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SynergEyes™ A (paflufocon D hem-iberfilcon A) and SynergEyes™ M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of hyperopic, and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicted for the correction of up to +20.00 and -20.00 D in eves with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

SynergEyes™ KC (paflufocon D hem-iberfilcon A) and ClearKone™ (paflufocon D hem-iberfilcon A) Daily Wear Hybrid Contact Lenses for keratoconus are in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

SynergEyes™ PS (paflufocon A hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Duette™ (SiH) (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic, and astigmatic refractive error including presbyopia, in aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat), prior to reinsertion, as recommended by the eye care professional.

UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

UltraHealth™ Flat Cornea SiH (petrafocon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and irregular astigmatism in aphakic and not aphakic, non-diseased eyes, with or without presbyopia. The lenses are indicated for daily wear for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular assigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Not Found

This document is a 510(k) premarket notification from the FDA, approving various SynergEyes™ Hybrid Contact Lenses. It outlines the indications for use for different models of these lenses. However, it does not contain information about:

1. Acceptance criteria for device performance.
2. Details of a study proving the device meets acceptance criteria.
3. Sample sizes for test sets or data provenance.
4. Experts used to establish ground truth or their qualifications.
5. Adjudication methods.
6. Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect sizes for human readers with/without AI assistance.
7. Results of a standalone (algorithm only) performance study.
8. Type of ground truth used.
9. Sample size for the training set.
10. How ground truth for the training set was established.

The document is purely a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices, along with the device names and their indications for use. It doesn't delve into the detailed performance studies or the methodologies behind them for acceptance testing.

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The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eves with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

The SynergEyes® SiH with Hydra-PEG (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, non-diseased eyes with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +25.00 and -25.00 Din eyes with astigmatism or irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using only a chemical (not heat) disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The SynergEves® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens-at the central optical portion of the lens corresponding to the cornea-and soft hydrophilic silicone-hydrogel skirt-straddling the limbus of the eye peripherally. The lenses are manufactured by lathe cutting process for custom Rx, and fabricated from petrafocon A (rigid, central portion) and hem-larafilcon A (soft, peripheral portion). The soft skirt is comprised of silicone hydrogel copolymer (hem-larafilcon A). The lens consists of 28% water and 72% (petrafocon A and hem-larafilcon A). The (petratocon A and hem-larafilcon A) names have been adopted by the United States Adopted Names Council (USAN). When placed on the human cornea, the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens acts as a refractive medium to focus light rays onto the retina.

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens incorporates a violet visibility tint in the rigid gas permeable center, and a UV absorber. The device is available in the spherical, aspheric, multifocal (progressive), post-surgical, & irregular cornea design configurations with the following properties:
• Chord Diameter 13.0 mm to 25.00 mm
• Center Thickness 0.050 mm to 0.500 mm
• Base Curve 5.50 mm to 9.50 mm
• Power Range (sphere) -25.00D to +25.00D
• Add Power +1.00D to +4.00D

The Physical properties of the lens are:
Refractive Index (wet) RGP Center 1.442 Soft Skirt 1.435
Luminous Transmittance (tinted) (380nm to 780) 87% 97%
Surface Character hydrophobic hydrophilic
Water Content 28 ± 2%
Specific Gravity 1.15 N/A
Oxygen Permeability (revised Fatt method) 130 84

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (petrafocon A hem-larafilcon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (dynamic contact receding angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30nm in thickness.

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

This document describes the premarket notification (510(k)) for the SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens. The core of the submission revolves around demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the data and analyses presented to the FDA to establish this substantial equivalence, particularly focusing on how the new Hydra-PEG technology impacts the lens properties.

The document does not describe a traditional AI/ML model's acceptance criteria or performance study in the way one might evaluate a diagnostic algorithm. Instead, it focuses on the physical and chemical properties of a medical device (contact lens) and its clinical safety and effectiveness through comparisons to existing devices.

Here's an interpretation based on the provided text for the requested information, understanding that "acceptance criteria" here relates to demonstrating comparable performance and safety, primarily in terms of wettability improvement:

Overview of Device and Purpose of Submission:

The SynergEyes® SiH with Hydra-PEG Hybrid Daily Wear Contact Lens is a modification of existing SynergEyes® SiH lenses to include Hydra-PEG Technology (HPT). HPT is a polyethylene glycol (PEG)-based polymer designed to improve the wettability of the contact lenses. The submission aims to demonstrate that this modification does not change the design or indications for use, and that the lens with HPT is substantially equivalent to the predicate devices while offering improved wettability.

1. Table of Acceptance Criteria and Reported Device Performance

For a contact lens, acceptance criteria for physical properties typically involve demonstrating that the new device performs at least as well as, or better than, the predicate device in key safety and performance metrics. The primary criterion highlighted for the new technology (Hydra-PEG) in this submission is improved wettability.

Note on "Acceptance Criteria": This document primarily focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. For the Hydra-PEG modification, the key "acceptance" is that it improves wettability without negatively impacting other critical safety and performance parameters, and that its overall safety and efficacy are maintained as per the predicate device.

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

• Sample Size for Wettability Test: n = 20 lenses (for the statistical comparison of mean contact angle between coated and uncoated lenses).
• Data Provenance: Not explicitly stated regarding country of origin or specific study sites. The non-clinical toxicology and biocompatibility tests were conducted "in vitro and in vivo" and "in accordance with the GLP regulation." The clinical safety and effectiveness were "previously established" for the base hybrid contact lenses and for contact lenses treated with Hydra-PEG, suggesting reliance on existing data rather than a new, dedicated clinical trial for this specific 510(k) submission. Therefore, it's retrospective in the sense of leveraging prior data, but the wettability test itself was likely a specific laboratory test for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This submission is for a medical device (contact lens), not an AI/ML diagnostic system. Therefore, the concept of "experts establishing ground truth" in the diagnostic image interpretation sense does not apply directly. The "ground truth" for device performance is based on quantifiable physical properties (e.g., contact angle, water content, oxygen permeability) measured through validated laboratory methods, and clinical safety and efficacy data from previous studies.

4. Adjudication Method for the Test Set

Not applicable in the context of device physical property testing or clinical safety and efficacy data for a contact lens. Adjudication methods are relevant for subjective interpretations of data, particularly in medical image analysis.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This was not done. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess reader performance with and without AI assistance. This submission is for a therapeutic device (contact lens) where the primary mechanism of action is physical correction of vision and surface properties, not diagnostic interpretation.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone performance" refers to the intrinsic performance of the lens itself (e.g., wettability, refractive correction, safety profile).

7. The Type of Ground Truth Used

The "ground truth" (or basis for claiming safety and effectiveness and substantial equivalence) for this device includes:

• Quantitative Physical Property Measurements: Laboratory measurements of properties like contact angle (wettability), refractive index, luminous transmittance, water content, specific gravity, and oxygen permeability. These are objective, measurable parameters.
• Non-clinical Toxicology and Biocompatibility Data: Results from in vitro and in vivo tests confirming the safety of the materials and the finished lens, in accordance with GLP regulations.
• Clinical Safety and Effectiveness Data (Referenced): "[T]he clinical safety and effectiveness has been previously established for hybrid contact lenses manufactured from (petrafocon A hem-larafilcon A) and contact lenses treated with Hydra-PEG." This implies reliance on existing clinical data for the base material and the Hydra-PEG technology itself, rather than a new, dedicated clinical trial for this specific lens permutation.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML model that requires a "training set." The development of the Hydra-PEG technology and the contact lens material would involve R&D and optimization, but not in the sense of an AI model's training data.

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

Not applicable, as it's not an AI/ML model.

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UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.

The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:

• in the power range of -20.00 to +20.00 diopters for sphere,
• with center thickness from 0.16 mm to 0.39 mm
• with base curves of 5.5 mm to 9.00 mm
• with diameter of 14.50mm

When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material.

The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.

This document describes the premarket notification for UltraHealth™ SiH and UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses. It details the device, its intended use, and its substantial equivalence to previously approved devices.

Here's a breakdown of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already been proven safe and effective. The "reported device performance" is essentially that the new lenses are equivalent in design and material to previously cleared safe and effective lenses. The table below summarizes the characteristics of the new lenses compared to predicate and reference lenses, implying that similarity to the predicate is the primary criterion for acceptance.

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Duette™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Not Found

This FDA document is a 510(k) clearance letter for the Duette SiH Hybrid Contact Lenses. It does not contain a detailed study description with acceptance criteria and device performance data.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA reviewed data provided by the manufacturer to show the device is substantially equivalent to a predicate device already on the market, rather than requiring a detailed clinical study demonstrating the device meets specific acceptance criteria for performance as would be required for a novel device or a PMA application.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human reader effectiveness from this document. Such information would typically be found in the 510(k) submission itself, often in a section detailing clinical or non-clinical performance studies.

In summary, the provided document does not contain the information required to answer your request.

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SynergEyes® SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens is a combination of high Dk rigid gas permeable contact lens corneal option surrounded by a soft hydrophilic silicone-hydrogel skirt (periphery) that straddles the limbus of the eye :

• in the power range of -20.00 to +20.00 diopters for sphere,
• . cylinder powers up to 6.00 diopters for astigmatism
• with center thickness from 0.12mm to 0.30mm .
• with base curves of 7.10mm to 9.00mm
• with diameter of 14.50mm
• Add Powers 1.00 to 4.00 (multifocal)
  This lens material for the rigid portion is petrafocon A, an upgrade high Dk silicone base RGP material, lathe cut, surrounded by soft hydrophilis silicone-hydrogel copolymer (hem-larafilizon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™ SiH Hybrid Contact Lens acts as a refracting medium to focus light rays onto the The device is available in the following indications: spherical, toric, and multifocal, with retina. spherical or aspheric surfaces in violet visibility tim the RGP center, and multing, will may device is substantially equivalent to the SyneryEyes™ A and M (paflufocon D hem-iberfilion A) Hybrid Daily Wear Contact Lens predicate devices manufactured by the sponsor, Synerglyes, Inc.
  The SynergEyes™ Sill Hybrid Daily Wear Contact Lens center is a highly oxygen permeable (Dk 130) rigid gas material of (petrafocon A). The soft skirt is comprised of silicone-hydrogel copolymer (hem-larafilcon A) of 33% water and 73% polymer.
  The junction between the rigid material is bound by a proprietary chemical bonding method.

Acceptance Criteria and Study for SynergEyes™ SiH Hybrid Contact Lens

This document describes the acceptance criteria and the study conducted to demonstrate the substantial equivalence of the SynergEyes™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lens to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "no worse than" performance compared to the predicate device across various safety and effectiveness measures. The study aimed to show substantial equivalence, meaning the new device performs at least as well as the existing one.

Note: The submission frames the "acceptance criteria" as demonstrating that "the test lens performed no worse than the control lens on a daily basis," thereby establishing substantial equivalence. Specific quantitative thresholds for "no worse than" are not explicitly stated in the provided text for each outcome.

2. Sample Size and Data Provenance for Test Set

• Sample Size:
  • Total Subjects Randomized and Dispensed: 87
  • Test Cohort (dispensed): 56 subjects (eyes implicitly, given contact lens context)
  • Control Cohort (dispensed): 31 subjects (eyes implicitly)
  • Completed 90-day study: 41 Test cohort subjects (73.2%), 27 Control cohort subjects (87.1%)
• Data Provenance: The study was conducted at 8 investigational sites. The country of origin is not explicitly stated, but the submission is to the FDA (United States), suggesting the study likely took place in the USA. The study was prospective and unmasked, open-label.

3. Number of Experts and Qualifications for Ground Truth

This type of study (clinical trial for contact lenses) does not typically involve external experts establishing a "ground truth" for the test set in the way an imaging AI study would. Instead, the ground truth is clinical data collected by investigators/clinicians at the 8 investigational sites.

Their qualifications are not explicitly stated but would be assumed to be licensed ophthalmologists or optometrists experienced in fitting and evaluating contact lenses and ocular health, as is standard for clinical trials. They performed slit-lamp examinations, visual acuity assessments, and recorded adverse events and patient complaints.

4. Adjudication Method for Test Set

There is no mention of an independent adjudication method (like 2+1 or 3+1 consensus) for the collected clinical data. The data interpretation and reporting appear to be based on the findings of the individual investigators at the 8 sites, compiled and analyzed statistically.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a clinical trial comparing a new device (contact lens) to a predicate device in human subjects, not an assessment of AI's assistance to human readers. Therefore, an effect size of human readers improving with/without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance assessment was not done. This device is a physical contact lens, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the clinical observations and outcomes data collected directly from the study subjects. This includes:

• Adverse events (e.g., abrasions, microbial keratitis)
• Slit lamp findings (e.g., staining, other ocular signs)
• Visual acuity measurements
• Patient-reported symptoms and complaints (e.g., discomfort, dryness, itching/burning, halos)
• Wearing times
• Lens deposit and fitting evaluations
• Reasons for discontinuation

These are directly observed or reported clinical realities in the study population.

8. Sample Size for the Training Set

This submission describes a clinical trial for a physical medical device (contact lens). There is no "training set" or "algorithm" involved in the development or evaluation of this contact lens, as it is not an AI/ML device. Therefore, this question is not applicable.

9. How Ground Truth for Training Set Was Established

As there is no training set for an algorithm, this question is not applicable.

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SynergEyes"16 A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive crror including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10,00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes 106 PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20,00 D eves with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes TM - A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens

This FDA 510(k) clearance letter for the SynergEyes Hybrid Contact Lenses does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving device performance. This document is a clearance letter, indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, not a scientific study report.

Here's a breakdown of what can be extracted and what is missing:

The core of the request is to describe the acceptance criteria and a detailed study proving the device meets those criteria, specifically for an AI/ML context. This document is for a medical device (contact lenses) and does not involve AI/ML. Therefore, most of the requested fields related to AI/ML study design (test sets, ground truth, experts, MRMC, standalone performance, training sets) are not applicable or cannot be found in this document.

Information Extracted from the Provided Text:

• Device Name: SynergEyes (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for Daily Wear

Table of Acceptance Criteria and Reported Device Performance:

Based on the document, there are no explicit acceptance criteria or reported device performance metrics in the format usually provided for AI/ML or efficacy studies. The "acceptance" here is the FDA's determination of substantial equivalence, which is based on demonstrating the device is as safe and effective as a predicate device, not necessarily on meeting specific numerical performance targets outlined in this letter.

The "Indications for Use" section defines what the lenses are for, which can be seen as the intended performance scope, but not numerical acceptance criteria.

Missing Information (Not present in this 510(k) clearance letter):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The 510(k) process relies on equivalence to predicate devices, and while testing would have been done by the manufacturer, the details of those studies are not in this clearance letter.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not described as this is not an AI/ML study.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is not an AI/ML study. Performance for contact lenses would typically involve clinical trials assessing visual acuity, comfort, fit, and physiological response, but these details are not in this clearance letter.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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SynergEyes™ A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear fo rhte correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 D and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas pearmeable lenses.

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Not Found

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is an FDA 510(k) premarket notification letter for SynergEyes™ contact lenses, detailing:

• Device Name: SynergEyes™ A, M, KC, and PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens.
• Regulation Number and Name: 21 CFR 886.5916, Rigid gas permeable contact lens.
• Regulatory Class: II.
• Product Code: HQD.
• Submission Date: January 25, 2008.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: Specific uses for correction of hyperopic, myopic, astigmatic refractive errors, presbyopia, irregular astigmatism in keratoconus, and refractive errors from corneal surgery or trauma.
• Disinfection Method: Compatible chemical disinfecting system for both hydrogel and rigid gas permeable lenses.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than presenting a performance study with detailed acceptance criteria and results.

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SynergEyes® A and M (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ KC (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses for keratoconus are indicated for use in the correction of eyes with refractive errors that include hyperopia and myopia that manifest irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 10.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

SynergEyes™ PS (paflufocon D hem-iberfilcon A) Hybrid Contact Lenses are indicated for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism in aphakic and not aphakic, nondiseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to SynergEyes, Inc. for their hybrid contact lenses. This type of document declares substantial equivalence to a predicate device, allowing the device to be marketed.

Crucially, this document is not a study report or clinical trial summary. It does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, expert qualifications, or details about ground truth establishment. These are typically found in the submission itself or associated clinical reports.

Therefore,Based on the provided document, I cannot fulfill your request as the information regarding acceptance criteria, device performance, study details, and ground truth establishment is not present within this FDA clearance letter. This document only confirms the FDA's determination of substantial equivalence for the device.

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For use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 in eyes with astigmatism or irregular astigmatism up to 6.00D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.

The SynergEves™ PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens is a combination rigid gas permeable contact lens corneal optic portion surrounded by a soft hydrophilic skirt that straddles the limbus of the eye :

• in the power range of -20.00 to +20.00 diopters for sphere .
• . in the range of 0.25 to 6.00 diopters cylinder
• with center thickness from 0.18mm to 0.30mm .
• with base curves of 7.10mm to 9.60mm .
• with diameter of 14.50mm .
  The lens material (paflufocon D hem-iberfilcon A) is identical to the predicate current material cleared under K051035 and K052675. There are no differences to the chemical composition, formulation, manufacturing process, packaging and sterilization as described in the referenced 510(k).
  This lens material for the rigid portion is paflufocon D lathe cut, surrounded by soft hydrophilic copolymer (hem-iberfilcon A), sterilized by means of e-beam sterilization. When placed on the human cornea, the SynergEyes™Hybrid Contact Lens acts as a refracting medium to focus light rays onto the retina. The device is available as a lathe cut contact lens in the following design for post surgical refractive errors and trauma: multi concentric zones in blue visibility tinted material. This device is equivalent to the SynergEyes™ A and M Hybrid Contact Lens is material design and composition, and the SoftPerm® hybrid RGP manufactured by Ciba Vision Corporation.
  The SynergEyes™ PS Hybrid Daily Wear Contact Lens center optical portion is a rigid gas permeable material of (paflulofon-D) polymer. TThe soft skirt is comprised of HEMA (hydroxyethylmethacrylate) of 27% water and 73% polymer.
  The junction between the rigid material and soft material is bound by a proprietary chemical bonding method.

Here's a breakdown of the acceptance criteria and study information for the SynergEyes™ PS Hybrid Contact Lens, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense of a medical device submission beyond showing substantial equivalence to predicates. However, it evaluates safety and efficacy by tracking specific outcomes. I'll frame the reported device performance against generally understood good outcomes for contact lenses.

• 20/20 or better: 20.0%
• 20/25 or better: 45.0%
• 20/30 or better: 68.8%
• 20/40 or better: 81.3%
  Discontinued Subjects:
• 20/20 or better: 8.6%
• 20/25 or better: 39.7%
• 20/30 or better: 53.4%
• 20/40 or better: 70.7%
  3 completed eyes and 8 discontinued eyes had VA decreases of >2 lines (expected in this population). |
  | Efficacy: Wearing Time | Acceptable daily wearing time for daily wear lenses (e.g., >8-10 hours). | Average daily wearing time: 10.6 hours per day for completed patients. |
  | Comfort | Low rates of discomfort/awareness leading to discontinuation. | Discontinuation due to poor comfort: 27.5% of discontinuations.
  Reported Symptoms (Completed Subjects):
• Discomfort and awareness: 28.4%
• Dryness and scratchiness: 23.4%
• Itchiness and burning: 9.3%
• Variable vision: 8.2%
  Symptoms decreased over time for completed eyes. |
  | Overall Performance | Satisfactory performance and safe/effective use for intended purpose. | "The SynergEyes™ PS Hybrid Contact Lens for Post Surgical refractive error and cases involving trauma provided satisfactory performance as expected... Overall, the lens performance demonstrated safe and effective use of the device for its intended use." It notes the higher than estimated discontinuation rate was anticipated given the challenging patient population. |

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set:
  • Subjects: 76 subjects were dispensed into the study.
  • Eyes: 80 eyes (from 44 completed subjects) reached study completion. The total number of eyes enrolled isn't explicitly stated but would be at least 76 (assuming one eye per subject) and up to 152. The "58 eyes" mentioned for discontinued subjects suggests that some subjects wore lenses in both eyes.
• Data Provenance: The study was a "three month clinical study," implying a prospective design within a controlled clinical environment (likely in the US, given the FDA submission). No specific country of origin is mentioned beyond the applicant's US address.

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

This is not applicable. The study is a clinical trial assessing the direct performance of the contact lens on patients. The "ground truth" is the actual patient experience and objective clinical measurements (visual acuity, adverse events) as documented by clinical investigators and optometrists/ophthalmologists involved in the study. There's no mention of independent experts establishing a "ground truth" for a diagnostic performance metric.

4. Adjudication Method for the Test Set

This is not applicable, as it's a clinical trial for a contact lens, not a diagnostic device requiring adjudicated interpretations of images or data. Clinical investigators and study coordinators would have managed data collection and reported outcomes.

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. This type of study is typically performed for diagnostic imaging devices where multiple readers interpret cases to assess diagnostic accuracy and inter-reader variability. This document describes a clinical trial for 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. This document describes a clinical trial for a physical medical device (contact lens) worn by human patients, inherently involving human interaction (wearing, fitting, clinical evaluation).

7. The Type of Ground Truth Used

The "ground truth" in this context is based on clinical observation, patient-reported outcomes, and objective ophthalmological measurements collected during the prospective clinical study. This includes:

• Measurement of visual acuity (Snellen VA).
• Documentation of adverse events.
• Patient-reported symptoms and complaints (comfort, dryness, variable vision).
• Measured wearing time.
• Clinical assessments by practitioners (e.g., corneal health).

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device submission. This device (contact lens) is a physical product, not an AI/ML-based algorithm that requires a "training set" in the computational sense. The document describes a clinical study to evaluate the device's performance, not to develop or train an algorithm.

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

This information is not provided and is not applicable, as there is no "training set" for an AI/ML algorithm.

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