(280 days)
Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.
Eye-Cept® Sterile Saline Solution is provided in single use, carry-on size bottles that are preservative free. It rinses loose debris and cleaning solution off soft (hydrophilic) contact lenses. It is only for use to rinse and wet soft contact lenses (a) after cleaning before disinfection and (b) after disinfection before using. It is not a disinfectant nor should it be used as eye drops. It is a clear solution and should not be used, if cloudy or discolored. The individual 10 ml bottle should not be kept once used; it should be discarded after opening. It should not be used after its labeled expiry date.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Eye-Cept® Sterile Saline Solution.
Important Note: The provided document is a 510(k) Summary for a contact lens care product, not a medical device in the typical sense of AI/CADe systems that require clinical studies with human readers. Therefore, many of the requested elements (like sample sizes for test sets, number of experts, MRMC studies, standalone performance for AI, etc.) are not applicable to this type of submission. The "study" here refers to pre-clinical and laboratory testing to demonstrate safety and effectiveness for a chemical solution.
Acceptance Criteria and Reported Device Performance for Eye-Cept® Sterile Saline Solution
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for "Eye-Cept® Sterile Saline Solution" are primarily based on demonstrating substantial equivalence to predicate devices and conformance to specified physicochemical properties and safety/effectiveness standards outlined in FDA guidance documents for contact lens care products.
| Characteristic / Acceptance Criterion | Eye-Cept® Sterile Saline Solution Performance | Reference/Standard |
|---|---|---|
| Intended Use Equivalence | Matches predicate devices’ intended use for rinsing soft (hydrophilic) contact lenses after cleaning and wetting before use after disinfection. | Substantial Equivalence to K093367, P790011 |
| Preservative-Free | Yes | K093367, P790011 |
| Sterile | Yes | K093367, P790011 |
| Aqueous solution of NaCl & Borates | Yes | K093367, P790011 |
| pH balanced | Yes (pH 7.2-7.8) | K093367, P790011 |
| Tonicity | 290-320 mOsm/kg | - |
| Container Material | Polyethylene | K093367, P790011 |
| Propellants | None | K093367, P790011 |
| In vitro cytotoxicity | Non-toxic solution and polyethylene container | FDA Guidance Document |
| Acute Ocular Irritation | No acute ocular irritation | FDA Guidance Document |
| Antibacterial Effectiveness | Effective (as saline, not a disinfectant) | FDA Guidance Document |
| Overall Safety & Effectiveness | As safe, effective, and performs as well as predicate devices. | Substantial Equivalence |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify exact sample sizes for the in vitro cytotoxicity, acute ocular irritation, or antibacterial effectiveness tests. For these types of tests, sample sizes are typically determined by established laboratory protocols and standards for chemical testing, rather than patient-based test sets used for AI/CADe.
- Data Provenance: The studies were conducted by Optics Laboratory, Inc. to support their 510(k) submission. The data is internal to the manufacturer, as is standard for pre-market submissions of this nature. The country of origin for the data is implicitly the USA, where the sponsor is located and where the FDA operates. The studies are described as having been completed "to demonstrate the substantial equivalence," implying they were specifically conducted for this submission (prospective in that sense, but not a prospective clinical trial).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable to this type of device. "Ground truth" in the context of diagnostic devices typically refers to expert consensus, pathology, or clinical outcomes for patient data. For a sterile saline solution, the "ground truth" is established by laboratory measurements (e.g., pH meters, osmometers, cytotoxicity assays) and standardized animal or in vitro tests for irritation and antimicrobial properties. These are measured by laboratory technicians and scientists following established protocols, rather than medical experts forming a consensus.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret medical images or perform clinical assessments, and disagreement needs to be resolved. For laboratory-based chemical and safety testing, the results are typically quantitative measurements or qualitative observations directly interpreted by trained laboratory personnel.
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
- This question is not applicable. An MRMC study is relevant for AI/CADe diagnostic devices that assist human readers in interpreting medical data. The Eye-Cept® Sterile Saline Solution is a chemical solution, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This device is a chemical solution, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established through:
- Physicochemical Measurements: Direct measurements of properties like pH (7.2-7.8) and tonicity (290-320 mOsm/kg).
- In vitro Laboratory Assays: Tests for cytotoxicity (evaluating non-toxicity of the solution and container).
- Animal Testing: Acute ocular irritation studies (demonstrating no irritation).
- Microbiological Testing: Antibacterial effectiveness (to ensure it does not promote microbial growth, though it is not a disinfectant).
- Substantial Equivalence: Demonstrating that its characteristics and performance are comparable to legally marketed predicate devices.
8. The Sample Size for the Training Set
- This question is not applicable. The concept of a "training set" and "test set" applies to machine learning algorithms. For a chemical solution, there is no "training set" in this context. The manufacturing process is developed and validated, but this is distinct from training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reasons above.
§ 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.”