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Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.

Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The document describes the device, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, as being substantially equivalent to the predicate device, OPTI-FREE Replenish Rewetting Drops. The "acceptance criteria" are implicitly defined by demonstrating non-inferiority to the predicate device in terms of safety and effectiveness.

Here's a table summarizing the implicit acceptance criteria (non-inferiority to the predicate) and the reported device performance, as evidenced by the clinical study:

Study Details:

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Study):
  • Enrolled: 369 subjects
  • Completed: 365 subjects
  • Test Group (Bausch + Lomb Preservative Free): 188 subjects
  • Control Group (OPTI-FREE Replenish): 181 subjects
• Data Provenance: The study was a "multicenter, randomized, masked, parallel, bilateral study conducted in the USA." This indicates prospective data collection from multiple sites within the contiguous United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number of experts used or their qualifications for establishing ground truth for the clinical study's endpoints. The "ground truth" for safety and effectiveness endpoints (e.g., slit lamp findings, comfort, dryness, lens deposits) would typically be assessed by the clinicians (e.g., optometrists or ophthalmologists) participating in the multicenter study.

4. Adjudication method for the test set:

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). Since it was a "masked" study, assessors were likely blinded to the treatment assignment. The primary endpoints were compared statistically between the two groups. It's implied that the findings from the clinicians at each site contributed to the data for analysis.

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:

No, an MRMC comparative effectiveness study was not done. This study is for contact lens rewetting drops, not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

Not applicable. This device is a medical product (rewetting drops) and not an algorithm or AI system.

7. The type of ground truth used:

For the clinical study, the ground truth was based on clinical assessments and subjective patient reporting.

• Clinical Assessments: E.g., slit lamp findings (graded by clinicians).
• Subjective Patient Reporting: E.g., overall comfort and dryness (self-reported by subjects).
• Objective Observations: E.g., lens deposits (likely observed and graded by clinicians).

8. The sample size for the training set:

Not applicable. This is a medical product (rewetting drops), not an AI algorithm that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

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Aqua Naina Plus Sterile Saline Solution: The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.

Aqua Naina Sterile Saline Solution: The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only.

Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

The provided text is a 510(k) summary for a medical device (Aqua Naina Sterile Saline Solution and Aqua Naina Plus Sterile Saline Solution). This document outlines the device's characteristics and its substantial equivalence to existing predicate devices, but it does not contain information about acceptance criteria or specific performance studies as would be typically found for AI/ML-based diagnostic devices.

The relevant section, "VII. PERFORMANCE DATA," explicitly states:
"The package volume change was validated using the same methods identified in K193441. No other performance data (clinical or non-clinical) are required for this special 510(k) submission."

This indicates that for this specific type of device (saline solution), comprehensive performance studies with acceptance criteria, sample sizes, ground truth establishment, expert reviews, and MRMC studies, as typically requested for AI/ML medical devices, were not required by the FDA for this submission. The submission relies on establishing substantial equivalence to previously cleared predicate devices based on chemical composition, intended use, and production methods, rather than demonstrating performance against specific clinical metrics.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details because such data is not present in the provided document.

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The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.

The proposed device consists of two versions:

• For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
• For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.

The provided document describes the VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System. It does not contain a study explicitly proving the device meets acceptance criteria. Instead, it relies on a battery of non-clinical tests and a comparison of technological characteristics with predicate devices to establish substantial equivalence.

Therefore, many of the requested details about a specific study, acceptance criteria for performance, and ground truth establishment cannot be extracted directly from this document.

However, I can provide the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for device performance in the form of specific thresholds or metrics for cleaning effectiveness. Instead, it lists the non-clinical tests performed, implying that satisfactory results from these tests constitute meeting the requirements for substantial equivalence. The "reported device performance" in terms of cleaning effectiveness is described through the successful completion of a "Protein and Lipid Removal Test."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the "Protein and Lipid Removal Test" or any other non-clinical test. It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes non-clinical tests, which typically rely on standardized protocols and laboratory measurements rather than expert consensus for ground truth.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a contact lens cleaning system, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This concept is not directly applicable to a contact lens cleaning device. The "algorithm" in this context refers to the device's mechanical cleaning mechanism (3D sonic vibration technology), which operates in a "standalone" manner in that it performs its cleaning function without human intervention during the cleaning cycle. However, the overall process requires human interaction for placement of lenses and solution.

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

For the "Protein and Lipid Removal Test," the ground truth would likely be established through quantitative laboratory measurements of protein and lipid levels on the contact lenses before and after cleaning, using standardized analytical methods. For other non-clinical tests (e.g., biocompatibility), the ground truth is based on the adherence to specified ISO standards and the absence of adverse biological reactions or safety failures.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical cleaning system and does not employ a machine learning model that would require a training set in the conventional sense.

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

This information is not applicable and not provided, as there is no mention of a machine learning model or a training set.

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Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses during (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.

Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free sterile, aqueous solution containing proteolytic enzyme (subtilisin) as the active ingredient, and glycerol.

The provided text describes a 510(k) premarket notification for a contact lens care product, the "Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner." The submission seeks to add an alternative manufacturing site and change packaging resin and raw material suppliers.

However, the document does not contain information about acceptance criteria for a device's performance based on AI/algorithm/software output, nor does it detail a study proving the device meets such criteria. The "Preclinical testing" mentioned is related to biocompatibility and confirms the safety and effectiveness of the product itself, not a software device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information (specifically points 1-9 regarding an AI/algorithm-based device and its validation) is absent from the provided text.

The text focuses on the following:

• Device Type: A contact lens care solution (not an AI/software device).
• Purpose of 510(k) Submission: To add an alternative manufacturing site and modify packaging components, not to introduce or validate a new AI/software feature or performance.
• Testing Mentioned: Biocompatibility, cytotoxicity, and ocular irritation studies related to the chemical solution and its packaging components. These are standard tests for medical devices that come into contact with human tissue, not for evaluating AI performance metrics like sensitivity, specificity, or reader improvement.

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The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VibrantVue Scleral Saline:

This document describes a medical device, VibrantVue Scleral Saline, and its clearance through the FDA's 510(k) pathway. The 510(k) process is for devices found to be "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. As such, the "acceptance criteria" discussed below relate to demonstrating substantial equivalence and meeting established standards for saline solutions and contact lens care products.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" with numerical performance metrics in the way one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to the predicate device and meeting recognized standards for saline solutions and contact lens care products.

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

The document states that only non-clinical studies were conducted. There was no "test set" in the context of human patient data for the VibrantVue Scleral Saline device.

The non-clinical studies would have involved laboratory testing of the saline solution itself, its packaging, and its interaction with contact lens materials. The data provenance for these non-clinical studies is not specified (e.g., in-house lab, third-party lab), nor are specific sample sizes for these tests detailed in this summary.

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

Not applicable. No clinical test set involving human data was used, therefore no experts were required to establish ground truth for such a set. The "ground truth" for the non-clinical tests would be defined by established scientific methods, standards (e.g., USP monograph for 0.9% saline), and regulatory requirements for sterility, compatibility, and toxicity.

4. Adjudication Method for the Test Set

Not applicable. As there was no clinical test set requiring human interpretation, no adjudication method was used. Non-clinical studies rely on standardized test protocols and objective measurements.

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 done. This type of study is typically used to assess human reader performance, often with and without AI assistance, for diagnostic or interpretive tasks. The VibrantVue Scleral Saline is a contact lens care solution, not a diagnostic or AI-powered device, so such a study is not relevant or required for its clearance.

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

Not applicable. The VibrantVue Scleral Saline is a physical medical device (a saline solution), not an algorithm or AI system. Therefore, "standalone (algorithm only)" performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical studies, the "ground truth" was established based on:

• USP Monograph for 0.9% Saline: This defines the chemical composition and purity standards for saline.
• Industry Standards and Regulatory Requirements: For sterility, packaging safety (non-toxicity, non-irritating), and physical compatibility with RGP contact lenses. These are typically objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. As VibrantVue Scleral Saline is a physical medical device and not an AI/ML algorithm, there was no "training set."

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

Not applicable. There was no training set.

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PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.

The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.

This submission describes a 510(k) for a contact lens solution, PuriLens Plus Preservative Free Saline, and argues for its substantial equivalence to a predicate device based on similar formulation, manufacturing, and packaging, and expands its indications for use.

Since this is a submission for substantial equivalence based on a predicate device and there have been no changes to the device design, formulation, or manufacturing, no performance data or studies are presented. Therefore, I cannot provide information on acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert involvement as these were not required or reported in this 510(k) summary.

The summary states: "Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence." (Page 5)

As such, for all the requested points regarding acceptance criteria, performance data, sample sizes, ground truth, expert involvement, and comparative effectiveness studies, the answer is that this information is not applicable or not provided in this 510(k) summary due to the nature of the submission (substantial equivalence based on an identical product with expanded indications, requiring no new bench testing).

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Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.

The Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution system consists of: Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case. The lens case consists of a transparent cup and a lens holder-lens case cap assembly with a neutralizer catalyst disk. Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution and the special lens case must always be used together.

The preservative free, aqueous Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution contains: hydrogen peroxide 3%, phosphonic acid compound (stabilizer), citric acid, polyethylene glycol, sodium chloride, sodium hydroxide, and phosphate (buffer system).

The provided document describes the FDA 510(k) clearance for Menicon 3% Hydrogen Peroxide Cleaning & Disinfecting Solution. Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. Instead, it states that tests were conducted according to established guidance and protocols, and the results "demonstrated" effectiveness or compatibility. The general acceptance criterion for most tests appears to be "similar to the predicate device" or "effective/compatible."

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

The document does not specify the exact sample sizes (e.g., number of lenses, microorganisms, or test runs) for each non-clinical test. It mentions testing with:

• Lens Compatibility: Six commercially available hydrogel/silicone hydrogel soft contact lenses and two commercially available RGP lenses.
• The data provenance (country of origin, retrospective/prospective) and specific details about the laboratories conducting these non-clinical tests are not provided in this summary.

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)

This device is a cleaning and disinfecting solution, not an AI or diagnostic imaging device that requires human expert review for "ground truth." The "ground truth" for its performance is established through objective laboratory tests and scientific protocols that measure chemical properties, microbiological reduction, and material compatibility. Therefore, the concept of "experts establishing ground truth" in the way it applies to AI diagnostic studies is not relevant here.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI diagnostic evaluations where human readers interpret data. This is a non-clinical, laboratory-based performance study for a chemical solution. Therefore, such adjudication methods are not applicable and not mentioned.

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

No MRMC comparative effectiveness study was done. This is a chemical cleaning solution, not an AI-assisted diagnostic device, so comparison with human readers is not relevant.

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

This refers to an algorithm's performance. As the device is a chemical solution, this concept is not applicable.

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

The "ground truth" for the performance of this device is established through:

• Scientific Protocols and Laboratory Measurements: For lens compatibility, neutralization profiles (residual hydrogen peroxide levels), disinfecting efficacy (microbial reduction counts against ISO standards), preservative efficacy, cleaning efficacy (quantification of protein/lipid removal), and toxicology (in-vitro and in-vivo biocompatibility tests based on GLP regulations). This is essentially objective, measurable data generated by laboratory instruments and techniques following validated methods.

8. The sample size for the training set

This device is not an AI algorithm requiring a "training set." Therefore, the concept of a training set sample size is not applicable. The performance studies are validation tests, not machine learning model training.

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

As there is no training set for an AI algorithm, this question is not applicable.

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REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

This document is a 510(k) Summary for the REFRESH® RELIEVA™ FOR CONTACTS device. It describes the device, compares it to predicate devices, and summarizes testing performed to support its substantial equivalence. The document is a regulatory submission for a medical device and does not inherently describe a study that uses AI, nor does it provide detailed acceptance criteria related to AI performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as this document pertains to a medical device (contact lens solution), not an AI/ML powered device.

However, I can extract the information relevant to the performance of the device as described in this document.

Device Name: REFRESH® RELIEVA™ FOR CONTACTS

Device Description: A sterile, buffered, isotonic, preserved solution containing carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%).

Indications for Use: To lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Predicate Devices:

• REFRESH® Contacts Lubricating and Rewetting Drops (K992028)
• REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for an AI/ML device. Instead, the "acceptance criteria" are implied by the requirement for "substantial equivalence" to predicate devices, which the studies aimed to demonstrate. The performance is reported in terms of safety and efficacy.

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

• Sample Size for Test Set:

  • Clinical Study: The document states "A 3-month clinical study was conducted... in contact lens wearers." However, the exact number of participants (sample size) in this clinical study is not provided in the available text.
  • Biocompatibility/Stability: Not applicable as these are bench/lab tests, not human test sets.

• Data Provenance: Not explicitly stated (e.g., country of origin). The clinical study was conducted to evaluate the device against a marketed predicate, implying a controlled clinical trial setting. The studies are prospective as they were specifically performed to support the 510(k) submission.

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

This section is not applicable as the described studies are for a contact lens solution, not an AI/ML powered device where expert readers typically establish ground truth. Clinical endpoints in this context would likely be based on participant reporting of symptoms and potentially objective ophthalmological assessments, not "expert ground truth" for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Clinical study endpoints would be collected and analyzed, but "adjudication" in the sense of resolving discrepancies between expert interpretations of data (as typically seen in AI/ML performance studies) is not relevant here.

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

This section is not applicable. This document describes the safety and effectiveness testing for a contact lens comfort solution, not an AI/ML diagnostic or assistive device. There are no "human readers" interpreting images with or without AI assistance in this context.

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

This section is not applicable. The device is a physical product (contact lens solution), not an algorithm.

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

For the clinical study, the "ground truth" or primary endpoints would likely be based on:

• Patient-reported outcomes (PROs): Subjective relief of dryness, discomfort, and irritation; comfort upon lens insertion.
• Clinical assessments: Potentially objective measures of ocular surface health or lens-eye interaction, as assessed by an optometrist or ophthalmologist, though specific measures are not detailed in this summary.
• The study aimed to demonstrate substantial equivalence in safety and efficacy compared to a predicate device, meaning its performance was judged against the established acceptable performance of the predicate.

For biocompatibility, the ground truth involves adherence to and successful completion of established test methods (e.g., cytotoxicity, irritation, sensitization) as per FDA guidance.

For stability, the ground truth involves chemical, physical, and microbiological specifications being met over time.

8. The sample size for the training set

This section is not applicable. The device is a contact lens solution, not an AI/ML model that requires a training set.

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

This section is not applicable for the reasons stated above.

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For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered 3% hydrogen peroxide contact lens solution.

The device is a specialized lens case consisting of a transparent cup with a connected unit of screw cap, lens holders (baskets) and platinum-coated neutralization disc. The platinum catalyst coating and shape of the plastic disc are designed to effectively neutralize hydrogen peroxide in the lens care system to harmless water and oxygen gas.

This looks like a 510(k) summary for a medical device with a minor modification (change in silicone material of a gasket). Generally, devices with such minor changes do not contain extensive studies as they are not typically required for demonstrating substantial equivalence. The document confirms this in Section VII, "Performance Data," stating that the device was evaluated in "biocompatibility, physicochemical and design functionality tests."

Given the information provided in the 510(k) summary:

• No extensive clinical study was conducted or is reported for the device. The primary purpose of this 510(k) (K191795) is to demonstrate substantial equivalence to a legally marketed predicate device after a change in a gasket material.
• The "performance data" mentioned refers to nonclinical testing, which is generally not a clinical trial involving human subjects or AI algorithm performance as you might expect in more complex device submissions.
• The information you are asking for (e.g., sample size for training set, MRMC study, number of experts for ground truth) is typical for AI/ML-driven devices or devices requiring extensive clinical validation. This device (AOCup Lens Case with AODisc) is a contact lens case, which falls under a different regulatory pathway and testing requirements.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars in the format you specified, as those types of studies and criteria are not described in this 510(k) submission for this specific device. The provided text outlines a regulatory submission for a contact lens case after a material change, not an AI or imaging-based diagnostic device.

However, I can interpret the "Performance Data" section to infer general acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:

General Acceptance Criteria and "Study" (Nonclinical Testing) for AOCup Lens Case with AODisc (K191795)

The primary acceptance criterion for this 510(k) submission is to demonstrate that the modified device (with the new silicone gasket material) maintains the same safety and effectiveness as the predicate device. This is achieved through nonclinical testing to ensure the material change does not negatively impact the device's intended function or biocompatibility.

1. A table of acceptance criteria and the reported device performance

Regarding the other points in your request:

• 2. Sample sized used for the test set and the data provenance: Not applicable. These were nonclinical (bench) tests, not involving a "test set" in the context of clinical data or AI algorithms.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for nonclinical tests is based on established testing standards and specifications, not expert interpretation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an imaging or diagnostic device that would require such a study.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device does not involve an algorithm.
• 7. The type of ground truth used: For biocompatibility, physicochemical, and design functionality tests, the "ground truth" would be defined by the established industry standards, test methods (e.g., ISO standards for biocompatibility), and internal product specifications for the performance of the gasket and the lens case.
• 8. The sample size for the training set: Not applicable. There is no training set for this type of device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a regulatory submission for a physical medical device (contact lens case) with a minor material change. The "study" refers to nonclinical laboratory and bench testing rather than clinical trials or AI performance evaluations, therefore, most of your requested information is not relevant to this specific type of device and submission.

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MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.

The MaxiTears CONTACTS PF are ready-to-use, isotonic, sterile eye contact lens care products (lubricants) intended to moisturize and lubricate the lens drops in eyes to reduce minor symptoms of dry eyes such as burning or itching. The intended use of these contact lens rewetting solutions is to alleviate the symptoms of dryness, discomfort, and minor irritation caused by ocular fatigue induced by the wearing of contact lenses, for example, by environmental conditions (dust, smoke, dry heat, air conditioning, wind, cold) tiredness or extended computer screen use. The MaxiTears CONTACTS PF solution can be used with all types of contact lenses, except contact lenses manufactured from Efrofilcon A, and are intended for repeated use over an extended period of time.

The MaxiTears CONTACTS PF solution it to be introduced to the US-market as an Over the Counter (OTC) medical device similar to other 510k-cleared lens drop lubricants (and identical to predicate Blink CL Lubricant Eve Drops K032030), sold as OTC medical device in retail outlets and through the internet.

OmniVision AG is offering the MaxiTears CONTACTS PF solution as Over the Counter device:

• MaxiTears' CONTACTS PF is a medium viscous preservative-free solution packaged in single-use . ampoules (single-dose units -SDU). They are supplied as single-dose unit plastic ampoules designed to administer one drop and then to be discarded. They are indicated for users with a known history of allergy to preservatives and those who wear contact lenses.

The provided text is a 510(k) summary for MaxiTears® CONTACTS PF, an over-the-counter eye drop. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

Instead, the submission primarily focuses on demonstrating non-clinical equivalence to a predicate device (blink™ CL Lubricant Eye Drops) through various performance tests and material comparisons.

Therefore, I cannot provide the requested information for an AI/ML device, as the document explicitly states:

• "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
• "The non-clinical testing detailed in this submission supports the substantial equivalence of the device." (Section 10. Clinical Performance Data)

This submission is for a contact lens care product (eye drops), not an AI/ML medical device. Hence, the questions related to AI/ML device validation (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to the content provided.

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