The Acumen ™ Surgical Navigation System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The Acumen ™ Surgical Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as-

Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
Orthopedic surgical procedures .

Device Description

The Acumen ™ Surgical Navigation System described in this notification consists of the same following components as the previously cleared Z Box System by Z Kat :

High Resolution color liquid crystal display (LCD) touch screen .
Uninterruptible Power Supply (UPS) .
Central Processing Unit (CPU) ●
Isolation Transformer .
Keyboard and Mouse .
Optical Detector (on wheeled-base pedestal) .
Operating Room Cart .
Tool and accessories surgical tools and accessories . instrumented with LED or reflective markers
dMIS kit- surgical instrument lit containing IGS tools and . accessories and dMIS key
dMIS key- electronic storage media containing disposable . software application

AI/ML Overview

This 510(k) submission (K051724) for the Acumen™ Surgical Navigation System is a "duplicate 510(k)" due to a transfer of ownership of the technology from Z-Kat, Inc. to EBI, L.P. The submission explicitly states that the Acumen™ system is identical to the previously FDA-cleared Z-Box system (K030764) in terms of intended use, indications for use (with minor exclusions), technological characteristics, and principles of operation/software applications.

Therefore, the "study that proves the device meets the acceptance criteria" refers to the performance data and acceptance criteria established and met for the original Z-Box system (K030764), as no new performance studies are presented in K051724. Without access to the original K030764 submission, a detailed table and comprehensive answers to all questions directly from K051724 are not possible. However, based on the information provided in K051724, we can infer the following:

1. A table of acceptance criteria and the reported device performance

Since this is a duplicate 510(k) for a transfer of ownership, new acceptance criteria and performance data are not typically presented or required. The acceptance criteria and reported device performance would have been established and reviewed during the clearance of the predicate device, Z-Box (K030764).

Based on the nature of a surgical navigation system, typical acceptance criteria would likely relate to accuracy, precision, and usability. Without the K030764 document, specific numerical values cannot be provided.

Acceptance Criteria (Inferred from general surgical navigation system requirements)	Reported Device Performance (From K030764, not explicitly stated in K051724)
Accuracy of navigation (e.g., target registration error, fiducial registration error)	Presumed to meet established accuracy thresholds for surgical navigation, as cleared under K030764.
Precision/Repeatability of tracking	Presumed to demonstrate consistent and repeatable tracking, as cleared under K030764.
Usability/Workflow efficiency	Presumed to have demonstrated acceptable usability for its intended surgical procedures, as cleared under K030764.
Safety (e.g., electrical safety, electromagnetic compatibility, software validation)	Presumed to meet all applicable safety standards, as cleared under K030764.

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

No new test set data is mentioned for K051724. The sample size and data provenance for the test set would have been part of the K030764 submission.

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

Not applicable to K051724, as no new ground truth establishment is described. This information would have been part of the K030764 submission.

4. Adjudication method for the test set

Not applicable to K051724, as no new test set adjudication is described. This information would have been part of the K030764 submission.

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. Surgical navigation systems are generally not assessed through MRMC comparative effectiveness studies involving "human readers" in the same way imaging AI is. Their effectiveness is typically evaluated through accuracy and precision metrics in simulated or cadaveric trials, and then confirmed through clinical use. No such study is mentioned in K051724.

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

This concept doesn't directly apply to a surgical navigation system in the same way it does to an AI diagnostic algorithm. A surgical navigation system "assists the physician" and provides "orientation and reference information during intra-operative procedures." Its performance is inherently tied to being used by a human surgeon. The "standalone" performance for such a device would relate to its technical specifications like tracking accuracy and precision, which would have been evaluated during the clearance of the predicate device (K030764).

7. The type of ground truth used

For a surgical navigation system, ground truth would typically involve:

Physical measurements/phantom models: Highly precise measurements of actual positions and orientations using metrology equipment.
Cadaveric studies: Comparison of navigated tool positions against anatomical landmarks identified by physical dissection or high-resolution imaging.
Clinical outcomes (less commonly the primary ground truth for initial clearance): While clinical outcomes are important for overall effectiveness, the technical ground truth for navigation accuracy usually precedes widespread clinical use for initial clearance.

This information would have been detailed in the K030764 submission.

8. The sample size for the training set

Surgical navigation systems, especially of this era (2005), often rely on well-established geometric principles, image processing, and tracking algorithms rather than deep learning models that require large training sets of labeled data. Therefore, the concept of a "training set" in the context of machine learning's supervised learning might not be directly applicable or extensive in the same way it is for modern AI diagnostic tools. If any training was involved (e.g., for certain image registration algorithms), the sample size would have been detailed in K030764.

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

As with point 8, the relevance of a "training set" in the modern AI sense is likely limited. If components of the system involved optimization or parameter tuning, the "ground truth" for these processes would have been established through methods relevant to the specific algorithms, such as:

Simulated data: Known transformations or image distortions.
Expert-defined parameters: Calibration using known physical objects.

This information would have been part of the K030764 submission.

In summary, K051724 is a re-submission due to ownership transfer and explicitly states identity to the predicate device (Z-Box, K030764). Therefore, all performance studies, acceptance criteria, and related methodological details refer to the K030764 submission, which is not provided here.

Summary

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KOS 1724

510 (K) SUMMARY

JUL 1 9 2005

SUBMITTER: EBI, L.P.

100 Interpace Parkway ADDRESS: Parsippany, NJ 07054

PHONE NUMBER: 973-299-9300

FAX NUMBER: 973-257-0232

CONTACT PERSON: Whitney Törning

DATE PREPARED: June 24 2005

TRADE NAME: The Acumen ™ Surgical Navigation System

COMMON NAME: Stereotaxic Instrument

CLASSIFICATION NAME: Stereotaxic Instrument

CLASSIFICATION #: Class II

SUBSTANTIAL EQUIVALENCE CLAIMED TO: Z-Box; Z-Kat, Inc. K030764

PURPOSE OF PREMARKET NOTIFICATION:

The Acumen™ Surgical Navigation System is identical to the previously FDA cleared Z Kat Inc., Z-Box system which was cleared by FDA (K030764). EBI is submitting this 510(k) notice as a "duplicate 510(k)" due to a transfer of ownership of the technology.

DEVICE DESCRIPTION/SOFTWARE APPLICATIONS:

The Acumen ™ Surgical Navigation System has the same intended use and indications for use as stated in the Z-Box 510(k) notice except that EBI does not indicate use in intra-cranial surgical procedures involving space occupying lesions or malfunctions (including soft tissue, vascular and osseous) or for ENT procedures.

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K051724

Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
Orthopedic surgical procedures .

Technological Characteristics

The technical characteristics of the Acumen ™ Surgical Navigation System are the same as stated in the Z-Box 510(k) notice. The Acumen described in this notification consists of the same following components as the previously cleared Z Box System by Z Kat :

High Resolution color liquid crystal display (LCD) touch screen .
Uninterruptible Power Supply (UPS) .
Central Processing Unit (CPU) ●
Isolation Transformer .
Keyboard and Mouse .
Optical Detector (on wheeled-base pedestal) .
Operating Room Cart .
Tool and accessories surgical tools and accessories . instrumented with LED or reflective markers
dMIS kit- surgical instrument lit containing IGS tools and . accessories and dMIS key
dMIS key- electronic storage media containing disposable . software application

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KOSITZY

Principles of Operation/Software Applications

The Acumen ™ Surgical Navigation System principles of operation are the same as stated in the Z-Box 510(k) notice (K030764).

The Acumen ™ Surgical Navigation System described in this I he flouinen - - Stis of the same following software components as the previously cleared Z-Box System by Z-Kat:

Software application .
Linux operating system .
Software drivers for video grabber, standard computer . components (keyboard, mouse, monitor, etc.)

SUBSTANTIAL EQUIVALENCE

The Acumen ™ Surgical Navigation System is substantially equivalent to the Z Box System by Z-Kat . The Acumen ™ Surgical Navigation System has the same intended use and indications, technological characteristics, and principles of operation and software applications as the previously cleared Z-Box System. The only difference is that EBI does not indicate use in intra cranial surgical procedures involving space occupying lesions or malfunctions procedures oft tissue, vascular and osseous) or for ENT procedures. This difference does not present any new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, often interpreted as representing people or waves, which is the main symbol of the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2005

Ms. Whitney Törning Manager of Regulatory Affairs EBI, L.P. 100 Interpace Road Parsippany, New Jersey 07054

Re: K051724

Koorrez+
Trade/Device Name: Acumen™ Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 23, 2005 Received: June 27, 2005

Dear Ms. Törning:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and nave decemined are are are are are and one marketed in interstate for use stated in the encrosule) to regally manated provice Americal Device Americal Society of Cool. Drug commerce provide to May 20, 1970, the enatinent with the provisions of the Federal Food. Drug, devices that have been recuired in acceraaned was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosment Act (Act) that do not require approvial controls provisions of the Act. The Act. The Y ou may, therefore, market the device, basjon to the ments for annual registration, listing of general controls provisions of the rise 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 If your device is classified (socure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Extrems, and to 898. In addition, FDA may be found in the Ood of Peacher.
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 Please be advised that FDA s issuation of a building with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal stations of the of any Pederal Statutes and regulations damindiered of not limited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTK Part 807), fabeling (21 CFR Part 800), government 820), and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 1000, 1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Whitney Törning

This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to oegin manxeting of substantial equivalence of your device to a legally premarket nothication. The PDA mumg of backanded of .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 1 : .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acc (240) 276-0115. Also, please note the regulation entitled, p Conlact the Office of Complance at (216) 216 at 807.97). You may obtain "Misbranding by Telefone to premainterions in this in the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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 Statement

KOS 1724 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Acumen ™ Surgical Navigation System

The Acumen ™ Surgical Navigation System is intended for use as a device which I he Houten - - Bargecof the patient acquired specifically to assist the physician uses uraguous infage in agains and to provide orientation and reference information during intra-operative procedures.

The Acumen ™ Surgical Navigation System is indicated for any medical condition I he health - - Dargiour and surgery may be considered to be safe and effective, In where a reference to a rigid anatomical structure may be made, such as-

Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
Orthopedic surgical procedures .

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

(Division Sign-Off) (Division of General, Restorative Divisionrological Devices

510(K) Number Ko 51724

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).