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The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lenses for Daily Wear is available as a single vision lens in an aquamarine visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. When hydrated the Inns consists of 45.0% HEMA and 55.0% water by weight of saline immersed in normal saline. The lens is visibility tinted aqua with: Reactive Blue No. 4 and Reactive Yellow Dye # 86. A benzophenone UV absorbing monomer is used to block UV radiation.

The average transmittance characteristics are less than 10% in the UVB range of 280 to 315nm and less than 40% in the UVA range of 315-380mm.

The SAUFLON 55 UV Contact Lens is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera.

The provided text describes specific information about a contact lens and its comparative testing. However, it does not include the details requested in your prompt regarding acceptance criteria for a device performance study, the study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information.

Instead, the document focuses on:

• Device Description: SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear.
• Substantial Equivalence Claim: To FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lenses, based on physical and optical properties.
• Preclinical Testing: Toxicology, residual monomer, and color leachability to demonstrate non-toxicity and non-irritation.
• Physical/Optical Property Comparison Table: Between the SAUFLON 55 UV and the predicate device, FREQUENCY 55. This table presents performance metrics but these are not explicitly framed as "acceptance criteria" for a study in the context of the prompt's request.
• Indications for Use: Correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes; daily wear in a Frequent Replacement Program; disinfection compatibility.
• Transmittance Curves: Showing UV blocking characteristics compared to human cornea and crystalline lens.

Therefore, I cannot populate the table or provide the detailed study information as requested because the document does not contain that specific type of performance study data or acceptance criteria. It primarily relies on demonstrating substantial equivalence through material properties and basic preclinical safety tests.

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The FREQUENCY™ 55 UV (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) which is cross-linked with ethyleneglycol dimethacrylate. When hydrated, the lens consists of 45.0% HEMA and 55.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.

The provided document is a 510(k) Pre-market Notification for a contact lens, the FREQUENCY 55 UV (methafilcon A) Hydrophilic Contact Lens. It details the device's properties and its substantial equivalence to a predicate device. This type of regulatory submission does not typically include information about studies to prove device performance against acceptance criteria in the same way a software or AI/ML device would.

Instead, for contact lenses, "acceptance criteria" are usually based on demonstrating that the new device has equivalent or better physical, optical, and chemical properties, as well as safety (toxicology, leachable compounds), compared to a previously cleared predicate device. The "study" proving this involves direct comparison of these properties through laboratory testing, rather than clinical trials with human readers or AI performance metrics.

Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size) are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the provided text, recognizing the different nature of this device type:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to the predicate device, FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear. This is achieved by showing comparable physical, optical, and chemical properties, and acceptable safety profiles.

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The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera.

The provided document is a 510(k) summary for the FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens for Daily Wear. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving a new device meets predefined acceptance criteria through a traditional clinical study with statistical significance targets. Instead, the "study" is a comparison to the predicate device to show it performs similarly and is thus safe and effective.

Here's an analysis of the provided information in the context of acceptance criteria and the "study" that supports it:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are generally that the new device's properties are either identical or "substantially equivalent" to the predicate device, and any differences do not raise new questions of safety or effectiveness. The document effectively presents a comparison of the new device's properties against the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in the way a clinical trial would. For material property comparisons, it implies laboratory testing of samples from the device production.
• Data Provenance: The data for the FREQUENCY UV™ comes from direct testing of the device itself ("Preclinical Testing" and "COMPARISON OF PHYSICAL/OPTICAL PROPERTIES" sections). The predicate device data (Acuvue) is presented as established characteristics for a previously cleared product. The data is likely from the United Kingdom (Aspect Vision Care, Ltd.'s location) for the new device, and presumably from the US for the predicate's marketing clearance. This is retrospective for the predicate and prospective for the tests performed on the FREQUENCY UV™ to demonstrate substantial equivalence.

3. Number of Experts for Ground Truth and Qualifications

• This type of submission (510(k) for contact lenses) does not typically involve expert consensus for "ground truth" in the diagnostic sense, as it focuses on material properties and performance equivalence.
• The "experts" involved would be the engineers, chemists, and statisticians who designed and conducted the physical, chemical, and biological compatibility tests, along with the regulatory review team at the FDA (Division of Ophthalmic Devices). Their qualifications are implicit in their professional roles and adherence to regulatory standards for device testing.

4. Adjudication Method

• Not applicable in the conventional sense of a clinical trial where image interpretations or clinical outcomes are adjudicated. The "adjudication" here is the FDA's review process, where their experts assess whether the presented data for the new device demonstrates substantial equivalence to the predicate, and whether any differences raise new safety or effectiveness concerns.

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

• No, an MRMC comparative effectiveness study was not done. This device is a contact lens, not an imaging algorithm or diagnostic tool that requires human interpretation of outputs.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device (contact lens), not an algorithm or AI.

7. Type of Ground Truth Used

• The "ground truth" for this submission are the established physical, chemical, and biological properties of the contact lens material and design, as measured by standard laboratory tests (e.g., water content, Dk, transmittance, tensile strength, cytotoxicity). For the predicate device, its 'truth' is its FDA clearance (K962804) based on similar prior testing. The overall "ground truth" is that the device is safe and effective when its properties are substantially equivalent to a legally marketed predicate.

8. Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant here.

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

• Not applicable, as there is no training set for a contact lens.

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