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SEE3™ (lotrafilcon A) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection and monthly replacement. SEE3™ (lotrafilcon A) lenses may be cleaned using a chemical, not heat, disinfection system.

The SEE3™ (lotrafilcon A) soft contact lens is a new soft contact lens suiteble for daily wear. The lens material is 24% water and 76% lotrafilcon A, a silicone containing hydrogel treated with a plasma coating.

The SEE3™ (lotrafilcon A) contact lens is available in a spherical lens design of the following dimensions:

Chord Diameter: 14.0 mm
Center Thickness: 0.05 to 0.35 mm (varies with power)
Base Curve: 8.8 mm
Power Range: -20.00D to +20.00D
Powers Available: -5.00D to +5.00D (0.25D steps), -6.00, -5.50, +5.50, +6.00D

A clear lens has the following properties:

Specific gravity: 1.08
Refractive index: 1.43 (hydrated)
Light transmittance: 99 %
Water content : 24 % by weight in normal saline
Oxygen permeability : 140 x 10^-11 [(cm^2 /sec)(ml O2 /mlommHg)] measured at 35°C, Coulometric method.

Lenses are supplied sterile in sealed glass vials containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the glass vial packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Vial containers are labeled with the lens parameters. Iot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterlity). Stability study data currently supports a twelve (12) month shelf-life for the SEE3" (lotrafficon A) soft contact lons in sealed glass vials. Shelf-life studies are ongoing to determine extension of expiration dating.

The provided document is a 510(k) Summary of Safety and Substantial Equivalence for the CIBA Vision SEE3™ (lotrafilcon A) Soft Contact Lens. It outlines the device description, indications for use, and a summary of nonclinical and clinical testing performed to demonstrate its safety and effectiveness, and substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria (e.g., minimum performance thresholds for specific metrics like visual acuity or comfort levels) or detailed quantitative results from the clinical study that would allow for a direct comparison in a table as requested. It generally states that the device performed "satisfactorily" and demonstrated "similar overall performance" to a predicate device.

Given the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria in terms of quantitative thresholds (e.g., "visual acuity must be ≥ 20/20 in 95% of subjects" or "incidence of adverse events must be ≤ X%"). Instead, it states that the device was evaluated against a predicate lens and performed "satisfactorily" and demonstrated "similar overall performance" in key areas.

Therefore, a table cannot be constructed with detailed acceptance criteria and reported numerical performance values from the provided text.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a daily wear clinical study" and "The three month clinical evaluation" but does not provide the number of subjects or lenses included in this study.
• Data Provenance: The study was conducted as a "daily wear clinical study" and "three month clinical evaluation." There is no mention of the country of origin, but CIBA Vision Corporation is located in Duluth, GA, USA, suggesting the study was likely conducted in the USA. It appears to be a prospective study given it was an "investigation" and "evaluation" of the new device.

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

This information is not provided in the document. For a contact lens study, "ground truth" would typically refer to clinical assessments by optometrists or ophthalmologists. The document mentions "clinically relevant areas of vision, health, comfort and fit," which would have been assessed by clinical experts, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

An MRMC study is typically associated with imaging diagnostics. This document describes a contact lens, which is a medical device for optical correction, not an diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study, as typically understood in AI/imaging, would not be applicable or performed for this type of device. The clinical study performed was a comparison of the new lens against a predicate device in human subjects. The document does not discuss AI assistance or human reader improvement with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable as the device is a contact lens, not an algorithm or AI system. Its performance is directly tied to human wearers.

7. Type of Ground Truth Used

For a contact lens clinical study, the "ground truth" is typically established through clinical assessments by qualified healthcare professionals (optometrists/ophthalmologists), potentially combined with patient-reported outcomes. The document mentions evaluation of "vision, health, comfort and fit," which are all clinical endpoints determined by expert examination and patient feedback. It does not mention pathology or outcomes data in the sense of long-term health consequences beyond the 3-month study period.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device (contact lens), not a machine learning algorithm that requires a "training set."

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

This information is not applicable for the same reason as above (not an AI/ML algorithm).

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