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The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Spherical Soft Contact Lens are indicated for daily wear for the correction of hyperopia in pediatric aphakic persons. The lens may be disinfected with chemical (not heat) disinfection system.

The OCU-FLEX PEDIATRIC APHAKIC (ocufilcon B) Soft Contact Lens for Daily Wear (lathecut) is fabricated from ocufilcon B which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The aphakic lens designs are made for daily wear for the correction of refractive hyperopia in pediatric aphakic persons. The design elements of the OCU-FLEX PEDIATRIC APHAKIC (ocufileon B) Soft Contact Lens for Daily Wear (lathe-cut) is intended to accommodate pediatric patients. The lens design has a higher power range and smaller lens to compensate for the increased power. In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The non-ionic lens material, ocufilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) methacrylic acid and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 47% ocufilcon B and 53% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Reactive Blue 21.

The provided text is a 510(k) summary for a medical device (soft contact lens) and does not contain information about acceptance criteria, study details, or performance metrics in the way that would typically be described for an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's an attempt to address the points based on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or a reported device performance table in the context of a "study" as one would expect for an AI/ML device. Instead, it implies acceptance through "substantial equivalence" to a predicate device based on characteristics like indications, material, design, and physical parameters.

Note: The "acceptance criteria" here are implicitly that the new device's characteristics are comparable to or fall within an acceptable range relative to the predicate device to establish substantial equivalence.

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

• Sample Size: Not specified in the provided text. The document refers to "Pre-clinical performance data" for the material (ocufilcon B) referenced in a PMA (P820051) and a previous 510(k) (K960291) for the tint. It does not describe a clinical performance study with a specific test set.
• Data Provenance: Not specified for any explicitly described "test set". The pre-clinical data is referenced from previous submissions, implying it would be related to material properties rather than clinical performance with a specific patient cohort.

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

• This information is not applicable and not provided in the document, as it does not describe a study involving expert-established ground truth for a test set. This type of information is typically related to diagnostic or prognostic AI/ML devices.

4. Adjudication method for the test set

• This information is not applicable and not provided. As no test set and ground truth establishment by experts is described, no adjudication method would be detailed.

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, a MRMC comparative effectiveness study was not done. This document describes a soft contact lens, not an AI-powered diagnostic or assistive tool. Therefore, effects on human reader improvement are not relevant.

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

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

7. The type of ground truth used

• This information is not applicable and not provided. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for diagnostic/prognostic studies, which are not described here. The "truth" demonstrated in this submission is the physical and material properties of the contact lens.

8. The sample size for the training set

• Not applicable and not provided. This device is a physical product, not an AI/ML model that requires a training set.

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

• Not applicable and not provided. As there is no AI/ML model or training set, this information is irrelevant.

Summary of what the document does provide regarding device evaluation:

The document primarily focuses on demonstrating substantial equivalence to an existing legally marketed predicate device (Flexlens Pediatric Aphakic). This is achieved by comparing:

• Indications for Use: Both for daily wear, soft contact lenses, for pediatric aphakic persons.
• Material: Both hydrophilic, with similar oxygen transmissibility (dk/l).
• Design: Both Aphakic Spherical.
• Parameters: Comparable ranges for base curve, diameter, powers available, thickness, and optical zone.

Pre-clinical data for the ocufilcon B material (cytotoxicity, systemic injection, ocular eye irritation) and for the Reactive Blue 21 tint are referenced from previously accepted FDA submissions (PMA #P820051 and 510(k) K960291, respectively), indicating that the safety of the materials has been previously established.

The evaluation method relies on comparison with a predicate device and referencing existing safety data for the materials, rather than conducting new clinical performance studies with specific patient cohorts and ground truth for the specific application of AI/ML or diagnostic devices.

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The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical (not heat) disinfection system only.

The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens is a partially or totally white opaque lens that can be painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The lens material (ocufilcon B) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate, methacrylic acid and cross-linked with ethylene glycol dimethacrylate, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The approved pigment, titanium dioxide, is incorporated into the monomer during polymerization with the help of a coupling agent. The titanium dioxide is evenly distributed throughout the lens and cannot be extracted. The lens is available in opaque patterns including Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, and Solid Annular Opaque with Clear Pupil & Clear Edge.

The provided text is a 510(k) summary for a medical device called "Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens." This type of submission to the FDA is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a novel study.

The document does not contain any information about a study designed to prove the device meets specific acceptance criteria. Instead, it focuses on establishing substantial equivalence to previously approved devices based on materials, manufacturing, intended use, and physical properties. Therefore, I cannot construct a table of acceptance criteria and reported device performance from this document, nor can I provide information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

Here's what I can infer from the document regarding the device and its characteristics, which in a different context might be parts of a performance specification:

• Intended Use/Indications for Use: The key "performance" aspect described is its intended use.
  • Daily wear to enhance or alter apparent eye color, including ocular masking.
  • For cosmetic management of conditions like corneal, iris, or lens abnormalities (sighted or non-sighted eyes).
  • For persons wishing to change the appearance of their eyes without abnormalities.
  • Correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic or not-aphakic persons.
  • Occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia.
• Material: ocufilcon B (a hydrophilic copolymer).
• Physical Properties (these are listed as characteristics, not performance against criteria):
  • Refractive Index: 1.41
  • Light Transmission: varies depending on prosthetic design
  • Specific Gravity: 1.18
  • Water Content: 53%
  • Color Pigment Name: Titanium dioxide
  • Oxygen Permeability: $18.1 \times 10^{-11}$ @ 35°C (Revised Fatt Method)
• Disinfection Method: Chemical (not heat) disinfection system only.
• Prosthetic Design Options: Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, Solid Annular Opaque with Clear Pupil & Clear Edge.

Conclusion based on the provided document:

No specific study proving the device meets quantitative "acceptance criteria" is described. The document's purpose is to establish substantial equivalence to predicate devices, not to present a new clinical or performance study with defined acceptance criteria and statistical results. Therefore, most of the questions cannot be answered from the given text.

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The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The lens may be disinfected with chemical (not heat) disinfection system.

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design.

The physical properties of the lens are:
Refractive Index 1.4153
Light Transmission greater than 95% T
Specific Gravity 1.090 g/cc
Water Content 55%
Color Pigment Name Phthalocyanine Blue
Oxygen Permeability Dk=18x10-11 @ 35°C

This 510(k) premarket notification is for contact lenses, which are regulated as medical devices. The submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics in the way an AI/ML device would. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses seeking 510(k) clearance via substantial equivalence, the "acceptance criteria" are not reported as specific performance metrics derived from a clinical trial, but rather as demonstrating equivalence in critical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if these characteristics are substantially equivalent.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" is a comparative analysis demonstrating substantial equivalence to a legally marketed predicate device (Horizon 55). This is explicitly stated: "The following matrix illustrates that the production method, lens function and material of the Ocu-Flex 55... is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."

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

Not applicable for this type of 510(k) submission. There was no "test set" in the context of an AI/ML or a new clinical performance study. The data provenance is a comparison of product specifications and intended use.

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

Not applicable. Ground truth in the context of clinical expert consensus for a test set is not relevant for a substantial equivalence submission of a contact lens based on material and design specifications.

4. Adjudication Method for the Test Set

Not applicable.

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/ML diagnostic tool.

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

Not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, Horizon 55, and other similar methafilcon A lenses (BENZ - MF). The manufacturer is demonstrating that the Ocu-Flex 55 matches the characteristics that have already been deemed safe and effective by the FDA through the predicate's prior clearance. This includes:

• Manufacturing/Chemistry Data: The production method (lathe-cut), material (methafilcon A), water content, Dk value, refractive index, specific gravity, and light transmission are all compared to the predicate.
• Intended Use Compatibility: The indications for use are aligned with the predicate device.
• Safety Profile: The submission references the established safety profile (pre-clinical toxicology) of BENZ - MF (methafilcon A), noting equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical or heat disinfection system.

The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a hydrophilic polymer of 2-hydroxyethyl-methacrylate crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 38% water and 62% polymacon by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a spherical conic lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens design begins with a spherical 5.0mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then flattens into the base curve, which is considered the fitting curve of the lens. The cone curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with a peripheral curve to maintain alignment and comfort.

The provided document is a 510(k) summary for the Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.

Therefore, the document does not contain information regarding:

• Acceptance criteria and a study proving the device meets those criteria.
• Sample sizes for a test set, data provenance, or details about training sets.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone (algorithm only) performance studies.
• Specific types of ground truth used in novel studies (e.g., pathology, outcomes data).

Instead, the submission demonstrates substantial equivalence by comparing the Ocu-Flex-38 lens to a predicate device (Harrison Keratoconus Lens PMA #N17976 (hefilcon A) Manufactured By: Paragon Vision Sciences Flexlens Products) based on:

1. Intended Use: The intended use of the Ocu-Flex-38 is for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes, for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons, and allows for chemical or heat disinfection. This is compared to the intended use of the Flexlens Harrison Keratoconus Lens.
2. Technological Characteristics: Evaluation of manufacturing method, lens function, and material properties.

Here's a table summarizing the comparison, which serves as the basis for demonstrating "acceptance" of substantial equivalence:

Study to Prove Acceptance Criteria:

The "study" to prove acceptance criteria in a 510(k) submission is primarily the comparison table and the narrative argument for substantial equivalence. The manufacturer asserts that the new device will be manufactured under specified process controls and a Quality Management System (CGMP guidelines), and that its established safety profile (preclinical toxicology and manufacturing/chemistry data) is equivalent to the predicate device.

The FDA's review and subsequent clearance (K992466) signifies their agreement that the Ocu-Flex-38 is "substantially equivalent" to the predicate device and does not raise different questions of safety and effectiveness. This is the "proof" the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. No new clinical safety or effectiveness data from human trials are presented in this summary beyond the comparison to the predicate device's known safety and effectiveness profile.

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indicated for use as a daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes.

Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version.

The provided text describes the substantial equivalence of tinted and untinted Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lenses. The "acceptance criteria" here refers to maintaining the physical and optical properties of the contact lens within specified tolerances after tinting, demonstrating that the tinted version is as safe and effective as the untinted predicate device.

Here's an analysis of the provided information, formatted as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size:
  • Light Transmittance: Not explicitly stated, refers to "the minimum tint, or Visitint" and "Ocu-Flex-53 Lenses, tinted with the maximum intensity of dye."
  • Refractive Index: Not explicitly stated, refers to "Ocu-Flex-53 Tinted Lenses (maximum intensity)" and "the untinted version of the same lens."
  • Water Content: Ten (10) Ocu-Flex-53 Contact Lenses, Lot IR.
  • Linear Swell: Ten (10) Ocu-Flex-53 Contact Lenses, Lot IR.
  • Optical Properties (Overall Rating): Ten (10) untinted Ocu-Flex-53 lenses, Lot IR (same lenses after tinting).
  • Oxygen Permeability/Transmissibility: Not explicitly stated, but refers to "the untinted lenses first was established. The lenses were then tinted and the permeabilities determined again on the same lenses."
• Data Provenance: The studies cited (STS Final Report, Study No. GLP-1995-605, of 09/11/95 and STS Final Report, Study No. GLP-1995-324 of 06/08/95) indicate these were internal company reports or studies performed by a testing laboratory (STS). The document is a K960291 submission to the FDA in the US. This suggests the data is likely prospective for the purpose of demonstrating substantial equivalence, and originates from internal testing primarily in the USA.

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

This document does not involve human expert consensus for "ground truth" in the way a diagnostic AI study would. The acceptance criteria for the contact lens properties are based on physical and optical measurements against established manufacturing specifications and performance standards for medical devices of this type. There are no "experts" establishing ground truth in the sense of medical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations. The data is based on direct physical and optical measurements.

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-based device, nor a study on human reader performance.

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

Not applicable. This is a contact lens, not an algorithm. The "performance" is the physical and optical characteristics of the lens itself.

7. The Type of Ground Truth Used

The "ground truth" is defined by established physical and optical specifications and regulatory standards for contact lenses. The untinted Ocu-Flex-53 lens, which has prior FDA approval (PMA P820051), serves as the predicate device against which the tinted version must maintain substantial equivalence in its performance characteristics. Thus, the performance of the untinted lens within its approved specifications implicitly defines the "ground truth" or acceptable range for the tinted version.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study requiring a training set.

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

Not applicable. This is not an AI/machine learning study.

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