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HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) with isotonic buffered saline solution.

The provided text is a 510(k) Summary for the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens. It outlines the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, but it explicitly states that no clinical study was conducted to prove the device meets acceptance criteria. Therefore, most of the requested information regarding a study, sample sizes, experts, adjudication, MRMC, and standalone performance cannot be provided as they are not applicable to this submission.

However, based on the provided "Technological characteristic" and "Performance Data" sections, we can infer some aspects of what would typically be considered "acceptance criteria" for a contact lens and how its performance was assessed non-clinically.

Here's a breakdown of the requested information, adapted to what is available in the text:

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was performed with explicit acceptance criteria and corresponding performance metrics from that study, I will extract relevant technical specifications of the HydroSens A lens from the "Technological characteristic" and "Performance Data" sections, along with performance from non-clinical physiochemical studies. These values represent the device's intended performance.

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The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.

The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.

The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.

Evecare practitioners prescribe the lens for single-use disposable wear.

The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot 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 sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

The provided text is a 510(k) summary for a contact lens device, not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML device.

Specifically, the document states:
"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 7, Section 11. Clinical study)

The information requested regarding AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, is not present in this document.

The document focuses on the physicochemical properties, manufacturing process, and comparison to a predicate contact lens device to demonstrate substantial equivalence, which is typical for a contact lens submission.

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The OxySoft (olifilcon C) Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The OxySoft (olifileon C) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The OxySoft (olifilcon C) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with nondiseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 46% olifilcon C and 54 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.9% (

The provided document is a 510(k) premarket notification for a soft contact lens called OxySoft (olifilcon C). It does not describe an AI medical device. Therefore, a response matching the format of an AI device's acceptance criteria and study cannot be generated. However, I can summarize the information provided regarding the clinical study conducted for the contact lens.

Here's a summary of the clinical study for the OxySoft (olifilcon C) silicone hydrogel soft contact lens:

Clinical Study for OxySoft (olifilcon C) Silicone Hydrogel Soft Contact Lens

1. Acceptance Criteria and Reported Device Performance (as inferred from the summary):

The document does not explicitly state quantitative acceptance criteria for device performance in the same way an AI device would have specific metrics (e.g., sensitivity, specificity). Instead, the study aimed to demonstrate safety and effectiveness by comparison to a predicate device, focusing on:

• No symptom or syndrome requiring treatment for all subjects during the study period.
• No significant slit lamp findings (i.e., Grade 3 or Grade 4) were found. |
  | Effectiveness (Visual Acuity) | Visual acuity comparable to the predicate device and correctable to 0.1 LogMAR or better. | - The mean visual acuity (VA) for both lenses (OxySoft and predicate Si-Hy) was similar at each visit.
• Visual acuity could be corrected to 0.1 LogMAR or better for all subjects.
• None of the subjects had VA decreased more than 2 lines. |
  | Wear Time | Safe for daily wear up to 9 hours a day for 30 days. | Found safe for daily disposable single use, worn up to 9 hours a day during 30 days follow-up. |

2. Sample Size and Data Provenance:

• Test Set Sample Size: 36 subjects were enrolled.
  • Trial group (OxySoft): 24 subjects
  • Control group (Si-Hy predicate): 12 subjects
• Data Provenance: The document states, "All of them are Asia people." This suggests the data was collected in an Asian population, likely Taiwan, given the manufacturer's location. The study was prospective.

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided in the document. For contact lens studies, "ground truth" usually refers to clinical measurements (visual acuity, slit lamp evaluations by optometrists/ophthalmologists) rather than expert consensus on images. The clinical evaluations were likely performed by the study investigators or their staff.

4. Adjudication Method for the Test Set:

• This information is not provided in the document. Clinical trials typically have protocols for handling discrepancies in measurements or adverse events, but a specific "adjudication method" in the context of expert review for ground truth (as relevant to AI) is not applicable here.

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

• No, an MRMC study was not done. This type of study model is generally used for diagnostic devices that involve human interpretation of images, often with AI assistance. This document describes a clinical study for a physical medical device (contact lens).

6. Standalone (Algorithm Only) Performance:

• No, this is not applicable. The device is a physical contact lens, not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this study was established through a combination of clinical measurements and observations by healthcare professionals. This included:
  • Visual acuities
  • Slit lamp findings (e.g., for corneal health, lens fit)
  • Subjective symptoms, problems, and complaints (patient-reported outcomes)
  • Adverse reactions

8. Sample Size for the Training Set:

• This is not applicable. The study describes a clinical trial for a physical medical device, not an AI model that requires a "training set."

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

• This is not applicable as there is no AI training set.

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The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the single-use daily disposable wear, or for frequent/ planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. The OxyPure A (olifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Vexillum Zephyr (olifilcon A) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon A, with UV blocker available as spherical lens. The composition of the lens is 53% olifilcon A and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

OxyPure A (olifilcon A) Silicone Hydrogel Soft Contact Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

This document is a 510(k) summary for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device testing (e.g., sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies) is not applicable to this document.

However, I can extract information related to the device attributes and the comparisons made to establish equivalence, which can be seen as meeting "acceptance criteria" for chemical/physical properties rather than AI performance.

Here's a breakdown of what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance (Analogous for Contact Lenses)

In the context of contact lenses, "acceptance criteria" are not thresholds for AI performance, but rather specifications and physical/chemical properties that demonstrate the new devices (Vexillum Zephyr and OxyPure A) are substantially equivalent to the predicate device (OxyPure Color). The table below summarizes these comparisons.

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The Vexillum (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Daily Breeze (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.

The Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.

The provided document discusses the 510(k) premarket notification for two soft contact lenses: Vexillum (olifilcon B) with Tangible Polymers and Daily Breeze (olifilcon B). It asserts substantial equivalence to a predicate device (Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, K160344).

It is important to note that this document does not describe a study involving an AI/Machine Learning device. It pertains to contact lenses and their physical/chemical properties. Therefore, many of the requested criteria (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through non-clinical bench testing and comparisons of material, design, and performance characteristics.

Here's an attempt to answer the applicable parts of your request based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the format of a typical AI/ML study (e.g., target specificity and sensitivity values). Instead, it demonstrates "substantial equivalence" by comparing various parameters of the new devices (Vexillum and Daily Breeze) against a legally marketed predicate device (Si-Hy, K160344). The acceptance criterion, implicitly, is that the new devices are "substantially equivalent" to the predicate in terms of their intended use, technological characteristics, and performance characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's a table summarizing the comparison parameters and their reported performance/characteristics, which effectively serve as the "acceptance criteria" for substantial equivalence in this context:

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The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (

The provided text describes a 510(k) premarket notification for a medical device, specifically a soft contact lens. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new clinical trial with specific acceptance criteria.

Therefore, the information requested in your prompt (acceptance criteria, study design for proving acceptance, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training set details) is not applicable in this context as this submission is for a contact lens which does not utilize AI. The FDA letter and the 510(k) summary explicitly state that clinical data is not required because the new device uses the same lens material as a previously cleared device and the same color additives as another previously cleared device.

The review primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, similar technological characteristics, and is as safe and effective as a legally marketed predicate device.
• Nonclinical Testing: Performance of physicochemical studies (e.g., according to ISO 18369) and toxicology studies to ensure the material and lens properties meet established specifications and are biocompatible.

Here's how to interpret the provided information in the context of your request, highlighting why many aspects are not present:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not overtly stated as distinct "acceptance criteria" in the sense of a clinical trial endpoint. Instead, the "acceptance" is suitability for substantial equivalence, based on demonstrating similar properties and performance to the predicate devices.
  • Physicochemical Properties: The reported performance is that the "physical, optical and chemical properties of the lens are within established specifications for the lenses" (Section 1.9.1).
  • Toxicology: "toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment" (Section 1.9.2).
• Device Performance: The comparison table (Section 1.8) shows various characteristics of the new device and the predicate devices. The "performance" is implicitly demonstrated by these characteristics being similar or equivalent to the predicates. For example:
  • Water Content: 47% (new device) vs. 47% (predicate K160344) and 42% (predicate K162317)
  • Oxygen Permeability (DK, 35°C): 120 (new device) vs. 120 (predicate K160344) and 10.89 (predicate K162317)
  • Light Transmittance: 94% (new device) vs. 94% (predicate K160344) and 97% (predicate K162317)

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

• Not Applicable. No human clinical test set was used given the nature of the submission. The "test sets" would be the batches of lenses manufactured for physicochemical and toxicology testing. No information on the number of lenses tested is provided.

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

• Not Applicable. No human-interpreted "ground truth" was established. The "ground truth" for the non-clinical tests is based on objective measurements and established scientific methods (e.g., ISO standards, toxicology protocols).

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

• Not Applicable. No human adjudication was involved.

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 is not an AI device, and no MRMC study was conducted.

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

• Not Applicable. This is not an algorithm.

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

• For the non-clinical tests (physicochemical, toxicology), the "ground truth" is derived from objective laboratory measurements and adherence to established international standards (e.g., ISO 18369) and biocompatibility testing protocols.

8. The sample size for the training set:

• Not Applicable. There is no training set for an AI/ML model for this device.

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

• Not Applicable. There is no training set for an AI/ML model for this device.

In summary, the provided document is a regulatory submission for a contact lens, not an AI/ML-powered medical device. Therefore, the detailed criteria for AI/ML model validation are not present and not relevant to this specific product's clearance. The "proof" of meeting "acceptance criteria" here is the demonstration of substantial equivalence to predicate devices through shared material, similar intended use, and satisfactory non-clinical laboratory testing.

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The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft (hydrophilic) contact lenses are daily wear single use soft contact lens indicated for the corrective ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft (hydrophilic) Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft (hydrophilic) Contact lenses are indicated as daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 42% olifilcon D and 58 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (

The document describes the premarket notification for a new soft contact lens, the "OxyAqua (olifilcon D) silicone hydrogel soft contact lens," seeking substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and supporting study:

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a way that is typically found in a clinical trial report for software. However, the regulatory submission for the OxyAqua contact lenses implicitly relies on demonstrating that the device is "as safe, as effective, and performs as well as the predicate device."

Here's an interpretation of the implied acceptance criteria and reported device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "At least 30 evaluable subjects were participated."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "a three-month clinical study" strongly suggests it was a prospective study conducted to specifically support this submission. The manufacturer is based in Taiwan.

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

This type of information is generally not applicable for contact lens clinical trials in the same way it is for AI/computer vision devices. Ground truth for contact lenses is established through direct clinical observations and measurements by eye care professionals (e.g., ophthalmologists, optometrists) during the study visits. The document does not specify the number or qualifications of these clinical professionals, but it can be inferred that appropriately qualified clinicians would have performed the evaluations as part of a "clinical study."

4. Adjudication Method for the Test Set

Not specified. Clinical studies for contact lenses typically involve direct observation and measurement by qualified eye care practitioners. There is no mention of a separate adjudication process by experts, as common in AI device evaluations where multiple readers interpret images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. MRMC studies are typically performed to evaluate the diagnostic performance of a new system (often AI-based) by comparing reader interpretations with and without the system's aid. This study compared two contact lenses (OxyAqua vs. an existing predicate) in a clinical trial setting.

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

This question is not applicable. The device is a physical medical device (contact lens), not an AI algorithm. Its performance is inherent to the lens itself when worn by a human.

7. The Type of Ground Truth Used

The ground truth was established through clinical observations and measurements (e.g., visual acuity, slit-lamp findings, adverse event reporting) by clinicians during a prospective clinical study directly on human subjects. This is considered direct clinical evidence.

8. The Sample Size for the Training Set

This question is not applicable. The device is a manufactured physical product (contact lens), not a machine learning model that requires a training set. The "study" refers to the clinical trial conducted for regulatory submission, not machine learning model development.

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

This question is not applicable for the same reason as above.

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The OxyPure Color Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The OxyPure Color Silicone Hydrogel Soft Contact Lenses is a daily wear lens in spherical design. It may be prescribed as daily wear. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%. A benzotriazole UV absorbing monomer is used to block UV radiation. OxyPure Color Silicone Hydrogel Soft Contact Lenses contain a pigmented area that will alter or enhance the appearance of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phythalocyanine green and carbazole violet. Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot 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 sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

This document is a 510(k) premarket notification for the OxyPure Color Silicone Hydrogel Soft Contact Lenses. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for the new device. Therefore, much of the requested information regarding acceptance criteria, study sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable or available in this specific document.

Here's a breakdown of the available information related to acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of clearly defined acceptance criteria and reported device performance for a new study, this document provides a comparison table between the new device (OxyPure Color Silicone Hydrogel Soft Contact Lenses) and its predicate device (VISCO SOFT CONTACT LENS K141348). The "Result of Comparison" column essentially indicates whether the new device meets the performance characteristics of the predicate (implied acceptance) or if there's a difference.

The document states: "The differences between those two devices are mechanical properties and color additives, but other reference devices have same technical characteristic as new devices to support the substantial equivalence." This implies that while the values might be numerically different for some mechanical properties and the color additives differ, these differences are not considered to raise new questions of safety or effectiveness because they align with established characteristics of other marketed devices. The acceptance criteria essentially appear to be "comparable to the predicate device or other legally marketed devices, with no new questions of safety or effectiveness raised by differences."

2. Sample size used for the test set and the data provenance

The document explicitly states: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This indicates that there was no specific "test set" of patients or data collected for a clinical study with this device. The data provenance would be from laboratory bench testing (non-clinical tests) and comparison to the predicate device's characteristics, not a clinical trial with patient data.

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

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted.

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

Not applicable, as no clinical study with a test set requiring adjudication was conducted.

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, not an AI-powered diagnostic tool, and no MRMC comparative effectiveness study was performed.

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

Not applicable. This device is a contact lens, not an algorithm.

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

For the non-clinical tests, the "ground truth" refers to established scientific and engineering standards and validated test methods. These include:

• ISO18369-3: Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
• ISO18369-4: Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
• ISO18369-2: Ophthalmic optics - Contact lenses - Part 2: Tolerances
• ISO11986: Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for etermination of preservation uptake and release
• ISO11987: Ophthalmic optics -- Contact lenses and contact lens care products --Determination of physical compatibility of contact lens care products with contact lenses
• ISO17665-2: Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
• ISO17665-1: Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO11980: Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations (though a clinical study was not used for this submission, compliance with this standard for potential future studies is implied).
• ASTM D792-13: Standard Test Methods For Density And Specific Gravity (Relative Density) Of Plastics By Displacement. (Materials)
• ISO10993-1, -5, -10, -11: For Biocompatibility.

The "ground truth" for the device's properties is established through these standardized measurement methods, with the results compared to the known and acceptable properties of the predicate device and other legally marketed devices.

8. The sample size for the training set

Not applicable, as no AI/algorithm training set was used.

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

Not applicable, as no AI/algorithm training set was used.

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The VISCO (olifilcon A) Toric Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

The VISCO (olifilcon A) toric/multifocal soft contact lenses are manufactured in toric or multifocal configurations with UV blocker. The lens material, olifilcon A, is a silicon hydrogel with water content 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. The lens is supplied in a sterile state, packaged in a buffered saline solution containing Sodium Hyaluronate and Sodium Alginate

The provided document is a 510(k) Premarket Notification for a soft contact lens (VISCO (olifilcon A) Soft Contact Lens). It explicitly states that clinical studies were NOT required for this submission. Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The basis for the substantial equivalence claim relies on physicochemical studies and the equivalence of the technical characteristics, formulation, manufacturing, and sterilization processes to previously cleared predicate devices.

Specifically, the document states:

• "1.10 Clinical Studies: The technical characteristic, formulation, manufacturing, and sterilization processes of the subject device are equivalent to the VISCO (olifilcon A) soft contact lens currently available (K141348). Therefore, the clinical data is not required." (Page 9)
• "1.9 Nonclinical Tests Performed: Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses. Toxicology studies show that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment." (Page 9)

In summary, as this is a 510(k) submission for a contact lens cleared based on substantial equivalence to existing devices through non-clinical testing and manufacturing data, the detailed information about an AI/algorithm performance study (which would typically involve ground truth, expert adjudication, MRMC, etc.) is not applicable and not present in this document.

Therefore, I cannot provide the requested table and study details.

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The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

The Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are about 2.2% (

The provided document is a 510(k) premarket notification for a soft contact lens device. It describes the device, its intended use, and comparative information with predicate devices, including nonclinical and clinical study summaries.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the format of a table with specific thresholds for device performance. Instead, it states that "the physical, optical and chemical properties of the lens are within established specifications for the lenses" and that "the clinical study provided data to establish substantial equivalence with the predicate, control lens." The reported performance is primarily compared to the predicate device to demonstrate substantial equivalence, rather than meeting predefined numerical acceptance criteria for specific metrics.

However, we can infer some performance metrics from the device characteristics and the clinical study summary.

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

• Sample Size: "At least 50 evaluable subjects were participated."
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical studies conducted for regulatory submission for a new device are almost always prospective. The manufacturer is based in Taiwan, so the study was likely conducted there or in a region convenient for the manufacturer.

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

This information is not provided in the document. The clinical study describes "parameters measured," implying a quantitative assessment by clinical investigators, but it does not specify the number or qualifications of experts involved in establishing a "ground truth" in the way one might for diagnostic accuracy studies (e.g., radiologist consensus). For contact lens clinical trials, "ground truth" is typically established by measurements and observations made by trained optometrists or ophthalmologists during eye examinations.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1 consensus) are common in studies where expert interpretation is subjective and needs consensus, such as pathology or imaging reads. For contact lens clinical evaluations, direct measurements and clinical findings by investigators typically serve as the primary data, and formal adjudication by multiple independent experts might not be a standard practice unless there are highly subjective or ambiguous outcomes.

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

No, an MRMC comparative effectiveness study involving AI assistance was not done. This device is a contact lens, not an AI-powered diagnostic tool. The clinical study performed was a direct comparison of the new contact lens ("Si-Hy (olifilcon B)") against a legally marketed predicate contact lens ("Vistakon (narafilcon A) Contact Lens").

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

No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established through:

• Clinical Measurements and Observations: This includes objective measurements (e.g., visual acuities) and subjective observations/assessments by investigators (e.g., slit lamp findings, adverse reactions, symptoms, complaints).
• Comparison to a Predicate Device: The study's primary goal was to demonstrate substantial equivalence to a legally marketed control contact lens for safety and effectiveness. The "ground truth" for what constitutes an acceptable contact lens performance is implicitly tied to that of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" typically applies to machine learning models. For a physical medical device like a contact lens, there isn't a "training set" in the computational sense. The device underwent manufacturing and quality control processes, and then was tested in nonclinical and clinical studies.

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

This question is not applicable as there is no "training set" for this device in the context of AI/machine learning. For the manufacturing and design of the contact lens, the "ground truth" for its properties and performance would have been established through extensive material science research, engineering specifications, and validated in vitro testing to meet performance standards.

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