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For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.

ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ALCON® Multi-Purpose Solution:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes general categories of studies and concludes that the device performed acceptably.

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

• Sample Size:
  • Cleaning Studies: Not specified, but implied by "clinical evaluations."
  • Compatibility Studies: Not specified.
  • Microbiology Studies: Not specified beyond adherence to standards.
  • Clinical Studies: The document mentions "Two clinical studies were conducted." The exact number of subjects in these studies is not specified.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Clinical studies are generally prospective.

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

• This information is not provided in the document. The studies performed are tests of the chemical solution itself (cleaning, microbiology, biocompatibility) and clinical outcomes in human subjects, not dependent on expert interpretation of images or other data that would require a "ground truth established by experts" in the traditional sense of AI/medical device studies.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided as the studies are focused on direct chemical/biological assays and clinical outcomes rather than expert adjudication of interpretations.

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

• No, an MRMC comparative effectiveness study was not done. The document describes clinical studies where subjects were assigned to either the ALCON® Multi-Purpose Solution regimen or a control regimen (Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution). This is a direct comparison of solution performance, not a study involving multiple human readers interpreting results with and without AI assistance.**

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 contact lens solution, not an AI algorithm. The performance evaluation is inherently "standalone" in that it's evaluating the product itself, not an algorithm's output.

7. The Type of Ground Truth Used:

• For Cleaning Studies: The "ground truth" was likely derived from the Critical Micelle Concentration (CMC) measurement and subsequently confirmed by clinical evaluations (which would involve direct observation of lens cleanliness or indirectly through patient comfort/health).
• For Compatibility Studies: The "ground truth" would be established by direct observation and measurement of lens material integrity after exposure to the solution.
• For Microbiology Studies: The "ground truth" was adherence to established international and ANSI standards (EN ISO 14729:2001, EN ISO 14730:2000) for disinfection and preservative efficacy, which involve quantitative microbial reduction targets.
• For Biocompatibility: The "ground truth" was likely established through preclinical tests designed to assess tissue irritation, cytotoxicity, and other adverse biological reactions, guided by recognized biocompatibility standards.
• For Clinical Studies: The "ground truth" for efficacy (e.g., corneal staining) was established through direct clinical observations and measurements by eye care professionals in the studies.

8. The Sample Size for the Training Set:

• This information is not applicable as the device is a physical solution, not an AI model that requires a training set.

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

• This information is not applicable as the device is a physical solution, not an AI model.

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The InteliPORT® Occluding Device is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by occluding the lacrimal drainage system in order to increase tear volume.

The InteliPORT® Occluding Device may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.

Other patients that may benefit are: patients with arthritis, patients taking systemic or topical medications known to produce dry eyes, contact wearers who experience dry eye related problems, and patients who live in dry climates, or spend extended periods of time in low humidity environments (such as air conditioning). Topical eye drops may be more effective with punctal occlusion because tear drainage will be retarded, and tear breakup time extended.

The InteliPORT® Occluding Device is designed to deliver a custom fit plug through the punctal opening to block tear drainage. The self-forming plug (Intelimer Occluding Material*) is heated and inserted through the punctal opening into the proximal canaliculus as a melted viscous liquid. It rapidly solidifies to conform to the shape of the ampulla and canaliculus. The InteliPORT® Occluding Device is composed of a transitional and continuous block of Intelimer Occluding Material (matrix) which is adequate for delivering two doses in a single patient use applicator and is provided in a sealed, sterilized package. The Intelimer Occluding Material is liquefied in the applicator by warming it a few degrees above body temperature via an internal 1.5 volt battery and a heating coil. The narrow applicator tip is then inserted into the punctal opening and the plunger is pushed to deliver the Intelimer Occluding Material. Once inside the duct, the material cools to form a customized plug that conforms to the shape of the individual's ampulla and canaliculus. The volume of material delivered, approximately 4-7 micro liters, is controlled so as to flow into the common ampulla and canaliculus. Restoration of patency may be accomplished by irrigation with warm sterile saline.

The provided text is for a 510(k) premarket notification for a medical device (InteliPORT® Occluding Device), not an AI/ML device. Therefore, the questions about acceptance criteria, study design for AI evaluation (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable.

The document describes the safety and effectiveness of the InteliPORT® Occluding Device based on non-clinical and clinical data, comparing it to a predicate device for substantial equivalence.

Here's an overview of the safety and effectiveness information provided, structured to best fit the spirit of the request, acknowledging the non-AI nature of the device:

Acceptance Criteria and Device Performance (Interpreted for a non-AI medical device submission)

For a device like the InteliPORT® Occluding Device, "acceptance criteria" are not framed as statistical thresholds for AI metrics. Instead, they are implicitly defined by the demonstration of safety, biocompatibility, and clinical effectiveness similar to a legally marketed predicate device, with an acceptable risk profile for its intended use. The "reported device performance" refers to the findings from the non-clinical and clinical studies that support these claims.

Table: Summary of Safety and Effectiveness Findings (Non-AI Device)

• Non-cytotoxic, non-hemolytic, non-pyrogenic for Intelimer Occluding Material/extracts.
• Non-mutagenic in Ames Salmonella and chromosomal aberration assays. |
  | Applicator Safety | Safe for user, no hazard. | - Plastic applicator determined safe in standard USP plastics testing. |
  | MR Compatibility | Safe for patients undergoing MR imaging, no interference with image quality. | - Safe and compatible with static magnetic resonance fields up to 1.5 Tesla, no safety hazard, no interference with MR image quality. |
  | Thermal Safety | No unacceptable histological effects at operational temperatures. | - No unacceptable or marginal histological effects at 75°C (highest temperature evaluated). Specification for maximum temperature of 70°C considered safe. |
  | Removal Techniques | Restoration of patency without adverse effects on the nasolacrimal duct. | - Mineral oil-based ophthalmic lubricant with or without warm saline (less than 50°C) and warm compress restored duct patency for 100% of rabbits, with no adverse effects. |
  | Chronic Irritation (Animal) | No significant chronic irritation or adverse effects on nasolacrimal duct. | - Evaluated in rabbits for 182 days. Minimal conjunctival redness observed sporadically in both eyes, not indicative of ocular irritation.
• 2/30 rabbits had discharge/conjunctivitis in right eye, resolved with topical antibiotics; attributed to subclinical infection facilitated by occlusion. No signs in rabbits implanted for 180 days. Average histopathology scores

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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.

OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.

OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.

The provided 510(k) summary for K031193, OPTI-ONE® Multi-Purpose Solution, focuses on demonstrating substantial equivalence to a predicate device and adherence to FDA guidelines for contact lens care products. While some study details are mentioned, it primarily summarizes the findings rather than providing in-depth study protocols and results with specific acceptance criteria and performance metrics in a structured format often seen in clinical trial reports.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for its clinical study. Instead, it makes a general statement about clinical acceptability and similarity to the control. For the microbiology study, it references FDA guidelines and ISO 14729:2001 requirements as the acceptance criteria.

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

• Cleaning Studies: The sample size for the cleaning study is not specified. The data provenance is implied to be a "laboratory study," suggesting it was conducted in a controlled environment, likely in the US, but this is not explicitly stated. It's retrospective in the sense that the lenses were "laboratory deposited."
• Microbiology Studies: The sample size for the microbiology study is not specified. The data provenance is implied to be a "study" conducted in a laboratory, likely in the US.
• Clinical Study: The sample size for the clinical study is not specified, only that it was a "90-day clinical study." The data provenance is a "clinical study," implying prospective human subject data, likely from the US, but the country of origin is not explicitly stated.

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

This information is not provided in the summary. For studies involving contact lens care products, "ground truth" might refer to:

• Cleaning Studies: The standard or method for assessing the level of laboratory-deposited debris removal. This would typically be assessed by laboratory technicians or validated instrumental methods, not clinical experts.
• Microbiology Studies: The standard microbiological methods for quantifying microbial reduction. Experts would be microbiologists or laboratory personnel.
• Clinical Study: Clinical outcomes (e.g., adverse events, comfort, visual acuity, lens condition). These would be assessed by eye care practitioners, such as optometrists or ophthalmologists. However, the exact number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Clinical studies often employ adjudication for subjective endpoints or adverse events.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device is a contact lens care solution, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

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

This section is not applicable. The device is a chemical solution, not an algorithm. Its performance is inherent to the solution itself when used with contact lenses.

7. The Type of Ground Truth Used

• Cleaning Studies: Laboratory-deposited lenses (simulated dirt/debris) and likely an objective assessment of cleanliness.
• Microbiology Studies: Reduction of specified microorganisms as per FDA and ISO standards (laboratory-based microbiological assays).
• Clinical Study: Safety and efficacy outcomes, likely including clinical examinations, patient surveys/feedback on comfort, and documented adverse events. The control used was Bausch & Lomb ReNu MultiPlus®.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train machine learning models. This device is a chemical solution assessed through laboratory and clinical studies, not an AI/ML algorithm.

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

This information is not provided and not applicable for the same reasons as point 8.

Summary of Limitations:

The provided 510(k) summary is typical for a medical device product like a contact lens solution, which focuses on demonstrating safety and efficacy through laboratory and clinical studies. It highlights substantial equivalence to a predicate device and compliance with relevant guidelines. However, it lacks the detailed methodological and quantitative information (e.g., precise sample sizes, specific quantitative acceptance criteria values, expert qualifications, and adjudication methods) that would be expected in a full clinical study report, especially for AI/ML-driven devices. The nature of the device (a chemical solution) means many of the requested points related to AI/ML performance (MRMC, standalone algorithm, training sets) are not relevant.

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