(336 days)
Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
Bausch & Lomb BPZ02 MultiPurpose Solution is a sterile, isotonic solution that contains hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium and sodium chloride; and preserved with a dual disinfection system. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
The provided text describes the Bausch & Lomb BPZ02 MultiPurpose Solution, a soft contact lens care solution. The document focuses on demonstrating the substantial equivalence of this solution to predicate devices through various tests rather than establishing acceptance criteria and conducting a study to prove a device meets those criteria in the context of an AI/ML device.
However, I can extract the information relevant to the studies performed for this product, interpreting "acceptance criteria" as the successful demonstration of safety and effectiveness parameters established for contact lens solutions.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-ocular irritant, non-sensitizing. | BPZ02 MultiPurpose Solution is non-cytotoxic, and not an ocular irritant or sensitizing agent. |
| Microbiology | Exceeds criteria for disinfection and preservative efficacy as per EN ISO 14729:2001 and EN ISO 14730:2000. | Bausch & Lomb BPZ02 MultiPurpose Solution exceeds the criteria for disinfection and preservative efficacy. |
| Lens Compatibility | Compatible with soft contact lenses, including silicone hydrogel contact lenses. | Bausch & Lomb BPZ02 MultiPurpose Solution is compatible with soft contact lenses including silicone hydrogel contact lenses. |
| Cleaning Efficacy | Surfactant concentrations are well above the Critical Micelle Concentration (CMC) for individual surfactants (indicating effective cleaning). | The surfactant concentrations are well above the CMC for the individual surfactants. |
| Clinical Efficacy & Safety | Safety and efficacy comparable to predicate devices (AQuify Multi-Purpose Disinfecting Solution). | A controlled clinical study demonstrated comparable safety and efficacy of Bausch & Lomb BPZ02 MultiPurpose Solution to AQuify Multi-Purpose Disinfecting Solution for soft and silicone hydrogel contact lenses. The results support substantial equivalence. |
Regarding the other requested information, which is more applicable to AI/ML device studies, the provided text does not contain it:
- Sample size used for the test set and the data provenance: Not applicable or not specified for these types of studies (biocompatibility, microbiology, lens compatibility, cleaning efficacy). For the clinical study, the sample size is not mentioned, nor is data provenance beyond "controlled clinical study."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of studies is based on established laboratory methods and clinical assessments.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 solution, not an AI/ML diagnostic or assistive device for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the preclinical studies (biocompatibility, microbiology, lens compatibility, cleaning) would be based on validated laboratory standards and measurements. For the clinical study, it would be direct clinical observation (e.g., patient comfort, adverse events, lens clarity) and potentially objective measures relevant to lens care.
- The sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) summary for the Bausch & Lomb BPZ02 MultiPurpose Solution demonstrates its safety and effectiveness by comparing its performance against established industry standards and predicate devices through a series of preclinical and clinical studies, rather than through an AI/ML-specific validation framework.
§ 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.”