(15 days)
The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.
This document is a 510(k) summary for a contact lens case, not a study presenting acceptance criteria and device performance data from a clinical trial or algorithm evaluation. Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, etc.) is not present in the provided text.
The document discusses toxicology testing for the contact lens case, which is a type of pre-market safety evaluation. It mentions "Systemic Injection Test," "Eye Irritation Test," and "Cytotoxicity Test." However, it does not provide the specific acceptance criteria for these tests nor the detailed results demonstrating the device meets them. Instead, it merely states that information from these tests was submitted for review.
Here's an attempt to address the request based only on the provided text, highlighting what's missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/Missing Details) | Reported Device Performance |
|---|---|
| Toxicology Testing: | |
| Systemic Injection Test: (Specific criteria for passing - e.g., no systemic toxicity observed) | Information submitted. (Specific results not provided) |
| Eye Irritation Test: (Specific criteria for passing - e.g., no significant eye irritation) | Information submitted. (Specific results not provided) |
| Cytotoxicity Test: (Specific criteria for passing - e.g., non-cytotoxic) | Information submitted. (Specific results not provided) |
| Substantial Equivalence: | |
| Device is substantially equivalent to predicate device (K951552) based on similar designs and indications for use. | Stated as equivalent to BOSTON® Contact Lens Case (K951552) |
Missing Information: The specific acceptance criteria (e.g., quantitative thresholds, qualitative outcomes) for the toxicology tests are not detailed in this summary. The actual numeric or descriptive performance results are also not provided beyond "information from the following was submitted for review."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not mentioned. (Toxicology tests would involve animal models or in-vitro samples, but the number is not specified).
- Data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/mentioned. For toxicology tests, results are typically determined by laboratory protocols and evaluated by qualified personnel in toxicology, but this document does not specify the number or qualifications of "experts" in the context of ground truth establishment.
4. Adjudication method for the test set
- Not applicable/mentioned.
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 contact lens case, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a contact lens case, not an algorithm.
7. The type of ground truth used
- For the toxicology tests (Systemic Injection, Eye Irritation, Cytotoxicity), the "ground truth" would be established by the standardized methods and observations of these specific biological assays.
- For substantial equivalence, the "ground truth" is regulatory equivalence to an already marketed device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- 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.”