EBI ACUMEN SURGICAL NAVIGATION SYSTEM by EBI, L.P.

The EBI® Acumen™ Surgical Navigation System is intended to assist the surgeon in accurately locating anatomical structures during open or percutaneous orthopedic surgical procedures. The EBI® Acumen™ Surgical Navigation System is indicated for use in spine 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.

Device Description

The EBI® Acumen Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-Kat, Inc., Hollywood, FL.
Passive markers(spheres) are attached onto the Acumen instrumentation. An infrared light source generated by the camera refects off 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. They will be rigidly connected to the instrumentation utilized in the surgical procedure and 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 in spine and trauma procedures and are designed as single use components.

AI/ML Overview

The provided text describes the EBI® Acumen Surgical Navigation System, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics.

The document primarily focuses on establishing substantial equivalence for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device. This is often demonstrated by showing similar technological characteristics and intended use, rather than presenting a performance study against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document states "Software verification and validation was performed to establish substantial equivalence," but it does not detail the specific performance criteria or the results of these validation activities.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method: Not mentioned.
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: This is a surgical navigation system, not an AI-assisted diagnostic tool. An MRMC study is not applicable, and no such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a surgical navigation system, inherently designed for human-in-the-loop use. Standalone performance as an "algorithm only" is not relevant or described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The document asserts that "Software verification and validation was performed to establish substantial equivalence to the predicate systems." This implies that some testing was conducted to ensure the software's functionality and safety. However, the details of what specific performance "acceptance criteria" were used (e.g., accuracy in locating anatomical structures within a certain tolerance) and the results of meeting those criteria are not disclosed in this 510(k) summary. The FDA's letter of clearance confirms that the device was deemed "substantially equivalent" to predicate devices, allowing it to be marketed, but this regulatory decision is based on the comparison to existing devices rather than a direct presentation of performance against novel acceptance criteria.

Summary

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OCT 1 5 2003

K03/732

510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness for the EBI® Acumen Surgical Navigation System is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

EBI, L.P. Contact Person: Jon Caparotta 1. Submitter: 100 Interpace Parkway Tel: (973) 299-9300,x3964 Parsippany. NJ 07054
Date prepared: 8/18/03
1. Proprietary Name: EBI® Acumen Surgical Navigation System Common Name: Instrumentation, Stereotaxic Classification Name: Stereotaxic Instrument (21CFR 882.4560)
1. Predicate or legally marketed* devices that are substantially equivalent:

Voyager Linux	(K023975)
FluroLab Plus	(K013025)
Z-Box	(K030764)

1. Description of the device: The EBI® Acumen Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-Kat, Inc., Hollywood, FL.
  Passive markers(spheres) are attached onto the Acumen instrumentation. An infrared light source generated by the camera refects off 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. They will be rigidly connected to the instrumentation utilized in the surgical procedure and 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 in spine and trauma procedures and are designed as single use components.

1. Intended Use: The EBI Acumen™ Surgical Navigation System is intended to assist the surgeon in accurately locating anatomical structures during open or percutaneous orthopedic surgical procedures. The EBI Acumen" System is indicated for use in spine and trauma procedures, in which the use of stereotactic 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.
1. Materials: The instruments are manufactured from: ABS Thermoplastic Polymer (Acrylonitrile Butadiene Styrene), Stainless Steel, Aluminum Alloy, Dupont Hytrel #5526 Natural, Loctite, Rigid PVC Clear Film, Reflective Material - Silver Transfer Film, 410 or 420 Stainless Steel.

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1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the EBI® Acumen Surgical Navigation System and other Systems currently on the market. It is substantially equivalent* to the predicate device(s) in technological characteristics and intended use. Software verification and validation was performed to establish substantial equivalence to the predicate systems.
  *Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with three lines representing the body and head. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.

Public Health Service

OCT 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K031732

Trade/Device Name: EBI Acumen™ Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 20, 2003 Received: August 21, 2003

Dear Mr. Caparotta:

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 reguirements 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 - Mr. Jon Caparotta, RAC

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 vours.

Mark A. Melkus

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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Statement of Indications for Use

Page_1_of_

Ko31732 510(k) Number (if known):

Device Name: EBI® Acumen™ Surgical Navigation System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

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

for Mark N Mellem

neral, Restorative d Neurological Devices

510(k) Number K031732

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).