(73 days)
Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.
The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage.
This document describes a 510(k) submission for Sauflon Contact Lens Cases and focuses on their substantial equivalence to a predicate device rather than a study with acceptance criteria for a new device's performance. Therefore, most of the requested information regarding acceptance criteria, study details, and expert ground truth is not explicitly available in this type of submission.
However, I can extract the information relevant to the safety and effectiveness assessment conducted:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a contact lens case, the "acceptance criteria" are not reported as specific numerical thresholds for performance metrics. Instead, "acceptance" is implicitly defined by demonstrating that the device is substantially equivalent to a predicate device, particularly regarding safety aspects. The reported "performance" is the successful completion of safety studies without adverse findings.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No evidence of cellular toxicity (Cytotoxicity) | Results of testing show no evidence of cellular toxicity. |
| No evidence of systemic toxicity | Results of testing show no evidence of systemic toxicity. |
| No evidence of ocular irritation | Results of testing show no evidence of ocular irritation. |
| Substantial equivalence in indications for use to predicate device | The SAUFLON contact lens cases are substantially equivalent in terms of indication for use (storage of contact lenses during chemical disinfection) to the Bausch and Lomb Lens Case. |
| Substantial equivalence in safety to predicate device | Demonstrated through the absence of toxicity and irritation, showing similar safety profile to the predicate. |
| Substantial equivalence in effectiveness to predicate device | Demonstrated through similar design and intended function for chemical disinfection, implying similar effectiveness in maintaining lens hygiene as the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in terms of number of units or biological samples used for the cytotoxicity, systemic toxicity, and ocular irritation studies.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is typically detailed in the full study reports, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable/not stated. The safety studies (cytotoxicity, systemic toxicity, ocular irritation) would be assessed by trained toxicologists and histopathologists, but a "ground truth" derived from expert consensus in the diagnostic sense is not relevant here.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/not stated. The results of the toxicology studies would be interpreted by specific scientific methods rather than through an adjudication process among multiple experts as typically seen in clinical diagnostic studies.
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:
- MRMC study: No, this type of study is not relevant for a contact lens case. MRMC studies are typically for diagnostic AI systems that assist human readers in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone performance: No, this is not a diagnostic algorithm. The "device" is a physical product (contact lens case), not software or AI.
7. The type of ground truth used:
- Type of ground truth: For the safety studies (cytotoxicity, systemic toxicity, ocular irritation), the "ground truth" would be established by scientific methods and measurements (e.g., cell viability assays, histopathological examination, irritation scoring) against established toxicity standards and biological responses. It's objective scientific criteria rather than "expert consensus" or "pathology" in a diagnostic imaging context.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This device is not an AI/ML product that requires a "training set."
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable.
§ 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.”