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510(k) Data Aggregation
(241 days)
Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing 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 ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
Based on the provided text, the device in question is a multi-purpose contact lens solution (ABT12 multi-purpose solution), not an AI-powered medical device for image analysis. Therefore, many of the typical acceptance criteria and study details related to AI performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of product and approval process.
The document describes the regulatory approval of a contact lens solution (Bausch + Lomb ABT12 multi-purpose solution) for which the primary claims are related to its safety and effectiveness in cleaning, disinfecting, and storing contact lenses. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device (COMPLETE multi-purpose solution Easy Rub Formula) through a combination of preclinical (biocompatibility, microbiology, lens compatibility, cleaning efficacy) and clinical studies.
Here's a breakdown of the requested information, adapted to the context of this non-AI medical device:
Acceptance Criteria and Study for Bausch + Lomb ABT12 Multi-Purpose Solution
As the device is a contact lens solution, not an AI-powered diagnostic tool, the typical "acceptance criteria" table for AI performance metrics (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a contact lens solution primarily revolve around meeting established safety and effectiveness standards, often demonstrated through non-inferiority to a legally marketed predicate device.
| Criteria Category | Specific Acceptance Criteria (Demonstrated via Non-Inferiority to Predicate) | Reported Device Performance (ABT12 Multi-Purpose Solution) |
|---|---|---|
| Clinical Safety | Non-inferiority in ophthalmological findings (e.g., slit lamp findings) compared to predicate. Absence of serious adverse events (SAEs) or device-related adverse events (AEs). No significant changes to corneal health. | The ABT12 group demonstrated non-inferiority to the COMPLETE group Over All Follow-up Visits for slit lamp findings greater than Grade 2. No serious adverse events, adverse device effects, or significant non-serious adverse events were reported in the ABT12 multi-purpose solution group. No eyes were discontinued due to an AE. None of the AEs were considered related to the study solution. No corneal infiltrates were reported, and no changes to pre-existing corneal scars. Visual acuities were similar between groups. Conclusion: Safe for use. |
| Clinical Effectiveness | Non-inferiority in user-reported comfort and dryness. Non-inferiority in lens deposit prevention/removal. | For the three primary effectiveness endpoints (overall comfort averaged over all follow-up visits; dryness averaged over all follow-up visits; and optimal [{none or light} lens deposits at all follow-up visits), the treatment differences indicated that the ABT12 solution is non-inferior to the COMPLETE solution. No notable differences were found regarding symptoms/complaints, worn lens characteristics, and dispensed lens characteristics. Conclusion: Effective for use. |
| Biocompatibility | No significant cytotoxicity, ocular irritation, oral toxicity, or sensitization. Compatibility with various lens materials. | Studies demonstrated the biocompatibility of ABT12 multi-purpose solution, including tests on the solution itself, with maximum preservative concentrations, and with extracts from different lens materials. Leveraged existing clearance for packaging components. Predicate K014202 was used for side-by-side comparison in relevant studies. |
| Microbiological Efficacy | Meets or exceeds criteria for disinfection and preservative efficacy against relevant microorganisms (e.g., as per EN ISO 14729:2001 and EN ISO 14730:2014). | The solution exceeds the criteria for disinfection and preservative efficacy. |
| Lens Compatibility | Compatible with soft contact lenses, including silicone hydrogel contact lenses. | Studies demonstrated compatibility with soft contact lenses, including silicone hydrogel contact lenses. |
| Cleaning Efficacy | Demonstrates effective cleaning properties (e.g., protein removal). | In-vitro laboratory studies demonstrated cleaning properties with artificially protein-deposited contact lenses. Surfactant concentrations are well above the Critical Micelle Concentration (CMC). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study - Test Set): A total of 252 subjects were enrolled. 240 subjects completed the study. These subjects were randomized into two groups:
- ABT12 multi-purpose solution (Test): 127 subjects
- COMPLETE multi-purpose solution (Control/Predicate): 125 subjects
- Data Provenance: The clinical study was a multicenter study conducted in the USA.
- Retrospective or Prospective: This was a prospective, randomized, masked, parallel, bilateral clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for a contact lens solution's performance is established through direct clinical observations (e.g., slit lamp findings by ophthalmologists/optometrists) and patient-reported outcomes, as well as laboratory testing results, rather than expert consensus on image interpretation. The study was masked, implying that the clinicians assessing outcomes were blinded to the treatment assignment.
4. Adjudication Method for the Test Set
This concept (adjudication of interpretations) is not applicable to this type of study. Clinical outcomes were measured directly by investigators in a masked fashion and patient-reported outcomes were collected.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are typically used to evaluate the impact of a diagnostic tool (like AI) on physician performance in interpreting medical images. This study focused on the safety and effectiveness of a physical product (contact lens solution) in a clinical trial setting.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm for this device. The "standalone performance" of the contact lens solution is demonstrated through the preclinical studies (biocompatibility, microbiology, cleaning efficacy, lens compatibility) which evaluate the product's intrinsic properties irrespective of human handling errors (though proper usage instructions are provided).
7. The Type of Ground Truth Used
The ground truth was established through a combination of:
- Clinical Measurements: Objective clinical assessments by masked investigators (e.g., slit lamp findings, visual acuities).
- Patient-Reported Outcomes: Subjective data gathered directly from subjects regarding comfort, dryness, and other symptoms.
- Laboratory Testing: In-vitro and ex-vivo studies to assess intrinsic properties like microbiological efficacy, cleaning efficacy, and biocompatibility.
- Comparison to Predicate: The "truth" of effectiveness and safety was established by demonstrating non-inferiority to a known, legally marketed predicate device.
8. The Sample Size for the Training Set
This question is not applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as this is not an AI/machine learning device.
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(222 days)
For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.
The provided text describes the Alcon Multi-Purpose Disinfecting Solution (MPDS) and its clearance through a 510(k) premarket notification. It outlines the safety and effectiveness studies conducted, but does not present acceptance criteria in a table format with numerical performance metrics for the device. The term "acceptance criteria" is used in a general sense, referring to compliance with guidelines.
Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance Study for Alcon Multi-Purpose Disinfecting Solution (MPDS)
The Alcon Multi-Purpose Disinfecting Solution (MPDS) was evaluated against guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, as well as relevant ANSI and EN ISO standards for microbiological requirements (EN ISO 14729:2001) and antimicrobial preservative efficacy (EN ISO 14730:2000).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table. Instead, it refers to meeting established guidelines and demonstrating clinical equivalence or superiority. The reported performance is qualitative.
| Category | Acceptance Criteria (Implied based on guidance/standards) | Reported Device Performance |
|---|---|---|
| Cleaning Efficacy | Effective removal of protein deposits and reduction of lipid deposition from contact lenses. Surfactant concentrations above Critical Micelle Concentration (CMC). | Alcon MPDS is "effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses." Studies "also demonstrated cleaning activity." Surfactant concentrations are "well above the CMC." |
| Compatibility | Compatibility with soft (hydrophilic) and silicone hydrogel lenses, ensuring no adverse effects on lens material or performance. | "The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses." |
| Microbiology | Meeting or exceeding criteria for disinfection and preservative efficacy as defined by FDA guidance (May 1, 1997), ANSI Z80, EN ISO 14729:2001, and EN ISO 14730:2000. This typically involves specific log reductions for various microorganisms and maintenance of antimicrobial activity over time. | "Alcon MPDS exceeds the criteria for disinfection and preservative efficacy." |
| Biocompatibility | Compliance with guidelines set forth in FDA's May 1, 1997 Guidance, ensuring safety for consumer under recommended and reasonably foreseeable misuse conditions. This typically involves cytotoxicity, sensitization, irritation, and other systemic toxicity tests. | "Based on the results of the comprehensive preclinical evaluations, Alcon MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse." |
| Clinical Efficacy | Clinically acceptable safety and efficacy in silicone hydrogel and soft contact lens wearers, comparable to or better than a legally marketed predicate device (Bausch & Lomb™ renu® fresh™). Outcomes on comfort and moisture from insertion to removal should be adequate. | "The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control." "The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal." |
2. Sample Size and Data Provenance (for test set/clinical study)
- Sample Size: Not explicitly stated for the clinical study. The text only mentions "a clinical study was conducted" with "silicone hydrogel and soft (hydrophilic) contact lens wearers."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and is prospective in nature, as it evaluates the safety and efficacy of the new Alcon MPDS in lens wearers.
3. Number of Experts and Qualifications (for ground truth)
- This information is not provided in the given text. For a medical device like a contact lens solution, ground truth regarding safety and efficacy in a clinical setting would typically be established by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed.
4. Adjudication Method (for test set)
- This information is not provided in the given text. While a clinical study was performed, the method of adjudicating outcomes (e.g., adverse events, comfort scores) is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for diagnostic imaging AI devices, not for a contact lens care solution. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. Standalone Performance (Algorithm only)
- No, a standalone (algorithm only) performance study was not conducted. This device is a chemical solution, not an AI algorithm. Its performance is inherent to its chemical formulation and interaction with biological and material components.
7. Type of Ground Truth Used (for test set)
- The ground truth for the clinical study would be based on clinical assessments and patient reports of outcomes (e.g., safety events, comfort levels, visual acuity where relevant) in comparison to the control product. For microbiological studies, ground truth is established by standard laboratory culture methods. For cleaning and compatibility, it's based on laboratory analytical methods.
8. Sample Size for the Training Set
- This concept is not applicable as the device is a chemical solution, not an AI algorithm that requires a training set. The development of the solution involved chemical formulation and in-vitro testing.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable for a chemical solution. The "ground truth" during development would be based on scientific principles, chemical analysis, and iterative testing in vitro to optimize the formulation for its intended functions (cleaning, disinfection, compatibility).
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