(83 days)
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in OPTI-FREE® EXPRESS Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Bolution, Or ITT FRD - Icansing, Diomisoning and Stering Colution or conditioned in OPTI-SOAK® Conditioning Solution. Use as recommended by your eye care practitioner.
OPTI-FREE® SUPRACLENS® Daily Protein Remover is a preservative-free solution which contains propylene glycol, sodium borate, and highly purified porcine pancreatin enzymes as the active cleaning ingredient.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, formatted as requested:
Device: OPTI-FREE® SUPRACLENS® Daily Protein Remover
Context: 510(k) Premarket Notification (K990480)
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several aspects of performance and safety, but it does not present explicit, quantitative acceptance criteria with corresponding performance metrics in a clear, tabulated format. Instead, it describes studies and concludes that the device "meets FDA criteria," "is not cytotoxic," "ocular effects... were of no clinical significance," and "provides clinically equivalent cleaning."
Below is an attempt to synthesize the information into a table, inferring "acceptance criteria" from the described outcomes.
| Aspect Evaluated | Implied Acceptance Criteria (from FDA Guidelines/Clinical Significance) | Reported Device Performance |
|---|---|---|
| Non-Clinical Data | ||
| Disinfection Efficacy | Meets FDA guidelines for contact lens solutions disinfection efficacy | Meets FDA criteria for disinfection of contact lenses |
| Cytotoxicity | Not cytotoxic in agar overlay assay | Not cytotoxic in the agar overlay assay |
| Ocular Irritation (14-day study) | Ocular effects should be minimal and of no clinical significance | Ocular effects were generally confined to the conjunctiva, minimal in nature, and judged to be of no clinical significance |
| Cleaning Efficacy | Satisfactorily cleans laboratory deposited lens | Satisfactorily cleans deposits commonly found on hydrophilic contact lenses |
| Product Compatibility | Compatible with hydrophilic soft contact lenses (Groups I-IV) | Compatibility demonstrated with hydrophilic soft contact lenses (Groups I-IV) |
| Clinical Data | ||
| Clinical Cleaning Efficacy | Clinically equivalent cleaning compared to historical control | Provides clinically equivalent cleaning compared to historical control regimen in maintaining visibly clean lenses |
| Overall Clinical Acceptability | Clinically acceptable for all efficacy variables | Clinically acceptable as measured by: lens replacements, patient convenience and comfort, corrected visual acuity, and lens wearing time |
| Serious Adverse Events | No serious adverse events related or unrelated to the regimen | No serious adverse events related or unrelated to the regimen were reported |
| Intolerance Incidence | Clinically equivalent to historical control regimen | Incidence of intolerance (3.2%) was clinically equivalent to historical control (2.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 62 patients / 124 eyes
- Data Provenance: The document does not explicitly state the country of origin. The submission is to the US FDA, so it's reasonable to infer the study was conducted in the US or under US regulatory standards, but this is not explicitly stated.
- Retrospective or Prospective: Prospective. The clinical study was "a three-month, open-label, multi-site study with a descriptive control," indicating a planned, forward-looking design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the study evaluated "clinically clean" lenses and "efficacy variables," which would typically involve expert assessment, but the specifics are not given. For the non-clinical studies (microbiological, cytotoxicity, ocular irritation), the "ground truth" is based on standard scientific assay results and interpretations rather than expert consensus in the same way a clinical image might be.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical study. It mentions a "descriptive control" and evaluation of "efficacy variables," suggesting direct assessment by investigators rather than an independent adjudication panel for potentially ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The clinical study compares the new regimen to a "historical control regimen" (OPTI-FREE® SUPRACLENS® Daily Protein Remover/ OPTI-FREE® Rinsing. Disinfection and Storage Solution/OPTI-FREE® Daily Cleaner), but it's not structured as an MRMC study designed to assess reader improvement with or without AI assistance. The device is a cleaning solution, not an AI diagnostic tool.
6. Standalone Performance Study
The reported studies (non-clinical and clinical) evaluate the performance of the product (OPTI-FREE® SUPRACLENS® Daily Protein Remover in combination with Bausch & Lomb ReNu® Multi-Purpose Solution). Since this is a contact lens care product, not an algorithm or AI, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable. The product's performance is its standalone performance within the context of its indicated use.
7. Type of Ground Truth Used
- Non-Clinical Studies:
- Microbiological: Standard FDA guidelines for disinfection efficacy (laboratory-based measurements).
- Cytotoxicity: Agar overlay assay results (laboratory-based measurements).
- Ocular Irritation: Observational findings in rabbits by qualified personnel (pre-clinical animal model).
- Cleaning Efficacy: Laboratory-deposited lens cleaning assessment (objective laboratory-based assessment).
- Clinical Study:
- Clinical assessment of "visibly clean" lenses, lens replacements, patient convenience and comfort, corrected visual acuity, lens wearing time, and incidence of intolerance. This combines objective measures with subjective patient reports and clinical observations by investigators.
8. Sample Size for the Training Set
The document describes studies for a marketed product (cleaning solution), not an AI algorithm. Therefore, there is no concept of a "training set" as understood in machine learning. The studies conducted are for performance validation rather than model training.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" is not applicable here as this is not an AI/algorithm-based device.
§ 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.”