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510(k) Data Aggregation
(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.
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(84 days)
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK" Conditioning Solution or Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is for the disinfection and conditioning after cleaning and rinsing of clear and tinted, daily and extended wear fluorosilicone acrylate and silicone acrylate rigid gas permeable lenses.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
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.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is a sterile, aqueous solution buffered to approximate the pH and tonicity of the eye. It contains METHOCEL", a wetting and cushioning agent, boric acid, sodium borate, sodium chloride and mannitol, and is preserved with POLYQUAD® (polyguaternium-1) 0.0011%, and edetate disodium 0.10%.
The provided text describes the regulatory filing for a contact lens cleaning and disinfecting solution, detailing its components, intended use, and substantial equivalence to existing products. It also mentions safety and effectiveness studies. However, the document does not contain the specific kind of performance metrics, acceptance criteria, study details, and ground truth information that would typically be found in a study proving a device meets acceptance criteria in the context of a medical device evaluation for diagnostic or AI-based devices.
The information provided pertains to contact lens solutions, which are regulated differently and typically require demonstration of antimicrobial efficacy, cleaning efficacy, and lens compatibility rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information using the provided text.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance in terms of diagnostic metrics.
- Sample sizes used for a "test set" or information about data provenance for such a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance results.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
The "studies" mentioned are largely microbiological studies, preclinical cytotoxic evaluations, compatibility/cleaning efficacy evaluations, and a general clinical study stating safety and effectiveness for a contact lens solution regimen. These are not equivalent to a performance study for a diagnostic AI device.
If you can provide a document related to a diagnostic or AI-based device, I would be happy to help extract the information you are seeking.
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(83 days)
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while they are being disinfected (soaked) in Alcon Multi-Purpose Disinfecting Solution ID 90746, OPTI-FREE Rinsing, Disinfection and Storage Solution, OPTI-FREE EXPRESS Multi-Purpose Solution or OPTI-ONE Multi-Purpose Solution. Use as recommended by your eye care practitioner.
OPTI-FREE® SUPRACLENS® Daily Protein Remover is a sterile, preservative-free aqueous suspension, containing pancreatin as the active cleaning agent.
This document describes the acceptance criteria and supporting studies for the OPTI-FREE® SUPRACLENS® Daily Protein Remover.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Microbiological Safety & Effectiveness | Meet FDA Stand-Alone criteria for disinfection against bacteria, yeast, and mold during simultaneous enzymatic cleaning and disinfection. | "The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold." | Non-Clinical: Microbiological Studies |
| Preclinical Toxicology | Demonstrate safety for use in cleaning all soft (hydrophilic) contact lenses (Group I, II, III, and IV). | "Preclinical toxicology tests have been conducted to substantiate the safety of the product for use in cleaning, of all soft (hydrophilic) contact lens (Group I, II, III, and IV)." Specific tests included cytotoxicity (agar overlay) and ocular safety (irritation) evaluations. | Non-Clinical: Preclinical Toxicology Tests |
| Compatibility/Cleaning Efficacy | Demonstrate product compatibility with soft contact lenses. | "The studies demonstrated the compatibility... of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen." | Non-Clinical: Compatibility Studies |
| Compatibility/Cleaning Efficacy | Demonstrate cleaning efficacy for laboratory deposited lenses. | "The studies demonstrated... cleaning efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen." | Non-Clinical: Cleaning Efficacy Studies |
| Clinical Safety & Efficacy | Clinically evaluate safety and efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen for cleaning, rinsing, and disinfection of all soft (hydrophilic) contact lenses. | "This clinical study demonstrated the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses." | Clinical Study |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Study Test Set:
- Sample Size: 65 patients / 130 eyes
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve prospective data collection within a controlled clinical trial setting, likely within the US given the submission to the FDA. The document does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
-
Non-Clinical Studies (Microbiological, Preclinical, Compatibility/Cleaning Efficacy):
- Sample Size: Not specified in the provided text for these studies.
- Data Provenance: Not specified. These are laboratory-based studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The clinical study evaluated safety and efficacy, which generally involves clinicians assessing outcomes, but the number and qualifications of experts for establishing 'ground truth' in the context of diagnostic performance are not applicable or detailed for this type of product (a contact lens cleaning solution).
4. Adjudication Method for the Test Set
- Not applicable/Not specified. For a contact lens cleaning solution, outcomes are typically measured through objective and subjective clinical assessments (e.g., irritation, protein removal, microbial counts) rather than a diagnostic 'ground truth' established by multiple expert readers requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices where human readers interpret medical images or data. The OPTI-FREE® SUPRACLENS® is a contact lens cleaning solution, not a diagnostic device.
6. Standalone Performance Study
- Yes, a standalone study was performed in the context of microbiological effectiveness.
- The "Microbiological Studies" section states, "The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold." This refers to established regulatory guidelines for testing the disinfectant properties of contact lens solutions acting alone without human intervention in the disinfection process itself.
7. Type of Ground Truth Used
- Microbiological Studies: Ground truth was based on established FDA Guidelines for contact lens solutions, which define the "Stand-Alone criteria" for microbial reduction (bacteria, yeast, mold). This is a quantitative, laboratory-based standard.
- Preclinical Toxicology: Ground truth was based on scientific standards for cytotoxicity and ocular irritation, measured through laboratory tests (agar overlay, ocular irritation evaluations).
- Compatibility/Cleaning Efficacy: Ground truth was based on objective measures of compatibility with contact lens materials and the ability to remove laboratory-deposited substances.
- Clinical Study: Ground truth for safety and efficacy was established through clinical observation and assessment by eye care practitioners, likely involving a combination of objective clinical findings and potentially patient-reported outcomes (e.g., comfort).
8. Sample Size for the Training Set
- Not applicable/Not specified. This device is a cleaning solution, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning model development. The product development would involve formulations and testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/machine learning device, so there is no training set or associated ground truth establishment in that context.
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