PARAGON LENS CARE

• K Number: K974635
• Device Name: PARAGON LENS CARE
• Manufacturer: PARAGON VISION SCIENCES
• Date Cleared: 1998-02-04 ( 54 days)
• Product Code: LRX
• Regulation Number: 886.5928
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: k962512

Intended Use

The Paragon Contact Lens Case is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.

Device Description

Trade Name: Paragon Contact Lens Case
Common Name: Contact lens Case
Classification Name: Contact Lens Case

AI/ML Overview

The provided text is a 510(k) summary for a contact lens case, which is a physical medical device, not a software algorithm. Therefore, the questions regarding acceptance criteria and studies for a device meeting those criteria, particularly those related to AI/algorithm performance, ground truth, expert consensus, and sample sizes for training/test sets, are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and includes information about toxicology testing for the materials used in the contact lens case.

Here's a breakdown of what is available in the provided text, related to the nature of the device:

1. Acceptance Criteria and Reported Device Performance: Not applicable in the context of an algorithm. For a physical device like a contact lens case, acceptance criteria typically involve material biocompatibility, structural integrity, and effective containment/disinfection properties. The document mentions Toxicology Testing as follows:

   • Systemic Injection Test
   • Eye Irritation Test
   • Cytotoxicity test
     No specific quantitative "performance" metrics for these tests are provided in the summary, just that information from these tests was submitted in support of the premarket notification.

2. Sample size used for the test set and the data provenance: Not applicable. Toxicology testing usually involves in-vitro or animal studies, not "test sets" of data in the AI sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This pertains to AI-assisted reading, which is not relevant for a contact lens case.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable. For toxicology, the "ground truth" would be the observed biological response to the materials.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In essence, the provided document is a regulatory submission for a physical medical device (contact lens case) and does not contain information relevant to the performance evaluation of an AI or algorithmic device as requested by your prompt.

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.”