The Smith & Nephew Dyonics® Vision 325Z DV 3-CCD Color Video Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals, when used with an appropriately indicated endoscope.

Additionally, when used in conjunction with a Dyonics® light source and light cable, the 325Z DV Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Device Description

The Smith & Nephew Dyonics® Vision 325Z DV Hermes- Ready™3 CCD Camera is used in endoscopic surgical procedures to capture and transmit video images. The Hermes-Ready™ feature will enable voice and pendant control of white balance, zoom, shutter control, enhancement and on/off ability from a central location when used in conjunction with a Hermes™ Digital O.R. Control Center.

AI/ML Overview

The provided document is a 510(k) summary for the Dyonics® Vision 325Z DV 3-CCD Hermes-Ready™ Camera System. It outlines the device's description, intended use, technological characteristics, and comparison to a predicate device. However, the document does not contain the detailed performance data or study results typically used to establish acceptance criteria for a medical device's specific functional performance.

The "Summary Performance Data" section in the document (Section H) states: "All verification and validation data demonstrates that the device is safe and effective and performs as intended." This is a general statement and does not provide specific acceptance criteria or the study details requested.

Most of the requested information (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary because it focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, rather than reporting detailed performance studies against specific acceptance criteria for a new clinical claim. In 2003, for simple devices like a camera system, the FDA often relied on verification and validation testing demonstrating adherence to recognized standards and that the device operates as intended, without requiring extensive clinical performance studies that are common for AI/ML devices today.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the detailed study information using only the provided text.

Based on the available document, here's what can be inferred or stated about the device and its assessment:

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

Cannot be provided as the document does not specify quantitative acceptance criteria or detailed performance metrics. The summary only states that "All verification and validation data demonstrates that the device is safe and effective and performs as intended."

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

Not provided. The document does not describe a clinical test set or its characteristics.

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)

Not applicable/Not provided. No clinical test set or human-interpreted ground truth is mentioned in this 510(k) summary.

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

Not applicable/Not provided. No clinical test set or adjudication process is 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

No. This device is a camera system, not an AI-assisted diagnostic tool. An MRMC study would not be relevant for this type of product.

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

Not applicable/Not provided. This is a camera system, not an algorithm.

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

Not applicable/Not provided. No clinical ground truth is mentioned. For a camera system, ground truth would typically relate to optical performance, resolution, color accuracy, and safety standards, which are assessed through engineering verification and validation, not clinical ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is a hardware camera system, not a machine learning algorithm that requires a training set.

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

Not applicable/Not provided. As above, no training set for an algorithm is relevant here.

Summary of what the document does state regarding acceptance/verification:

Standards for Verification: The device "will be tested with the following domestic and international standards:"
- UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- EN 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendments 1 and 2
- EN 60601-1-1: Medical Electrical Equipment General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
- EN 60601-1-2: Medical Electrical Equipment General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
- CAN/CSA C22.2 No. 601.1-M90- Medical Electrical Equipment General Requirements for Safety: A National Standard for Canada
General Performance Statement: "All verification and validation data demonstrates that the device is safe and effective and performs as intended."
Substantial Equivalence: The primary "proof" for this 510(k) submission is the comparison to the predicate device (Smith & Nephew Images Digital 3-Chip Color Video Camera), demonstrating that the Dyonics® Vision 325Z DV Hermes-Ready™ 3-CCD Color Video Camera System has "the same technological characteristics and intended use." The Hermes-Ready™ feature is an "addition of communication interface for voice activation... without changing the intended use or features."

Summary

{0}------------------------------------------------

031379

Endoscopy Division

Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: 978-749-1000 Fax: 978-749-1599

MAY 22 2003

Smith < Nephew

Exhibit F

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.

Dyonics® Vision 325Z DV3-CCD Hermes -Ready™ Camera System

Date Prepared: April 28, 2003

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150Minuteman Road Andover, MA 01810 USA

B. Company Contact:

Janice Haselton Regulatory Affairs Specialist II Phone: (978)749-1494 (978)749-1443 Fax:

C. Device Name

Trade Name: Smith & Nephew Dyonics® Vision 325Z DV Hermes-Ready™ Camera System Common Name: Camera Control Unit Classification Name: General and Plastic Surgery

D. Predicate Devices

The Smith & Nephew Dyonics® Vision 325Z DV Hermes-Ready™ CCD Color Video Camera System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: Images Digital 3-Chip Color Video Camera.

{1}------------------------------------------------

E. Description of Device

Intended Use F.

G. Comparison of Technological Characteristics

The Smith & Nephew Dyonics® Vision 325Z DV Hermes-Ready™ 3-CCD Color Video Camera System has the same technological characteristics and intended use as the predicate device, Smith & Nephew Images Digital 3-Chip Color Video Camera. The addition of communication interface for voice activation with the Hermes™ control center offers the surgeon direct communication without changing the intended use or features of the Smith & Nephew Dyonics® Vision 325Z DV 3-CCD Color Video Camera.

The Smith & Nephew Dyonics® Vision 325Z DV Hermes-Ready™ 3-CCD Color Video Camera System will be tested with the following domestic and international standards:

UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for . Safety
EN 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendments 1 and 2
EN 60601-1-1: Medical Electrical Equipment General Requirements for Safetv 1. . Collateral Standard: Safety Requirements for Medical Electrical Systems
EN 60601-1-2: Medical Electrical Equipment General Requirements for Safety2, ● Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
CAN/CSA C22.2 No. 601.1-M90- Medical Electrical Equipment General Requirements . for Safety: A National Standard for Canada

H. Summary Performance Data

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

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circumference of the circle.

Public Health Service

MAY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janice Haselton Regulatory Affairs Specialist II Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K031379

Trade/Device Name: Dyonics®Vision 325Z DV 3-CCD Hermes-Ready Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 28, 2003 Received: May 1, 2003

Dear Ms. Haselton:

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.

{3}------------------------------------------------

Page 2 - Ms. Janice Haselton

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. 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" (21CFR Part 807.97) you may obtain. 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 vours.

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Dyonics® Vision 325Z DV 3-CCD Hermes- Ready Camera System Device Name:

-031379

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Signature
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K031379
---------------	---------

325Z Camera System

Page 11 of 313

ઠુદ્ધા G

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.