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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.

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

• Sample Size:
  • For the "Average Sessile Drop Wetting Angle," the sample size was n=30.
  • For most other non-clinical tests (cytotoxicity, systemic toxicity, ocular irritation, physicochemical, mechanical, optical properties, bioburden, physical parameter stability, care solutions compatibility), a specific sample size is not provided in the document. It generally states that "a series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed."
• Data Provenance: The document does not specify the country of origin for the data. The studies were non-clinical toxicology and biocompatibility tests, conducted "in vitro and in vivo." It states that "All nonclinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols." This suggests these were laboratory-based studies. The document does not mention any human clinical trials for primary performance evaluation of this specific device, instead referring to prior clinical performance data for the material. The studies listed are retrospective in the sense that they are presented as completed tests rather than ongoing prospective trials.

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

This information is not provided in the document. The document describes non-clinical laboratory testing, not studies requiring expert consensus for ground truth determination.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The non-clinical tests primarily involved objective measurements and adherence to standards (e.g., ISO 10993). There is no mention of a human adjudication process for the results of these tests.

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

This information is not applicable/not provided. The device is a rigid gas permeable contact lens, not an AI-powered diagnostic or decision-support system involving human readers.

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

This information is not applicable/not provided. The device is a medical device (contact lens) and not an algorithm or software.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" implicitly refers to established scientific standards and regulations (e.g., ISO 10993 standards for biocompatibility). For example, "not cytotoxic" is the ground truth based on the criteria in ISO 10993-5. There is no mention of expert consensus, pathology, or outcomes data as a ground truth in the context of these specific non-clinical performance studies.

The document states: "Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from tisilfocon A has been previously addressed." This implies that prior clinical studies on the material (tisilfocon A) have established its ground truth for safety and effectiveness in human use. However, the details of those past clinical studies (e.g., how their ground truth was established – e.g., expert clinical assessment, patient outcomes) are not provided in this document.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a physical medical device (contact lens), not a machine learning model that requires a training set.

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

This information is not applicable/not provided, as the device is not an AI/ML system requiring a training set.

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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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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

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

The document does not explicitly state specific sample sizes for each test set or the exact country of origin for the data. However, it indicates that preclinical toxicology and biocompatibility tests were performed "in vitro and in vivo."

• Bench Performance Testing: The testing involved various batches of "lenses" (e.g., 30 disinfection cycles, 30 days of accelerated aging) but specific numbers of lenses per test are not stated.
• Animal Performance Testing: "Both the final finished subject devices" were tested, implying at least one sample of each type.
• In Vitro Performance Testing: "Both the final finished subject devices" were tested, implying at least one sample of each type.
• Clinical Performance Testing: This relied on the clinical safety and effectiveness previously demonstrated by predicate devices and prior submissions for Tangible™ Hydra-PEG® treated lenses. This suggests a retrospective reliance on existing clinical data rather than a new prospective clinical study for this specific submission.

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

This document describes a 510(k) submission for rigid gas permeable contact lenses, which primarily relies on bench testing, animal testing, and in vitro testing, along with demonstrated equivalence to predicate devices for clinical performance. The establishment of "ground truth" in the context of expert review for image-based diagnostic AI models or similar scenarios is not directly applicable here. The performance evaluation is based on objective, quantifiable physical, chemical, and biological tests following recognized ISO standards and GLP regulations.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements and biological assessments rather than subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is not a submission for an AI-assisted diagnostic device, but rather for a physical medical device (contact lenses).

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

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is established by:

• Objective measurement standards: For physical properties, wettability (sessile drop contact angle), and bioburden.
• Compliance with recognized standards (ISO): For biocompatibility (acute ocular irritation, acute systemic toxicity, cytotoxicity).
• Previous regulatory clearances: For the clinical safety and effectiveness of the base contact lens materials and the Tangible™ Hydra-PEG® coating, demonstrated through prior predicate device submissions.

8. The Sample Size for the Training Set

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

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

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

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Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in 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 Acuity™ 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon 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. Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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.

Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for spheres .
• with base curves of 4.0 mm to 11.50 mm ●
• with base curve chord of 6.0 mm to 6.5 mm ●
• with diameters of 7.0 to 21.0 mm

The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.

The provided text describes the regulatory clearance of a medical device, the Acuity 200™ with Tangible® Hydra PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, based on substantial equivalence to predicate devices, rather than a direct study validating specific acceptance criteria against reported performance in a clinical setting.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in the provided text in the format you requested, as the submission relies on demonstrating similarity to already approved devices.

However, I can extract information related to the performance data mentioned and the basis for determining substantial equivalence.

Here's an analysis based on the provided text, addressing your points as much as possible:

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

The document states that the new device has been shown to be "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the new device's performance is comparable to the predicate devices across various characteristics. The "Comparison of Characteristics with the Predicate Device" table serves as the primary evidence for this.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data for clinical evaluation of the current device. The clearance is based on non-clinical data and substantial equivalence.
• Data Provenance: Not applicable in the context of clinical testing of this specific device for its performance against clinical acceptance criteria. The data presented is primarily non-clinical (biocompatibility, material testing, performance testing) to demonstrate substantial equivalence to previously cleared devices.

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

This information is not provided. The clearance is based on non-clinical testing and comparison to predicate devices, not on a clinical study requiring expert ground truth establishment for a test set.

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

Not applicable, as no clinical test set requiring adjudication is described for this specific device.

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

Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool, so an MRMC study is outside its scope.

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

Not applicable, as this is a medical device (contact lens), not a standalone algorithm.

7. The type of ground truth used:

• For the non-clinical tests (biocompatibility, performance testing), the "ground truth" would be established by validated laboratory testing methods and industry standards (e.g., ISO 10993-1:2018).
• For the overall device, the "ground truth" for its safety and effectiveness is primarily established by its substantial equivalence to predicate devices that have prior clearance based on their own safety and effectiveness data (which would include clinical studies for those predicate devices as referenced).

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

Not applicable.

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The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Acuity 200™ (fluoroxyfocon 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:

This document describes the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens and its substantial equivalence to predicate devices, focusing on its expanded indications for use.

Here's the breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity, as it's a 510(k) submission for a medical device (contact lens) and not an AI/software device. The primary "acceptance criteria" for such a device effectively revolve around demonstrating substantial equivalence to legally marketed predicate devices and proving its safety and effectiveness for its intended use and expanded indications.

The reported device performance is primarily qualitative and based on the outcomes of a retrospective clinical study.

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

• Sample Size: 41 patients (66 total eyes).
• Data Provenance: The data was obtained from a retrospective review of medical charts. The country of origin of the data is not explicitly stated, but the submitter (Acuity Polymers, Inc.) is based in Rochester, NY, United States.

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

• Number of Experts: Four (4) independent practitioners.
• Qualifications of Experts: The document refers to them as "independent practitioners" but does not specify their exact qualifications (e.g., ophthalmologists, optometrists, or years of experience).

4. Adjudication method for the test set

• The document does not specify an adjudication method. It states that "Four (4) independent practitioners retrospectively reviewed medical charts," but it does not detail how potential discrepancies or disagreements among these practitioners were resolved or if their findings were aggregated. It appears each practitioner's assessment of their own patients' outcomes was used.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a contact lens submission, not an AI-assisted diagnostic or interpretative device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. The Acuity 200™ is a physical medical device (contact lens) and does not involve any algorithm or AI for standalone performance evaluation.

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

• The ground truth was based on clinical outcomes data derived from the medical charts reviewed by the independent practitioners. Specifically, it focused on whether "irregular corneal conditions and vision remained stable or improved."

8. The sample size for the training set

• Not applicable. This device is a physical contact lens, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development. The safety and effectiveness of the material and design were established through previous clearances and the clinical study mentioned.

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

• Not applicable. As there is no training set for an algorithm, this question is not relevant to this device submission.

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The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive error (myopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear.

The Acuity 200™ (fluoroxyfocon 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• . in the power range of -20.00 to +20.00 diopters for spheres
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm ●
• with diameters of 7.0 to 21.0 mm ●
  The lens material incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, scleral and aspheric surfaces in visibility tinted material.

The provided text describes the acceptance criteria and study proving the performance of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens.

Here's an analysis of the requested information:

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

The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for an AI device (e.g., target accuracy, sensitivity, specificity thresholds). Instead, the study aims to demonstrate substantial equivalence to a predicate device (Acuity 100). The "acceptance criteria" are implied by the comparison to the predicate device in terms of safety and effectiveness endpoints.

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

• Test Set Sample Size: 74 subjects (148 eyes) were enrolled.
  • 50 subjects (100 eyes) were in the test group (Acuity 200™).
  • 24 subjects (48 eyes) were in the control group (Acuity 100).
  • 58 subjects completed the scheduled visits (40 in test group, 18 in control group).
• Data Provenance:
  • Country of origin: United States. Subjects were evaluated at four independent clinical sites across the United States.
  • Retrospective or Prospective: Prospective. The study design is described as an "open-label, multi-center, randomized concurrent-control study with the treatment duration of 90 days."

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

This document describes a clinical study for a contact lens, not an AI/ML device relying on expert-annotated ground truth for image analysis. Therefore, the concept of "experts used to establish ground truth" in the AI sense (e.g., radiologists marking images) does not directly apply here.

The "ground truth" for this study is derived from:

• Objective clinical measurements: Slit lamp observations (staining, edema, vascularization, hyperemia, infiltrates), keratometry, refractive changes, best corrected visual acuity, adverse event reporting. These are direct measurements/observations by licensed healthcare professionals at the clinical sites.
• Subjective patient reporting: Symptoms (discomfort, dryness, irritation), problems, and complaints.

The qualifications of the clinicians performing these assessments are not explicitly stated beyond them being affiliated with "four independent clinical sites."

4. Adjudication method for the test set:

Not applicable in the typical AI/ML context of image interpretation. The study is a clinical trial with observational and measurement endpoints. Data was collected by clinicians at study sites. There's no mention of an independent adjudication panel reviewing discrepancies in diagnoses or measurements in the way one would for an AI ground truth dataset.

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 a clinical trial for a physical medical device (contact lens), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is a physical medical device; there is no "algorithm only" performance.

7. The type of ground truth used:

As explained in point 3, the "ground truth" for this clinical study consists of:

• Objective Clinical Findings: Slit lamp observations, keratometry, refractive changes, visual acuity measurements.
• Subjective Patient Outcomes/Symptoms: Self-reported discomfort, dryness, irritation, problems, and complaints.
• Adverse Event Data: Documented adverse events.

This is fundamentally an outcomes data and expert clinical observation driven ground truth, rather than pathology or image-based consensus in an AI context.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning model development. The "training" for such a device would refer to its manufacturing process development and quality control, which is implied by the non-clinical performance testing.

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

Not applicable, as there is no machine learning training set in this submission. The non-clinical performance data (biocompatibility, lens/solution compatibility, manufacturing verification, extractable testing, contact angle, dry shelf life, lens stability testing) are established through standard laboratory and manufacturing evaluation processes.

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The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon 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 lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. 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. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose solution.

The provided text describes the regulatory clearance of "The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses." However, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and results.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies is not found in the provided document.

The document explicitly states: "Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated."

Instead, the submission relies on:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a legally marketed predicate device (BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution, K073184).
• Prior Clearances for Materials and Solutions: The gas permeable lens materials themselves (Acuity 100, Acuity 18, Acuity 85, Acuity 58) were previously cleared under separate 510(k)s. The multi-action solutions (BOSTON SIMPLUS and Menicon Unique pH) were also previously cleared. The current submission bundles these cleared components.
• Biocompatibility Testing: The materials have been tested and found to meet biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009).
• Solution Compatibility Studies: Previous 510(k)s for the individual RGP lens materials included solution compatibility studies demonstrating stable lens parameters when using the specified solutions.
• Microbiological Methods (Bioburden Studies): Bioburden studies (in accordance with ISO 11737-1) were conducted to monitor lens manufacturing. These were extended to evaluate wet storage and shipping for up to 30 days, finding "no CFUs were found at any test point during the 30-day period." This represents a specific "performance" aspect, but not in the context of clinical efficacy.
• Conformance to Standards: The quality system conforms to ISO Standard 13485 (2003).

In summary, the document argues that the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device and by referencing prior clearances and standard-based testing for its constituent materials and solutions, rather than presenting a new, dedicated study with specific performance acceptance criteria.

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The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, bresbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D for daily wear. 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.

The Acuity 85™ (oprifocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm
• with diameter of 7.0 to 21.0 mm
  The lens material (oprifocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material.

The provided document is a 510(k) Summary for the Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, which seeks to establish substantial equivalence to a predicate device. As such, it does not detail a study involving AI or human readers, or clinical trials with acceptance criteria for device performance in the way a new medical device would typically be evaluated for accuracy or diagnostic capability.

Instead, the "acceptance criteria" here refers to demonstrating that the new device's material properties and design are substantially equivalent to a legally marketed predicate device, as per FDA guidelines for daily wear contact lenses. The "study" mentioned is primarily non-clinical testing of the material properties.

Here's a breakdown based on the information provided, framed to address your specific questions where applicable, and noting where information is not relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the properties of the predicate device (Boston Equalens II) and the "performance" is the new device's (Acuity 85) equivalent properties. The goal is to show the new device meets or is comparable to the predicate's established properties.

Note: The differences in Refractive Index, Oxygen Permeability, Specific Gravity, Hardness, and Modulus between the new and predicate device are considered acceptable for demonstrating substantial equivalence for this type of device, falling within expected manufacturing variations or improvements that do not raise new questions of safety or effectiveness. For example, a higher oxygen permeability is generally considered an improvement for contact lenses.

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

This submission relies on non-clinical testing of the lens material. The sample size for material testing is not explicitly stated in the document, but it would typically involve multiple batches or samples of the material to ensure consistency. The provenance is internal to Acuity Polymers, Inc., where the oprifocon A lens material is manufactured. This is laboratory testing, not human subject data, so "retrospective" or "prospective" as applied to clinical studies is not relevant here.

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

This type of submission does not involve "experts" establishing ground truth in the context of diagnostic interpretation. The "ground truth" for material properties is established by standardized laboratory testing methods and measurements (e.g., ISO standards or internal validated methods). The document states the material testing meets ISO 10993-1 (2009) for biocompatibility and FDA Daily Wear Contact Lens Guidance Document standards. The staff performing these tests would be qualified laboratory technicians and scientists, but their number and specific qualifications are not detailed in this summary.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of medical images or patient outcomes. This is not relevant to the non-clinical material testing conducted for this 510(k) submission.

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 MRMC comparative effectiveness study was done, as this submission is for a contact lens material and design, not an AI-powered diagnostic device. The concept of "human readers improve with AI" is not applicable here.

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

No standalone algorithm performance study was done. This device is a physical contact lens, not a software algorithm.

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

The "ground truth" in this context refers to the objectively measured chemical, mechanical, and optical characteristics of the oprifocon A material and the finished lens, obtained through established laboratory testing protocols. These metrics are then compared to the established properties of the predicate device material and design, as well as relevant guidance documents (e.g., FDA Daily Wear Contact Lens Guidance Document, May 1994, and ISO 10993-1 (2009)).

8. The sample size for the training set

This submission did not involve a "training set" in the context of machine learning or deep learning algorithms. It concerns the substantial equivalence of a medical device (contact lens) based on material properties and design.

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

As there was no training set for an algorithm, this question is not applicable. The "ground truth" for the material characteristics was established through laboratory testing and conformity to existing standards and predicate device properties.

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The Acuity 58™ (en:flufocon B) 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 nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. 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.

The Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm
• with diameter of 7.0 to 21.0 mm
  The lens material (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.

The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.

Here's an attempt to extract the requested information based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.

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

The submission states that no clinical studies were deemed necessary (Page 5, Section 13) because "no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." Therefore, there isn't a specific "test set" in the context of a clinical trial with human subjects. The evaluation for substantial equivalence was based on non-clinical (bench) testing of the material and physical characteristics.

The data provenance for these non-clinical tests is not specified in terms of country of origin or retrospective/prospective nature, as they are laboratory tests performed by the manufacturer, Acuity Polymers, Inc., located in Rochester, NY, USA.

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

Not applicable. As no clinical studies were performed, there was no "ground truth" derived from expert assessment of patient outcomes or conditions. The "ground truth" for material properties would be established by standard laboratory testing methodologies.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a rigid gas permeable contact lens, not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

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

7. The Type of Ground Truth Used

For biocompatibility, the ground truth was established by adherence to regulatory standards and guidance documents: FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.

For the chemical, mechanical, and optical characteristics, the "ground truth" for comparison was the properties of the predicate device material (Boston EO Material, enflufocon B). The new device's properties were compared against these established values to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable.

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The Acuity 1800 (enflufocon 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 nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. 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.

The Acuity 18TM (enflufocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:

• in the power range of -20.00 to +20.00 diopters for sphere
• with base curves of 4.0 mm to 11.50 mm
• with base curve chord of 6.0 mm to 6.5 mm ●
• . with diameter of 7.0 to 21.0 mm
  The lens material enflufocon A) incorporates an ultraviolet light absorber and lenses are lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material. The material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston ES (AKA Boston 7-30) Material and Contact Lenses (enflufocon A) described K943177 and K053124.

The provided text describes a 510(k) premarket notification for the Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert review.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and adjudication methods for a study proving the device meets acceptance criteria is not explicitly available in this document in the typical sense of a diagnostic or AI-driven device.

Instead, the submission relies on the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a "Side-by-Side Comparison" of the new device (Acuity 18) and its predicate device (Boston ES (enflufocon A) RGP Lens). The "acceptance criteria" here are implicitly the characteristics and values of the predicate device, which the new device aims to match or be substantially equivalent to.

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

• No specific "test set" in the context of performance evaluation for an AI/diagnostic device is described. The comparison is based on the chemical, mechanical, and optical characteristics of the materials and designs.
• Data provenance: Not specified beyond the material properties, which would likely be derived from laboratory testing of the material itself.

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

• Not applicable. This submission does not involve clinical "ground truth" derived from expert consensus in the way a diagnostic device would. Substantial equivalence is established through material and design similarity, and non-clinical testing.

4. Adjudication method for the test set:

• Not applicable. No adjudication process is relevant for this type of submission.

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 a contact lens submission, not an AI-assisted diagnostic device.

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

• Not applicable. This is a contact lens submission, not an algorithm. However, non-clinical tests were performed on the lens material.

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

• Laboratory-measured physical and chemical properties are the "truths" used for comparison. The biocompatibility requirements were met according to FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.

8. The sample size for the training set:

• Not applicable. This is a contact lens submission, not a machine learning model.

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

• Not applicable. This is a contact lens submission, not a machine learning model.

Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria (i.e., substantial equivalence to the predicate) is a non-clinical study involving chemical, mechanical, and optical characterization of the Acuity 18 (enflufocon A) RGP contact lens material and design.

• Methodology: The enantiomer A lens material manufactured by Acuity Polymers, Inc. was tested.
• Criteria for "acceptance": The new lens material and its characteristics were compared "side-by-side" with the predicate device (Boston ES (enflufocon A) Daily Wear Contact Lens). The "acceptance" was that the Acuity 18 material and lenses meet the biocompatibility requirements and that its chemical, mechanical, and optical characteristics are equivalent or sufficiently similar to the predicate lenses to demonstrate substantial equivalence.
• Results: The properties of the new lens (refractive index, oxygen permeability, specific gravity, hardness, modulus, and water content) were measured and compared. The submission concludes that "it is concluded that the material and contact lens made thereof meet the requirements of a daily wear rigid contact lens and is substantially equivalent to Boston ESTM (aka Boston 7-30) (enflufocon A) Daily Wear Contact Lens."
• Clinical Studies: "Clinical studies for the Acuity 18™ (enflufocon A) material have been deemed as not necessary in support of clearance of this premarket notification as no new or additional questions of safety or effectiveness have been raised as a result of the preclinical testing and evaluation of the material." This implies that the non-clinical data was sufficient to establish substantial equivalence based on existing guidance.

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