(132 days)
Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.
There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.
The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.
Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.
The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.
Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Objective) | Reported Device Performance (Conclusion) |
|---|---|
| Cytotoxicity (per ISO 10993-5): Assess if the device material extracts cause cell death or harm. | "Based on the results obtained under laboratory testing conditions, the extract of test item, Contact Lens Case was found to be 'non-cytotoxic' to the subconfluent monolayer of L-929 mouse fibroblast cells." |
| Intracutaneous skin irritation (per ISO 10993-23): Assess if extracts cause skin irritation when injected intradermally. | "Based on the results of the experiment, it is concluded that the polar extracts of test item, Contact Lens Case was 'Nonirritant' to the skin of New Zealand White Rabbits under the experimental conditions and the dose employed as per the ISO 1093 Part 23:2021 (E) Specification." |
| Guinea pig maximization (GPMT) skin sensitization (per ISO 10993-10): Assess the potential for the device material to cause allergic sensitization. | "Based on the above results of the experiment, it is concluded that the polar extracts of Contact Lens Case was found to be 'Non-sensitizer' to the skin of the Guinea pigs under the experimental conditions employed." |
| Acute systemic injection (per ISO 10993-11): Assess the potential for general toxic effects after systemic exposure to extracts. | "Based on the results of the experiment, it is concluded that the polar extracts of test item, Contact Lens Case when administered to Swiss Albino Mice through and intraperitoneal routes respectively at a dose volume of 50 mL/kg body weight did not reveal any systemic toxicity under the experimental conditions employed." |
| Material mediated pyrogenicity (per USP ): Assess the potential for the device material to induce fever. | "Based on the results of the experiment, it is concluded that the extract Lens Case evaluated for progen test in New Zealand White Rabbits is Non-pyrogenic as it meets the requirements of progen test as per U.S. Pharmacopoeia, and General Chapters: Pyrogen Test." |
| Acute ocular irritation testing (per ISO 10993-23): Assess the potential for the device material to cause irritation to the eye. | "Under the experimental conditions employed and based on the observed results of the experiment, it is concluded that polar and non-polar extract of test item, Contact Lens Case did not produce any irritant effects to the eyes of New Zealand White Rabbits as per ISO 10993 'Biological Evaluation of Medical Devices' Part 23:2021(E) 'Test for Irritation'." |
The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.
- Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
- Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
- 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 study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
- The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
- How the ground truth for the training set was established: Not applicable.
§ 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.”