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3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.

The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions.

The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses.

The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.

The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.

The document describes the submission of a 510(k) premarket notification for the "3N Contact Lenses Adjunct Cleaner" (K211361). The study provided is a non-clinical performance test (bench test) to demonstrate the device's deproteinization efficiency and physical compatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample size:
  • Deproteinization efficiency and Service life testing: Four kinds of contact lens materials (Johnson and Cooper Optics, Ocufilcon D, Etafilcon A, Comfilcon A, and Senofilcon A). The service life test specifically mentions "151 times" for the Ocufilcon D lens.
  • Physical compatibility testing: "3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials)".
• Data Provenance: The document does not specify the country of origin for the test data directly. It is a submission by "Suzhou 3N Biological Technology Co., Ltd" from China. The tests are described as "Non-Clinical Data" and "Performance Testing - Bench." It is a retrospective analysis of test data conducted on the device.

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

Not applicable. This study is a bench test assessing the physical performance and deproteinization efficiency of the device on contact lenses, not a study involving human interpretation or expert ground truth for medical imaging/diagnosis.

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

Not applicable, as this is a physical performance bench test, not a human reader study.

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. The submission explicitly states: "This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence."

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

Yes, this was a standalone device performance test. The tests (deproteinization efficiency, service life, physical compatibility) were conducted solely on the device and contact lenses, without human intervention in the performance measurement itself.

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

The "ground truth" for this device's performance is based on measurable physical and chemical properties of the contact lenses before and after treatment by the device. Specifically:

• Protein removal: Measured by quantifying protein adsorption/removal percentage.
• Physical compatibility: Assessed against the requirements of ISO 18369-2:2017, which defines standards for contact lens physical properties.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or software algorithm that requires a training set. The "Software Verification and Validation" section refers to software contained within medical devices, but there's no indication of an AI/ML component requiring a "training set" in the context of typical AI model development.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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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® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of 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 BPZ02 MultiPurpose Solution is a sterile, isotonic solution that contains hyaluronan, sulfobetaine, poloxamine 1107, boric acid, sodium borate, edetate disodium and sodium chloride; and preserved with a dual disinfection system. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

The provided text describes the Bausch & Lomb BPZ02 MultiPurpose Solution, a soft contact lens care solution. The document focuses on demonstrating the substantial equivalence of this solution to predicate devices through various tests rather than establishing acceptance criteria and conducting a study to prove a device meets those criteria in the context of an AI/ML device.

However, I can extract the information relevant to the studies performed for this product, interpreting "acceptance criteria" as the successful demonstration of safety and effectiveness parameters established for contact lens solutions.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is more applicable to AI/ML device studies, the provided text does not contain it:

2. Sample size used for the test set and the data provenance: Not applicable or not specified for these types of studies (biocompatibility, microbiology, lens compatibility, cleaning efficacy). For the clinical study, the sample size is not mentioned, nor is data provenance beyond "controlled clinical study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of studies is based on established laboratory methods and clinical assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 a contact lens solution, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the preclinical studies (biocompatibility, microbiology, lens compatibility, cleaning) would be based on validated laboratory standards and measurements. For the clinical study, it would be direct clinical observation (e.g., patient comfort, adverse events, lens clarity) and potentially objective measures relevant to lens care.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the 510(k) summary for the Bausch & Lomb BPZ02 MultiPurpose Solution demonstrates its safety and effectiveness by comparing its performance against established industry standards and predicate devices through a series of preclinical and clinical studies, rather than through an AI/ML-specific validation framework.

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The AUTOLENS ® Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENS® Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENS® Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENS® Multipurpose Solution.

AUTOLENS® Multipurpose Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) and PMMA contact lenses as recommended by your eye care practitioner.

The device is a holder, cleaning and disinfection system for contact lenses. It consists of a contact lens holder, bottle, cap and base. A separate battery operated tumbler device is integral to the system. It is designed to slowly tumble the bottle assembly including contact lens solution to effect cleaning of contact lenses.

The lens holder is a single piece molded plastic device including hinged snap closure covers to contain each contact lens separately. An easily identifiable, raised letter "R" and "L" is included adjacent each closure receptacle to allow clear identification for right and left contact lenses placed within the lens holder. The lens holder contains openings to sufficiently allow the free flow of solution to circulate on all surfaces of the contact lens during the cleaning process.

The bottle is made of molded plastic and is of oval shape to facilitate the flow of solution over the lens holder and lenses during operation. The bottle is of sufficient size to contain the lens holder and 8 ml. of contact lens solution to cover the contact lenses at all times during operation and storage. The bottle is designed to hold the contact lens holder securely to ensure its rotation as the bottle spins during operation. The bottle is designed with a fluid-tight, screw closure cap. The lens holder, bottle, cap and base are made of polypropylene resin plastic.

The tumbler device is a battery powered unit operating at 1.5 volts utilizing three "AA" batteries. A plastic housing is molded to contain a small electrical motor, tumbler drive, on/off switch, batteries and a battery door to easily replace batteries. A cradle is molded within the shape of the housing to contain the assembled lens holder bottle. The drive shaft is connected to the motor inside the base housing.

When the device is turned on at the switch, the battery operated electrical motor turns the extended drive shaft. The bottle assembly resting upon the drive shaft turns in unison. The mechanical action of the bottle assembly on the drive shaft provides for a rotation of approximately 10 RPM.

The AUTOLENS® System, which includes the AUTOLENS® Automatic Contact Lens Cleaning Accessory and AUTOLENS® Multipurpose Solution, aims to provide an automatic method for cleaning, rinsing, and disinfecting contact lenses. The device's acceptance relied on demonstrating its effectiveness and safety through bench testing.

Here's a breakdown of the acceptance criteria and the study that addressed them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Testing: The number of laboratory animals used is not specified, but the tests were "conducted on the plastic components of the system." The data provenance is laboratory testing.
• Effectiveness Testing (Bench Testing for Solution Stability): Three (3) test devices were used to measure solution pH and temperature gain. The data provenance is laboratory bench testing.
• Clinical Information: Clinical studies were deemed "unnecessary" as the multipurpose solution used in the AUTOLENS® System was already cleared for marketing. Therefore, there was no clinical test set for the AUTOLENS® system itself.

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

There were no human experts used to establish a ground truth for the device's performance as described in the summary. The "ground truth" for the device's safety and functionality was established via:

• Laboratory Animal Testing: For biocompatibility.
• Bench Test Measurements: For pH, temperature, and compatibility.
• Predicate Device Equivalence: The primary basis for the cleaning effectiveness claim stems from substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable, as no human readers or subjective assessments requiring adjudication were part of the described testing for the device's performance.

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 device is a contact lens cleaning system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical, electromechanical system and does not involve an "algorithm" in the sense of AI. Its performance is inherent to its mechanical action (tumbling) and the chemical properties of the solution. The bench testing performed can be considered "standalone" in that it assessed the device's direct physical and chemical effects.

7. The Type of Ground Truth Used

• Biocompatibility: Established by standardized toxicology tests on laboratory animals.
• Solution Stability (pH, temperature): Established by direct instrumental measurements (pH meter, thermometer) acting as the objective ground truth.
• Compatibility: Visual observation of precipitate formation established the ground truth for compatibility.
• Cleaning Effectiveness: Primarily inferred from the substantial equivalence to predicate devices that perform a similar cleaning function, rather than direct, quantitative ground truth data on cleaning efficacy presented within this summary for the AUTOLENS® system itself. The ground truth for the solution's efficacy (cleaning, rinsing, disinfecting, protein removal) was established through its prior marketing clearance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

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AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.

The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.

The provided text is a 510(k) summary for a contact lens care product, not a medical device that utilizes AI or algorithmic performance for diagnostics or treatment. Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI-specific metrics (like MRMC studies or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to a predicate device based on pre-clinical and clinical studies submitted previously (K003345 and K013512). It confirms its intended use for cleaning, disinfecting, daily protein removal, and storing soft contact lenses.

Without details from the referenced prior submissions (K003345 and K013512), it's impossible to extract specific acceptance criteria, reported performance, or study methodologies that traditionally apply to AI-driven medical devices.

Summary of inapplicable questions:

• 1. A table of acceptance criteria and the reported device performance: Not provided. This document describes a chemical solution, not a performance-based diagnostic device.
• 2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned (K003345, K013512) are for the chemical solution's safety and effectiveness.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to microbiological efficacy or clinical outcomes, not expert image interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but would likely involve microbiological challenge tests and clinical trial outcomes for safety/efficacy in contact lens care.
• 8. The sample size for the training set: Not applicable. There is no "training set" for this type of product.
• 9. How the ground truth for the training set was established: Not applicable.

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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.

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® (polvaminopropyl 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. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

The provided text describes a 510(k) Premarket Notification for the Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution. It details the device, its indications for use, and a clinical study conducted to demonstrate its safety and efficacy. However, the document does not contain a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy, etc.) typically found when evaluating the performance of a device against numerical acceptance criteria.

The study described is a clinical study for a contact lens care solution, which focuses on safety and efficacy in terms of lens cleanliness and eye health, rather than a diagnostic or AI-driven device with quantifiable performance criteria like those for image analysis or disease detection.

Here's an attempt to answer the questions based on the available information, noting the limitations of the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantifiable performance metrics in terms of sensitivity, specificity, or similar measures typically associated with diagnostic or AI devices. The study's conclusion is qualitative: "Both regimens demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated."

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

• Sample Size: Not explicitly stated in the provided text for the new clinical study. The text only mentions "A multi-site randomized, controlled clinical study."
• Data Provenance: The study was a "multi-site randomized, controlled clinical study," implying prospective data collection across various clinical sites. The country of origin is not specified, but the submission is to the U.S. FDA by a Rochester, New York-based company, suggesting the study likely involved U.S. sites.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. For a contact lens solution, ground truth would likely involve clinical assessments by ophthalmologists or optometrists, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study, as typically understood for diagnostic imaging or decision support AI, was not performed. The study mentioned compares ReNu MultiPlus solution with Alcon OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution (Control solution) in terms of "clinically acceptable lens cleanliness, safety and efficacy." This is a comparative study of two products, but not in the context of human readers improving with or without AI assistance.

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

This question is not applicable. The device is a contact lens care solution, not an algorithm or AI system. Its performance is evaluated through clinical use by human subjects, not as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth was established through clinical assessment of lens cleanliness, safety (e.g., adverse events), and efficacy in human subjects. This would involve observations and evaluations by eye care practitioners.

8. The Sample Size for the Training Set

This question is not applicable. The device is a chemical solution, not an AI model that requires a training set. The clinical study described evaluates the product's performance directly.

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

This question is not applicable as there is no "training set" for this type of device.

Summary of Limitations:

The provided document is a 510(k) summary for a medical device (contact lens solution) and describes a clinical study to demonstrate its safety and efficacy for its intended use. The questions posed, however, are typically asked when evaluating diagnostic devices, particularly those involving Artificial Intelligence (AI) algorithms, which require specific metrics like sensitivity, specificity, sample sizes for training/test sets, expert adjudication, and ground truth methodologies (e.g., pathology, outcomes data). The information required to fully answer these questions in the context of an AI device is largely absent because the device being described is not an AI diagnostic tool.

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ContaClair® Multi-Purpose Solution is indicated for use in cleaning, rinsing, disinfecting, protein removal and storing daily and extended wear soft (hydrophilic) and RGP (rigid gas permeable) contact lenses as recommended by your practitioner. ContaClair is indicated for use in chemical (not heat) lens care regimen.

Not Found

This document is a 510(k) clearance letter from the FDA for a multi-purpose contact lens solution called ContaClair®. It does not contain information about acceptance criteria or a study proving that a device (in the context of an AI/ML medical device) meets acceptance criteria. The product is a chemical solution, not a software or hardware device that would typically involve acceptance criteria and a study as requested.

Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory approval for a contact lens care product, not a description of a device's performance study.

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The Purilense System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.

The device is a cleaning and disinfection unit for contact lenses. It consists of the Purilens Unit and Purilens Solution. The Purilens Unit is compact, with an upper housing containing a germicidal UV light, and a lower housing which contains a removable, clear cleaning chamber with a lens holder for the contact lenses. A mechanism in the lower portion of the cleaning chamber creates the cleaning turbulence activity. Within the lower housing unit is an electronic control unit which operates the UV light and turbulence vibrating mechanism. The lower unit contains an internal automatic timing device which shuts the unit after its 15 minute cycle. The lens holder consists of a removable basket which houses the contact lenses in separate chambers and is suspended within the cleaning chamber in the lower housing. The removable basket assembly is shielded from the UV light. The cleaning chamber contains an unpreserved saline medium as a storage solution for the contact lenses. The Purilens Solution is a preservative free saline solution which is used to fill the cleaning chamber. The turbulence mechanism is a magnetic pedal suspended on the end of a flexible spring located in the bottom of the cleaning chamber. When activated by the electronic connection, the pedal osillates in a subsonic range of 50 - 120 cycles per second creating a whirlpool effect that swirls the Purilens Solution surrounding the lens baskets and removes debris and microorganisms from the lenses during the 15 minute cycle. UV radiation energy from the upper housing disinfects loosened microorganisms in the solution. Disinfection is accomplished without heating, preservatives, or chemicals. The unit cannot function unless the electrical interlock is complete between the upper and lower housings. An electrical transformer is located on the power cord. The transformer converts house current of 110 VAC to 14 VAC for the purpose of operating the device.

The PuriLens System is a cleaning and disinfection unit for soft (hydrophilic) contact lenses. It uses subsonic agitation to remove lens deposits and microorganisms, and ultraviolet (UV) irradiation of the surrounding storage solution for disinfection.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a dedicated table. Instead, it describes various studies and their successful outcomes as evidence of performance. The implicit acceptance criterion for all studies described is "successfully performed all tests" or "no negative affect" or "performs equally as" or "superior to" a comparable control.

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

• Clinical Study: The document states that a clinical study was performed.
  • Sample Size: Not explicitly stated for subjects. Each subject experienced both the Purilens System and the control for three months each, implying a paired or crossover design. The number of lenses examined for cleaning analysis is also not explicitly stated but involved "all lenses worn in the clinical study."
  • Data Provenance: Not specified (e.g., country of origin). The study design is described as "clinical study," implying a prospective study.
• Pre-clinical Studies (Toxicology, Solution Compatibility, Microbiological):
  • Sample Size: Not explicitly stated for toxicology tests (e.g., number of mice, rabbits) or for microbiological challenge tests (e.g., number of test repetitions or organisms). Solution compatibility was tested "after 180 cycles of the device on Groups I, II, III, and IV soft contact lenses."
  • Data Provenance: Not specified. These are laboratory-based pre-clinical studies.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical or pre-clinical test sets.

• For the clinical study, the "results of the clinical study indicate..." suggests a clinical assessment, likely by ophthalmologists or optometrists, but their number and qualifications are not provided.
• For the lens cleaning analysis, "computer image processing quantification of visible light reflections of hydrogel contact lens deposits was performed." While this is an objective measure, expert interpretation of the images or the results might have occurred, but is not detailed.
• For pre-clinical studies, laboratory personnel with relevant expertise in toxicology, microbiology, and materials science would have been involved, but specific details are not given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical or pre-clinical studies.

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

No. The clinical study described is a crossover design comparing the Purilens System to a comparable multipurpose contact lens cleaning and disinfection system. It evaluates the device's effectiveness rather than the effect of AI assistance on human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone system for cleaning and disinfection; it does not involve AI or human-in-the-loop performance in the context of diagnostic interpretation. The studies assessed the standalone performance of the device in cleaning and disinfecting contact lenses.

7. The Type of Ground Truth Used

• Toxicology: Biological response in animal models (mice, rabbits) and in vitro assays (MEM Elution Method, cytotoxicity).
• Solution Compatibility: Objective measurements of lens parameters after cycling.
• Microbiological Efficacy: Laboratory culture-based methods (e.g., "D" value test, multi-item challenge test) to quantify reduction of microorganisms.
• Cleaning Efficacy: Objective quantification of deposits using "computer image processing quantification of visible light reflections."
• Clinical Analysis: Clinical observations and outcomes from subject use over time, comparing the device to a control system.

8. The Sample Size for the Training Set

This question is not applicable. The Purilens System is a mechanical/UV device, not a machine learning or AI-based system that requires a "training set" in the computational sense.

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

This question is not applicable for the same reason as point 8.

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The LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions.

Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allergan Soft Mate Consept-2 Neutralizing and Rinsing Solution, or Spray. The LENSERVER Automatic is indicated for cleaning rigid gas permeable lenses in conjunction with approved solutions such as Allergan Gas Permeable Daily Cleaner and Allergan ComfortCare Gas Permeable Wetting and Soaking Solution.

The LENSERVER Automatic Contact Lens Cleaning Accessory is an electro-mechanical contact lens cleaning device designed to be used in conjunction with approved contact lens cleaning solutions. The cleaning components of the LENSERVER Automatic consist of a motorized cleaninq unit and a partitioned fluid reservoir functioning as the cleaning beaker.

The motorized unit is manufactured from a polymer and houses the battery compartment. motor and control circuits. The fluid reservoir or lens receptacle/cleaning beaker is partitioned and injection molded from medical grade polymer. Fill marks are engraved on the outer wall of the beaker indicating a fluid volume sufficient to completely submerge contact lenses. Each contact lens would be placed into the appropriate compartment. designated "L' or 'R'.

The base of the fluid reservoir or cleaning beaker fits snugly onto a vibrating platform on the motorized cleaning unit. When placed on the vibrating platform and the power button is actuated, the cleaning beaker vibrates, and after a predetermined period the timing mechanism halts rotation of the motor.

The provided 510(k) summary describes the LENSERVER Automatic Contact Lens Cleaning Accessory and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with quantifiable metrics. Instead, the study focuses on demonstrating safety and compatibility with contact lenses, which are indirect measures of "performance" in this context.

However, based on the information provided, we can infer some "acceptance criteria" and describe the study that addresses them.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Acute Ocular Irritation Test: The document mentions "saline cycled through the device" and "LENSERVER test solution," but does not explicitly state the number of samples or animal subjects used for this test.
  • Lens Compatibility Test:
    • 10 lenses of each lens type.
    • Total of 30 cleaning cycles for each individual lens.
    • Lens types: 2 types of soft hydrophilic lenses (FDA groups I and IV) and 2 different rigid gas permeable lenses of different manufacture.
    • "Ten different LENSERVER Automatic devices" were used.
• Data Provenance: The tests were conducted by:
  • An independent testing facility for the acute ocular irritation test.
  • Highly trained and expert investigators at a recognized college of optometry (specifically, Southern California College of Optometry, Fullerton, California) for the lens compatibility test.
• Retrospective or Prospective: These appear to be prospective studies specifically conducted for this 510(k) submission.

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

• Acute Ocular Irritation Test: Performed by an "independent testing facility" according to USP XXII guidelines. The specific number or qualifications of experts are not detailed, but the reference to USP XXII suggests adherence to recognized standards for such tests.
• Lens Compatibility Test: "Highly trained and expert investigators" at the Southern California College of Optometry. The document does not specify the exact number of investigators or their detailed qualifications (e.g., "radiologist with 10 years of experience"), but their affiliation with a recognized optometry college implies relevant expertise.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either test.

• For the Acute Ocular Irritation Test, results were determined by the "independent testing facility" according to USP XXII guidelines, which would have defined assessment criteria.
• For the Lens Compatibility Test, the "trained investigators" at the optometry college measured lens parameters ("power, base curve, diameter and clarity") before and after cleaning cycles. The determination of "no detectable damage or changes" would likely have been based on established clinical or optical tolerances for these parameters, not necessarily inter-expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a cleaning accessory, not an diagnostic imaging tool where human readers assess cases. The studies performed focused on the device's safety and compatibility with lenses.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical electro-mechanical accessory, not an AI algorithm. Its performance is inherent in its physical operation. The "standalone" performance refers to the device's ability to clean without causing harm to the lenses or eyes.

7. The Type of Ground Truth Used

• Acute Ocular Irritation Test: The ground truth for safety was based on the biological response observed in the test (e.g., lack of irritation) compared to established toxicity standards (USP XXII guidelines). This could be considered a form of outcomes data in a controlled biological setting.
• Lens Compatibility Test: The ground truth for lens compatibility was established through objective measurements of lens parameters (power, base curve, diameter, clarity) before and after cleaning cycles, and the absence of visually detectable damage or changes. This is a form of objective measurement data interpreted by experts.

8. The Sample Size for the Training Set

This device does not involve an AI algorithm; therefore, there is no training set in the context of machine learning. The device's design and operation are based on engineering principles comparable to predicate devices.

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

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

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The New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses.

The New Comfort Contact lens Care Accessory is indicatod as aid for cleaning as an accessory for soft hydrophilic lenses and gas pormoablo lonsos whon usod with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfoction Systom which is comprisod of the Allergan® Soft Mato® Consept®-1 Cleaning and Disinfecting solution and Allergen® Soft Mate® Consept - 2 Neutralizing and Rinsing Solution or Spray. The New Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Allergan® Gas Permeable Daily Cleaner and Allergan® ComfortCare GP Wetting and Soaking Solution. The New Comfort Contact Lens Care Accessory may be used for a receptacle for chemical disinfection.

The New Comfort Ultrasonic Contact Lens Care Accessory uses a piezo-electric crystal to generate a wave form, in a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of temperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The New Comfort device uses standard power (110 v/120 v). There is a four (4) foot cord and a UL approved wall transformer.

The New Comfort device consists of the housing, lens baskets, a reservoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally marketed predicate devices in the United States. The housing is injection molded of ABS. The baskets and supporting structure are injection molded from ABS. The reservoir is deep drawn stainless steel, is passivated and electropolished. The electronic circuitry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.

Acceptance Criteria and Device Performance for "The New Comfort Contact Lens Care Accessory"

This document describes the acceptance criteria and the study that demonstrates the "New Comfort Contact Lens Care Accessory" meets these criteria, based on the provided 510(k) summary (K974724).

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list "acceptance criteria" in a formal, quantifiable manner. Instead, the demonstration of substantial equivalence is based on the device performing comparably to legally marketed predicate devices, particularly regarding its impact on contact lenses during cleaning cycles. The acceptance criteria can be inferred from the study's objective: to ensure no adverse changes to the contact lenses after prolonged use with the device.

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

• Sample Size for Test Set: Lenses were selected from "Group 1, Group 3, Group 4 and the Gas Permeable class." The exact number of lenses used is not specified in the document, but it includes representatives from key contact lens types.
• Data Provenance: The study was conducted by an optometrist in a large ophthalmology practice, strongly suggesting prospective data collection. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA, it is highly likely to be the United States.

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

• Number of Experts: One expert.
• Qualifications of Expert: The study was conducted by "an optometrist who is director of optometric services in a large ophthalmology practice." This indicates a qualified eye care professional with clinical experience relevant to contact lenses.

4. Adjudication Method for the Test Set

• Adjudication Method: None explicitly stated. The evaluation was conducted by a single optometrist. There's no mention of a consensus process or multiple reviewers for the ground truth establishment.

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

• MRMC Study Done: No. This device is an accessory for cleaning contact lenses, not an diagnostic imaging tool where MRMC studies are typically performed. The evaluation focuses on the physical effects of the device on lenses, not on human interpretation or diagnostic accuracy.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, in essence. The described study evaluates the device's performance (its effects on contact lenses) in isolation from human intervention in the cleaning process itself. The optometrist observes and measures the lens characteristics after the device has completed its function.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established through expert observation and measurement by a qualified optometrist. This involves physical and optical parameter measurements (color, clarity, power, diameter, base curve) and visual inspection for deposits, residue, or damage.

8. Sample Size for the Training Set

• The 510(k) summary describes a performance study for the device, not a machine learning model. Therefore, there is no concept of a "training set" as would be applicable to AI/ML devices. The device operates mechanistically based on physics (ultrasound), not learned patterns.

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

• As stated above, this is not applicable as there is no training set for this type of device.

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