(54 days)
CyberCases by Bausch & Lomb are indicated for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
CyberCases by Bausch & Lomb consist of a polypropylene cap and polypropylene body for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
Acceptance Criteria and Study for CyberCases™ by BAUSCH & LOMB
This submission is for a contact lens case, which is a relatively low-risk device. The regulatory pathway chosen is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, a comprehensive clinical study with specific performance metrics such as sensitivity, specificity, or AUC is not typically required or performed for this type of device. The "acceptance criteria" are primarily established through a series of in-vitro studies to demonstrate safety and effectiveness equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Submission) | Reported Device Performance |
|---|---|
| Biocompatibility/Toxicity: No significant toxicological effects on contact lenses or ocular tissues from materials in the contact lens case. | "A series of in-vitro toxicological... studies were performed to assess the safety... All studies were conducted in compliance with the Good Laboratory Practice Regulation for Nonclinical Laboratory Studies. Results of the testing demonstrate that the safety... of the CyberCases by Bausch & Lomb is equivalent to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case." |
| Chemical Compatibility/Leachables: Materials in the contact lens case do not leach harmful substances into contact lens solutions or affect lens integrity. | "A series of in-vitro... chemical studies were performed to assess the... effectiveness of the CyberCases by Bausch & Lomb in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products." Results support equivalence to the predicate device. |
| Material Durability/Functionality: The device should maintain its structural integrity and function (e.g., proper sealing) during its intended use. | Implied by "effectiveness" studies demonstrating equivalence to the predicate. No specific performance metrics (e.g., seal strength, number of cycles) are provided in the summary. |
| Indications for Use: The device can safely and effectively store hard, rigid gas permeable, and soft contact lenses during chemical disinfection. | "CyberCases by Bausch & Lomb are substantially equivalent in terms of indications for use, safety and effectiveness to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case..." |
| Equivalence to Predicate Device: Demonstration of substantial equivalence to the Bausch & Lomb® Sight Savers® Contact Lens Case (K852384) in terms of safety and effectiveness. | "Results of the testing demonstrate that the safety and effectiveness of the CyberCases by Bausch & Lomb is equivalent to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for the in-vitro toxicological and chemical studies. It generically states "A series of in-vitro toxicological and chemical studies were performed." Without explicit mention, it is assumed these were laboratory-based studies, not involving human subjects or patient data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective does not apply in the typical sense for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. Given that the studies were "in-vitro toxicological and chemical studies" conducted in a lab environment, there would not be "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). The "ground truth" would be objective scientific measurements and observations from the laboratory tests (e.g., chemical assays, cell viability tests), interpreted by qualified scientists or toxicologists. The submission does not specify the number or qualifications of the personnel who interpreted these lab results.
4. Adjudication Method for the Test Set
N/A. This is not applicable to in-vitro toxicological and chemical studies. Adjudication methods like 2+1 or 3+1 are used for clinical trials or image interpretation where human expert agreement is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for medical imaging devices or diagnostic aids where human interpretation is involved and the impact of an AI algorithm on reader performance is being evaluated. This submission relates to a contact lens case, not a diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical product (contact lens case), not an algorithm or AI-powered system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's "performance" is demonstrated through its physical and chemical properties and interaction with contact lenses and solutions.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the CyberCases™ was established through objective laboratory measurements and scientific observations from in-vitro toxicological and chemical studies. This would include direct measurements of material properties, chemical leachables, and effects on cell cultures or contact lens materials.
8. Sample Size for the Training Set
N/A. This device is not an AI/ML algorithm or software that requires a "training set." The submission describes a physical product, and its evaluation relies on established in-vitro testing methodologies rather than machine learning.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for this physical device, there is no ground truth to establish for it.
§ 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.”