SOHNIKS by SOHNIKS ENDOSCOPY, INC.

The Sohniks Endoscopy Arthroscopes are intended for use by qualified surgeons during procedures of small and large joints. The intended use for Sohniks Endoscopy, Inc.'s arthroscopes are for examining, diagnosing, visualizing and to aid in treating the interior problems of orthopedic joints, otolaryngology, thinology, endoscopic plastic and reconstructive surgery. Our arthroscopes are intended for use in the shoulder, wrist, knee, ankle, elbow, and jaw and visualization of the hip joint to diagnose disease and removal of loose bodies.

Device Description

The Söhniks Arthroscopes are reusable manually operated surgical devices that are provided in 0. 30. 45. and 70 degree direction of view. The Arthroscopes are provide non-sterile and must be cleaned and sterilized by the user prior to each use. The components that contact the body are composed of surgical grade stainless steel, which is commonly used in medical devices and has a long history of biocompatibility for human use.

AI/ML Overview

This document is a 510(k) summary for the Sohniks Endoscopy Arthroscope from 2003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance data on a novel AI-powered device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI-specific metrics (like MRMC studies) cannot be extracted from this document.

Here's what can be gathered based on the provided text, and where gaps exist:

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

This document does not specify quantitative acceptance criteria or report specific performance metrics for the Sohniks Arthroscope in the way one would for a new diagnostic or AI-powered device. The submission focuses on demonstrating substantial equivalence.

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(The document states: "The Söhniks Arthroscope is substantially equivalent to its predicate devices. The basic design, materials and intended uses are the same and there are no new issues of safety and effectiveness.")

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable/not specified. This document is a 510(k) summary for a manual surgical device (arthroscope), not a data-driven AI device. There is no mention of a "test set" of data in the context of evaluating performance.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a "test set" or establishing ground truth by experts for the evaluation of this device.

4. Adjudication method for the test set:

Not applicable. No test set mentioned.

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:

Not applicable. This is not an AI-powered device.

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

Not applicable. This is a manual surgical device.

7. The type of ground truth used:

Not applicable. No ground truth is mentioned for the evaluation of this arthroscope. The evaluation relies on demonstrating equivalence to existing, legally marketed arthroscopes.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

Summary of Device and Regulatory Context (Based on Document):

Device: Arthroscope
Intended Use: Examining, diagnosing, visualizing, and aiding in treating interior problems of orthopedic joints (shoulder, wrist, knee, ankle, elbow, jaw, hip joint visualization for diagnosis and loose body removal), otolaryngology, rhinology, endoscopic plastic and reconstructive surgery. For use by qualified surgeons during procedures of small and large joints.
Device Description: Reusable, manually operated surgical device available in 0, 30, 45, and 70-degree directions of view. Provided non-sterile, requiring user cleaning and sterilization. Components are surgical grade stainless steel.
Regulatory Basis: The FDA determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976. This means the FDA believes the device is as safe and effective as legally marketed devices, and does not require a rigorous performance study with specific acceptance criteria as would be needed for a novel device or an AI/software as a medical device. The focus is on similar design, materials, and intended uses to existing devices, with "no new issues of safety and effectiveness."

In conclusion, this document describes a 510(k) submission for a traditional, manually operated medical device where substantial equivalence to existing devices is the primary criterion for market clearance, rather than a study demonstrating performance against specific acceptance criteria for a novel technology like AI.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for SOHNIK'S ENDOSCOPY, Inc. The word "SOHNIK'S" is in large, bold, black letters. Below that, the words "ENDOSCOPY, Inc." are in smaller, black letters. There is a line under the word "SOHNIK'S" that extends to the right and ends in a starburst.

930 Blue Gentian Road Suite 1400 Eagan, MN 55121 (651) 452-4059 Fax (651) 452-4056

FEB 0 7 2003

KO23783

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device act of 1990 and 21 CFR 807.92. All data in this document is accurate and complete to the best of Söhniks Endoscopy's knowledge.

Applicant: Söhniks Endoscopy, Inc. 930 Blue Gentian Road Suite 1400 Eagan, MN 55121 651-452-4059 phone 651-452-4056 fax

Contact: Marc Hoskins

Device ID: Arthroscope

Indication: The Sohniks Endoscopy Arthroscopes are intended for use by qualified surgeons during procedures of small and large joints. The intended use for Söhniks Endoscopy, Inc.'s arthroscopes are for examining, diagnosing. visualizing and to aid in treating the interior problems of orthopedic joints, otolaryngology, rhinology, endoscopic plastic and reconstructive surgery. Our arthroscopes are intended for use in the shoulder, wrist, knee, ankle, elbow, and jaw and visualization of the hip joint to diagnose disease and removal of loose bodies.

Device Description: The Söhniks Arthroscopes are reusable manually operated surgical devices that are provided in 0. 30. 45. and 70 degree direction of view. The Arthroscopes are provide non-sterile and must be cleaned and sterilized by the user prior to each use. The components that contact the body are composed of surgical grade stainless steel, which is commonly used in medical devices and has a long history of biocompatibility for human use.

Substantial Equivalence: The Söhniks Arthroscope is substantially equivalent to its predicate devices. The basic design, materials and intended uses are the same and there are no new issues of safety and effectiveness.

Man R. L.

Mard Hoskins Regulatory Affairs Söhniks Endoscopy, Inc.

November 1, 2002

Arthroscope and Accessories 510 (k) Submission

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Marc Hoskins Regulatory Affairs Söhniks Endoscopy, Inc. 930 Blue Gentian Road, Suite 1400 Eagan, Minnesota 55121

FEB 0 7 2003

Re: K023783 Trade Name: Söhniks Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX

Dated: November 1, 2002 Received: November 12, 2002

Dear Mr. Hoskins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Mr. Marc Hoskins

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Melkerson

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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510(k) Number: K023783

Device Name: Arthroscope

Indications for Use:

DO NOT WRITE BELOW THIS LINE

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Millman

Division Sign-Off Division of Ceneral, Restorative and Neurological Devices

510(k) Number K023783

(Optional Format 3-10-98)

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.