The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surgical knee and hip procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures, can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). These procedures include, but are not limited to, knee and hip arthroplasty procedures.

Device Description

The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).

Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of the passive markers to allow their position and orientation to be identified. The Acumen™ instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.

All Acumen™ instruments will have a minimum of three (3) passive markers to be tracked by the camera system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, will have a defined geometry of the passive marker position for a unique identification by the camera and software system.

The instruments can be utilized with knee and hip applications. The Acumen™ instruments are designed as one-time use components.

AI/ML Overview

The Acumen™ Surgical Navigation System is a Class II device (21 CFR 882.4560, Stereotaxic Instrument) indicated for use in surgical knee and hip procedures where stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). This includes, but is not limited to, knee and hip arthroplasty procedures.

No clinical testing was used to establish substantial equivalence for this device. Instead, substantial equivalence was established through software verification and validation. Therefore, the information typically associated with acceptance criteria from clinical studies is not available in the provided document.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical testing was performed and substantial equivalence was based on software verification and validation, there are no specific performance criteria or reported device performance metrics in the document that would typically be found in a clinical study for diagnostic accuracy or effectiveness.

Acceptance Criteria	Reported Device Performance
Not specified as clinical testing was not conducted to establish substantial equivalence. Instead, software verification and validation were performed.	Not applicable, as no clinical performance data are presented in this 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set data is reported as clinical testing was not used to establish substantial equivalence. Software verification and validation would have internal test sets, but details are not provided in this regulatory summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for clinical performance was not established as no clinical testing was performed to establish substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical testing or MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

While the device's function is an algorithm-driven navigation system, no standalone performance evaluation in a clinical or simulated clinical setting is described in this document. Substantial equivalence was based on software verification and validation, but the details of this testing (e.g., specific metrics, test cases) are not provided.

7. Type of Ground Truth Used

For the software verification and validation, the ground truth would likely refer to expected and validated software behaviors, calculations, and system outputs. However, the exact nature of this "ground truth" (e.g., established engineering specifications, mathematical models, simulated inputs with known correct outputs) is not detailed in the provided document. Clinical ground truth (e.g., pathology, outcomes data) was not used.

8. Sample Size for the Training Set

Not applicable. If machine learning was used, details of the training set are not provided. The document focuses on software verification and validation, not on a machine learning-based development paradigm where a distinct training set would typically be described.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no clinical training set is mentioned, the method for establishing its ground truth is not relevant here.

Summary

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K031454
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JUL - 8 2004

Image /page/0/Picture/2 description: The image shows the logo for BIOMET INC. The logo is in black and white and features a stylized font. The letters are bold and blocky, with a unique design for each letter. The word "INC" is smaller and placed to the right of the main word.

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Kristine C. (Kacy) Arnold, RN. MBATelephone: (574) 267-6639Fax: (574) 372-1683
Proprietary Name:	Acumen™ Surgical Navigation System
Common Name:	Instrument, Stereotaxic
Classification Name:	Stereotaxic Instrument (21 CFR 882.4560)
Device Classification:	Class II
Legally MarketedDevices to WhichSubstantial Equivalenceis claimed:	Voyager™ Linux (K023975)FluroLab® Plus (K013025)

Device Description: The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).

The instruments can be utilized with knee and hip applications. The Acumen™ instruments are designed as one-time use components.

Intended Use: The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surgical knee and hip procedures, in which the use of stereotaxic surqery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to fluoroscopy (hip procedures) or an imageless model of the anatomy (knee procedures). These procedures include, but are not limited to, knee and hip arthroplasty procedures.

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K031454
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Summary of Technologies: The Acumen™ Surgical Navigation System's technological characteristics are similar to or identical to the predicate devices.

Non-Clinical Testing: Software verification and validation was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

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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 and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2004

Ms. Kristine C. Arnold, RN, MBA Regulatory Affairs Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K031454

Trade/Device Name: Acumen™ Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Arnold:

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 - Ms. Kristine C. Arnold, RN, MBA

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,

Miriane C. Provost

Celia M. Witten, 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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Indications for Use

510 (k) Number (if known) :

Device Name: Acumen™ Surgical Navigation System

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE) Provos William, I

Division Sign-Off Division of General. Restorative. and Neurological Devices

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510(k) Number K031454

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).