The Axxion Light Guide is a bifurcated light guide that stems from a single cable and branches twice to terminate into four cables with illumination tips at each distal end. The end existing as a single cable contains a universal light source adapter that can be attached to a multitude of high intensity external light sources (ranging from 150 Watts to 300 Watts). Light provided from the external source is propagated through fiberoptic bundles contained by a jacket made of silicone sheathe. Fiberoptic bundles terminate at four stainless steel illumination tips that deliver light to the surgical site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Axxion™ Light Guide. It focuses on establishing substantial equivalence to predicate devices rather than reporting on a study or acceptance criteria for device performance. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be extracted. The document states that the Axxion Light Guide "was shown to be substantially equivalent in design, technical requirements, materials, and intended use to the following predicate devices." This indicates a comparison to existing devices rather than a presentation of specific performance acceptance criteria and test results for the Axxion Light Guide.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be extracted. No study details (sample size, data provenance) are provided for the Axxion Light Guide's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be extracted. No information on ground truth establishment or expert involvement is present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be extracted. No information on adjudication methods is present.

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

Cannot be extracted. The device is a surgical light guide, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not applicable and not mentioned.

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

Cannot be extracted. The device is a physical light guide; thus, an "algorithm only" standalone performance is not relevant or described.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be extracted. No information on ground truth is present.

8. The sample size for the training set

Cannot be extracted. No training set for a study is mentioned.

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

Cannot be extracted. No training set or ground truth establishment is mentioned.

Summary of available information:

Premarket Notification Number: K082992
Device Name: Axxion™ Light Guide
Manufacturer: Spinal Elements, Inc. (Carlsbad, CA, USA)
Date Prepared: October 3, 2008
Device Description: A bifurcated fiberoptic light guide designed to provide surgical site illumination from an external high-intensity light source. It stems from a single cable, branches twice, and terminates into four cables with illumination tips.
Intended Use: To provide surgical site illumination from a high intensity light source.
Regulatory Class: II (Surgical Lamp, 21 CFR 878.4580)
Predicate Devices:
- Medical Light Guide by Fiberoptics Technology, Inc. (K904378)
- MIS Light by Zimmer (K080367)
- MaZcess Light Guide by NuVasive (K042034)
Basis for Clearance: Substantial equivalence to the listed predicate devices in design, technical requirements, materials, and intended use. The document implies that the device meets the necessary performance characteristics by being substantially equivalent to already approved devices. No specific performance study for the Axxion Light Guide itself is detailed in this 510(k) summary.

Summary

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Spinal Elements, Inc. Premarket Notification - Axxion™ Light Guide

FEB 1 8 2009

510(k) Summary Axxion™ Light Guide

K082992 510(k) Number

Page ① of ②

Manufacturer Identification Submitted by:

Contact Information:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121

Kerri DiMartino Regulatory Affairs Specialist Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad、CA 92010 760-607-1816 760-607-0125 (fax) kdimartino@spinalelements.com

Date Prepared:

October 3, 2008

Device Identification Proprietary Name Common Name Classification Name Device Classification Proposed Regulatory Class Device Product Code

Axxion™ Light Guide Light Guide Light, Surgical, Fiberoptic 21 CFR 878.4580 (Surgical Lamp) Class II FST

Device Description

Intended Use of the Device

The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

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u82992 Page (2) of (2)

Substantial Equivalence

The Axxion Light Guide was shown to be substantially equivalent in design, technical requirements, materials, and intended use to the following predicate devices: Medical Light Guide by Fiberoptics Technology, Inc. (K904378), MIS Light by Zimmer (K080367), and MaZcess Light Guide by NuVasive (K042034).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 an abstract symbol resembling an eagle or bird-like figure with three stylized wing segments.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2009

Spinal Elements, Inc. % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K082992

Trade/Device Name: Axxion™ Light Guide Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: February 10, 2009 Received: February 11, 2009

Dear Ms. DiMartino:

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. Fire . . . . . . . . . . . . . .

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.

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Page 2 - Ms. Kerri DiMartino

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 Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 SurveillancesSystems 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.html.

Sincerely yours,

Mark N. Milliman

Mark N. Melkerson 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

ku82992 510(k) Number (if known):

Device Name: Axxion™ Light Guide

Indications for Use:

The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

Prescription Use X (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)

WARRE Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Page 1 of 1 and Neurological Devices

510(k) Number K072992

Page 1 of 1

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.