For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. Do not use heat disinfection.

Device Description

Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for a contact lens case. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain a study that proves the device meets explicit acceptance criteria in the way an AI/ML device submission would.

The document is a regulatory submission for a medical device (contact lens case), not an AI/ML diagnostic or prognostic device. Therefore, the detailed information requested regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies for AI/ML performance is not applicable and not present in this document.

For traditional medical devices like a contact lens case, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device has the same intended use, technological characteristics, and raises no new issues of safety or effectiveness. The "study" in this context is the comparison against the predicate device, along with adherence to general controls and relevant regulations.

Here's how the provided information relates to your request, noting the differences for this type of device:

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

Acceptance Criteria (Implicit for a 510(k) submission): That the device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to the predicate device.

Reported Device Performance: The document states that "The applicant contact lens case is similar to the predicate device in - . Intended use - . Materials - . Design" and "The applicant contact lens case introduces no new questions concerning safety and efficacy." This is the core "performance" claim for substantial equivalence. No quantitative performance metrics (like sensitivity, specificity, AUC) are reported because they are not relevant for a contact lens case's function in the way they would be for a diagnostic tool.

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
Same Intended Use as Predicate	Yes (Intended use is identical; see comparison table)
Similar Technological Characteristics as Predicate	Yes (Materials and design are similar; see comparison table)
No New Questions of Safety or Efficacy	Yes (Explicitly stated in the conclusion)

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. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" is the comparison against the predicate device based on its design, materials, and intended use as described in the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is not an AI/ML device requiring expert consensus for ground truth. "Ground truth" for a contact lens case would relate to its physical properties and intended function, which are evaluated through standard engineering and manufacturing processes, and regulatory review based on established standards and the predicate device.

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

Not Applicable. No adjudication method for a test set is mentioned or required for this type of device submission.

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. This is a physical non-AI medical device; MRMC studies are irrelevant.

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

Not Applicable. This is a physical device, not an algorithm.

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

Regulatory Substantial Equivalence: The "ground truth" here is the established safety and effectiveness profile of the predicate device (Arlington Contact Lens Service, Inc. Contact Lens Case, K120969), as determined by its prior FDA clearance. The new device demonstrates "truth" by showing it aligns with this established profile. Its own physical properties and performance (e.g., fluid containment capacity) are verified through internal company testing and manufacturing controls, but not typically detailed in this type of summary.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that uses a training set.

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

Not Applicable. This is not an AI/ML device that uses a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2014

Maca Plastics, Inc. Mr. Jesse F. Grooms Assistant Quality Manager 3455 Cross Road Winchester, Ohio 45697

K140488 Trade/Device Name: Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: July 23, 2014 Received: August 1, 2014

Dear Mr. Grooms:

Re:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

for 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) K140488

Device Name Contact Lens Case

Indications for Use (Describe)

For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. Do not use heat disinfection.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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SPONSOR

Company Name:	MACA Plastics Inc
Company Address:	3455 Cross RoadWest Union, Ohio 45693
Telephone:	(937) 544-8618
Contact Person:	Jesse Grooms
Contact Email:	jgrooms@macaplastics.com

Summary Preparation Date: 04/10/2014

DEVICE NAME		807.92
Trade Name:	Contact Lens Case
Common/Usual Name:	Contact Lens Case
Classification Name:	Soft (hydrophilic) contact lens care products
Regulation Number:	886.5928
Product Code:	LRX

PREDICATE DEVICE

Legally Marked Equivalent Device

Company	Device Name	K Number
Arlington Contact Lens Service,Inc.	Contact Lens Case	K120969

DEVICE DESCRIPTION

807.92(a) (4)

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DEVICE INTENDED USE

The applicant contact lens case is intended for use by contact wearers or practitioners for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection.

Comparison Elements	MACA Contact Lens	Predicate Device
Device Name	Multiple Brand Names	Multiple Brand Names
Classification Name	Contact Lens Case	Contact Lens Case
Product Code	LRX	LRX
Comparison Statement	The applicant device has same classification information as predicate device.
Intended Use	The applicant contact lens case is intended for use by contact wearers or practitioners for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection.	The predicate contact lens case is to be used by the contact wearer or practitioner for storing soft, rigid gas permeable or hard contact lenses. This particular contact lens case is not designed for heat disinfection. It is only designed for chemical disinfection.
Indications	Storage and disinfection of soft, rigid gas permeable or hard contact lenses.	Storage and disinfection of soft, rigid gas permeable or hard contact lenses.
Disinfection Type	Chemical disinfection, not heat disinfection.	Chemical disinfection, not heat disinfection.
Design	Two adjoining chambers with screw top into which contact lenses are immersed.	Two adjoining chambers with screw top into which contact lenses are immersed.
Main Material	Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS)	Polypropylene (PP) and Acrylonitrile-Butadiene-Styrene copolymer (ABS)
Comparison Statement	The applicant device has a similar design and uses the same materials as the predicate.
Screw On Caps	Yes	Yes
R/L indications on chamber bottoms and/or top	Yes	Yes
Non-vented caps	Yes	Yes

COMPARISON OF TECHINICAL CHARACTER

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CONCLUSION

807.92(b) (3)

The applicant contact lens case is similar to the predicate device in

. Intended use
. Materials
. Design

The applicant contact lens case introduces no new questions concerning safety and efficacy.

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.”