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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 .

COMPLETE® brand MULTI-PURPOSE Solution is a sterile, isotonic, buffered, solution containing hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, a phosphate buffer, Poloxamer 237 as a surfactant, edetate disodium as a chelating agent, sodium chloride, potassium chloride, and purified water. COMPLETE® brand MULTI-PURPOSE Solution contains no chlorhexidine or thimerosal.

The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.

The provided text is a 510(k) summary for COMPLETE® brand Multi-Purpose Solution (K030092). This document focuses on demonstrating substantial equivalence to a predicate device for a contact lens care solution, rather than providing detailed acceptance criteria and a study design for evaluating a novel medical device's performance against specific metrics. Therefore, many of the requested categories are not directly applicable or explicitly stated in the document.

However, based on the information provided, here's an attempt to address your request:

Acceptance Criteria and Device Performance for COMPLETE® brand Multi-Purpose Solution (K030092)

Note: The document describes in-vitro and clinical studies to support substantial equivalence for a contact lens solution, not a medical imaging or diagnostic device. As such, the typical metrics for device performance (e.g., sensitivity, specificity, accuracy) are not relevant here. Instead, the focus is on physical, chemical, and subjective user experience.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Clinical Studies: "Study subjects in three clinical studies" were used for subjective comfort and acceptability. An "additional clinical study" provided objective data for rub vs. no-rub regimens.
  • Sample Size: Not explicitly stated. The number of participants in each study is not provided.
  • Data Provenance: Not explicitly stated. However, given the context of a US regulatory submission (510(k)), it is highly probable the data originated from studies conducted in the United States and were prospective in nature, as they were designed to evaluate the new formulation.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable directly. This is a contact lens solution, not an interpretive device. The "ground truth" for subjective comfort comes from the study subjects themselves via questionnaires. For objective data (rub vs. no-rub), unspecified "objective data" was collected, likely related to lens cleanliness or disinfection efficacy, which would be measured by laboratory techniques rather than expert consensus on interpretation.

4. Adjudication Method for Test Set

• Not applicable. There is no "adjudication" in the sense of multiple experts independently reviewing and then resolving discrepancies for medical image interpretation. Clinical subjective data was gathered via questionnaires, and objective data via laboratory methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is relevant for diagnostic imaging systems where human readers interpret cases. The provided document concerns a contact lens solution.

6. Standalone (Algorithm Only) Performance

• Not applicable. The device is a chemical solution, not an algorithm.

7. Type of Ground Truth Used

• Clinical Studies:
  • Subjective Data: User-reported comfort and acceptability via questionnaires.
  • Objective Data: Unspecified objective measures related to contact lens care performance (e.g., disinfection, cleaning, protein removal efficacy) for the rub vs. no-rub regimen comparison. This would typically be laboratory-based measurements.
• In Vitro Studies: Laboratory measurements of physical (viscosity, surface fluid retention, receding contact angle) and chemical (HPMC uptake/release) properties.

8. Sample Size for Training Set

• Not applicable. This isn't a machine learning model, so there isn't a "training set" in that sense. The studies described are for validation of the product's performance and equivalence.

9. How Ground Truth for Training Set was Established

• Not applicable. See point 8.

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TRADE NAME 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

TRADE NAME Multipurpose Solution is a sterile, isotonic, buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative. As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.

Acceptance Criteria and Study for Allergan TRADE NAME Multipurpose Solution

The provided document describes the acceptance criteria and supporting studies for Allergan's "TRADE NAME Multipurpose Solution," which is a soft (hydrophilic) contact lens care product. The submission is a 510(k) premarket notification, seeking substantial equivalence to predicate devices (COMPLETE® brand Multi-Purpose Solution, K003252 and K013479). The key change in the new product is the removal of the lubricant HPMC, leading to the deletion of the "conditioning" claim. Therefore, the studies primarily focus on demonstrating that removing HPMC does not negatively impact the remaining indicated uses and that the new formulation is comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-clinical device (not an AI/ML medical device as would typically have performance metrics like sensitivity/specificity), the "acceptance criteria" are based on demonstrating equivalence to the predicate device. The performance is assessed through various nonclinical studies.

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for each study, but provides the following details:

• Solution Compatibility: Used FDA Group I and IV soft contact lenses for 30 cycles.
• Cleaning Studies: Used Group I and IV lenses over a 30-day/30-cycle period.
• Toxicological Studies (In-vivo): A 21-day rabbit study was performed.
• Data Provenance: The studies were conducted by Allergan, presumably in the USA. Given the submission date (2002), these are retrospective studies on the newly formulated product.

3. Number of Experts and Qualifications for Ground Truth

This type of product (contact lens solution) does not typically involve human expert adjudication for ground truth in the way a diagnostic AI/ML device would. The "ground truth" for the non-clinical studies is based on objective measurements and established laboratory protocols.

• Solution Compatibility/Cleaning: Assessment of lens parameters (diameter, power, basecurve), integrity, visual appearance, and presence of deposits would be performed by lab technicians or scientists following standardized procedures.
• Microbiological Studies: Efficacy against microorganisms assessed via standardized microbiological assays.
• Toxicological Studies: In-vitro cytotoxicity assessed by laboratory techniques. In-vivo rabbit study would involve veterinarians or toxicologists assessing ocular effects, but the document doesn't specify a "number of experts" or their specific qualifications beyond what implied for such studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission concerns non-clinical performance of a contact lens solution, not an AI/ML diagnostic system requiring human adjudication of results. The results are based on objective laboratory measurements and observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, and no human reader performance is being evaluated or compared with or without AI assistance. The studies assess the intrinsic properties and performance of the contact lens solution itself.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm based device. The "device" is a chemical solution. The studies describe the standalone performance of the solution as a product.

7. Type of Ground Truth Used

The ground truth for these studies is based on:

• Objective measurements: E.g., lens diameter, power, basecurve changes, protein removal percentages, cytotoxicity levels.
• Standardized protocols and assays: E.g., for microbiological efficacy, cleaning effectiveness.
• Veterinary/Toxicological observations: For the in-vivo rabbit study regarding ocular effects.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "formulation" is the "design" of the product, which is then tested.

9. How Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

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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.

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.

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COMPLETE® brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

COMPLETE® brand Multi-Purpose Solution is a sterile, isotonic, buffered, preserved solution. This aqueous formulation includes purified water, sodium chloride, hydroxypropyl methylcellulose as a lubricant, preserved with polyhexamethylene biguanide 0.0001%, Poloxamer 237 as a surfactant, a phosphate buffer, and edetate disodium as a chelating agent. This preparation contains no chlorhexidine, no thimerosal and no other mercury containing ingredients. Both current and reformulated products are clear, colorless solutions packaged in plastic bottles with controlled dropper tips.

The provided document is a 510(k) summary for a contact lens solution, not an AI device. Therefore, many of the requested criteria, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "sample size for the training set," and "number of experts used to establish the ground truth," are not applicable.

However, I can extract the relevant acceptance criteria and study information for the COMPLETE® brand Multi-Purpose Solution (Revised) as presented in the document.

Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical and Clinical)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Non-Clinical Studies: No specific sample sizes for each non-clinical test (e.g., solution compatibility, protein cleaning, microbiological, toxicology) are provided, only the results. The data provenance is not explicitly stated beyond "The product was tested with the same protocol used to test the prior (substantially equivalent) formulation."
• Clinical Study:
  • Total Subjects Enrolled: 124 subjects
  • Investigational MPS Group: 62 subjects (60 evaluable after disqualifications)
  • COMPLETE® MPS Group (Predicate): 62 subjects (all evaluable)
  • Data Provenance: Not specified (e.g., country of origin). A clinical study implies prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Non-Clinical: Not applicable in the context of expert consensus for ground truth as these are lab-based tests.
• Clinical: The clinical study involved "Six clinical investigators," but their specific qualifications or their role in establishing "ground truth" (beyond conducting the study and evaluating subjects) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is a clinical trial for a contact lens solution, not an imaging device requiring expert adjudication for ground truth. The "adjudication" in this context would be the assessment of individual investigators.

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 is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI algorithm. The device itself (contact lens solution) is "standalone" in its function, but this term typically refers to AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Non-Clinical:
  • Solution Compatibility & Cleaning, Protein Cleaning: Lab-based quantitative measurements of cleaning efficacy.
  • Microbiological Studies: Adherence to established FDA guidelines (FDA's Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, USP Modified criteria).
  • Toxicology: Observation of biological responses in animal models and in vitro tests (cytotoxicity, sensitization, oral toxicity, ocular safety).
  • Stability: Accelerated aging tests to predict shelf-life.
• Clinical:
  • Safety Data: Clinical observations and measurements by investigators (slit lamp findings, visual acuity, refraction, keratometry, mire distortion) and reported adverse events.
  • Acceptability Data: Clinical observations and measurements by investigators (lens cleanliness, fit, discoloration, wearing time) and subjective symptom reporting by subjects (comfort, discomfort).

8. The sample size for the training set

• Not applicable as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI algorithm.

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COMPLETE® (and Private Label) brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

COMPLETE® brand Multi-Purpose Solution is a sterile, isolonic solution containing hydroxypropyl methylcellulose as a lubricant, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, ederate disodium as a chelating agent, sodium chloride, and purified water. COMPLETE® brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.

Private label brand Multi-Purpose Solution is a sterile, isotonic solution containing purified water, sodium chloride, preserved with TrisChem™ (polyhexamethylene biguanide) 0.0001%, buffered with tromethamine, tyloxapol as a surfactant, and edetate disodium as a chefating agent. Private label brand Multi-Purpose Disinfecting Solution contains no chlorhexidine or thimerosal.

The provided text describes a 510(k) submission for "COMPLETE® brand Multi-Purpose Solution" and a "Private label brand Multi-Purpose Solution." This is a medical device submission for a contact lens care solution, which acts as a disinfectant, cleaner, and storage solution. The submission focuses on demonstrating substantial equivalence to previously approved devices, rather than a novel device requiring extensive de novo studies. Therefore, the traditional format of acceptance criteria and a study proving a device meets them (as would be applicable for a diagnostic or therapeutic device with measurable performance metrics) is not directly presented in the provided text.

Instead, the submission leverages previous approvals and existing FDA criteria to establish the safety and effectiveness of the updated or rebranded solutions.

Here's an interpretation based on the provided text, aligning with the requested categories where possible:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a new, standalone study. The primary "testing" relies on previous approvals (P910075 and P860023/S12).
  • For the additional protein removal study, the sample size is not specified.
• Data Provenance: The studies referenced (P910075 and P860023/S12) would have been conducted by the manufacturers (Allergan and Bausch & Lomb respectively) according to FDA guidelines applicable at the time. The country of origin and whether they were retrospective or prospective are not detailed in this 510(k) summary. These would be found in the original PMA (P910075, P860023/S12) documentation. The "additional study" on protein removal would presumably be prospective research commissioned by Allergan.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance claims (disinfection, preservation, safety, cleaning) is established by adherence to recognized FDA and USP standards and the results of laboratory tests and clinical trials conducted during the original PMA approvals (P910075 and P860023/S12). Expert consensus, as typically applied in diagnostic imaging, is not relevant here.

4. Adjudication Method for the Test Set

• This is not applicable. The data presented is from laboratory tests and clinical outcomes, not expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic algorithms with human readers. This submission is for a medical device (contact lens solution) evaluated through microbiological, preclinical, and clinical trials, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• This is not applicable. This is not an AI algorithm. The device's performance is inherently "standalone" in the sense that it performs its chemical function (disinfection, cleaning) independently, but its safety and efficacy are evaluated through biological and chemical tests, not an algorithm's output.

7. The Type of Ground Truth Used

• Microbiological Studies: Ground truth is established by quantitative microbiological methods based on FDA and USP standards for log reduction of specific microorganisms (bacteria, yeast, molds) and sterility.
• Preclinical (Biocompatibility/Toxicity): Ground truth is established by in vitro and in vivo animal and potentially human irritation/toxicity studies (implied from the P910075 approval for safety).
• Cleaning Efficacy: Ground truth is established by laboratory assays/methods to quantify the removal of protein and non-protein deposits from contact lenses.
• Clinical Studies: Ground truth is established by clinical endpoints and adverse event monitoring in human subjects, demonstrating safety and effectiveness as a contact lens care solution.

8. The Sample Size for the Training Set

• This is not applicable. The concept of a "training set" is for machine learning models. This submission references previous approvals (P910075, P860023/S12) which included their own study populations, but these are not "training sets" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

• This is not applicable as there is no "training set" for an AI model being discussed. The ground truth for the performance studies (as described in point 7) was established through established scientific and regulatory methods for evaluating medical devices of this type.

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