(162 days)
The Hydron ActiToric(ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
The ActiToric soft contact lens is a hemispherical shell manufactured of polymerised material of HEMA and other monomeric incredients crosslinked with EGDMA and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eve. This lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (near-sightedness), hyperopia (farsightedness) and astigmatism (multiple foci). The lens provides corrective power which is to correspond to the refractive power of the eve to which it is being treated. The lens has an aspheric base curve that is formed in the free surface during the spinning process. Secondary and tertiary curves as well as bevelled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mould to provide consistent optics. Onentation marks are moulded into the front surface as part of the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort. Axis stabilisation is action of the action of the lids on the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hydron ActiToric contact lens:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with novel acceptance criteria and extensive clinical trials. Therefore, many of the requested elements for a study proving device meeting acceptance criteria (like sample size for test sets, expert qualifications, effect size with AI assistance, MRMC studies, etc.) are not applicable (N/A) in this context, as the primary method of demonstrating safety and effectiveness is through comparison to the predicate device.
The "acceptance criteria" here are largely implicit in the comparison to the predicate device, meaning the new device must perform comparably to the predicate across various properties.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (ActiToric) |
|---|---|
| Material: USAN | ocufilcon A |
| Material: Group | 3 (ionic) |
| Material: Monomers | 2-HEMA, MA, EGDMA |
| Manufacturing: Process | Spun-cast |
| Manufacturing: Diameter (mm) | 14.5 |
| Manufacturing: Center Thickness (mm) | 0.15 |
| Manufacturing: Base curve (mm) | 8.95 (equivalent to 8.90 of predicate) |
| Physical Properties: Refractive Index | 1.43 ± 0.001 |
| Physical Properties: Water content % | 45 ± 0.00 |
| Physical Properties: Oxygen Permeability | $11.9 \pm 1.85 \times 10^{-11}$ (cm² x ml O₂)/(sec x ml x mmHg) |
| Physical Properties: Light Transmittance % | 98 ± 0.4 |
| Mechanical Properties: Modulus (N/mm²) | 0.32 ± 0.045 |
| Mechanical Properties: Tensile strength (N/mm²) | 0.32 ± 0.116 |
| Mechanical Properties: Elongation at break (%) | 208 ± 94 |
| Toxicology: Within normal limits | All necessary toxicology studies were undertaken and results were within normal limits. |
| Microbiology: Relevant test procedures | Relevant test procedures have been undertaken and are included. |
| Compatibility: (No specific requirement if similar material and approved care products) | Compatibility testing not required as recommended lens care products have been approved for the same lens material (ocufilcon A). |
| Lens Stability: (Determined lifespan without adverse effect) | Indicates storage for up to 8 years with no adverse effect. |
| Clinical Safety: (Comparability to predicate) | Not required due to same USAN and manufacturing method as predicate device. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for a clinical trial. The comparison is based on product specifications and laboratory testing of the ActiToric lens, which are then compared to the specifications of the predicate device.
- Data Provenance: The manufacturing process, material, and testing would originate from Hydron Limited, United Kingdom. The document implies these are measurements from their own product and comparisons to established data for the predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in this context is established by objective laboratory measurements of physical, chemical, and mechanical properties, not expert consensus on interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective assessments or when discrepancies arise in expert interpretations, which is not the primary method of demonstration here.
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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:
- N/A. This device is a contact lens and does not involve "readers" or "AI assistance."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Measurements / Objective Product Specifications. The ground truth for equivalency is derived from direct measurements of the lens's physical, optical, and mechanical properties, toxicology results, microbiology tests, and stability data.
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The sample size for the training set:
- N/A. No "training set" in the machine learning sense is relevant for this type of device submission. The device is characterized through laboratory measurements of its properties.
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How the ground truth for the training set was established:
- N/A. No training set for an algorithm is involved. The ground truth for the device's properties is established through standard manufacturing quality control and laboratory testing methodologies.
Summary of the Study:
The "study" presented here is a substantial equivalence demonstration for a 510(k) premarket notification. It primarily relies on a side-by-side comparison of the physical, optical, and mechanical properties, material composition, manufacturing processes, and established safety tests (toxicology, microbiology, lens stability) of the new device (ActiToric) against a legally marketed predicate device (Specialty UltraVision Specialty T).
The acceptance criteria are effectively met if the new device exhibits equivalent properties and performance characteristics to the predicate device, as detailed in Table 2.1. Clinical safety data was not required because the device used the same USAN (ocufilcon A) and method of manufacture as the predicate, which implies that their clinical safety profiles are expected to be similar.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.