(195 days)
For storage of soft (hydrophilic), hard, and rigid gas permeable contact lenses during chemical disinfections. Use for storage during chemical disinfections only. Do not use heat disinfection.
Our contact lens case will consist of a lens base with dual adjoining wells for the containment of fluid. The case covers are two screw top caps. The contact lens case has a capacity of over 3.0 ml, therefore, any contact lens can be submerged into the chambers.
The provided text is a 510(k) premarket notification summary for a contact lens case. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain a study that proves the device meets explicit acceptance criteria in the way an AI/ML device submission would.
The document is a regulatory submission for a medical device (contact lens case), not an AI/ML diagnostic or prognostic device. Therefore, the detailed information requested regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies for AI/ML performance is not applicable and not present in this document.
For traditional medical devices like a contact lens case, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device has the same intended use, technological characteristics, and raises no new issues of safety or effectiveness. The "study" in this context is the comparison against the predicate device, along with adherence to general controls and relevant regulations.
Here's how the provided information relates to your request, noting the differences for this type of device:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Implicit for a 510(k) submission): That the device has the same intended use, similar technological characteristics, and raises no new issues of safety or effectiveness compared to the predicate device.
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Reported Device Performance: The document states that "The applicant contact lens case is similar to the predicate device in - . Intended use - . Materials - . Design" and "The applicant contact lens case introduces no new questions concerning safety and efficacy." This is the core "performance" claim for substantial equivalence. No quantitative performance metrics (like sensitivity, specificity, AUC) are reported because they are not relevant for a contact lens case's function in the way they would be for a diagnostic tool.
Acceptance Criteria (Implied for 510(k) Equivalence) Reported Device Performance Same Intended Use as Predicate Yes (Intended use is identical; see comparison table) Similar Technological Characteristics as Predicate Yes (Materials and design are similar; see comparison table) No New Questions of Safety or Efficacy Yes (Explicitly stated in the conclusion)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" is the comparison against the predicate device based on its design, materials, and intended use as described in the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is not an AI/ML device requiring expert consensus for ground truth. "Ground truth" for a contact lens case would relate to its physical properties and intended function, which are evaluated through standard engineering and manufacturing processes, and regulatory review based on established standards and the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned or required for this type of device submission.
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 physical non-AI medical device; MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Regulatory Substantial Equivalence: The "ground truth" here is the established safety and effectiveness profile of the predicate device (Arlington Contact Lens Service, Inc. Contact Lens Case, K120969), as determined by its prior FDA clearance. The new device demonstrates "truth" by showing it aligns with this established profile. Its own physical properties and performance (e.g., fluid containment capacity) are verified through internal company testing and manufacturing controls, but not typically detailed in this type of summary.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that uses a training set.
§ 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.”