined technical parameters.

8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm with a training set.

9. How the ground truth for the training set was established: Not applicable. There is no training set for this device.

Summary

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K133604

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510(k) Summary

JAN 10 2014 The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93.

Submitter	The Anspach Effort, Inc.4500 Riverside DrivePalm Beach Gardens, FL 33410
Official Correspondent	Jeannette G. DaileyRegulatory Affairs ManagerTel. 561-494-3710Fax. 561-625-9110Email: dailey.jeannette@synthes.com
Date Prepared	November 22, 2013
Device Name	Anspach eG1 High Speed Electric System
Common Name	Electric Drill Motor System
Classifications	Class IINeurological Devices21 CFR § 882.4360HBCClass IIEar, Nose and Throat Devices21 CFR § 874.4250ERL
Predicate Devices	eMax Drill SystemThe Anspach Effort, Inc.K011444HBC, ERL
Device Description	The Anspach eG1 High Speed System, which consists of acontrol console, handpiece, and various attachments, is anelectrically powered surgical drill that handles a range ofsurgical procedures ranging from power-demandingapplications to delicate dissection.
Indications for Use	The Anspach eG1 High Speed Electric System is intendedfor cutting and shaping bone including spine and cranium.

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K133604 Page 2 of 2

Technological Characteristics The Anspach eG1 High Speed Electric System and attachments are provided non-sterile, reusable. The Anspach eG1 High Speed Electric System and attachments are designed utilizing the same materials and contains features and functions which are similar to the predicate devices. Design verification was conducted on the proposed design Performance Testing changes of the Anspach eG1 High Speed Electric System and attachments. These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards. Based on the testing, risk analysis and comparison to the Conclusion predicate devices, the Anspach eG1 High Speed Electric System and attachments described in this submission perform as intended and raises no new safety or effectiveness issues.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

The Anspach Effort, Inc. Ms. Jeannette G. Dailey Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, Florida 33410

January 10, 2014

Re: K133604

Trade/Device Name: Anspach eG1 High Speed Electric System Dissection Tools Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC, ERL Dated: December 12, 2013 Received: December 13, 2013

Dear Ms. Dailey:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jeannette G. Dailey

forth in the quality systems (OS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K133604

Device Name: Anspach eG1 High Speed Electric System

Indications for Use:

The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.

Prescription Use V (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 OF NEEDED)

この……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Concurrence of CDRH, Office of Device Evaluation (ODE)

By Ugmed by Long N. Chen . A
Art, But J. Constructions, may Long H. ... Chen -A Date: 2014.91.10 1 2014.91.10 1 209-02 -05 00 for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number: K133604

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Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).