The TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation: The SpineAssist™ System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. The SpineAssist™ System may be used in either open or percutaneous procedures.

The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly in orthopedic applications.

Device Description

The TenZing system is a device modification of the SpineAssist system, designed to incorporate both the original SpineAssist system and the C-InSight system in one workstation. The TenZing console is identical to the SpineAssist console. The system is intended to be used in a variety of hospital locations (e.g., OR, trauma unit, etc.). The main components of the TenZing System include:

A. Workstation

B. SpineAssist accessories:

Surgical Accessories Kit .

Setup Kit .

C. SpineAssist Device

D. C-InSight accessories:

Spine Target Kit .

Extremities Target Kit .

E. Image Adaptor

F. Spine Assist Disposable kits

G. C-InSight Sterile Sheath Disposable kits

AI/ML Overview

Here's an analysis of the provided text regarding the TenZing System's acceptance criteria and studies, organized by your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K102130) does not explicitly state specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) for the Tenzing System. It focuses on demonstrating substantial equivalence to predicate devices and software validation rather than specific performance metrics against pre-defined criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document. The document states:

"There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the TenZing device." (Section 7)
"The TenZing System software was subject to software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002)." (Section 8)
"The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the TenZing device are substantially equivalent to the predicate device cited above." (Section 9)

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

The document does not provide details on sample sizes for test sets used in performance evaluation, nor does it specify the provenance (country of origin, retrospective/prospective) of data used for any testing. The testing described is "software validation testing," which typically involves internal verification and validation against requirements rather than clinical performance testing with patient data detailed in this type of submission.

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

This information is not provided in the document. Software validation testing usually involves internal testing teams and engineers, not external clinical experts for ground truth establishment in the way described for AI/diagnostic devices.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The TenZing System is a surgical navigation and 3D imaging system, not a diagnostic AI system intended to improve human reader performance in interpreting images. Its purpose is to guide surgeons and provide 3D imagery from 2D fluoroscopy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "software validation testing" (Section 8). This constitutes a form of standalone testing of the algorithm and software components against their specifications and functional requirements. However, specific performance metrics (e.g., accuracy of 3D reconstruction, precision of navigation guidance) from such standalone testing are not detailed in this submission. The "substantial equivalence" argument (Section 9) implies that its standalone performance characteristic is comparable to its predicates.

7. The Type of Ground Truth Used

For the "software validation testing," the ground truth would typically be defined by the system's functional and technical specifications, and the accuracy of its outputs (e.g., 3D reconstruction from 2D, positioning accuracy) would be verified against known inputs and expected computations. It is not based on expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. The Sample Size for the Training Set

The document does not mention a training set, as the TenZing System is not described as an AI/machine learning device that requires a training set in the conventional sense. It's a system that combines existing technologies (SpineAssist, C-InSight) and associated software.

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

As no training set is mentioned or implied for an AI/ML model, this information is not applicable and therefore not provided.

Summary of Device and Approval Context:

The TenZing System (K102130) is a combination device integrating features of two previously cleared Mazor Surgical Technologies systems: SpineAssist (K073467) and C-InSight (K081672). It acts as a workstation to run both applications.

SpineAssist: Indicated for precise positioning of surgical instruments or implants during general spinal surgery (open or percutaneous procedures).
C-InSight: Provides processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D images, for high contrast objects in orthopedic applications.

The approval is based on substantial equivalence to these predicate devices. The primary performance testing mentioned is software validation to FDA guidance. This type of 510(k) submission generally relies on demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed predicates, rather than presenting novel clinical performance data or extensive studies like those required for de novo AI devices.

Summary

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SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

(102/30

Israel

AUG 26 2010

(Premarket Notification [510(k)] Number)

Submitter Information 1.

Manufacturer Name & Address
Mazor Surgical Technologies Ltd.
7 HaEshel Str.
P.O.B. 3104
Southern Caesarea Industrial Park, 38900
ISRAEL

Official Correspondent Ahava Stein A. Stein - Regulatory Affairs Consulting 20 Hata'as St. Kfar Saba 44425

Date Prepare: July 2010
Device Name

Proprietary Name:	TenZing System
Common / Usual Name:	Combination of:1. Spinal Stereotaxic instrument; and2. 3-D Reconstruction Tool for Mobile X-Ray Devices
FDA Classification Name:	1. 21 CFR 882.4560; Stereotaxic instrument with product code HAW.2. 21 CFR 892.2050; System, image Processing, Radiological and product code LLZ.
FDA Classification:	Class II, Product Code HAW and LLZ

. 4. Predicate Devices

The TenZing System is substantially equivalent to the following devices

Manufacturer	Device	510(k)	Date Cleared
Mazor Surgical Technologies	SpineAssist	K073467	05/23/2008
Mazor Surgical Technologies	C-InSight	K081672	08/15/2008

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ട. Device Description

A. Workstation

B. SpineAssist accessories:

Surgical Accessories Kit .

Setup Kit .

C. SpineAssist Device

D. C-InSight accessories:

Spine Target Kit .

Extremities Target Kit .

E. Image Adaptor

F. Spine Assist Disposable kits

G. C-InSight Sterile Sheath Disposable kits

6. Intended Use / Indications

470

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7. Performance Standards

There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the TenZing device.

8. Performance Testing

The TenZing System software was subject to software validation testing in accordance with the FDA Guidance for the Premarket Submissions for Software Contained in Medical Devices (January 11, 2002).

9. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the TenZing device are substantially equivalent to the predicate device cited above.

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Image /page/3/Picture/0 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The logo is a stylized image of an eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mazor Surgical Technologies. Ltd. % Ms. Ahava Stein Consultant A. Stein-Regulatory Affairs Consulting 20 Hata'as*St. (POB 124) Kafr Saba, 44425 ISRAEL

Re: K102130

AUG 2 6 2010

Trade/Device Name: TenZing System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: July 27, 2010 Received: July 29, 2010

Dear Ms. 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premyaket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K102130

Indications for Use

510(k) Number (if known): K102130

Device Name: TenZing System

Indications for Use:

The TenZing System is a combination of the SpineAssist System and C-InSight System, allowing the C-InSight application to run on the SpineAssist Workstation:

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

The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image.

It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects, particularly for orthopedic applications.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

hddo'sh
(Division Sign-Off)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

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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).