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The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hvperopia.

The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs.

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

l . cannot be adequately corrected with spectacle lenses

2. requires a rigid gas permeable contact lens surface to improve vision

3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities.

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration ( e.g. keratoconus, keratoglobus, pellucid marqinal degeneration. Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome and Filamentary Keratitis}, limbal stem cell deficiency ( e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin ( e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure ( e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.

Eyecare practitioners may prescribe the lenses or frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Acuity 181™ (tisilfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process.

Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Contact Lenses are 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 coated with Tangible™ Hydra-PEG® the underlying material, tisilfocon A, is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle compared to untreated lenses).

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens are available in spherical, toric, multifocal/bifocal, orthokeratology, and scleral design for daily wear only.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a pass/fail sense for its non-clinical studies. Instead, it reports the results of various tests and asserts that the device meets safety and effectiveness requirements. The table below compiles the reported physical properties and biocompatibility findings.

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The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorber.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

This is an FDA 510(k) summary for a rigid gas permeable contact lens. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against predefined acceptance criteria for a novel device through clinical trials. Therefore, much of the information you requested regarding acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, training set details) is not applicable to this type of submission.

Here's a breakdown of what is available in the document related to acceptance criteria and performance, and why other elements are absent:

Context: This 510(k) submission is for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. The manufacturer is not introducing a new type of device or technology but is demonstrating that their product is "substantially equivalent" to existing, legally marketed predicate devices. For this type of submission, extensive clinical studies and a complex acceptance criteria framework (as would be seen for a novel AI device, for example) are generally not required. The focus is on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate devices.

Acceptance Criteria and Device Performance (as evident from the document):

The acceptance criteria are implicitly based on demonstrating that the device's physical properties and manufacturing quality fall within acceptable ranges and meet the standards set by the predicate devices and relevant industry standards (like ANSI Z80.20 for lens specifications).

1. In-Vitro Cytotoxicity
2. Systemic Toxicity
3. Acute Ocular Irritation | 1. In-Vitro Cytotoxicity: Per ISO 10993-5, results indicated that the finished lenses are not cytotoxic.
4. Systemic Toxicity: Per ISO 10993-11, the finished lenses met the requirements of the systemic injection test, and extracts did not induce acute systemic toxicity.
5. Acute Ocular Irritation: Per ISO 10993-23, extracts did not induce ocular irritation. |
   | Physical Properties (Matching Predicate and Industry Standards) | Specific values are listed, demonstrating they are within typical ranges for such lenses and comparable to predicate devices:

• Refractive Index: 1.430
• Modulus (MPa): 1194
• Hardness (Shore D): 78
• Specific Gravity: 1.18
• Oxygen Permeability (Dk): 200 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
• Water Content:

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The BostonSight® Specialty Lenses (roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A) for daily wear are indicated for the correction of refractive ametropia (myopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise nondiseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment, and the saline bath provided by scleral lens designs.

The BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use in eyes with ocular surface disease including, but not limited to, ocular Graft-versus-Host disease, Siögren's syndrome, dry eve syndrome and Filamentary Kerattis, limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.

Additionally, the BostonSight Specialty Lenses for daily wear in the scleral lens designs are indicated for therapeutic use for the management of irregular and distorted corneal surfaces. Common causes of corneal distorion include, but are not limited to, corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy). When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the BostonSight Specialty Scleral Lenses for daily wear may concurrently provide correction of refractive error.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The BostonSight® Specialty Lenses for daily wear are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate rigid gas permeable (RGP) lens materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon B, oprifocon A, fluoroxyfocon A. The lenses fabricated from roflufocon D, roflufocon E, tisilfocon A, hexafocon B, fluoroxyfocon A are available with or without Tangible® Hydra-PEG coating. The lenses fabricated from oprifocon A are not available with Tangible® Hydra-PEG. The lenses may be shipped "dry" or "wet" in a polypropylene contact lens case. When shipped "wet", the lenses are packaged non-sterile in Boston SIMPLUS® Multi-Action Solution.

The provided document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the BostonSight® Specialty Lenses to existing predicate devices. It does not present a study proving the device meets specific acceptance criteria based on performance data. Instead, it relies on the predicate pathway, meaning the device is considered safe and effective because it is similar in design, materials, and intended use to devices already on the market.

Therefore, many of the requested elements for a study proving the device meets acceptance criteria (such as sample size, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of regulatory submission.

However, based on the information provided, here's what can be inferred or stated regarding "acceptance criteria" through the lens of substantial equivalence:

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

The "acceptance criteria" in this context are primarily the material properties and physical parameters that establish similarity to predicate devices already cleared by the FDA. The performance is assessed by demonstrating these properties are within acceptable ranges, consistent with the predicates.

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

• Sample Size: Not applicable. This submission relies on "Non-Clinical Studies" and "Clinical Studies" sections where it explicitly states that the safety and effectiveness have been "addressed by reference to previous 510(k) clearances." No new specific test set or clinical study data is presented for this particular submission.
• Data Provenance: The underlying data for the predicate devices would have come from their respective clearance processes. This document does not provide details on the provenance (country of origin, retrospective/prospective) of those original predicate studies.

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

• Not applicable as no new test set data is presented. The "ground truth" for the predicate pathway is essentially the FDA's prior determination of safety and effectiveness for the predicate devices.

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

• Not applicable as no new test set data is presented.

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-assisted device. Also, this is a substantial equivalence submission, not a new clinical trial comparing performance.

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

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

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

• For this 510(k) submission, the "ground truth" is the established safety and effectiveness of the identified predicate devices, as previously determined by the FDA. The manufacturer is asserting that their new device is fundamentally similar in materials, design, and intended use, and therefore shares that established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise nondiseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eve syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservor and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorbers.

Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses are treated to incorporate Hydra-PEG Technology developed by Tangible Sciences. This PEG polymer is permanently attached to the surface and is designed to enhance surface (wetting) properties while not affecting the mechanical or optical properties of the underlying material.

The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device (Rigid Gas Permeable Contact Lenses). It is not a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, I cannot extract the requested information about acceptance criteria, study sizes, expert ground truth establishment, MRMC studies, or training sets, as these concepts are not applicable to the type of device and submission described in the provided document. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for contact lenses based on material properties, manufacturing methods, and intended use.

The "PERFORMANCE DATA VII." section specifically mentions "Non-Clinical Studies" and "Clinical Studies". However, these sections refer to studies that were "addressed through previously cleared 510(k) premarket notifications" for the materials and existing uses of the contact lenses, rather than a new study demonstrating the performance of an AI-powered device.

If you have a document describing an AI/SaMD study, I would be happy to analyze it for the criteria you've outlined.

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The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzman's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, or fluoroxyfocon A.

The provided FDA 510(k) summary (K233325) for the Visionary Optics Scleral Contact Lens describes non-clinical and clinical studies conducted to support the substantial equivalence claim. However, it does not provide specific acceptance criteria or detailed study results in the format requested. The document primarily focuses on demonstrating equivalence to predicate devices rather than providing a standalone performance validation for a novel device with explicit performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available within the provided text.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not present specific numerical acceptance criteria (e.g., "X% accuracy," "Y precision"). Instead, for non-clinical studies, it states that manufacturing tolerances were met and bioburden was "within the established acceptance criteria of less than 100 CFU per lens." For clinical studies, the "acceptance criteria" appear to be implied by the outcome: no serious adverse events and stable/improved patient conditions.

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

• Test set sample size: 33 patients (63 total eyes).
• Data provenance: Not explicitly stated, but the study involved "Nine (9) independent practitioners," suggesting a multi-center, prospective clinical evaluation. The document does not specify the country of origin of the data.

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

• Number of experts: Nine (9) independent practitioners.
• Qualifications of experts: Not explicitly stated other than "independent practitioners." Their specific specializations (e.g., ophthalmologists, optometrists, or subspecialties) or years of experience are not provided.

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

• Adjudication method: Not described. The text states that "The practitioners reviewed all patients therapeutically managed... and reported the outcome of each patient." There is no mention of an adjudication process among these practitioners for establishing a unified ground truth.

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

• MRMC comparative effectiveness study: No, this document pertains to a medical device (scleral contact lens), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable and was not performed.

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

• Standalone performance: No, this device is a physical contact lens, not an algorithm. The clinical performance inherently involves human fitting and patient use.

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

• Type of ground truth: The "ground truth" for the clinical study appears to be the observed clinical outcome reported by the independent practitioners, specifically: "no serious or significant adverse reactions reported" and "for all patients, the ocular condition(s) and vision remained stable or improved." This is a form of outcomes data based on clinical observation and assessment by practitioners.

8. The sample size for the training set

• Training set sample size: Not applicable and not mentioned. This is a medical device, not a machine learning model. The "training" described in the context of this submission refers to the historical data and previous 510(k) clearances that establish the safety and effectiveness of the materials used in the lens.

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

• Ground truth establishment for training set: Not applicable and not mentioned. As this is not an AI/ML device, the concept of a "training set ground truth" as you've framed it is not relevant. The safety and effectiveness of the materials (roflufocon D, roflufocon E, etc.) used in the device were established through "reference to previous 510(k) clearances" and "previous 510(k) clearances," implying that historical data and prior regulatory assessments for these materials served as the basis for their use in the current device.

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Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

TYRO™ 97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyonic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected only by using chemical disinfection.

Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from a currently marketed contact lens material, hexafocon A. comprised of a siloxanyl fluoromethacrylate copolymer (fluorosilicone acrylate monomers), tinted for visibility, and with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).

Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently 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 Tangible™ Hydra-PEC® , the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

TYRO" -97 (hofocon A) Rigid Gas Permeable Contact Lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from currently marketed contact lens material. hofocon A. polymer of trifluoroethyl methacrylate and silicone methacrylate (fluorosilicone acrylate monomers), tinted for visibility, with or without UV light absorber. Non-proprietary names were assigned by the United States Adopted Names Council (USAN).

TYRO""-97 (hofocon A) Rigid Gas Permeable Contact Lenses are treated to incorporate Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer that is covalently 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 Tangible™ Hydra-PEG® .the underlying material is encapsulated in a thin laver of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses.

This document describes the premarket notification (510(k)) for Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG® and TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

The acceptance criteria and device performance information related to this submission are described below.

1. Table of Acceptance Criteria and Reported Device Performance

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The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmam's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy. ectodermal dysplasia), neurotrophic keratiis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the New Vision SC (tisilfocon A) Scleral Lens may concurrently provide correction of up refractive error.

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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The NewVision SC (tisilfocon A) Scleral Lens is a large diameter rigid gas permeable lens designed to vault over the cornea and rest on the conjunctiva overlying the sclera. The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens partly rests on the cornea, centrally or peripherally, and partly on the limbus or conjunctiva over the sclera. The NewVision SC and New Vision SC Daily Wear Ortho-K (tisilfocon A) Lenses are lathe cut from tisilfocon A, which is an FDA Group #3 fluoro-silicone acrylate material.

The provided document is a 510(k) premarket notification for a medical device (contact lenses) and does not contain information about an AI/ML-based device or a study involving AI/ML performance. Therefore, I cannot extract the required details such as acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the content of this document.

The document discusses the substantial equivalence of the NewVision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses to a legally marketed predicate device (Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses). The performance data cited are "Non-Clinical Studies" (bench testing and bioburden testing) and "Clinical Studies" based on previous 510(k) clearances, rather than a new clinical study.

Therefore, I cannot provide the requested table or answer the specific questions related to an AI/ML device study.

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The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and non aphakic persons with nondiseased eyes. The lenses may be disinfected using a chemical disinfection system only.

The Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs: Spherical, Aspherical, Toric, Mulifocal, Scleral, Semi-scleral. Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404. These devices will not be marketed with multiple components or any required accessories.

This document describes a 510(k) premarket notification for a new rigid gas permeable (RGP) contact lens, Oxfore®100 (hexafocon A), seeking to establish substantial equivalence to a predicate device, the Boston XO™ (hexafocon A) Daily Wear Contact Lens (K171404).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, it compares the characteristics of the new device (Oxfore®100) directly against its predicate device (Boston XO™), concluding they are "substantially equivalent." The implicit acceptance criterion is that the new device's material and physical properties should be comparable to or meet the established standards of the predicate device and relevant guidance documents.

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The Visionary Optics Scleral Contact Lens for daily wear is indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring from infection or trauma.

The Visionary Optics Scleral Contact Lens for daily wear is also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren's syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex. Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the Visionary Optics Scleral Contact Lens may incidentally provide correction of refractive error in persons with myopia, astigmatism or presbyopia.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Visionary Optics Scleral Contact Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluorosilicone acrylate materials: roflufocon D, roflufocon E, hexafocon B, or tisilfocon A.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and device performance. The document is a 510(k) summary for a contact lens, primarily focusing on its substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria, sample sizes, expert qualifications, or adjudication methods for performance evaluation.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No explicit Acceptance Criteria: The document mentions that lenses were manufactured to "established finished product specifications within the ANSI Z80.20 tolerance" for bench testing, and bioburden testing had an "established acceptance criteria of less than 100 CFU per lens." However, it does not provide a comprehensive table of acceptance criteria for the overall device performance as per your request (e.g., visual acuity, comfort, etc.).
• No detailed Device Performance Results: While it states that manufacturing verification testing demonstrated the ability to manufacture lenses "to a variety of prescribed parameters" and bioburden testing was "within the established acceptance criteria," it does not provide specific numerical results or a comparative performance table against a set of acceptance criteria.
• No information on Test Set Sample Size and Data Provenance: The document does not specify the sample size used for any performance testing, nor does it provide information about the country of origin or whether the data was retrospective or prospective.
• No information on Experts for Ground Truth: There is no mention of experts, their number, or qualifications used to establish ground truth for any testing described.
• No Adjudication Method: The document does not describe any adjudication methods used for a test set.
• No MRMC Comparative Effectiveness Study: The submission primarily relies on substantial equivalence to predicate devices and general claims of safety and effectiveness, not a multi-reader multi-case comparative effectiveness study with AI assistance.
• No Standalone Performance (AI-specific): This device is a contact lens, not an AI algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable.
• No Ground Truth Type (for performance studies): Since detailed performance studies with ground truth are not presented, this information is not available. The "ground truth" for a contact lens would typically involve clinical measurements by optometrists/ophthalmologists, patient feedback, and objective physiological responses, but these are not quantified or described in the provided text.
• No Training Set Sample Size or Ground Truth Establishment for Training Set: As this is not an AI device, the concepts of training sets and their ground truth establishment are not applicable here.

The section under "VII. PERFORMANCE DATA" explicitly states:

• "Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A has been addressed by reference to previous 510(k) clearances."
• "Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, hexafocon B and tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances."

This indicates that extensive new performance studies were not conducted for this specific 510(k) clearance, but rather reliance on prior clearances for similar materials and designs. The only specific tests mentioned are:

• Bench Testing: Manufacturing verification to ensure lenses meet ANSI Z80.20 tolerance for established finished product specifications. No specific results table or acceptance criteria other than "within the ANSI Z80.20 tolerance" are provided.
• Bioburden Testing: Demonstrated "colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens."

Therefore, I cannot extract the level of detail you are requesting from this document.

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The Optimum Infinite (tisilfocon A) SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia.

The Optimum Infinite (tisilfocon A) TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters.

The Optimum Infinite (tisilfocon A) MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Optimum Infinite (tisilfocon A) IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The Optimum Infinite (tisilfocon A) ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:

1. cannot be adequately corrected with spectacle lenses
2. requires a rigid gas permeable contact lens surface to improve vision
3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities

Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).

The Optimum Infinite (tisilfocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the Optimum Infinite (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error.

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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber. The lenses may be plasma treated during the manufacturing process. In the Optimum Infinite (tisilfocon A) Daily Wear Contact Lens with UV Blocker, a Benzophenone UV blocking monomer is used to block >99% of UV radiation in the UVB range (280mm - 315nm) and >85% in the UVA range (316 - 380nm). The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses incorporate a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2 and D&C Red No. 17. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of up to 5.00 diopters in nondiseased eyes. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses may be treated to incorporate Tangible TM Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently 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 Tangible™ Hydra-PEG, the underlying material (tisilfocon A) is encapsulated in a thin layer of polymer that results in measurable improvement of wettability (sessile drop contact angle) compared to untreated lenses. The resulting layer is hydrophilic and approximately 30mm in thickness. The Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses are available in the Spherical, Toric, Multifocal/Bifocal, Irregular Cornea (Scleral) design configurations.

The provided text describes a 510(k) premarket notification for the Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses, which doesn't typically follow the same acceptance criteria and study structure as an AI/ML device. Therefore, the specific questions regarding acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not directly applicable in the conventional sense for this type of device submission.

However, I can extract information related to the device's performance, clinical studies conducted, and the basis for its safety and effectiveness.

Here's an adaptation of the request based on the provided text, focusing on the information available:

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

Since this is a 510(k) submission for a contact lens, the "acceptance criteria" are generally based on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through non-clinical and clinical data. Specific quantitative "acceptance criteria" and "device performance" metrics of an AI/ML device (e.g., sensitivity, specificity thresholds) are not present. Instead, the performance is demonstrated by the absence of serious adverse events and positive clinical outcomes.

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

• Sample Size (Clinical Study): 62 patients (115 total eyes) were evaluated in the clinical study for therapeutic use of scleral lenses.
  • 55 eyes for irregular cornea management.
  • 62 eyes for ocular surface disease management.
• Data Provenance: The text does not explicitly state the country of origin of the data. The study appears to be prospective in nature, as practitioners were "instructed to review all patients treated... and to report the outcome." The study followed patients for "at least 3 months" over a "treatment follow-up period."

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

• Number of Experts: Six (6) independent practitioners.
• Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "independent practitioners." For contact lens studies, these would typically be ophthalmologists or optometrists experienced in fitting and managing contact lens patients, particularly those with complex conditions like irregular corneas or ocular surface diseases.

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

• The text does not mention an explicit adjudication method. The independent practitioners reported outcomes, and the overall clinical assessment ("remained stable or improved") was the basis for the conclusion. There's no indication of multiple readers adjudicating cases in the manner described for AI/ML studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study involving AI assistance was not conducted. This is a medical device (contact lens) submission, not an AI/ML diagnostic or assistive device.

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 contact lens and does not involve an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the clinical diagnosis and assessment of therapeutic outcomes by the independent practitioners based on objective and subjective patient data (e.g., vision improvement, stability of ocular conditions, absence of adverse events). It's essentially expert clinical assessment/outcomes data.

8. The sample size for the training set:

• This is not applicable as this is not an AI/ML device that requires a training set in that context. The device's safety and effectiveness are established through non-clinical testing and clinical studies on its material properties and patient outcomes, not through learning from data.

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

• Not applicable for the reason stated above.

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