Search Results

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):

• +10.00 D to -10.00 D Asphere
• with center thickness from 0.025mm to 0.40mm
• . with base curves of 8.00mm to 9.20mm
• . with diameter of 12.00mm to 18.00mm

The lens material for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same as the Biomedics® 60 UV (ocufileon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999.

The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002.

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This front optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.

This document is a 510(k) Premarket Notification for a contact lens, indicating that clinical studies were not deemed necessary to establish safety and efficacy because the device was determined to be substantially equivalent to previously cleared predicate devices. Therefore, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment in the context of a new clinical performance study.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

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

The document compares the subject device, HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens, to predicate devices, primarily HYDROGENICS® 60 UV Sphere and BIOMEDICS® 55 UV Asphere, to demonstrate substantial equivalence. The "acceptance criteria" are implied by the characteristics of the predicate devices which the new device must match or be equivalent to.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Clinical studies were not performed for this device submission as stated in Section 7: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the HYDROGENICS®2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses". Therefore, there is no test set sample size or data provenance from a new clinical study. The submission relies on equivalence to predicate devices, whose data provenance is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical studies were conducted that required expert-established ground truth.

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

Not applicable, as no new clinical studies were conducted requiring adjudication.

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-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

Not applicable for a new clinical study. The "ground truth" for the device's characteristics and safety/efficacy is established by the successful marketing and clearance of its predicate devices and the physical/chemical properties demonstrating equivalence.

8. The sample size for the training set

Not applicable, as no new clinical trials were conducted. For the manufacturing information and finished lens parameters comparison, sample sizes for quality control testing are implied but not specified in this summary.

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

Not applicable, as no new clinical trials were conducted that would involve a "training set" in the context of device performance evaluation. The "ground truth" for the predicate devices' safety and efficacy would have been established through their respective clearance processes, likely including clinical trials and performance testing, but details are not provided in this document.

Ask a specific question about this device

Spherical: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or lyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.
Toric: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.
The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for wither single use disposable wear.
The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are available with ultraviolet absorbing additive (benzophenone based):

• in the power range of -10.00 to +6.00 diopters for sphere
• in the cylinder power range pl to -6.00D cylinder .
• with center thickness from 0.025mm to 0.27mm
• with base curves of 8.00mm to 9.20mm .
• . with diameter of 12.00mm to 18.00mm.
  This lens material, design, cast molding manufacturing and sterilization process is equivalent to BIOMEDICS® 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses described in submission 52 PMA890023/S4,S6 and S7, 510(K) K003136.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BIOMEDICS® 52 1-Day contact lens, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device and assuring safety and efficacy after a manufacturing process change. Therefore, the "acceptance criteria" are largely framed as demonstrating non-inferiority or equivalence to the control lens and meeting general safety expectations for contact lenses.

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

• Sample Size: 36 subjects (72 eyes) were enrolled.
  • Test Cohort: 48 eyes (from 24 subjects, assuming 2 eyes per subject)
  • Control Cohort: 24 eyes (from 12 subjects)
  • Note: The text states "All of the 36 subjects were determined to be eligible... and were dispensed either the Test or the Control lenses." And later "Female Subjects: Test 19, Control 10; Male Subjects: Test 5, Control 2; Totals: Test 24, Control 12." This implies 24 subjects in the Test group and 12 in the Control group, totaling 36 subjects. It then refers to 48 "Completed Test Eyes" and 24 "Completed Control Eyes," which aligns with 2 eyes per subject.
• Data Provenance: Prospective, concurrent cohort control, randomized clinical trial conducted at three (3) investigational sites. The country of origin of the data is not explicitly stated, but the contact person is in Maryland, USA, and the applicant is in California, USA, suggesting a US-based study, although international marketing is mentioned elsewhere.

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

The study involves clinical observations and examinations by healthcare professionals during "scheduled follow-up visits" and "laboratory observations." However, the text does not explicitly state the number of experts used to establish ground truth nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that licensed eye care practitioners (optometrists or ophthalmologists) at the investigational sites conducted the examinations, as these are standard roles in contact lens clinical trials.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the clinical findings. Clinical trials for contact lenses typically rely on the observations and assessments of the examining clinician(s) at each site.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens, and the study is a clinical trial comparing a new manufacturing process of a contact lens to a predicate contact lens, not an AI-powered diagnostic device involving human readers or AI assistance.

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. This device is a physical contact lens, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established through a combination of:

• Clinical Observations: Daily health observations, macroscopic eye examinations, weekly biomicroscopic slit-lamp examinations, body weight observations by investigators.
• Subjective Symptoms and Complaints: Self-reported by subjects.
• Measurements: BCVA, wearing time, lens deposits.
• Toxicology Studies: Conducted in a laboratory setting (e.g., cell cultures for cytotoxicity, animal models for systemic and ocular irritation).

Essentially, the ground truth is derived from expert clinical assessment and objective measurements within a controlled clinical trial setting, supported by pre-clinical laboratory results.

8. The Sample Size for the Training Set

This submission is for a physical medical device (contact lens) and describes a clinical trial (human subject-based study) and non-clinical (laboratory/animal) studies. There is no "training set" in the context of an AI/algorithm. The sample sizes mentioned (36 subjects, 72 eyes) pertain to the clinical test set.

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

As there is no "training set" for an AI/algorithm in this context, this question is not applicable. The clinical study was designed to evaluate the safety and efficacy of the contact lens itself through direct observation and measurement, not to train a predictive model.

Ask a specific question about this device

BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Biomedics® UV Colors Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with ultraviolet absorbing additive (benzophenone based) and marketed in four colors: Blue, Green, Hazel and Grey in the power range of -20.00 to +10.00 diopters for sphere, with center thickness from 0.025mm to.40mm, with base curves of 8.00mm to 9.20mm, with diameter of 12.00mm to 15.00mm.

The lenses are made by affixing a color pigment on the front surface of the lens, which corresponds to the iris. The colored pigments consist of Iron Oxide (Black, Russet & Yellow), Titanium Dioxide (White), Cartozole The colored piginents consist of from Onle (Green), Chromium Oxide (Green). All colored additives used are listed in 21 CFR 73 subpart D and 74 subpart D.

This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/S4 and S7, 510(K) K984046.

The provided text is a 510(k) Premarket Notification for the BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. As such, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the traditional sense of a performance study for a new medical device.

Instead, the submission aims to show that the new device (BIOMEDICS® UV Colors) is as safe and effective as already legally marketed devices. This is done by comparing its characteristics and performance to those of the predicate devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size) are not applicable or not explicitly detailed in the provided document, as a head-to-head clinical performance study against pre-defined acceptance criteria for a novel device is not the primary objective of this type of submission.

However, I can extract information related to the comparisons made to establish substantial equivalence, which serves a similar purpose to demonstrating "meeting acceptance criteria" in the context of a 510(k).

Here's a breakdown based on the provided text, addressing the applicable points:

1. Table of "Acceptance Criteria" (Predicate Device Metrics) and Reported Device Performance

In the context of a 510(k) for substantial equivalence, the "acceptance criteria" are effectively the characteristics and performance of the predicate devices. The "reported device performance" is how the new device compares to these predicates.

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

• Material properties and physical characteristics (Tables 1 & 2): The measurements for "Characteristics comparison, -7.00 D" state "40 lenses" for both predicate and subject devices for Base Curve, Diameter, and Power. Other material properties likely involved similar or different sample sizes, but it's not explicitly stated for each property.
• Data Provenance: The document does not specify the country of origin of the data. It implies laboratory testing rather than human subject testing for these physical properties. The studies are "Non-clinical studies."

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. The submission focuses on comparing physical, chemical, and design characteristics of the subject device to predicate devices, and conducting non-clinical toxicology and materials testing. There is no "ground truth" established by experts in the context of diagnostic accuracy or clinical judgment, as would be relevant for an AI/CADe device.

4. Adjudication method for the test set

• Not applicable as there is no "test set" requiring adjudication in the context of clinical judgment or diagnostic accuracy.

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/CADe device, and no MRMC study was conducted. The submission specifically states: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Colored lenses."

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/AI.

7. The type of ground truth used

• For material properties and physical characteristics (Tables 1 & 2): The "ground truth" is measured physical and chemical properties and specifications, comparing the subject device's adherence to its own specifications and its similarity to predicate device specifications/measurements.
• For toxicology studies: Standardized ISO guidelines for biological evaluation (e.g., cytotoxicity, acute systemic injection, ocular irritation) are used. The "ground truth" are the established biological safety endpoints defined by these standards (e.g., absence of cytotoxicity, no systemic toxicity, no irritation).
• For chemistry studies (residual monomers, color extraction, shelf life): The "ground truth" is established analytical chemistry detection limits and stability protocols.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Summary of the Overall Study/Demonstration:

The submission demonstrates substantial equivalence through a series of non-clinical studies and comparisons to predicate devices.

• Chemical and Physical Property Comparisons: The subject device's material properties (e.g., water content, refractive index, Dk, mechanical strength, light transmittance) and physical parameters (base curve, diameter, power) were measured and compared to those of the predicate BIOMEDICS® UV Sphere lenses. The results showed "substantial equivalence."
• Toxicology Studies:
  • Cytotoxicity Test: Conducted according to ISO 10993: Part 5. Result: "test articles were not cytotoxic."
  • Acute Systemic Injection Test: In mice, according to ISO 10993: Part 11. Result: "Each test article met the test requirements" (i.e., no systemic toxicity).
  • Ocular Eye Irritation Test: In rabbits, according to ISO 10993: Part 10. Result: "the test article extracts are not considered irritants to the ocular tissue of rabbits."
  • The "worst case scenario" of Blue and Red Printed lenses were used for these toxicology studies.
• Chemistry Studies:
  • Material property data were generated and found "substantially equivalent."
  • Residual monomer levels were determined and found "substantially equivalent" to the predicate.
  • A color extraction study was conducted, and pigments were not detected in saline extracts above detection limits, indicating color fastness.
  • Shelf life stability protocols were included.
• Solution Compatibility: Tested with Allergan Complete and Essilor (OSL) Concerto, finding no adverse interaction.
• Design and Intended Use Comparison (Colored Lenses): The colored lens design aspects (pigments, tint process, print zone, location of print, manufacturing method) were compared to the FRESHLOOK Colorblends predicate device and found to be "equivalent."

The conclusion drawn from these studies is that the BIOMEDICS® UV Colors lenses are equivalent in optical, chemical, and physical properties to the predicate devices and do not raise new questions of safety or effectiveness.

Ask a specific question about this device

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Leases are available with in monomer tint (Vat Blue 9) and with ultraviolet absorbing additive (benzophenone based):

• in the power range of -20.00 to +10.00 diopters for sphere,
• +0.25 to +3.00 diopters for addition
• with center thickness from 0.025mm to.40mm .
• with base curves of 8.00mm to 9.20mm ●
• with diameter of 12.00mm to 15.00mm .

The lens material is the same as the one BIOMEDICS® UV (ocufilcon D) described in submission PMA890023/S4 and S7 ,K984046.

The Biomedics® UV Multifocal (ocufilton D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with ar without associated ametropia, allowing for the correction of up to +3.00 diopters of add, with refractive astigmatism of no more than 0.75 diopters that does not interfere with visual acuity. The multifocal lens is a aspheric center near design.

The medical device in question is the BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lens.

Here's an analysis of the acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices. The submission indicates that clinical studies were not necessary because the subject device was proven equivalent in material, physicochemical characteristics, parameters, and design to already approved devices. Therefore, the "performance" is implicitly deemed acceptable if it matches the established performance of the predicate devices.

Ask a specific question about this device

Ask a specific question about this device

Spherical:

Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

Toric:

Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.

The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EDGMA and other components which vield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

Here's a breakdown of the acceptance criteria and study information for the Biomedics 60 (ocufilcon "F") UV Blocking Daily Wear soft (Hydrophilic) Contact Lens, based on the provided 510(k) summary:

The entire submission is focused on demonstrating substantial equivalence to a previously cleared device, not on meeting specific acceptance criteria through a de novo clinical study for this specific device.

Because this is a 510(k) submission based on substantial equivalence, there isn't a traditional "acceptance criteria" table with numerical performance targets and reported device performance from a new clinical study for this specific device. Instead, the acceptance criteria are implicitly that the new device's physical, optical, and chemical properties, as well as its indications for use, are substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. No dedicated clinical "test set" was used for this device. The submission relies on preclinical data and the established safety and efficacy of predicate devices.
• Data Provenance: Preclinical data (toxicology) was likely generated internally or through contract labs. The "proof" of substantial equivalence comes from comparing the physical and chemical properties of the Biomedics 60 to already cleared devices.

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

• Number of Experts & Qualifications: Not applicable. There was no clinical trial for this specific device, and thus no "ground truth" established by experts for a test set. The FDA review process involves their own internal experts (e.g., A. Ralph Rosenthal, M.D., Director, Division of Ophthalmic Devices).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission specifically states: "There was no clinical investigation of this lens as the characteristics of the device are substantially equivalent to the device from which the lens was modified."

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

• Standalone Performance: Not applicable. This is a contact lens, not an AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the preclinical evaluations mentioned (toxicology), the "ground truth" would be the observed biological responses in the animal models, interpreted by scientists/toxicologists. For the substantial equivalence argument, the "ground truth" refers to the established safety and effectiveness of the predicate devices based on their prior clinical evaluations and market history.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The "training" in this context refers to the accumulated knowledge and clinical data from the predicate devices that form the basis for the substantial equivalence claim.

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

• Ground Truth for Training Set: Not applicable in the AI sense. However, the basis for the claim of safety and efficacy (analogous to "ground truth") for the predicate devices was established through:
  • Prior clinical evaluations (clinical trials) conducted for those specific predicate devices (e.g., P890023/S26, K984046, K972303, K942214).
  • Regulatory clearance processes for those predicate devices, which would have involved FDA review of clinical data, preclinical data, and manufacturing information.
  • "Performance data available on the predicate device(s) through product testing, literature review, and/or clinical experience." (implied by the substantial equivalence argument).

Ask a specific question about this device

The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or scheduled replacement program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including UVAM, an ultraviolet absorber. crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the same way a Premarket Approval (PMA) application would. Therefore, some of the information you requested, especially regarding human reader studies or detailed efficacy trials, is not typically found in this type of submission.

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating that the BIOMEDICS 55 (ocufilcon D) UV Blocking contact lens is substantially equivalent to already approved predicate devices. The acceptance criteria, therefore, revolve around matching the characteristics and performance of these predicates, particularly in terms of physical, optical, and chemical properties, and UV blocking capabilities.

• Ocufilcon D contact lens with UVAM significantly blocks UV light across the UVB (200-320 nm) and UVA (320-400 nm) spectrum, with transmission near 0% in parts of the UV range.
• Its UV blocking capabilities appear to be notably better than a 24-year-old human cornea and comparable to or better than a 25-year-old human crystalline lens in the UV region.
• In the visible spectrum (approx. 400-700 nm), the lens has high transmission, similar to the human eye structures, as expected for a clear vision lens. This explicitly demonstrates the UV blocking performance. |
  | Indications for Use | The indications for use match those of the predicate devices. | "Indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or scheduled replacement program...disinfected only with a chemical disinfection regimen." This is stated to be substantially equivalent to the predicate device K972303's indications. |
  | Wear Modality & Care | Daily wear, compatible with daily disposable or scheduled replacement programs, and chemical disinfection. | As above, "daily wear," "daily disposable or scheduled replacement program," and "disinfected only with a chemical disinfection regimen." |

Study Details (as inferable from a 510(k) Summary)

Given this is a 510(k) submission, the "study" for acceptance criteria is primarily a comparison to predicate devices and verification of compliance with established standards (like FDA Lens Group classification and UV transmittance testing). There isn't a traditional clinical trial described with independent test and training sets in the AI sense.

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

   • Test Set: No explicit "test set" in the context of an AI model is mentioned. The UV transmittance data is presented as "Typical Transmittance Profile," implying measurements taken on samples of the device. The exact number of lenses measured is not specified, but it would typically be a statistically representative sample from a manufacturing batch, tested under laboratory conditions.
   • Data Provenance: The UV transmittance data is laboratory-generated, likely from a manufacturing or R&D facility of Ocular Sciences, Inc., the submitter, or a contracted testing facility. No country of origin for patient data is relevant as clinical patient data is not the primary basis for this type of substantial equivalence.

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

   • Not applicable in the AI sense. The "ground truth" for the UV blocking criteria is derived from established scientific principles of UV absorption and transmission, measured by calibrated laboratory equipment, and compared against known human eye absorption profiles. The "experts" would be the scientists and engineers who designed the test, performed the measurements, and interpreted the results, upholding standard scientific and regulatory practices.

3. Adjudication method for the test set:

   • Not applicable. The data is objective measurement from laboratory instruments for UV transmittance.

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:

   • No. This is a contact lens, not an AI diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

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

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

   • The "ground truth" for demonstrating equivalence largely relies on:
     • Standardized material specifications: Conforming to the chemical composition of ocufilcon D as previously approved.
     • Laboratory measurements: Objective physical, optical (including UV transmittance), and chemical property measurements using calibrated instruments.
     • Regulatory classification: Adherence to FDA's established Lens Group IV criteria.
     • Comparison to predicate device claims: Verifying that the proposed indications for use align with those of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. There is no AI training set for this device submission. The design and validation of the contact lens material (ocufilcon D with UVAM) would have involved extensive R&D and material science studies, which effectively form the "training data" for the physical and chemical properties of the lens, but this is not an AI training set.

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

   • Not applicable due to the absence of an AI training set. The "ground truth" for the lens's design and manufacturing processes would have been established through years of material science research, clinical experience with the base material (ocufilcon D), and adherence to ophthalmic device manufacturing standards.

Ask a specific question about this device

The BIOMEDICS 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or frequent replacement scheduled program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Frequent Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

Acceptance Criteria and Study for OCULAR SCIENCES BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens

This document describes the acceptance criteria and supporting evidence for the Ocular Sciences BIOMEDICS® 55 (ocufilcon D) UV Blocking Daily Wear soft (Hydrophilic) Contact Lens, based on the provided 510(k) summary (K984046).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to previously cleared devices and outlining the optical and physical properties of the contact lens. The acceptance criteria are implicitly met by demonstrating these properties are equivalent to the predicate devices and conform to regulatory guidelines for daily wear contact lenses, particularly regarding UV blocking.

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

The provided document does not explicitly describe a separate "test set" in the context of a clinical trial or algorithm evaluation with a specific sample size. The primary evidence presented is a comparison to predicate devices and specifications, along with transmittance curves.

• Sample Size: Not applicable in the context of a traditional test set for performance evaluation. The data provenance for the transmittance curves is not specified (e.g., how many lenses were tested to generate the "typical" profiles).
• Data Provenance: The document does not specify the country of origin for any specific data, nor whether it is retrospective or prospective. The human cornea and lens data used for comparison in the transmittance graphs are from "24-year-old" and "25-year-old" individuals, respectively, without further detail on their origin.

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

This information is not applicable or provided in the context of this 510(k) summary. The summary focuses on manufacturing processes, material equivalence, and physical/optical properties, not on diagnostic accuracy tasks that would require expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no description of a test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document is for a medical device (contact lens) and does not involve human readers evaluating cases.

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

The "ground truth" for the claims in this submission is established through:

• Predicate Device Equivalence: The primary method for establishing that the new device meets acceptance criteria is by demonstrating its substantial equivalence in materials, manufacturing processes, and intended use to previously cleared devices. The "truth" here is built upon the regulatory acceptance of those predicate devices.
• Physical and Chemical Properties Measurement: Laboratory measurements of properties like hydrogel composition, water content, oxygen permeability (implied by material group), and UV transmittance.
• Regulatory Grouping: Classification within FDA's established Lens Group IV.

No clinical outcomes data or pathology results are presented as ground truth for this 510(k) in the usual sense of a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This device is a contact lens, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a contact lens, not an AI/ML algorithm that requires a training set.

Ask a specific question about this device

The Hydron Biomedics 55 (ocufilcon D) visibility tint soft (hydrophilic) contact lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity; it is available in powers from -10 to + 10 diopters.

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

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness) and hyperopia (farsightedness). Each lens provides corrective power which corresponds to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6 mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

The provided text is a 510(k) summary for the Hydron Biomedics 55 contact lens. It describes the device, its indications for use, and asserts its substantial equivalence to previously cleared devices. However, it does not contain information about acceptance criteria, detailed study designs, or performance data beyond stating equivalence.

Therefore, I cannot populate the requested table or answer the specific questions about formal acceptance criteria studies. The document focuses on demonstrating equivalence to existing devices rather than presenting novel performance testing against specific criteria for this particular submission.

Here's a breakdown of what is and isn't available related to your request:

Information NOT available in the provided text:

• A table of acceptance criteria and reported device performance (no specific performance criteria or data is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

What the document does indicate is that the device's substantial equivalence is based on:

• Predicate Device: K942214 (tinted daily wear lens of the same material) and PMA P890023/S4 (in-monomer tinted ocufilcon D contact lens for extended wear, currently marketed).
• Material and Manufacturing: The device is "identical to the in-monomer tinted ocufilcon D contact lens approved in PMA P890023/S4" and "manufactured by the same manufacturing process."
• Physical, Optical, and Chemical Properties: Stated to be "equivalent to the clear and identical to the tinted versions of the Hydron Biomedics 55 (ocufilcon D cast molded contact lens."
• FDA Lens Group: Classified as Lens Group IV high-water ionic group as established by the FDA.

In summary, this 510(k) submission relies on demonstrating that the new visibility-tinted contact lens is fundamentally the same as previously approved predicate devices, rather than providing new performance data against a set of acceptance criteria.

Ask a specific question about this device