The Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

In addition, the Smith & Nephew 4 mm diameter rigid VideoArthroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate

Device Description

The Smith & Nephew VideoArthroscope is a reusable VideoArthroscope. The proposed device is available in a variety if diameters, lengths, and with direction of view ranging from 0° to 110° and incorporates a mechanical focus mechanism.

AI/ML Overview

The provided 510(k) summary for the Smith & Nephew VideoArthroscope (K043395) describes a re-submission for a device that is substantially equivalent to a previously cleared predicate device (K971253). This type of submission relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.

Key takeaway regarding acceptance criteria and studies:

The 510(k) summary does not contain specific acceptance criteria or detailed study results proving the device meets those criteria. Instead, it makes a general statement that:

"All verification and validation data demonstrates that the device is safe and effective and performs as intended." (Section H. Summary Performance Data)

This is common for 510(k) submissions, especially for devices demonstrating substantial equivalence to a legally marketed predicate device with a similar design and intended use. The FDA determines substantial equivalence based on the provided information, which often includes engineering specifications, manufacturing controls, and bench testing, rather than extensive clinical trials or specific performance metrics listed as "acceptance criteria."

Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth, expert qualifications, and specific study types (MRMC, standalone) cannot be extracted from this document.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

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

Acceptance Criteria	Reported Device Performance
Not specified in 510(k) summary.	"All verification and validation data demonstrates that the device is safe and effective and performs as intended." (General statement, no specific metrics provided)

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data likely refers to internal testing conducted by Smith & Nephew, Inc., Endoscopy Division (Andover, MA, USA).

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

Not applicable as no specific test set or ground truth establishment by experts is detailed in this 510(k) summary. Performance data likely refers to bench testing and engineering validation.

4. Adjudication method for the test set

Not applicable as no specific test set requiring expert adjudication is detailed.

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

No. This device is a VideoArthroscope (an optical instrument), not an AI-powered diagnostic system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

No. This device is an optical instrument for direct human visualization, not an algorithm.

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

Not applicable in the context of an optical instrument's performance validation as described here. The "performance" likely refers to technical specifications like illumination, visualization clarity, field of view, mechanical focus function, durability, and biocompatibility, validated through engineering tests against internal specifications, rather than clinical ground truth like pathology.

8. The sample size for the training set

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

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

Not applicable. This is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device. For devices of this nature (optical instruments), the "study that proves the device meets acceptance criteria" typically involves internal design verification and validation testing (e.g., optical performance, mechanical integrity, sterilization effectiveness, biocompatibility, electrical safety) rather than clinical studies with human "readers" or AI algorithms. The document makes a blanket statement that this testing was performed and found acceptable, without detailing the specific criteria or results.

Summary

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K 043395

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew VideoArthroscope

Date Prepared: December 7, 2004

A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

B. Company Contact

Kathleen Burns Regulatory Affairs Associate Phone: (978)474-6301 (978)749-1443 Fax:

C. Device Name

Smith & Nephew VideoArthroscope Trade Name: Common Name: Arthroscope Classification Name: Arthroscope

D. Predicate Devices

The current Smith & Nephew VideoArthroscope serves as the predicate device for this submission (K971253).

E. Description of Device

F. Intended Use

The Smith & Nephew line of rigid Multimode VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

In addition, the Smith & Nephew 4.0mm diameter rigid Video Athroscopes/ENT Endoscopes are indicated to provide illumination and visualization in the removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

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G. Comparison of Technological Characteristics

The Smith & Nephew VideoArthroscope has the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and is manufactured under a Quality System.

H. Summary Performance Data

All verification and validation data demonstrates that the device is safe and effective and performs as intended.

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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 a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

Ms. Kathleen Burns Regulatory Affairs Associate Smith & Nephew, Inc. 150 Minuteman, Road Andover, Massachusetts 01810

Re: K043395

Trade/Device Name: Smith & Nephew VideoArthroscope Regulation Number: 21 CFR 888.1100, 21 CFR 874.4760 Regulation Name: Arthroscope, Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: HRX, EOB Dated: December 8, 2004 Received: December 10, 2004

Dear Ms. Burns:

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. Kathleen Burns

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

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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Indications for Use

Device Name: Smith & Nephew VideoArthroscope

Indications For Use: The Smith & Nephew VideoArthroscopes/ENT Endoscopes is indicated to provide illumination and visualization in diagnostic and operative arthroscopic procedures, endoscopic examination and treatment of the nasal cavities and nasal pharynx.

Prescription Use X (Per 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 Device Evaluation (ODE)

Neil R. Ogden
(Division Sign-Off) for

Division of General, Restora and Neurological Devices

510(k) Number K043395

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.