The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. These devices are for use with the Whitestar Signature™ System.

Device Description

The Vitrectomy Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure. The vittectomy mode is used to cut and remove vitreous matter from the anterior segment of the eye during secondary intraocular lens implantation following vitreous loss associated with trauma or during primary cataract surgery. It can also be used to provide vitreous cutting in the posterior segment by enabling surgeons to remove vitreous matter for the treatment of various posterior segment conditions.

AI/ML Overview

This is a 510(k) premarket notification for a medical device cleared by the FDA. As such, it does not contain a study that proves the device meets acceptance criteria in the manner requested (e.g., with detailed performance metrics, sample sizes, expert involvement, and statistical analyses typically associated with clinical trials or AI performance evaluations).

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared predicate device, rather than a de novo clinical study proving novel performance criteria. Clinical studies as described in your request are not typically required for 510(k) clearances if substantial equivalence can be established through other means, such as performance testing detailed below.

Therefore, many of the requested fields cannot be directly extracted or are not applicable in their usual sense for this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device and states that "The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices." It also states "The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use."

Specific, quantitative acceptance criteria and their corresponding reported device performance values are not explicitly detailed in the provided text. The assessment for this type of device typically involves engineering specifications and functional performance tests (e.g., cutting rate, aspiration flow, material compatibility, sterilization efficacy, etc.) to demonstrate equivalence to the predicate device. These specific test results are usually found in the full 510(k) submission, which is more extensive than this summary.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Physical Characteristics equivalent to predicate	Substantially equivalent to predicate devices (K950287)
Performance Characteristics equivalent to predicate	Substantially equivalent to predicate devices (K950287)
Manufactured to FDA (QSR) standards	In compliance with FDA (QSR) standards
Manufactured to ISO standards	In compliance with ISO standards
Safe for indicated use	Demonstrated to be safe for indicated use
Effective for indicated use	Demonstrated to be effective for indicated use

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

Sample Size: Not specified in the provided text. Performance testing for medical devices like this typically involves a defined number of units, but this information is not in the summary.
Data Provenance: Not specified, but likely obtained from internal laboratory testing conducted by Advanced Medical Optics, Inc. in the USA. Given it's a 510(k) for an existing type of device, it's almost certainly retrospective in the sense that it relies on established engineering principles and performance testing benchmarks rather than prospective clinical trials to prove efficacy.

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

Not Applicable (N/A): This type of medical device submission does not typically involve "ground truth" derived from expert consensus in a clinical diagnostic sense, as it is a surgical tool. Its performance is assessed through engineering and functional testing rather than diagnostic accuracy.

4. Adjudication method for the test set:

Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic outcomes. For this device, performance is evaluated against engineering specifications and predicate device equivalence, not expert adjudication of clinical findings.

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 is a surgical instrument, not a diagnostic imaging device or an AI-powered system that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

No: This device is a manual surgical instrument and does not involve an algorithm or AI operating in a standalone capacity.

7. The type of ground truth used:

Engineering Specifications / Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device (K950287 UnuVit and 4422CE) and adherence to recognized industry standards (FDA QSR, ISO). Performance is measured against these established benchmarks.

8. The sample size for the training set:

Not Applicable (N/A): This device does not use machine learning or AI, so there is no "training set."

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

Not Applicable (N/A): As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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OCT 0 8 2008

K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve - Request for Information Advanced Medical Optics, Inc.

K081681

510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the Medical Device Amendments of 1976, the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.

The applicant is:	Advanced Medical Optics, Inc.1700 E. St. Andrew PlaceSanta Ana CA 92705, USA
Est. Registration number:	2020664
The contact person is:	Evelyn De La VegaRegulatory Affairs SpecialistTel: (714) 247-8487Fax: (714) 247-8784
Date:	September 18, 2008
Device Trade Name:	AMO™ 20GA Vitrectomy Cutter andIrrigation Sleeve, AMO™ 20GAVitrectomy Cutter, AMO™ 20GA IrrigationSleeve.
Device Classification Name:	Vitreous Aspiration and Cutting Device, andIrrigation Sleeve
Classification:	Class II, Tier II

The devices to which substantial equivalence is claimed:

510(k) Number	Clearance Date	Device
K950287	March 3, 1995	UnuVit and 4422CE
		(Midlabs)

DEVICE DESCRIPTION

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K081861 Vitrectory Cutter/Aspiration Device and Irrigation Sleeve -- Request for Information Advanced Medical Optics, Inc.

The device has been placed in Class II under section 513 of the Federal Food, Drug, and Cosmetic Act. The device is a Tier II and the appropriate panel is the Ophthalmic devices Its classification maybe found in Part 886 of 21 CFR (Code of Federal Panel. Regulations); it's specifically identified under regulation number 886.4150.

INDICATIONS FOR USE

The Vitrectorny Cutter is a device intended to remove vitreous matter from the eye and the Irrigation Sleeve provides irrigation during the vitrectomy procedure.

SUMMARY

The physical and performance characteristics of the vitrectomy cutter and the irrigation sleeve are substantially equivalent to those of the predicate devices. The products will be manufactured in compliance with both FDA (QSR) and ISO standards and have demonstrated to be safe and effective for the indicated use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Medical Optics, Inc. c/o Evelyn De La Vega 1700 E. St. Andrew Place P.O. Box 25162 Santa Ana, CA 92705

Re: K081681

Trade/Device Name: AMOTM 20GA Vitrectomy Cutter and Irrigation Sleeve NGP0020, AMOTM 20GA Vitrectomy Cutter NGP0020A, AMOTM 20GA Irrigation Sleeve NGP0020B Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous Aspiration and Cutting instrument Regulatory Class: II Product Code: MLZ Dated: August 25, 2008 Received: August 26, 2008

Dear Evelyn De La Vega:

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.

Madina B. Eggleston, M.D.

Malvina B. Eydelman, M.I 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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INDICATION FOR USE STATEMENT

510(k) number (if known): K081681

Device Name: AMO™ 20GA Vitrectomy Cutter and Irrigation Sleeve,AMO™ 20GA Vitrectomy Cutter, AMO™ 20GA Irrigation Sleeve

Indication 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

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

M. O'Connell
(Division Sign-Off)

Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K081681

Regulation Number and Section

§ 886.4150 Vitreous aspiration and cutting instrument.

(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.