(115 days)
COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
- Chemically (NOT HEAT) Disinfect
- Clean
- Rinse
- Store
- Remove Protein
- Condition
There are no formulation or other changes in the device description.
The provided document describes the 510(k) summary for Allergan's COMPLETE® brand Multi-Purpose Solution. It details a clinical study conducted to demonstrate the substantial equivalence of a modified cleaning regimen with the existing standard regimen.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The device (COMPLETE® brand Multi-Purpose Solution with modified cleaning regimen) was evaluated for its non-inferiority compared to the standard regimen. The primary acceptability criterion was the mean change from baseline in lens comfort score.
| Criteria Category | Acceptance Criteria (Clinical) | Reported Device Performance (Clinical Study) |
|---|---|---|
| Primary Acceptability Variable | Non-inferiority of Modified Regimen to Standard Regimen for mean change from baseline in lens comfort score (established by 95% Confidence Intervals). | The modified regimen group was demonstrated to be non-inferior to the standard regimen for mean changes from baseline in lens comfort at Day 90. |
| Secondary Acceptability Variables (No statistically significant difference between regimens) | Mean lens comfort score at baseline or at any follow-up visit. | No statistically significant difference. |
| Symptoms of discomfort. | No statistically significant difference. | |
| Maximum severity grade of any symptom of discomfort. | No statistically significant difference. | |
| Number of subject visits with clinically significant symptoms of discomfort (all causes). | No statistically significant difference. | |
| Change from baseline for burning and stinging, blurry vision, unusual eye secretion, excessive tearing, itching, increased lens awareness, redness, or light sensitivity. | No statistically significant difference. | |
| Overall subjective vision quality. | No statistically significant difference. | |
| Mean lens wearing time. | No statistically significant difference. | |
| Average daily lens wearing time change from baseline. | No statistically significant difference. | |
| Number of Type II or Type IV lenses analyzed at the final study visit. | No statistically significant difference. | |
| Subject ratings of the contact lens solution used, comfort rating, and vision quality. | No statistically significant difference. | |
| Safety Results (No statistically significant difference between regimens) | Worst severity of subject eyes at each visit for slit lamp examination findings (edema, corneal neovascularization, bulbar hyperemia, palpebral conjunctival observations, or other complications). | No statistically significant difference. |
| Maximum severity grade of any slit lamp examination finding. | No statistically significant difference. | |
| Maximum Joseline and the worst change from baseline in any slit lamp parameter. | No statistically significant difference. | |
| Number of subjects with clinically significant slit lamp examination findings. | No statistically significant difference. | |
| Number of visits with clinically significant slit lamp examination findings. | No statistically significant difference. | |
| Change from baseline in study lens-corrected visual acuity. | No statistically significant difference. | |
| Number of eyes discontinued from the study, in the average wear time of lenses, or in the number of missed visits. | No statistically significant difference. | |
| Safety Results (No events or specific changes) | Unanticipated adverse device effect. | No subject experienced an unanticipated adverse device effect. |
| Sight-threatening event, iritis, infiltrate, ulcer, ocular infection, or two-grade change in neovascularization. | No subject experienced these events. | |
| Cleaning Effectiveness (Laboratory) | Equivalent to the standard regimen and effective cleaner for soft (hydrophilic) contact lenses based on surface deposits and general condition. | COMPLETE® brand Multi-Purpose Solution used with the modified regimen is equivalent to the standard regimen and is an effective cleaner. |
| Microbiological Studies | Meets FDA requirements for disinfection of contact lenses. | Meets FDA requirements for disinfection. |
| Meets USP Modified criteria for Preservative Effectiveness Testing. | Meets USP Modified criteria. | |
| Meets USP Sterility test requirements. | Meets USP Sterility test requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 157 subjects were enrolled. 151 subjects completed the study.
- Data Provenance: The document does not explicitly state the country of origin. However, Allergan is based in Irvine, California, USA, and the submission is to the US FDA, which implies the study was likely conducted within the USA or aligned with US regulatory standards. The study was prospective, as it involved enrolling subjects and randomizing them to different regimens over a three-month period.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. However, it mentions that nine investigators enrolled the subjects. It's implied that these investigators, likely eye care professionals, were responsible for evaluating lens comfort, symptoms of discomfort, and performing slit lamp examinations which contributed to the clinical ground truth. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not detailed.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 for resolving discrepancies). The clinical data likely rely on the assessments made by the individual investigators at each study site, potentially with standardized protocols for evaluation.
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 conducted as described in the provided text. This study was a clinical trial comparing two active treatment regimens (standard vs. modified) of the same product, rather than comparing human readers' performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This study relates to a contact lens care solution, a physical product used by humans, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission. The effectiveness of the solution is inherently tied to human use. The microbiological and cleaning effectiveness studies could be considered "standalone" in that they evaluate the product's intrinsic properties without human physiological interaction, but this is distinct from AI/algorithm standalone performance.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on a combination of:
- Expert Clinical Assessment: Mean change from baseline in lens comfort score, symptoms of discomfort, slit lamp examination findings (e.g., edema, neovascularization, hyperemia), visual acuity, and other ocular parameters assessed by the investigators.
- Subjective Patient Reporting: Subject ratings of comfort, vision quality, and self-reported symptoms.
- Laboratory Analysis: For cleaning effectiveness (surface deposits and general condition of lenses returned to Allergan).
- Standardized Microbiological and Toxicological Testing: As per FDA and USP guidelines.
8. The Sample Size for the Training Set
The document describes a single clinical study of 157 subjects (151 completed) that serves as the basis for the 510(k) submission. It does not mention a separate "training set" in the context of device development or machine learning. This study is the primary evidence for the modified regimen.
9. How the Ground Truth for the Training Set Was Established
As no separate "training set" is described in the context of machine learning, this question is not applicable to the provided information. The ground truth for the clinical study was established as described in point 7.
§ 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.”