The Alcon Contact Lens Case is intended for use for soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a side by side double well plastic case with two screw-on plastic closures.

AI/ML Overview

The provided text is a 510(k) summary for the Alcon Contact Lens Case. It describes the device, its intended use, and its performance characteristic. However, it is a pre-market notification to establish substantial equivalence to existing devices and does not present a study with statistical acceptance criteria or detailed performance metrics in the way a clinical trial for a novel AI device would.

Here's an analysis of the information, noting what is present and what is absent based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Overflow capacity for each lens well	5.0 mL in each lens well
Sufficiency of volume for immersion	"Sufficient volume to assure that the contact lens will remain immersed under use conditions." (Qualitative claim, not a quantitative metric with a statistical bound).
Material compatibility	"All the materials currently being used in the lens cases or proposed in this submission have passed the relevant physico-chemical, and toxicological tests."

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

Not Applicable. This document describes a physical medical device (contact lens case) and not a diagnostic AI or imaging device that would typically involve a "test set" of patient data. The performance claims relate to physical properties and material safety, not diagnostic accuracy.

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

Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant for this device. The "ground truth" would effectively be the physical properties and material safety standards, which are evaluated through laboratory tests rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. No test set or expert adjudication related to diagnostic accuracy is described.

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

No. This type of study is for evaluating the impact of an AI system on human reader performance, which is not relevant for a contact lens case.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is not an algorithm. Its performance is inherent in its physical design and material properties.

7. Type of Ground Truth Used

The "ground truth" for the performance claims would be based on physical measurements (e.g., volume capacity) and laboratory testing to assess physico-chemical and toxicological properties of the materials. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary of Study Described:

The document describes the design and intended performance characteristics of the Alcon Contact Lens Case and establishes its substantial equivalence to previously cleared devices (OPTI-FREE® Lens Case (K931620) and OPTI-LENS® Lens Case (K915082)). The "study" here is more accurately a demonstration that the device design meets certain functional requirements (like overflow capacity) and that the materials used are safe. This is fundamentally different from a clinical study for a diagnostic device. The basis for acceptance is primarily meeting regulatory requirements for substantial equivalence based on similar design and materials, rather than a clinical trial demonstrating a specific performance endpoint against a defined ground truth.

Summary

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April 30, 1997

K971618 Alcon

JUL | 4 1997

510(K) SUMMARY

Submitted by:

ALCON LABORATORIES, IN 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450

Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76132 (817) 551-4877 (Phone) (817) 551-4630 (Fax)

Device Name:

Common Name: Contact Lens Case Alcon Contact Lens Case Proprietary Name:

Device Classification:

Contact lens have not been officially classified, but have been recommended by the Ophthalmic Devices Panel to be classified in Class II and have historically been regulated through the 510(k) process.

Description:

Performance:

The Alcon Contact Lens Case is designed to have an overflow capacity of 5.0 mL in each lens well. This will be a sufficient volume to assure that the contact lens will remain immersed under use conditions.

Substantial Equivalence Comparison:

The Alcon Contact Lens Case is identical in its intended use to the OPTI-FREE® Lens Case (K931620) and the OPTI-LENS® Lens Case (K915082). It is intended for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. All the materials currently being used in the lens cases or proposed in this submission have passed the relevant physico-chemical, and toxicological tests.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. ................................................. 6201 South Freeway Fort Worth, TX 76134-2099

JUL 1 4 1997

Re: K971618 Trade Name: Alcon Contact Lens Case Regulatory Class: unclassified Product Code: LRX (0) Dated: April 30, 1997 Received: May 2, 1997

Dear Mr. Pfleger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael E. Pfleger

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

The Alcon Contact Lens Case __________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brunson, Ph.D
(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number K9711618

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_X___

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”