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The LensGiene™ Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The LensGiene™ Sterile Saline Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The LensGiene™ Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chloride, boric acid, and sodium borate provided in single does, carry-on size 10 ml bottles. The sterile saline solution has a pH 7.2-7.8 and a tonicity of 290-320 mOsm/kg. It rinses loose debris and cleaning solution off soft (hydrophilic), rigid gas permeable (RGP) and hard contact lenses prior to insertion. The rinsing solution removes debris and bacteria following proper disinfection as recommended by the eye care practitioner. The sterile saline solution can be used to rinse contact lens cases, rinse lenses as needed throughout the day and to fill the concave posterior surface of scleral lenses prior to insertion to provide a more natural environment than currently approved multipurpose solutions which contain preservatives and osmolarity agents that are not designed to be held against the cornea for extended periods of time.

The LensGiene™ Sterile Saline Solution is a clear solution and should not be used if cloudy or discolored. The individual 10 ml bottle should be discarded after opening and use and should not be used after its labeled expiry date.

This document describes the 510(k) summary for the LensGiene™ Sterile Saline Solution. It is a submission for a medical device and, as such, there are no acceptance criteria or studies to prove the device meets acceptance criteria in the way you've outlined for an AI/algorithm-based device.

The document states that non-clinical and clinical data were unnecessary because the solution was previously submitted and cleared under 510(k) K110221. This means the current submission is relying on prior approvals and established equivalence to predicate devices, rather than new performance studies with specific acceptance criteria.

Therefore, for the information you've requested, the answer is that these criteria and studies were not conducted for this 510(k) submission. However, I can still extract details that relate to the device's characteristics and the basis for its clearance, if reinterpreted for this context:

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for a sterile saline solution and not an AI or algorithm, there aren't "acceptance criteria" in the traditional sense of performance metrics for an algorithm. Instead, the "performance" is based on its composition and how it compares to predicate devices. The closest equivalent is the comparison table to predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. No new test set was used for this 510(k) submission as the device's performance relies on previously cleared data and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new adjudication was performed.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this submission. The "ground truth" for saline solutions generally pertains to sterility, biocompatibility, and chemical composition, which would have been established during the studies for the predicate devices (K110221 specifically).

8. The sample size for the training set: Not applicable. No training set for an algorithm was used.

9. How the ground truth for the training set was established: Not applicable. No training set was used.

Summary of the basis for clearance for this specific submission (K161622):

The LensGiene™ Sterile Saline Solution received 510(k) clearance based on its substantial equivalence to two predicate devices:

• Menicon Co., Ltd. Saline Rinse Solution (K151768)
• Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221)

The key justification was that the LensGiene™ solution has a similar composition (sterile, preservative-free aqueous solution of sodium chloride, boric acid, and sodium borate with specific pH and tonicity) and intended use as the predicate devices. The submission explicitly states: "Non-clinical tests were unnecessary for this application because this testing was previously submitted for this solution under cleared 510(k) K110221." and "Clinical studies were unnecessary for this application because this solution was previously cleared for rinsing soft (hydrophilic) contact lenses under K110221." This means that the original safety and effectiveness data for a very similar product (EyeCept™ Sterile Saline Solution, K110221) was leveraged for this new submission.

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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.

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.

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Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a US FDA 510(k) clearance letter for a device called "Eye-Cept Rewetting Drops". It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory information and indications for use. It does not contain any performance study data or details about an AI/algorithm-based device.

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