The SOPRO 184 is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and color contrast. Its contour enhancer gives the impression of a 3D image. This makes the camera a multidisciplinary tool. The SOPRO 184 is a modification of the SOPRO 162 previously cleared on 510(k) K031593. The modifications are the addition of RGBS & USB2 outputs, 2 SD1 outputs as an option and the modification of the head design for the ergonomic.

AI/ML Overview

The provided text (K082796) is a 510(k) summary for a medical device called the SOPRO 184 Digital Endoscopy Camera. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing data from a clinical study with specific acceptance criteria and performance metrics described in your request.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For devices claiming substantial equivalence, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This is typically done through comparing technical specifications, materials, and intended use, rather than presenting a performance table against predefined numerical criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and therefore not provided in this 510(k) summary. The document does not describe a "test set" in the context of a performance study to validate specific acceptance criteria for the SOPRO 184. The evaluation is based on comparing the new device's specifications to its predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided. No "ground truth" was established for a test set in the context of a performance study for the SOPRO 184 as described in this document.

4. Adjudication Method

This information is not applicable and therefore not provided. No adjudication method was used for a test set in the context of a performance study for the SOPRO 184 as described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not mentioned and likely not conducted for the SOPRO 184's 510(k) submission. This type of study is more common for AI-powered diagnostic devices where human reader performance is a critical outcome. The SOPRO 184 is a camera system for visualization.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not mentioned and likely not conducted. The SOPRO 184 is a digital endoscopy camera, not an algorithm in the sense of AI-driven analysis. Its performance is evaluated based on image quality, output options, and ergonomic design, usually through engineering tests and comparison to the predicate, not a standalone algorithmic performance study.

7. Type of Ground Truth Used

This information is not applicable and therefore not provided. As no performance study with a test set and ground truth establishment is described, this question cannot be answered from the provided text.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The SOPRO 184 is a camera system, not an AI model that requires a "training set" in the traditional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As the device is not an AI model requiring a training set with a ground truth, this question cannot be answered from the provided text.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in a 510(k) context):

The "study" in this 510(k) context is primarily a comparison of technical specifications and intended use between the SOPRO 184 and its predicate device, the SOPRO 162 (K070102).

Acceptance Criteria for a 510(k): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the new device is as safe and effective as the predicate.
Proof of Meeting Acceptance Criteria: The document explicitly states: "The SOPRO 184 is substantially equivalent to the predicate device by SOPRO, the SOPRO 162 (K070102) previously cleared by the FDA and currently marketed." It further elaborates: "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 184."

The specific modifications of the SOPRO 184 over the SOPRO 162 (K031593, which K070102 was also based on) include:

Addition of RGBS & USB2 outputs.
Addition of 2 SD1 outputs as an option.
Modification of the head design for ergonomic purposes.

The FDA's clearance letter (pages 2-4) confirms that based on the provided information, the FDA "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "study" is a technical comparison and declaration of equivalence reviewed by the FDA, rather than a clinical trial with specific performance metrics against an established ground truth. This is a common approach for devices undergoing the 510(k) pathway, especially when the changes from a predicate are minor.

Summary

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K082796 page w of 2

Summary of Safety and Effectiveness - "510(k) Summary"

A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE

APR - 1 2009

Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90

Contact Person: Rick Rosati

SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 37 Fax: 856 222-4726 E-mail: rick.rosati@us.acteongroup.com

Date Prepared: September 22, 2008

B. Device Identification

Classification Name: Laparoscope, General & Plastic Surgery

Common Usual Name: Laparoscope and accessories

SOPRO 184 camera Proprietary Name:

C. Identification of Predicate Device

Device	Applicant	510(k) No.	Date Cleared
SOPRO 162	SOPRO	K070102	February 20, 2007

The SOPRO 184 is substantially equivalent to the predicate device by SOPRO, the SOPRO 162 (K070102) previously cleared by the FDA and currently marketed.

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K082796

Page (2) of (2)

D. Device Description

The SOPRO 184 is a modification of the SOPRO 162 previously cleared on 510(k) K031593. The modifications are the addition of RGBS & USB2 outputs, 2 SD1 outputs as an option and the modification of the head design for the ergonomic.

E. Intended Use

The SOPRO 184 providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.

F. Substantial Equivalence

The SOPRO 184 camera and the predicate device, SOPRO 162 camera (K070102) are both laparoscopes and accessories for use in general and plastic surgery by qualified physicians. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 184.

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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 stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2009

Sopro % Acteon, Inc. Mr. Rick Rosati 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K082796

Trade/Device Name: SOPRO 184 Digital Endoscopy Camera Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 9, 2009 Received: March 11, 2009

Dear Mr. Rosati:

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. Iisting 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

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Page 2 - Mr. Rick Rosati

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.

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 of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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. 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

510(k) Number:

082796

Device Name:

SOPRO 184 Digital Endoscopy Camera

Indications for Use:

"Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals."

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Knoie for MXM 3/31/09

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

510(k) Number K062796

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.