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"CAREUS Contact Lens Case" is a device intended for the storage of soft (hydrophilic), rigid gas permeable, and/or hard contact lenses. Used for storage during chemical disinfection only. Not for use during heat disinfection.

"CAREUS Contact Lens Case" is a medical device for the storage of soft (hydrophilic) and rigid gas permeable contact lenses. The applicant device of Contact Lens Case consists of two parts: case body and case lid. The case body is based with adjoining dual wells for the containment of fluid, and the two lids are designed for screwing. "CAREUS Contact Lens Cases" have six different models, differ in dimension, case color, and packaging. The exterior of the cases total have 9 colors: white, pink, yellow, green, light green, red, purple, blue, and transparent (no color). Contact lenses can be fully immersed into the well from both models accommodates all lenses currently being sold in the market. The bottom of each well is marked with L (left) or R (right). CAREUS Contact Lens Cases are made of polypropylene.

The provided document is a 510(k) Summary for the "CAREUS Contact Lens Case." It describes a medical device, not a device that relies on algorithms for its function. Therefore, most of the requested information regarding acceptance criteria, study details, and AI/algorithm-related aspects is not applicable to this submission.

Here is the information that can be extracted from the document:

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

The document broadly states that "All tests were verified to meet acceptance criteria" for bench testing and biocompatibility. However, it does not provide specific numerical acceptance criteria or detailed reported performance figures for the physical and chemical specifications.

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 sample sizes for the bench testing or biocompatibility tests. It only states that testing was performed. The manufacturing country of origin for the device is China (Shanghai Care Us Medical Product Co., Ltd., Shanghai, China). The testing itself is not explicitly stated as retrospective or prospective, but bench and biocompatibility testing are generally prospective in nature for a new device submission.

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):

Not applicable. This device is a physical contact lens case and does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy, as would be relevant for an AI/algorithm-based device.

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

Not applicable. This concept applies to studies where expert interpretation is being evaluated, which is not the case for a contact lens storage device.

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 device does not involve human readers or AI assistance.

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

Not applicable. This device does not have an algorithm.

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

For the bench testing, the "ground truth" would be the predetermined physical and chemical specifications. For biocompatibility, the "ground truth" is adherence to the standards defined by ISO 10993. These do not fall into the categories of expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set:

Not applicable. This device is not an algorithm and does not have a training set.

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

Not applicable. This device is not an algorithm and does not have a training set.

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Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.

The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.

Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
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 tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
4. Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
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 study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
8. The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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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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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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Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.

Based on the provided text, the device in question is a multi-purpose contact lens solution (ABT12 multi-purpose solution), not an AI-powered medical device for image analysis. Therefore, many of the typical acceptance criteria and study details related to AI performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of product and approval process.

The document describes the regulatory approval of a contact lens solution (Bausch + Lomb ABT12 multi-purpose solution) for which the primary claims are related to its safety and effectiveness in cleaning, disinfecting, and storing contact lenses. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device (COMPLETE multi-purpose solution Easy Rub Formula) through a combination of preclinical (biocompatibility, microbiology, lens compatibility, cleaning efficacy) and clinical studies.

Here's a breakdown of the requested information, adapted to the context of this non-AI medical device:

Acceptance Criteria and Study for Bausch + Lomb ABT12 Multi-Purpose Solution

As the device is a contact lens solution, not an AI-powered diagnostic tool, the typical "acceptance criteria" table for AI performance metrics (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a contact lens solution primarily revolve around meeting established safety and effectiveness standards, often demonstrated through non-inferiority to a legally marketed predicate device.

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

• Sample Size (Clinical Study - Test Set): A total of 252 subjects were enrolled. 240 subjects completed the study. These subjects were randomized into two groups:
  • ABT12 multi-purpose solution (Test): 127 subjects
  • COMPLETE multi-purpose solution (Control/Predicate): 125 subjects
• Data Provenance: The clinical study was a multicenter study conducted in the USA.
• Retrospective or Prospective: This was a prospective, randomized, masked, parallel, bilateral clinical study.

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

This question is not applicable in the context of this device. The "ground truth" for a contact lens solution's performance is established through direct clinical observations (e.g., slit lamp findings by ophthalmologists/optometrists) and patient-reported outcomes, as well as laboratory testing results, rather than expert consensus on image interpretation. The study was masked, implying that the clinicians assessing outcomes were blinded to the treatment assignment.

4. Adjudication Method for the Test Set

This concept (adjudication of interpretations) is not applicable to this type of study. Clinical outcomes were measured directly by investigators in a masked fashion and patient-reported outcomes were collected.

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

No, an MRMC study was not done. MRMC studies are typically used to evaluate the impact of a diagnostic tool (like AI) on physician performance in interpreting medical images. This study focused on the safety and effectiveness of a physical product (contact lens solution) in a clinical trial setting.

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

This question is not applicable. There is no algorithm for this device. The "standalone performance" of the contact lens solution is demonstrated through the preclinical studies (biocompatibility, microbiology, cleaning efficacy, lens compatibility) which evaluate the product's intrinsic properties irrespective of human handling errors (though proper usage instructions are provided).

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

• Clinical Measurements: Objective clinical assessments by masked investigators (e.g., slit lamp findings, visual acuities).
• Patient-Reported Outcomes: Subjective data gathered directly from subjects regarding comfort, dryness, and other symptoms.
• Laboratory Testing: In-vitro and ex-vivo studies to assess intrinsic properties like microbiological efficacy, cleaning efficacy, and biocompatibility.
• Comparison to Predicate: The "truth" of effectiveness and safety was established by demonstrating non-inferiority to a known, legally marketed predicate device.

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/machine learning device.

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

This question is not applicable as this is not an AI/machine learning device.

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OTE MPS 045 Multi-Purpose Lens Care Solution is indicated for daily cleaning, chemical (not heat) disinfection, conditioning, rinsing and storage of hydrogel and silicone hydrogel soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

OTE MPS 045 Multi-Purpose Lens Care Solution is a sterile, buffered aqueous solution that contains sodium hyaluronate, poloxamer 407, boric acid, sodium borate, propylene glycol, and is preserved with Polyaminopropyl Biguanide Hydrochloride 0.00002%, Polyquaternium-2 0.00043%, and edetate disodium.

The provided text describes a 510(k) premarket notification for the "OTE MPS 045 Multi-Purpose Lens Care Solution." The document focuses on demonstrating substantial equivalence to a predicate device, BioTrue® Multi-Purpose Solution, rather than providing explicit acceptance criteria and performance against those criteria in a typical AI/device study format.

However, I can extract the relevant information from the "Clinical Data" section to answer your request in the closest possible way, interpreting "acceptance criteria" as the primary endpoints of the clinical study and "reported device performance" as the study findings for those endpoints.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

For the clinical study, the "acceptance criteria" can be interpreted as the successful demonstration of non-inferiority for the specified primary endpoints.

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

• Sample Size for Test Set: 199 subjects.
• Data Provenance: The study was a multi-center study, but specific country of origin is not mentioned. It was a prospective study, as it involved subjects using the device for a duration of 30 days.

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, nor their qualifications, used to establish ground truth for the clinical study endpoints. It mentions "Investigator" as one of the masked parties, suggesting that clinical investigators (likely ophthalmologists or optometrists) assessed the endpoints, but no specific number or detailed qualifications are provided.

4. Adjudication method for the test set

The document does not describe an adjudication method. It was a "double-masked (Investigator and Subject)" study, implying that the investigator assessments would form the basis of the outcome.

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

• MRMC Study: No, this was not an MRMC study related to AI. This was a clinical trial comparing a new lens care solution to a predicate device.
• Effect size of human readers improve with AI: Not applicable, as this study does not involve AI assistance for human readers.

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

No, this was a clinical study involving human subjects and a medical device (lens care solution), not an algorithm or AI.

7. The type of ground truth used

The ground truth was established through direct clinical observations and assessments by investigators (implied to be eye care practitioners) and subject-reported outcomes during the 30-day clinical study. This would encompass clinical findings (slit lamp, hyperemia, corneal staining) and subjective reports (comfort, visual acuity).

8. The sample size for the training set

Not applicable. The provided document describes a clinical study for a traditional medical device (lens care solution), not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device and study.

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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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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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Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

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 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

The provided text describes the 510(k) Premarket Notification for Aqua Naina Sterile Saline Solution and its substantial equivalence to predicate devices. It focuses on the chemical composition, intended use, and various safety tests (sterility, biocompatibility, ocular irritation, cytotoxicity).

However, this document does not describe acceptance criteria, performance data, or study details relevant to a machine learning or AI device. The device in question is a sterile saline solution, which is a chemical product, not a medical imaging or AI diagnostic device. Therefore, the requested information about test sets, data provenance, expert consensus, MRMC studies, or training sets is not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of chemical and biological tests conducted on the saline solution to demonstrate its safety and performance, as outlined in section (7) "PERFORMANCE STSTANDARDS APPLIED".

Here's a breakdown of what is provided and why it doesn't fit the typical AI/ML device study format:

• Device: Aqua Naina Sterile Saline Solution (a chemical product for contact lens care).

• Acceptance Criteria & Reported Performance: These are presented implicitly through the successful completion of various tests against established standards for saline solutions.

  • Sterility: USP
  • Bacteriostasis: USP
  • Ocular irritation: Tested per ISO 10993-10:2010
  • Cytotoxicity (Direct contact test & MEM Elution test): Tested per ISO 10993-5:2009
  • Biocompatibility: Tested per ISO 10993-1:2009
  • pH: 6.30 to 7.80 (reported in description)
  • Osmolality: 280 to 320 mOsmol/kg (reported in description)
    The document states: "Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates." This is the reported device performance meeting the acceptance criteria set by these standards.

• Sample Size for Test Set and Data Provenance: Not applicable. This refers to chemical and biological samples, not image datasets. The tests are laboratory-based, not based on patient data in the sense of AI/ML.

• Number of Experts, Qualifications, Adjudication Method: Not applicable. These relate to human interpretation of diagnostic data, which is not relevant for testing a saline solution.

• MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating AI assistance in diagnostic tasks.

• Standalone Performance (algorithm only): Not applicable, as there is no algorithm.

• Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth here is established by laboratory measurements and biological assays, comparing results against defined pass/fail criteria from recognized standards (e.g., USP, ISO).

• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There is no machine learning model involved, therefore no training set. The "training" of the product is its formulation and manufacturing process, and its "ground truth" is its chemical and physical properties verified through standard laboratory testing.

In summary, the provided document details the regulatory clearance of a contact lens saline solution, not an AI/ML-based medical device. Therefore, the questions posed regarding AI/ML device acceptance criteria and study methodology cannot be answered from this information.

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