The Endius® Atavi™ System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius® Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Device Description

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

AI/ML Overview

The provided text does NOT contain information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets specific acceptance criteria. This document is a 510(k) summary for the Endius Atavi System, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document discusses:

Device Name: Endius Atavi System
Submitter and Contact Information: Endius, Inc.
Classification: Class II, Endoscope and Accessories
Predicate Devices: Sofamor Danek Microendoscopic Discectomy System and Medtronic Sofamor Danek METRx System (K002931)
Device Description: Instruments for tissue dilation, retracting device, visualization components (endoscope, light source, light guide, camera control unit, camera head).
Indications for Use: Posterior or anterior access and visualization in cervical, thoracic, or lumbar spine for surgical procedures like discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Also, generic surgical use in knee, ankle, shoulder, hand, wrist, and TMJ.
Substantial Equivalence: Claimed to the listed predicate devices.
FDA Response Letter: Confirms substantial equivalence and allows marketing.

There is no mention of:

Acceptance criteria or reported device performance (e.g., accuracy, sensitivity, specificity, resolution, field of view, etc.).
Sample sizes for test sets or training sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications.
Adjudication method.
MRMC comparative effectiveness study or effect size with AI assistance.
Standalone algorithm performance.
Type of ground truth used.
How ground truth was established.

Summary

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OCT 02 2002

022199

Section 7 - 510(k) Summary of Safety and Effectiveness

7.1Statement	Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc.is required to submit with this Premarket Notification either an "... adequatesummary of any information respecting safety and effectiveness or state thatsuch information will be made available upon request of any person." Endius,Inc. chooses to submit a summary of information respecting safety andeffectiveness. According to §513(i)(3)(B), "Any summary undersubparagraph (A) respecting a device shall contain detailed informationregarding data concerning adverse health effects..."The summary regarding the adverse health effects of the modified device,Endius Atavi System is provided below.
7.2Submitter	Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 (USA)
7.3CompanyContact	Christine Kuntz NassifDirector, Regulatory AffairsEndius, Inc.508-643-0983
7.4Device Name/Classification	Proprietary Name: Endius Atavi SystemCommon Name: Endoscopic Spinal Access SystemClassification Name: Endoscope and AccessoriesThe devices in the Endoscopic Spinal Access System can be classified asclass II, 876.1500 Endoscope and Accessories. The primary device in thesystem is the endoscope. The accessory equipment is needed to gain accessfor placement of the endoscope, to support the endoscope in position, or towork with the endoscope for the purpose of visualization.
7.5PredicateLegallyMarketedDevices	Sofamor Danek Microendoscopic Discectomy System(Sofamor Danek Memphis, Tennessee)Medtronic Sofamor Danek METRx System, K002931
7.6 DeviceDescription	The Endius Atavi System includes instruments used to access the spine bydilation of the overlying tissues, as well as a retracting device that is used tomaintain the access. The visualization components of the system include, anendoscope, a light source, light guide, a camera control unit, and a camerahead.
7.7 Indicationsfor Use	The Endius® Atavi™ System is indicated for use for posterior or anterioraccess and visualization in the surgical area of the cervical, thoracic, orlumbar spine allowing the surgeon to perform any type of surgical spinalprocedures such as discectomy, nucleotomy, spinal fusion, spinaldecompression, and insertion of spinal implants. Other examples of genericsurgical use of the Endius® Atavi™ System would be for use in the knee,ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
7.8SubstantialEquivalence	The Endius Atavi System is substantially equivalent to the Sofamor DanekUSA Microendoscopic System (Memphis, TN)and the METRx System.

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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 stylized eagle with three wing feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

OCT 02 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endius, Inc. Christine Kuntz Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762

Re: K022199

Trade/Device Name: Endius Atavi System Regulation Number: 888.1100 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: HRX Dated: July 3, 2002 Received: July 5, 2002

Dear Ms. Kuntz Nassif:

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.

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Page 2 – Ms. Christine Kuntz Nassif

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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15022199 510(k) Number (if known):

Device Name: Endius® Atavi™ System

Indications for Use:

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Hyatt Gurdie

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022199

000002

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.