The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.

Device Description

The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

AI/ML Overview

The provided text is a 510(k) summary for the Bausch & Lomb D4600A Air Exchange Line Pack. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance evaluations for AI/software devices.

This document is a regulatory submission for a physical medical device (an accessory for ophthalmic surgery), not an AI/software device. Therefore, the specific types of information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or typically included in this kind of 510(k) submission for a physical accessory.

Instead, the "proof" for this device lies in its substantial equivalence to a legally marketed predicate device as demonstrated in the "DEVICE COMPARISON CHART."

Here's a breakdown of why each requested point cannot be answered from the provided text, along with what is provided:

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

Not Applicable/Not Provided: The document does not define specific "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) for a new algorithm, nor does it report performance data against such criteria.
What is provided: The comparison chart (Table in {1}) lists characteristics of the subject device (D4600A) and the predicate device (D4600), demonstrating their equivalence in design, intended use, recommended systems, and sterility. This comparison serves as the basis for regulatory acceptance through substantial equivalence.

Characteristic	Bausch & Lomb D4600A (Subject Device)	Storz D4600 (Predicate Device)
Intended Use	To deliver air to the eye during posterior surgical procedures	To deliver air to the eye during posterior ophthalmic surgical procedures
Recommended System	Bausch & Lomb STELLARIS® or MILLENNIUM® Microsurgical Systems	Bausch & Lomb PREMIERE® Microsurgical System
Instructions for Use Included	Yes	Yes
Single Patient Use?	Yes	Yes
Provided Sterile?	Yes	Yes
Sterilization Method	Gamma Irradiation (Cobalt)	Gamma Irradiation
Packaging	Singly in Tyvek® and PET/PE Pouch, 6 pouches per Box	Singly in Tyvek® and PET/PE Pouch, 10 pouches per Box

The acceptance criterion implicitly met is substantial equivalence to the predicate device in terms of safety and effectiveness, based on these similar characteristics.

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

Not Applicable/Not Provided: This device is a physical accessory evaluated for substantial equivalence, not a software/AI device that would use a "test set" of data in the sense you're describing. There's no data provenance information.

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

Not Applicable/Not Provided: There is no "ground truth" established by experts for a test set in this context. The substantial equivalence relies on comparing the device's physical and functional attributes to a predicate.

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

Not Applicable/Not Provided: No adjudication method for a test set is relevant or 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

Not Applicable/Not Provided: This is a physical accessory, not an AI system. MRMC studies are not relevant.

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

Not Applicable/Not Provided: This is a physical accessory, not an algorithm.

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

Not Applicable/Not Provided: The basis for approval is substantial equivalence to a predicate device, not comparison to a "ground truth" derived from expert consensus, pathology, or outcomes data for performance evaluation in the context of an AI/software device.

8. The sample size for the training set

Not Applicable/Not Provided: This device does not involve a "training set" in the context of machine learning.

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

Not Applicable/Not Provided: No training set or ground truth for it is relevant.

In summary: The K082132 document is a 510(k) premarket notification for a disposable ophthalmic surgical accessory. Its "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing, legally marketed predicate device (Bausch & Lomb D4600 Air Exchange Line Pack, K962131). The provided "study" is primarily the comparison table detailing the physical and functional characteristics of the new device against the predicate. This approach is standard for many medical devices that are not complex software or AI systems.

Summary

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

K082132

Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The logo consists of the company name, "Bausch & Lomb", in a serif font. Above the name is a geometric design, possibly representing a lens or other optical element, rendered in a halftone pattern.

AUG 2 8 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is provided in accordance with requirements of 21CFR 807.92:

Contact Person:	Ned LuceDirector Regulatory AffairsGlobal Surgical Devices
Date Prepared:	July 24, 2008
Proprietary Name:	Bausch & Lomb D4600A Air Exchange Line Pack
Common/Usual Name:	Ophthalmic surgical system accessory pack forposterior segment procedures.
Classification Name:	System, Phacofragmentation (86 HQC)

Device Description/Intended Use

Predicate Device: The proposed Bausch & Lomb D4600A Air Exchange Line Pack is substantially equivalent to the existing Bausch & Lomb D4600 Air Exchange Line Pack (K962131) for use with the Bausch & Lomb MILLENNIUM® Microsurgical System (K961310). The subject device may be used with each of these systems.

Predicate Comparison: A chart comparing the Bausch & Lomb D4600A to the predicate Bausch & Lomb D4600 device demonstrates substantial equivalence is attached.

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

DEVICE COMPARISON CHART Bausch & Lomb D4600A Air Exchange Line Pack

DEVICE	Bausch & LombD4600ASubject Device	Storz D4600K962131
Intended Use	To deliver air to theeye during posteriorsurgical procedures	To deliver air to theeye during posteriorophthalmic surgicalprocedures
Recommended System	Bausch & LombSTELLARIS® orMILLENNIUM®Microsurgical Systems	Bausch & LombPREMIERE®Microsurgical System
Instructions for UseIncluded	Yes	Yes
Single Patient Use?	Yes	Yes
Provided Sterile?	Yes	Yes
Sterilization Method	Gamma Irradiation(Cobalt)	Gamma Irradiation
Packaging	Singly in Tyvek® andPET/PE Pouch6 pouches per Box	Singly in Tyvek® andPET/PE Pouch10 pouches per Box

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

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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb, Inc. c/o Ned Luce Director Regulatory Affairs Global Surgical Devices 1400 North Goodman Street Rochester, NY 14609

AUG 2 8 2008

Re: K082132

Trade/Device Name: Bausch & Lomb™ D4600A Air Exchange Line Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC Dated: July 24, 2008 Received: July 29, 2008

Dear Mr. Luce:

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 - Ned Luce

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,

Malvina B. Egleston, und

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

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

082132

Indications for Use

510(k) Number (if known):

K082132

Device Name:

Bausch & Lomb D4600A Air Exchange Line Pack

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)

Bruce Drum

vision of Ophthalmic Ear Nose and Throat De

510(k) Number K082132

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.