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The CIBA Vision® (lotrafilcon B) spherical soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

The CIBA Vision® Toric (Iotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 10.00 diopters (D) or less of astigmatism.

The CIBA Vision® Progressives (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.

The CIBA Vision® Progressive Toric (lotrafilcon B) soft contact lens is indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eves. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or comeal astigmatism.

The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

The lens material is 33% water and 67% lotrafilcon B, a fluoro-silicone containing hydrogel which is surface treated. Lotrafilcon B lens designs include spherical, toric, multifocal and toric multifocal lenses in the following parameter ranges: Diameter Range: 13.0 to 15.0 mm, Base Curve Range: 8.0 to 9.2 mm, Power Range: -20.00D to +20.00D, Center Thickness: varies with power (0.080 mm for -3.00D spherical). Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling. Lenses have the following properties: Refractive index: 1.42 (hydrated), Light transmittance: > 96 %, Water content : 33% by weight in normal saline, Oxygen permeability: 110 x 10 -11 [(cm² /sec)(ml O2 /ml●mmHg)] measured at 35°C (intrinsic Dk-Coulometric method). Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution.

The provided document is a 510(k) Summary for a medical device (CIBA Vision® (lotrafilcon B) Soft Contact Lenses) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than establishing comprehensive acceptance criteria and detailed clinical study results in the way a pivotal trial might.

Therefore, many of the requested elements (e.g., specific acceptance criteria values, detailed device performance metrics, sample sizes for test/training sets in an AI context, expert qualifications, MRMC study details, standalone algorithm performance, and ground truth for training) are not explicitly present in this type of regulatory submission for a contact lens. The document establishes safety and effectiveness through comparisons to an existing, approved device.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format with specific performance metrics as one might expect for a novel diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating "substantial equivalence" to a predicate device. The general criteria relate to safety and comparable performance in clinical use.

Implied Acceptance Criteria and Reported Performance (based on "substantial equivalence"):

• Refractive index: 1.42 (hydrated)
• Light transmittance: > 96 %
• Water content: 33% by weight in normal saline
• Oxygen permeability: 110 x 10 -11 [(cm² /sec)(ml O2 /ml●mmHg)] measured at 35°C (intrinsic Dk-Coulometric method) |
  | Compatibility with Lens Care Products | The lens material is compatible with commonly available lens care products. |
  | Overall Clinical Performance (Vision) | Demonstrated similar overall performance in clinically relevant areas of vision compared to the control lens. |
  | Overall Clinical Performance (Health) | Demonstrated similar overall performance in clinically relevant areas of health compared to the control lens. |
  | Overall Clinical Performance (Comfort) | Demonstrated similar overall performance in clinically relevant areas of comfort compared to the control lens. |
  | Overall Clinical Performance (Fit) | Demonstrated similar overall performance in clinically relevant areas of fit compared to the control lens. |
  | Safety (General) | The modified lens remains non-toxic and biocompatible. Clinically, the lens has performed satisfactorily in a daily wear investigation. |
  | Effectiveness (General) | Results verify that the modified lens has material characteristics comparable to or better than other currently marketed soft contact lenses. |
  | Packaging & Sterility | Blister pack packaging system compatibility and integrity demonstrated (used for other marketed products). Effectively steam sterilized in a validated autoclave. |
  | Shelf-Life | Shelf-life established through stability product expiration actions; studies ongoing to extend. |
  | Equivalence to Predicate (Overall) | The modified (lotrafilcon B) contact lens is equivalent to the predicate lens and similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics. Any differences do not affect safety and effectiveness. |

Study Information (as inferable from the document)

Given that this is a 510(k) for a contact lens and not an AI/software device, many of the AI-specific questions are not applicable.

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

   • Test Set Sample Size: The document states "The two-month clinical evaluation was conducted..." but does not specify the number of subjects (sample size) for the clinical study.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were likely conducted to meet FDA requirements for US market approval. They were "conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, and 812)," implying a clinical trial environment. The nature (retrospective/prospective) is implicitly prospective as it describes a "two-month clinical evaluation" in which the lens "was investigated."

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

   • This question is not applicable in the context of this device and study type. Clinical performance (vision, health, comfort, fit) would have been assessed by eye care professionals participating in the clinical study, but there's no mention of "ground truth establishment" by a separate panel of experts in the way an AI diagnostic device would require.

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

   • This is not applicable to this type of clinical study for a contact lens. Clinical outcomes are typically assessed by the investigator(s) and potentially monitored by study coordinators/sponsors, not through an adjudication panel for "ground truth."

4. 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 type of study is relevant for AI-assisted diagnostic tools, not for a contact lens. The effectiveness was assessed by comparing the device to a "control lens" (predicate device) in terms of clinical performance during daily wear. There is no "AI assistance" component.

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

   • Not applicable. This device is a contact lens; there is no algorithm or AI component to operate in a standalone manner.

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

   • For the clinical study, the "ground truth" (or more accurately, the clinical endpoints) were based on physician assessments of vision, health, comfort, and fit, and potentially patient reported outcomes (for comfort, for example). This is essentially outcomes data and expert clinical assessment. For non-clinical tests, it would be direct measurement against established physical/mechanical standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

   • Not applicable. As there is no training set, there is no ground truth for it.

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