The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

Device Description

The SpineAssist™ system is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist™ is designed to assist surgeons in precisely guiding handheld surgical tools or implants in line with a computerized, image-based pre-operative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist device, which positions its articulating arm and tool guide. Using a special bone attachment component (i.e., a clamp and bridge or the Hover-T bridge) the SpineAssist device attaches to the bone in the area where the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools or implants according to the computerized, image-based, preoperative plan.

The main components of the SpineAssist™ system include:

A. SpineAssist™ device
B. Workstation
A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt (e.g., specific quantitative benchmarks for acceptance, detailed performance metrics with numerical results, sample sizes for test and training sets, expert qualifications, or adjudication methods).

However, based on the summary of non-clinical performance data and conclusions, I can infer the general acceptance criteria and report the mentioned performance.

Here's an analysis of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly suggests that the system's performance for "accuracy" and "safety and effectiveness" during "general spinal surgical procedures" were the key criteria.

Acceptance Criteria (Inferred)	Reported Device Performance
Safe and Effective for general spinal surgical procedures	Performance tests demonstrate that SpineAssist system may be safely and effectively used in general spinal surgical procedures.
Meets design and performance specifications	Software validation and accuracy performance tests demonstrate that the SpineAssist system meets its design and performance specifications.
Substantial Equivalence to predicate devices (original SpineAssist™ and StealthStation System)	The system is found to be substantially equivalent to the predicate devices.
Compliance with relevant standards	Complies with IEC 60601-1-4 (Software Validation) and ISO 10993 (Biocompatibility Testing).
Demonstrates "precision" in guiding instruments/implants	Indicated for "precise positioning of surgical instruments or implants."
Accuracy in new imaging scenarios	"New Imaging and Lateral to 30 degree Accuracy Test" completed.
Accuracy with Hover-T and Prisms	"Hover-T Accuracy Test Results Report" and "Use of Prisms in Translaminar Facet Cases Study" completed.

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

The document mentions "non-clinical performance data" and lists several "case studies" and "accuracy tests." It does not specify the sample size (e.g., number of cases, number of measurements) for any of these tests.

The data provenance is not explicitly stated. However, given the nature of "non-clinical performance data" for a surgical device involving "accuracy tests" and "case studies," it is highly likely that these were conducted in a controlled laboratory or cadaveric setting, rather than on human patients (since "Clinical Performance Data" is marked as "Not Applicable"). It is likely prospective for the specific tests conducted for this submission. The company is based in Israel, so the studies were likely conducted there or in a partnered facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the "accuracy tests" or "case studies."

4. Adjudication Method for the Test Set

The document does not provide any information regarding adjudication methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this summary. The device is a surgical navigation system, not an AI diagnostic tool that assists human readers in interpreting medical images. "Clinical Performance Data" is explicitly stated as "Not Applicable," further reinforcing that human reader studies are outside the scope of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the "Non-Clinical Performance Data" listed are all standalone algorithm/system performance tests. The device itself is designed to guide surgical tools based on algorithmic processing of imaging data, and the tests like "General Spinal Accuracy Test," "Hover-T Accuracy Test," and "New Imaging and Lateral to 30 degree Accuracy Test" directly assess the system's performance in this standalone capacity. The lack of "Clinical Performance Data" and MRMC studies further supports that the reported performance reflects the algorithm/system without human-in-the-loop performance for this specific submission.

7. The Type of Ground Truth Used

While not explicitly stated, for "accuracy tests" in a surgical navigation system, the ground truth would typically be established by:

Precise measurements using highly accurate calibration tools or coordinate measuring machines in a controlled environment (e.g., phantom, cadaveric models).
Known physical dimensions or fiducial markers on phantoms or cadavers which the system is attempting to target or guide to.
For "case studies" (e.g., Osteoid Osteoma, Thoracic Hover-T), the "ground truth" might refer to the actual anatomical position or intended trajectory as confirmed by intra-operative imaging or post-operative assessment against the surgical plan.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set.

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

The document does not provide any information regarding how the ground truth for the training set was established.

Summary

{0}------------------------------------------------

SECTION 5 -510(K) SUMMARY OF SAFETY & EFFECTIVENESS

SPINEASSIST™ SYSTEM

510(k) Number K063607

AUG 2 3 2007

Applicant's Name:

Company name:	Mazor Surgical Technologies Ltd.
Address:	7 HaEshel Str.
	P.O.B. 3104
	Southern Caesarea Industrial Park 38900
	ISRAEL
Tel.:	+972-4-6270171
Fax:	+972-4-6377234
e-mail:	armin@mazorst.com

Contact Person:

Official Correspondent:	Ahava Stein
Company name:	A. Stein - Regulatory Affairs Consulting
Address:	Beit Hapaamon (Suite 213)
Address:	20 Hata'as Str. (Box 124)
Address:	Kfar Saba 44425
Address:	ISRAEL
Tel:	+ 972-9-7670002
Fax:	+972-9-7668534
e-mail:	asteinra@netvision.net.il

Name of the device:

SpineAssist™ System

Trade or proprietary name, if applicable:

SpineAssist™ System

Common or usual name:

Surgical Navigation System / Image Guided Surgery

Establishment Registration No.:

3005075696

Classification Name:

Stereotactic Instrument

{1}------------------------------------------------

Classification:

FDA has classified Stereotactic devices as a Class II medical device, with product code HAW and 21 CFR classification code 882.4560. Review by the General & Plastic Surgery Devices Panel.

Predicate Device:

The SpineAssist™ system is substantially equivalent to the original SpineAssist™ system (manufactured by Mazor Surgical Technologies Ltd., and the subject of 510(k) document no. K033413 and K051676) and the StealthStation System (manufactured by Medtronic and the subject of 510(k) document nos. K954276 to K050438). A comparison table and detailed discussion are presented in Section 12 of this application.

Device Description:

The main components of the SpineAssist™ system include:

A. SpineAssist™ device
B. Workstation
A. Accessories including clamp, bridge, Hover-T bridge, targets, prism, wedge, etc.

Intended Use / Indication for Use:

Comparison of Technological Characteristics with the predicate device:

The modified SpineAssist system is identical to the original SpineAssist system regarding all components, design, materials, basic scientific technology, etc. The only differences are that the "modified" device is intended for general spinal surgery and a software change enabling a quicker and easier registration process using two fluoroscopy images instead of four and one target instead of two. The SpineAssist also includes some new accessories, including the wedge and prism for accessing extreme angles or trajectories, additional sterile sheaths to

{2}------------------------------------------------

cover the C-arm and X-ray shield and a few other minor accessories that are described later in this submission.

Non-Clinical Performance Data

The following performance tests were conducted on the SpineAssist™ system:

1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
1. Biocompatibility Testing (ISO 10993)
1. Osteoid Osteoma Case Study
1. Thoracic Hover-T Case Study
1. General Spinal Accuracy Test
1. New Imaging and Lateral to 30 degree Accuracy Test
1. Use of Prisms in Translaminar Facet Cases Study
1. Hover-T Accuracy Test Results Report
1. Hover-T Stability Test Results Report
1. Vertebroplasty Summary Report

Clinical Performance Data

Not Applicable

Conclusions Drawn from Non-Clinical and Clinical Tests:

The performance tests demonstrate that SpineAssist system may be safely and effectively used in general spinal surgical procedures requiring precise positioning of surgical instruments or implants during open or percutaneous thoracic and lumbar spinal surgery. The software validation and accuracy performance tests demonstrate that the SpineAssist system meets its design and performance specifications and is substantially equivalent to the previously cleared SpineAssist system.

Substantial Equivalence:

In summary, the intended use of the modified SpineAssist™ system is substantially equivalent to a combination of the original SpineAssist™ system and the StealthStation device, Furthermore, the basic technological characteristics of the modified SpineAssist™ system are identical to the original SpineAssist™ system, except for the minor software changes enabling an easier registration process using only one target. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the SpineAssist™ system is substantially equivalent to the original SpineAssist™ system and the StealthStation device.

Performance Standards:

The SpineAssist™ system complies with the voluntary recognized standards:

1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
1. Biocompatibility Testing (ISO 10993)

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mazor Surgical Technologies Ltd. % A. Stein Regulatory Affairs Consulting Ahava Stein 20 Hata'as Str. Kfar Saba Israel 44425

AUG 2 3 2007

Re: K063607

Trade/Device Name: SpineAssist™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 2, 2007 Received: August 8, 2007

Dear Ahava Stein:

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.

{4}------------------------------------------------

Page 2 - Ahava Stein -

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K063607

Device Name:

SpineAssist™ System

Indications for use:

The SpineAssist™ system is indicated for precise positioning of surgical instruments or implants during thoracic and lumbar spinal surgery. The SpineAssist™ system may be used in either open or percutaneous procedures.

Prescription Use V (Per 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use (Optional Format Subpart C)

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

Concur(Division Sign Off) of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K063607

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).