(75 days)
Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. It is also indicated for the in-office cleaning, rinsing and chemical (not heat) disinfection and storage of trial soft (hydrophilic) lenses for up to thirty (30) days.
Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE™ (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED* (polyaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution is also indicated for use in the in-office chemical (not heat) disinfection of trial soft (hydrophilic) contact lenses. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
The provided text describes the regulatory clearance of "BAUSCH & LOMB ReNu MultiPlusTM MULTI-PURPOSE SOLUTION" and its substantial equivalence to a predicate device. It details the product's indications for use and mentions certain preclinical and clinical studies, as well as adherence to specific ISO/CEN and FDA regimen procedures for disinfecting products.
However, the document does not contain the detailed information typically found in acceptance criteria and a study report for a medical device's performance characteristics in the context of an AI/algorithm-driven device. Specifically, it lacks:
- A table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures.
- Information on sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth establishment.
- Adjudication methods, MRMC studies, standalone performance details, training set size, or how ground truth for training data was established.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, particularly regarding safety and effectiveness for its intended use as a contact lens solution. The efficacy outlined is related to its biocidal properties against specific microorganisms.
Based on the provided text, here is an attempt to address your request, highlighting what is available and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document refers to adherence to specific standards rather than specific quantitative performance metrics like sensitivity or specificity.
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Primary performance criteria of the draft ISO/CEN Stand-alone Procedure for Disinfecting Products (March 23, 1995) | Results met the primary performance criteria |
| Draft Stand-alone Procedure for Disinfecting Products (June 7, 1995) from the draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products | Results met the primary performance criteria |
| ISO FDA Regimen Procedure for Disinfecting Regimens (for Herpes simplex Virus, Type 1 and Adenovirus Type 7) | Satisfactory results at thirty (30) days for both viruses tested |
Device Performance Details:
- Biocidal Efficacy: Demonstrated against S. aureus, Ps. aeruginosa, S. marcescens, C. albicans, and F. solani at thirty (30) days, with and without lenses, in glass vials.
- Viral Efficacy: Demonstrated against Herpes simplex Virus, Type 1 and Adenovirus Type 7 at thirty (30) days.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text for the biocidal and viral efficacy tests. The text mentions these tests were performed "in glass vials," implying laboratory-based testing rather than patient data.
- Data Provenance: The efficacy tests were laboratory-based (in vitro), conducted to meet international and FDA draft standards. The country of origin for the underlying data is not specified beyond "preclinical and clinical studies were completed on this product and have previously been submitted under Premarket Approval Application P860023/ S12." These previous submissions likely contain more detailed provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The "ground truth" for biocidal efficacy and viral efficacy tests would be determined by laboratory methods and established microbiological standards, not typically by human experts in the way that clinical imaging or diagnostic AI is assessed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically associated with human expert review of clinical cases. For laboratory efficacy studies, the results are typically quantitative and objective.
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 document pertains to a contact lens solution, not an AI or algorithm-driven diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- A standalone performance (algorithmic only) was effectively demonstrated for the solution's biocidal efficacy. The solution itself is the "algorithm" in this context, acting upon microorganisms without human intervention in its primary function. The reference to "ISO Stand Alone Procedure for Disinfecting Products" directly supports this.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for the efficacy studies was based on established laboratory testing methods for microbiological and virological reduction/inactivation, as defined by ISO/CEN and FDA draft standards. This is a form of objective, standardized laboratory measurement against known pathogens.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. The efficacy studies described are validation studies for the chemical solution itself, not for training a model.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this is not an AI/machine learning device using a training set.
§ 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.”