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Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/ or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The provided document (K222885) is a 510(k) Premarket Notification for contact lenses, specifically Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).

It is crucial to understand that this document describes a submission for a medical device (contact lenses), NOT an AI/ML-powered diagnostic device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML systems (such as those involving test sets, ground truth establishment by experts, MRMC studies, etc.) do not apply to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to demonstrate the safety and effectiveness of the contact lenses. The acceptance criteria are based on established standards for contact lens properties and safety.

Here's an interpretation based on the provided document, framed within the context of a traditional medical device submission, rather than an AI/ML algorithm:

Acceptance Criteria and Study for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

The device, Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), is a Class II medical device. Its acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to legally marketed predicate devices through a combination of non-clinical (laboratory) testing and established material safety.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this contact lens device are derived from the performance characteristics of predicate devices and general industry standards for soft contact lenses. The reported device performance is compared against these benchmarks to demonstrate substantial equivalence.

Key Findings:

• The proposed device matches the material, water content, refractive index, visible light transmittance, and UV blocking properties of the predicate devices.
• The oxygen permeability of the proposed device ($23.2 \times 10^{-11}$) falls within the range and is comparable to the predicate devices ($20.6 \times 10^{-11}$ and $25 \times 10^{-11}$).
• The lens designs (Sphere, Asphere, Toric, Multifocal) are covered by the combined designs of the two predicate devices, demonstrating equivalence in functionality.
• The indications for use are also substantially equivalent to or within the scope of the predicate devices.

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

For this type of device (contact lenses), there isn't a "test set" in the common AI/ML sense (i.e., a dataset of images or patient records for algorithmic evaluation). Instead, the "testing" involves laboratory characterization of the physical and chemical properties of manufactured lenses.

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many lenses were tested for oxygen permeability). This information would typically be detailed in the full test reports referenced in the submission, conforming to relevant ISO standards or FDA guidance.
• Data Provenance: The tests are performed on samples of the manufactured Pegavision contact lenses themselves. The document states, "All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses." This implies the testing was likely conducted in a controlled laboratory environment, presumably by the manufacturer or a contracted lab, with methodologies defined by regulatory guidance. The country of origin of the data is Taiwan, where Pegavision Corporation is located. The studies are prospective in the sense that they are specifically conducted to characterize the new device.

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

This concept is not applicable to this type of medical device submission. Ground truth for contact lenses is established through objective physical and chemical measurements (e.g., refractometers for refractive index, oxygen permeameters for oxygen permeability, spectrophotometers for light transmittance). There is no "expert consensus" on the "truth" of a lens's physical property; it's a direct measurement.

4. Adjudication Method for the Test Set

This concept is not applicable. Since the "ground truth" for the non-clinical tests is directly measured physical properties, there is no need for adjudication of human interpretations.

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 concept is not applicable. An MRMC study is a clinical study design used primarily for diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading X-rays). This submission is for a physical medical device (contact lenses), not an AI algorithm assisting human readers.

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

This concept is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to objectively measured physical and chemical properties of the contact lenses. This includes:

• Physicochemical Properties: Refractive Index, Oxygen Permeability, Water Content, Extractables, Mechanical Properties, Light Transmittance.
• Biocompatibility: Cytotoxicity, Ocular Irritation, Acute Systemic Toxicity (these tests assess the biological response to the material).
• Shelf Life and Sterility: Confirming the product's integrity and safety over time.

These are established through laboratory testing using validated methods and scientific instrumentation, not expert consensus or outcomes data in the typical sense of a diagnostic trial.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" is a term used in machine learning for data used to develop and optimize an algorithm. This submission is for a manufactured physical product, not an AI algorithm.

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

This concept is not applicable for the reasons stated above.

Summary regarding this specific submission (K222885):

The FDA's decision of substantial equivalence for these contact lenses is based on the following:

• Comparison to Predicate Devices: The proposed device uses the same USAN material (Hioxifilcon A) and has highly similar technological characteristics (water content, refractive index, UV blocking, oxygen permeability) to already cleared predicate devices.
• Non-Clinical Testing: The manufacturer performed standard non-clinical tests (physicochemical properties, biocompatibility, shelf life, sterility) in accordance with FDA guidance for Class II contact lenses. These tests demonstrated that the specific manufactured lenses meet safety and performance standards comparable to the predicates.
• No Clinical Study Required: Given the well-documented safety and effectiveness of the Hioxifilcon A material and the substantial equivalence to existing devices, the FDA deemed that clinical studies were "not required for the premarket notification." This is common for 510(k) submissions of well-understood device types with established predicates.

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