Search Results

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

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

Device Description

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.

AI/ML Overview

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.

Test/Property	Acceptance Criteria (Implied by equivalence/safety standards)	Reported Device Performance (Acuity 181™ (tisilfocon A))
Cytotoxicity	Not cytotoxic (per ISO 10993-5)	Not cytotoxic
Acute Systemic Toxicity	Not acutely systemically toxic (per ISO 10993-11)	Not acutely systemically toxic
Acute Ocular Irritation	Does not solicit acute ocular irritation (per ISO 10993-23)	Does not solicit an acute ocular irritation response
Physicochemical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Mechanical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Optical Properties (general)	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices
Bioburden Level	<100 CFU/lens (initially and after 30 days storage)	Below acceptance criteria
Physical Parameters Stability	Stable after 30 days storage	Stable after 30 days storage
Care Solutions Compatibility	Physically compatible with currently marketed solutions	Physically compatible with currently marketed solutions
Specific Physical Properties
Refractive Index	(Not explicitly stated as criteria, but measured)	1.434
Specific Gravity	(Not explicitly stated as criteria, but measured)	1.22
Water Content	(Not explicitly stated as criteria, but measured)	< 1.0%
Oxygen Permeability (Dk)	(Not explicitly stated as criteria, but measured)	181 x10^-11 (cm³ O₂ x cm/ (cm² x sec x mmHg)@ 35°C)
Hardness, Shore D	(Not explicitly stated as criteria, but measured)	81 [±2 D]
Flex Modulus, MPa	(Not explicitly stated as criteria, but measured)	1488
Maximum, Flexural Strength, MPa	(Not explicitly stated as criteria, but measured)	55.6
Toughness, J/m³	(Not explicitly stated as criteria, but measured)	2.23
Light Transmission (380-780nm)	(Not explicitly stated as criteria, but measured)	87.0% (Uncoated), 87.4% (Coated)
UVA Transmission (315-380nm)	(Not explicitly stated as criteria, but measured)	15.1% (Uncoated), 17.1% (Coated)
UVB Transmission (280-315nm)	(Not explicitly stated as criteria, but measured)	0.033% (Uncoated), 0.034% (Coated)
Average Sessile Drop Wetting Angle	(Not explicitly stated as criteria, but measured)	95.4 (Uncoated), 48.8 (Coated), 19.2 (Plasma Treated)

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.

Ask a Question

Ask a specific question about this device

Page 1 of 1