The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/aspiration, vitrectomy, illumination, air/fluid exchange and silicone oil injection & extraction.

Device Description

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

AI/ML Overview

This document is a 510(k) summary for the ASSOCIATE Phacoemulsification/vitrectomy System. It primarily focuses on demonstrating substantial equivalence to existing predicate devices based on device description, intended use, and compliance with non-clinical safety standards. This particular submission does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective.

The provided text describes a medical device, the "ASSOCIATE Phacoemulsification/vitrectomy System," and its intended use in ophthalmic surgery. It lists predicate devices and compliance with various safety standards (IEC, ISO). The FDA's 510(k) clearance letter confirms substantial equivalence to predicate devices.

Therefore, based on the provided text, I cannot extract the information required for your request.

The request specifically asks for information related to:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study.
Standalone algorithm performance.
Type of ground truth used.
Sample size and ground truth establishment for the training set.

These details are characteristic of studies evaluating the performance of an AI/algorithmic diagnostic or prognostic device, often involving classification, detection, or measurement tasks. The ASSOCIATE device described here is a surgical instrument (hardware) used during eye surgery. Its performance is typically evaluated through different means, such as:

Engineering specifications and tests: Flow rates, vacuum levels, ultrasonic power output, precision of controls, sterility, durability, etc. These would be detailed in technical specification documents and test reports, not typically in a 510(k) summary focused on substantial equivalence to predicates.
Safety and biocompatibility testing: As indicated by the listed IEC and ISO standards.
Usability studies: Ensuring the device is safe and effective for surgeons to operate.

Since the submission is for a surgical system and not an AI/algorithm, the concepts of "acceptance criteria," "test set," "training set," "ground truth," and "reader studies" in the context you've outlined for AI performance are not applicable to this document.

Summary

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510(k) Summary

K081877 1. COMPANY NAME AND ADDRESS

Dutch Ophthalmic Research Center International bv Scheijdelveweg 2 3214 VN Zuidland The Netherlands

JAN - 5 2009

: Mr. Ger Vijfvinkel, President Contact Phone .: +31 181 458080 Fax : +31 181 458090 Date of summary : September 10, 2008

2. DEVICE NAME

Trade Name	: ASSOCIATE
Common Name	: Phacoemulsification/vitrectomy System
Classification Name	: Phacofragmentation system (21 CFR 886.4670,Product Code HQC, HQE)

3. PREDICATE DEVICES

510(k)	ClearanceDate	Device Description
K063331	12/19/2006	Bausch & LombTM NGX Microsurgical System(Marketed as the Bausch & Lomb Stellaris)
K060366	4/7/2006	AMO Ophthalmic Surgical System(Marketed as the AMO Signature)
K021564	7/2/2002	Alcon InfinitiTM Cataract Extraction System
K961310	6/27/1996	Storz Premiere II Microsurgical System(Marketed as the Bausch & LombTM MillenniumMicrosurgical System)
K952213	8/9/1995	Alcon System 20000TM Legacy® MicrosurgicalSystem(Also marketed as the Alcon Accurus OphthalmicSystems)

4. DEVICE DESCRIPTION

The Associate is medical electrical equipment to be used during eye surgery. The Associate is intended for ophthalmic anterior and posterior segment surgery.

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I. . I

It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectorny, illumination, air/fluid exchange, silicone oil injection and extraction. The equipment has a display with touch screen for selecting and activating the functions. With the equipment a footswitch and a remote control are delivered for control by the surgeon. The equipment can be installed on a trolley and is able to control an automated infusion pole.

5. INTENDED USE

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The ASSOCIATE is intended for ophthalmic anterior and posterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation, vitrectomy, illumination, air/fluid exchange, silicone oil injection and extraction.

6. SUMMARY OF NON-CLINICAL TESTS

Prior to commercialization, safety tests of the ASSOCIATE have demonstrated compliance with applicable requirements of the following standards and the test reports have been filed as quality records for future review as required under 21CFR820.180.

Standards	Standards Title
IEC 60601-1:1988,A1:1991, A2:1995	Medical electrical equipmentPart 1: General requirements for safety.
IEC 60601-1-2:2001,A1:2006	Medical electrical equipmentPart 1-2: General requirements for safety - Collateral standard:Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-4:1996,A1:1999	Medical electrical equipmentPart 1: General requirements for safety; 4. Collateral Standard:Programmable electrical medical systems.
IEC 60601-2-2:1998	Medical electrical equipmentPart 2-2: Particular requirements for the safety of high frequencysurgical equipment.
ISO 14971:2000,A1:2003	Medical devices - Application of Risk Management to MedicalDevices
ISO 11607-1:2006	Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems andpackaging systems.
ISO 11135-1:2007	Sterilization of health care products - Ethylene oxide - Part 1:Requirements for the development, validation, and routinecontrol of a sterilization process for medical devices.

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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 or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dutch Ophthalmic Research Center International BV c/o Ger Vijfvinkel. President Scheijdelveweg 2 Zuidland, NL-3214 VN JAN - 5 2009 The Netherlands

Re: K081877

Trade/Device Name: Associate 2500 Dual and Compact Systems Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HOC Dated: December 19, 2008 Received: December 23, 2008

Dear Mr. Vijfvinkel:

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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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 the reporting 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.

M. B. Egleston, m.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081877

Device Name: ASSOCIATE

Indications For Use:

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)

(Division Sign-Off) Division of Ophthalmic and Eas, Nose and Throat Devices

510(k) Number

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Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.