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.

Device Description

C-InSight is a software based product, which converts a sequence of Two-dimensional fluoroscopy images into a 3D volume, intraoperatively. The C-InSight is an add-on to commercially available mobile x-ray systems.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the C-InSight System, based on the provided text:

Key Takeaways Before Diving In:

This device, the C-InSight System, is a software-based product that converts 2D fluoroscopy images into 3D volumes intraoperatively.
No clinical performance data (human studies) are provided or stated as applicable. The evaluation relies entirely on non-clinical performance tests.
The primary purpose of these tests is to establish substantial equivalence to predicate devices.
The acceptance criteria are implicitly tied to meeting design and performance specifications as demonstrated by a series of non-clinical tests.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical performance tests conducted and then concludes that these tests demonstrate the system "meets its design and performance specifications."

Implicit Acceptance Criteria and Reported Performance (Derived from the text):

Acceptance Criteria Category	Specific Test/Goal	Reported Performance
Software Validation	Compliance with IEC 60601-1-4 & FDA Guidelines	"Software validation...demonstrate that the C-InSight system meets its design and performance specifications."
Accuracy (Synthetic)	C-InSight synthetic accuracy test	"Accuracy performance tests demonstrate that the C-InSight system meets its design and performance specifications."
Accuracy (Spine)	C-InSight spine accuracy test	"Accuracy performance tests demonstrate that the C-InSight system meets its design and performance specifications."
Accuracy vs. CT	C-InSight accuracy vs. CT (cadaver tests)	"Accuracy performance tests demonstrate that the C-InSight system meets its design and performance specifications."
Image Quality	Image Quality test	(No specific quantitative metric provided beyond "meets specifications")
Radiation Dose Exposure	Radiation Dose Exposure test	(No specific quantitative metric provided beyond "meets specifications")
Safety & Effectiveness	Overall performance demonstration	"C-InSight system may be safely and effectively used in surgical operation rooms..."
Substantial Equivalence	Comparison to Siremobil Iso-C 3D and O-Arm software	"Substantially equivalent to the previously cleared systems." "Technological differences do not raise new questions of safety and effectiveness."

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." For the "C-InSight accuracy vs. CT (cadaver tests)," the sample size would refer to the number of cadavers used, but this number is not provided. For synthetic and spine accuracy tests, the "sample size" would likely refer to the number of simulated or phantom test runs, which is also not specified.
- Data Provenance:
  - Country of Origin: Not specified in the provided text.
  - Retrospective or Prospective: Not applicable, as no human clinical data was used. The tests seem to be controlled, laboratory-based non-clinical assessments.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable (N/A). The document describes non-clinical tests, not human-read clinical studies requiring expert ground truth establishment for a diagnostic output. For accuracy tests (synthetic, spine, cadaver vs. CT), "ground truth" would likely be established by known physical parameters of the phantom/cadaver or high-resolution CT scans, not human expert consensus on images generated by the C-InSight system.
Adjudication Method for the Test Set:
- Not applicable (N/A). No human readers are performing diagnoses or evaluations of the device output that would require adjudication. The accuracy tests likely compare the C-InSight's 3D reconstructions against known physical measurements or higher-resolution imaging (like CT).
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:
- No. The document explicitly states "Clinical Performance Data: Not Applicable." Therefore, no MRMC study involving human readers was conducted or reported.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this appears to be the primary focus of the performance evaluation. The "Non-Clinical Performance Data" section describes tests of the C-InSight system's intrinsic capabilities (e.g., accuracy, image quality, software validation) as a standalone software product. The device is a "3-D Reconstruction Tool," and its performance is evaluated based on how well it generates these reconstructions.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For the accuracy tests (synthetic, spine, cadaver vs. CT): The ground truth would presumably be the known physical reality or a higher-fidelity imaging modality's output.
  - For "synthetic accuracy," it likely refers to a simulated environment with known parameters.
  - For "spine accuracy," it could involve phantoms with precisely known anatomical dimensions.
  - For "accuracy vs. CT (cadaver tests)," the ground truth would be the 3D anatomical information obtained from high-resolution CT scans of the cadavers, against which the C-InSight's reconstructions are compared.
- For software validation, image quality, and radiation dose: Ground truth would be defined by pre-established engineering specifications, industry standards, or regulatory guidelines.
The Sample Size for the Training Set:
- Not provided. The document describes a ready-to-use software product and its validation tests, not a machine learning model that requires a "training set." While the software likely uses algorithms developed using data, the specifics of such development data (if any) are not discussed in this 510(k) summary.
How the Ground Truth for the Training Set Was Established:
- Not provided, as the document does not mention a training set in the context of device validation.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters that appear to be alphanumeric. The sequence reads as 'K081672'. The characters are written in a simple, somewhat crude style, with varying stroke thicknesses.

Allic 1 5 2008

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

DISCASSIST™ SYSTEM

510(k) Number K_

Applicant's Name:

Company name:	Mazor Surgical Technologies Ltd.
Address:	7 HaEshel Str.P.O.B. 3104Southern Caesarea Industrial Park 38900ISRAEL
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)20 Hata'as Str. (Box 124)Kfar Saba 44425ISRAEL
Tel:	+ 972-9-7670002
Fax:	+972-9-7668534
e-mail:	ahava@asteinrac.com

Name of the device:

C-InSight System

Trade or proprietary name, if applicable:

C-InSight System

Common or usual name:

3-D Reconstruction Tool for Mobile X-ray Devices.

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Establishment Registration No .:

3005075696

Classification Name:

System, Image Processing, Radiological

Classification:

FDA has classified Radiological Image Processing systems as a Class II medical device, with product code LLZ and 21 CFR classification code 892.2050. Review by the Radiology Panel.

Predicate Device:

The C-InSight™ system is substantially equivalent to the Siremobil Iso-C 3D software (manufactured by Siemens Medical Systems, Inc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K060344). A comparison table and detailed discussion are presented in Section 12 of this application.

Device Description:

Two-dimensional imaging is available nowadays in every operating room in the form of a mobile C-Arm. However, there is often a need for a three-dimensional imaging

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during the operation especially duc to the rise in the scope of minimally invasive procedures.

To answer the need for a reasonably priced, casy to use and highly mobile intraoperative 3D imaging, the C-InSight was developed.

C-InSight is a software-based product, which gives the solution for 3D imaging intraoperatively, using a standard 2D Mobile C-Arm.

Coupling the 3D capabilities of the C-InSight using existing C-Arms in the operating rooms, can give surgeons a real-time assessment of implant placement.

The clinician who uses the C-InSight should identify the anatomical area which is scanned, and cover it with the C-InSight Reference Belt. The user scans the body and the C-InSight Reference Belt for 20 seconds. The scanned data is sent to the C-InSight processing unit, which converts this data into three-dimensional volume.

The clinician is then able to view the scanned data in different anatomical projections: AP, LT, AX and 3D volume.

The main components of the C-Insight system include:

A. Workstation
B. Accessories, including C-InSight Reference Belt and Image Adaptor
C. Disposable kit, including C-InSight Sterile Sheath

Intended Use / Indication for Use:

3D imaging of high contrast objects particularly for orthopedic applications.

Comparison of Technological Characteristics with the predicate device:

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The C-InSight system is similar to the predicate device regarding intended use and regarding technological characteristics. All are intended to be used when the clinician and patient benefit from generated 3D imaging of high contrast objects. They all include software which provides conversion of 2D fluoroscopic projections from C-Arms into a volumetric 3D image. The C-InSight system uses a reference belt and target recognition algorithms to calculate the relative projection and location coordinates of each image, while the predicate devices use built-in sensors to receive these coordinates.

Non-Clinical Performance Data

The following performance tests were conducted on the C-InSight system:

1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
1. C-InSight synthetic accuracy test.
1. C-InSight spine accuracy test.
1. C-InSight accuracy vs. CT (cadaver tests)
1. Image Quality test
1. Radiation Dose Exposure test

Clinical Performance Data

Not Applicable

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Conclusions Drawn from Non-Clinical and Clinical Tests:

The performance tests demonstrate that C-InSight system may be safely and effectively used in surgical operation rooms, as an 3D visualization software, particularly for orthopedic applications. The software validation and accuracy performance tests demonstrate that the C-InSight system meets its design and performance specifications and is substantially equivalent to the previously cleared systems.

Substantial Equivalence:

In summary, the intended use of the C-Insight system is substantially equivalent to a combination of the Siremobil Iso-C 3D system and the O-Arm Imaging System. Furthermore, the basic technological characteristics of the C-InSight system are identical to the predicate devices. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the C-InSight system is substantially equivalent to the Siremobil Iso-C 3D system and the O-Arm Imaging System device.

Performance Standards:

The C-InSight™ system complies with the voluntary recognized standards:

1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
1. Medical Electrical Equipment (IEC 60601-1 / 2)

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Image /page/5/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

Mazor Surgical Technologies Ltd. % Ms. Ahava Stein/ Ofer Hornick Consultant A. Stein -- Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL

Re: K081672

Trade/Device Name: C-Insight System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2008 Received: June 13, 2008

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, 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.

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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 requivements 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Crance of Compliance of one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.btml

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: C-InSight System

Intended Use Statement:

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

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Reimer

ivision Sign-Off) ivision of Reproductive, Abdominal and ്adiological Devices K081672 J10(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).