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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.

Device Description

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).

AI/ML Overview

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:

Parameter	Acceptance Criteria (Range/Tolerance)	Reported Device Performance (Implied adherence to these ranges)
Chord Diameter	13.00 mm to 15.00 mm, ±0.20 mm	Meets specified range
Center Thickness	0.080 mm @ -3.00 D; When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5%	Meets specified range
Base Curve	8.00 mm to 9.50 mm, ±0.20 mm	Meets specified range
Back Vertex Power (F'v)	+20.00D to -20.00D; When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D	Meets specified range
Cylinder Power (F'c)	-0.25 D to -2.25 D (in 0.25 D steps); When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤4.00 D→±0.37 D	Meets specified range
Cylinder Axis	5° to 180° in 5° steps; When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D→± 5°	Meets specified range
Multifocal Power	+0.25 D to +4.00 D (in 0.25 D steps), ±0.25D	Meets specified range
Surface Appearance	Lenses should be clear with no surface defect	Meets specified criterion
Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg))	100, ±20%	Meets specified range (100 edge-corrected)
Light Transmittance - Tinted (@ 380-780nm)	95%, ±5%	Meets specified range (implied to be ≥ 95%)
Ultraviolet Radiation Transmittance	< 5% TUVB; < 30% TUVA	Meets specified criteria (< 0.05TV for TUVB, < 0.50TV for TUVA)
Water Content	38%, ±2%	Meets specified range (38±2%)
Refractive Index	1.415 (hydrated), ±0.005	Meets specified range (1.415 hydrated)

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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