ACUMEN SURGICAL NAVIGATION SYSTEM by BIOMET, INC.

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™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive 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 trauma applications. The Acumen™ instruments are designed as one-time use components.

AI/ML Overview

This FDA 510(k) summary for the Acumen™ Surgical Navigation System indicates that no clinical testing was performed to establish substantial equivalence. Therefore, there is no study provided within this document that demonstrates the device meets specific acceptance criteria based on clinical performance.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing, specifically software verification and validation.

Here's the breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed and no specific performance metrics with acceptance criteria are listed for the non-clinical testing, this table cannot be populated from the provided text. The document only states that "Software verification and validation was performed to establish substantial equivalence to the predicate devices." This implies that the acceptance criteria for software verification and validation were met, but these criteria are not detailed (e.g., accuracy tolerances, latency, reliability metrics).

Acceptance Criteria	Reported Device Performance
Not specified	"Software verification and validation was performed to establish substantial equivalence to the predicate devices."

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

Test Set Size: Not applicable as no clinical test set was used.
Data Provenance: Not applicable as no clinical data was used.

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

Number of Experts: Not applicable as no clinical test set requiring expert ground truth was used.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable as no clinical test set was used.

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:

MRMC Study: No. The document explicitly states "Clinical testing was not used to establish substantial equivalence." This type of study would fall under clinical testing.
Effect Size: Not applicable.

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

Standalone Performance Study: No. While the device is a navigation system that uses software, a standalone performance study in the context of clinical outcomes (e.g., surgical accuracy based on the algorithm's output alone) was not done. The "software verification and validation" addresses the functional correctness of the algorithm but not its clinical performance as a standalone tool.

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

Ground Truth Type: Not applicable for clinical performance. For the software verification and validation, the ground truth would typically be the expected functional behavior and output defined by the software requirements and design specifications.

8. The sample size for the training set:

Training Set Size: Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense for learning from data. The software described is an established navigation system using defined geometries and calculations for tracking.

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

Ground Truth Establishment: Not applicable as no training set was used.

In summary:

The provided document relies entirely on non-clinical software verification and validation to establish substantial equivalence for the Acumen™ Surgical Navigation System. It explicitly states that no clinical testing was performed. Therefore, information regarding acceptance criteria derived from clinical studies, expert-adjudicated ground truth, or study methodologies for clinical performance is not available in this document.

Summary

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Image /page/0/Figure/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The word "INC" is written in a smaller font size and is located below and to the right of the word "BIOMET". The letters "INC" are also outlined in black, with the interior of the letters being white.

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)Flurelab 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 trauma 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™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy.

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These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

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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Public Health Service

SEP 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine C. Arnold, RN, MBA Regulator Affairs Specialist Biomet, Inc. 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K031337

Trade/Device Name: Acumen™ Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 10, 2003 Received: July 14, 2003

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,

Muriam 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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510 (k) Number (if known) : _ | < 0 3 / 3 3 1

Device Name: Acumen™ Surgical Navigation Systems

Indications for 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 surqical knee and trauma procedures, in which the use of stereotaxic surqery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

Miriam C. Provost

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

510(k) Number K63/337

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

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).