(22 days)
Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
The provided document is a 510(k) summary for the Bausch + Lomb Boston® Scleral Lens Case, intended for storage of gas permeable contact lenses during chemical disinfection. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study establishing acceptance criteria and device performance based on a specific algorithm or AI.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (a contact lens case) undergoing a 510(k) clearance process based on substantial equivalence.
However, I can extract information related to the preclinical testing that was performed to demonstrate the safety and effectiveness of the device.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't outline specific numerical acceptance criteria in the way one might expect for a quantitative performance study (e.g., accuracy, sensitivity, specificity thresholds). Instead, safety and effectiveness are established through biocompatibility testing against established ISO standards and comparison to a predicate device.
| Test Category | Acceptance Criteria (Implicit from ISO Standards) | Reported Device Performance |
|---|---|---|
| Toxicology | Systemic Toxicity: Device materials should not cause systemic toxic effects (ISO 10993-11). | Demonstrated biocompatibility. Met requirements for ISO 10993-11. |
| Cytotoxicity: Device materials should not be toxic to cells (ISO 10993-5). | Demonstrated biocompatibility. Met requirements for ISO 10993-5. | |
| Ocular Irritation/Sensitization: Device materials should not cause ocular irritation or skin sensitization (ISO 10993-10). | Demonstrated biocompatibility. Met requirements for ISO 10993-10. | |
| Microbiology | Microbial Contamination: While not a performance metric for the device itself, the labeling must include warnings about contact lens cases being a source of microbial contamination. | Labeling includes a warning statement regarding cleanliness and replacement of contact lens cases to prevent eye infections. |
| Volume | Sufficient volume to ensure the lens remains completely immersed under conditions of use. | 6.5mL fill volume, which is greater than the predicate device's 3.3mL. (Implies sufficient volume) |
2. Sample size(s) used for the test set and the data provenance:
- Sample Size: Not specified in the document. Biocompatibility tests typically involve a certain number of samples, but the exact count is not given here.
- Data Provenance: The preclinical testing was "sponsored by Bausch + Lomb." The document does not specify country of origin for the data, but it's internal company testing. It is retrospective in the sense that the results were submitted after the tests were concluded.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert readers or ground truth establishment in the context of imaging or diagnostic accuracy. Biocompatibility testing relies on standardized laboratory protocols and analyses, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the preclinical tests 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 not an AI/algorithm-based device and no MRMC study was conducted. The document explicitly states: "Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: The "ground truth" is based on the results of standardized laboratory assays (e.g., cell viability in cytotoxicity tests, observation of reactions in irritation tests, systemic effects in systemic toxicity tests) as defined by the referenced ISO 10993 standards. These are objective measures rather than expert consensus on interpretations.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.”