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OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).

The provided text is a 510(k) summary for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. It details the similarity of the device to predicate devices rather than providing a standalone clinical study with specific acceptance criteria and performance results for the new device.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for a standalone study is not explicitly present in the provided document. The document refers back to predicate device studies (K213216, K191929, K213119) for clinical and non-clinical data.

However, I can extract the material properties and their tolerances which act as performance criteria for the device itself.

Acceptance Criteria and Reported Device Performance

The provided document lists material properties and tolerances (acting as acceptance criteria) for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. Since this is a 510(k) summary demonstrating substantial equivalence to predicate devices, the performance is generally asserted to meet these specified ranges, implying the device does meet these criteria. The table below presents these:

Study Information (Based on provided document)

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

• Test Set Sample Size: Not explicitly stated for the device in this document. The document refers to "Non-clinical performance tests were performed to demonstrate the safety and effectiveness of the linofilcon A finished contact lenses in K213216." and "A clinical study was performed to demonstrate the safety and effectiveness of the linofficon A finished contact lenses in K213216." This implies the testing relevant to safety and effectiveness, including clinical performance, was primarily conducted for the predicate device K213216.
• Data Provenance: The manufacturing facility is in Hsinchu Science Park, Baoshan Township, Hsinchu County, Hsinchu – District, TAIWAN. The specific country of origin for clinical data (if separate from manufacturing) is not detailed. The non-clinical studies followed GLP regulations.

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

• Not applicable as the document does not describe a study involving expert assessment for ground truth establishment in the context of AI or diagnostic imaging. This device is a medical device (contact lens), not an AI diagnostic tool.

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

• Not applicable for a contact lens safety and effectiveness study as described.

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:

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm. The device "OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™" is a physical contact lens. The "Non-Clinical Performance Testing" and "Bench Testing - Manufacturing Verification Testing" sections describe standalone testing of the physical properties and biocompatibility of the contact lenses.

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

• For the non-clinical and bench testing, the ground truth would be based on established scientific measurement methodologies (e.g., ISO standards for biocompatibility, ANSI Z80.20 for contact lens parameters).
• For clinical studies (referenced to K213216), the ground truth for safety and effectiveness would likely involve clinical assessments by ophthalmologists/optometrists based on established clinical endpoints, patient reported outcomes, and adverse event monitoring.

7. The sample size for the training set:

• Not applicable. This is not an adaptive algorithm or AI, so there is no "training set."

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

• Not applicable.

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Sphere/Asphere: Innova Vision Sphere and Asphere (mifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric: Innova Vision Toric (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal: Innova Vision Multifocal (inifilcon A) Silicone Hydrogel Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty.

Multifocal Toric: Innova Vision Multifocal Toric (inifiloon A) Silicone Hydrogel Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hvdrophilic) Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from inifilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 60.0% inifilcon A and 40.0% water by weight when immersed in saline solution. The inifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (316nm - 380nm).

The Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is manufactured in sphere/asphere, toric, multifocal and multifocal-toric design configurations.

The provided text describes the 510(k) premarket notification for the Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens. The document focuses on demonstrating the substantial equivalence of this new device to legally marketed predicate devices rather than providing acceptance criteria and a study proving a device meets specific performance criteria for an AI/ML-based medical device.

The information requested in the prompt, related to AI/ML device performance metrics such as sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI/ML models, is not present in the provided 510(k) summary for a contact lens.

This document discusses:

• Non-Clinical Performance Testing: Including toxicology (in-vitro cytotoxicity, systemic toxicity, acute ocular irritation, skin sensitization, 22-day ocular irritation), shelf life, solution compatibility, preservative uptake and release, and bench performance tests (refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity, quantification of polymerization residuals).
• Clinical Testing: A single-masked, bilateral, multi-center, randomized concurrent-control study comparing the Innova Vision lenses to Acuvue Vita lenses.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's questions are tailored for AI/ML device evaluations, which are distinct from the premarket notification requirements and testing specified for contact lenses in this document.

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Sphere/Asphere
Innova Vision Sphere and Asphere (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty.

Toric
Innova Vision Toric (Etafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal
Innova Vision Multifocal (Etafilcon A) Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric
Innova Vision Multifocal Toric (Etafilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eves in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Etafficon A) Soft (Hydrophilic) Contact Lens is to be cleaned. rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is available as spherical and aspherical lenses manufactured by cast-molding method. The material is a high water content (58% wt/wt) material. The hydrogel lens' material is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) a via UV photo-polymerization. Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens is tinted with Reactive Blue 19 to enhance the visibility for for handling and contains 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyl-phenyl]ethyl as an additive for ultraviolet blocking purpose. The average transmittance in the UVB region is less than 5% and less than 30% in the UVA region.

The properties of the lens are:
Chord Diameter: 13.00 mm to 15.00 mm
Center Thickness 0.080 mm to 0.580 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range
Sphere Power: -20.00 D to +20.00 D in 0.25 D steps
Cylinder Power (Toric): -0.25 D to -2.25 D in 0.25 D steps
Cylinder Axis (Toric): 10 degrees to 180 degrees in 10 degrees steps
Multifocal Power: +0.25 D to +4.00 D in 0.25 D steps
Specific Gravity: 0.98 to 1.12
Refractive Index: 1.400 plus or minus 0.005
Visible Light Transmittance: > 95%
UVA (315 nm380 nm) Absorbance < 30%
UVB (285 nm315 nm) Absorbance < 5%
Surface Character: Hydrophilic
Water Content: 58% plus or minus 2%
Oxygen Permeability: 24 times 10 to the power of -11 (cm squared dot ml O2)/(sec dot ml dot mmHg) plus 20%

The provided text describes the regulatory submission for the Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954). The submission demonstrates substantial equivalence to predicate and reference devices, primarily through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format for all aspects. Instead, it states that "All the test results met the requirements of product specification" and "The results complied with the testing guidance." It provides specific performance characteristics for the subject device and compares them to predicate and reference devices, asserting non-significant differences.

Based on the "Description of the Device" and the comparison tables, here's a summary of performance characteristics presented as implicit acceptance criteria and reported performance:

The document notes that no specifications were significantly different between the subject, predicate, and reference devices, and that differences in material properties (water content, oxygen permeability, refractive index) were "not significantly different and meets the requirements." The production method (cast-molded vs. spin-casting) was deemed "Equivalent" because "the performance of the device are not affected and meet the requirements."

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing."

Therefore, there is no "test set" in the context of human clinical data, nor is there information about data provenance (e.g., country of origin, retrospective/prospective) because such data was not utilized. The non-clinical tests would have involved specific numbers of contact lenses or samples of materials, but these specific sample sizes are not detailed in the provided summary.

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

Not applicable, as no clinical test data or human ground truth assessment was performed for the substantial equivalence determination.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test data requiring adjudication was used.

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 is a contact lens and does not involve AI assistance or human readers for diagnostic interpretation.

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

Not applicable. This device is a contact lens and does not involve algorithms or AI.

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

For the non-clinical tests, the "ground truth" implicitly refers to recognized consensus standards and established product specifications (e.g., ISO, ASTM standards, and Innova Vision's own product requirements). The reported performance meeting these standards and specifications serves as the "ground truth" for non-clinical aspects.

8. The sample size for the training set

Not applicable. This device is a contact lens; it does not involve a training set for an algorithm.

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

Not applicable, as no training set for an algorithm was used.

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