(39 days)
For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye practitioner.
For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-ZYME® Enzymatic Cleaning Tablets.
OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing borates, citrates, mannitol, and sodium chloride with PATONIC® and TETRONIC® surfactants, and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.001% preservatives.
The provided text describes a 510(k) premarket notification for a contact lens care solution, focusing on protein removal. However, it does not detail acceptance criteria in a quantitative manner, nor does it provide the specifics of a study in the format requested (e.g., sample sizes, expert qualifications, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance).
The information provided largely focuses on demonstrating substantial equivalence to a predicate device and a new claim for protein removal, rather than a detailed technical performance evaluation against specific quantitative acceptance criteria.
Therefore, much of the requested information cannot be extracted from the given document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Protein Removal (General, implicit) | "significantly more protein was removed from both human-worn and laboratory deposited Group IV lenses by OPTI-ONE Multi-Purpose Solution than by ReNu MultiPlus Multi-Purpose Solution." |
| Substantial Equivalence to Predicate Device (Bausch & Lomb ReNu MultiPlus™ Multi-Purpose Solution) for existing indications and actions | Claimed and accepted by FDA for existing actions and indications. |
| Compliance with FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products | Stated as meeting these guidelines. |
| Sterility, pH, isotonicity, chemical composition as described | Implicitly met to support safety and effectiveness. (No specific values provided) |
| Cleaning capabilities (general) | Implicitly met for daily cleaning claim. |
| Chemical disinfection capabilities (general) | Implicitly met for chemical disinfection claim. |
| Storage capabilities (general) | Implicitly met for storage claim. |
| Diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover | Claimed and accepted for this use. |
| Dissolution of OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets | Claimed and accepted for this use. |
Missing from the document regarding acceptance criteria:
- Specific quantitative thresholds for "significantly more protein removed."
- Any other specific, quantitative acceptance criteria for cleaning, disinfection, storage, or safety beyond the general claim of superiority in protein removal for certain lens types and substantial equivalence.
2. Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document only mentions "Group I and IV human-worn and laboratory deposited lenses." It does not provide the number of lenses or subjects used in these tests.
- Data Provenance: The document implies laboratory studies and human-worn lens studies, but does not specify the country of origin of the data. It is a prospective study as tests were conducted to support a new claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a contact lens solution, and the "ground truth" here relates to objective biochemical measurements (protein removal) rather than expert interpretation of images or patient data. No experts for ground truth establishment were mentioned or would typically be used in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As above, the evaluation is based on objective laboratory measurements for protein removal, not subjective interpretations requiring adjudication.
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 chemical solution, not an AI-powered diagnostic device. An MRMC study is irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a chemical solution, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the protein removal claim was based on objective laboratory measurements of protein removed from lenses (both human-worn and laboratory-deposited). This would involve analytical chemistry techniques to quantify protein levels.
8. The sample size for the training set:
- Not applicable. This product is a chemical solution, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for a chemical solution, this information is not relevant.
§ 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.”