(52 days)
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface.
The provided text describes the 510(k) summary for the SpecialEyes 59 and SpecialEyes 49 Sphere and Toric soft contact lenses. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be directly extracted or inferred from this document.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., visual acuity improvement percentage, lens fit success rate) and subsequent reported device performance against those criteria. Instead, it relies on demonstrating adherence to manufacturing specifications and substantial equivalence to existing predicate devices.
| Acceptance Criteria (Inferred from Preclinical Testing) | Reported Device Performance |
|---|---|
| Product conformance to dimensional specifications | All product conformed to specification requirements. |
| Adherence to specific manufacturing materials | Hioxifilcon A and Hioxifilcon B materials (non-ionic copolymers of 2-HEMA and Glycerol Methacrylate (GMA)). |
| Water content by weight | 49% for hioxifilcon B and 59% for hioxifilcon A (when immersed in normal saline). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Dimensional and verification testing has been completed" and "All product conformed to specification requirements." However, it does not specify the sample size used for this testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). This testing appears to be internal manufacturing quality control rather than a clinical trial.
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 information is not applicable or available in this submission. The "ground truth" here is adherence to manufacturing specifications, not a clinical assessment requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or available in this submission. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of this 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
An MRMC comparative effectiveness study was not done. This submission is for contact lenses, which are not typically evaluated using MRMC studies, especially not in the context of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a soft contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is based on manufacturing specifications and physical properties of the contact lenses (e.g., dimensions, material composition, water content). The document also extensively references substantial equivalence to predicate devices, implying that the performance and safety profiles of those previously cleared devices serve as an established baseline.
8. The sample size for the training set
This information is not applicable. The device is a physical product (contact lens), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. See point 8.
Summary of the Study:
The submission for SpecialEyes 59 and SpecialEyes 49 soft contact lenses is a 510(k) premarket notification. The "study" described is primarily preclinical testing focusing on dimensional and verification aspects to ensure the manufactured devices conform to specified requirements. The core argument for device acceptance is substantial equivalence to several predicate devices already cleared by the FDA (K983773, K964528, K042242, K981252, K953199, K964902).
The claim of substantial equivalence is based on the proposed device having an equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications as compared to the predicate devices. Toxicological, microbiological, lens compatibility, preservation uptake, and shelf life studies were completed on the predicate device (K964528) and directly leveraged for this submission, indicating that new comprehensive studies for these aspects were not performed on the SpecialEyes lenses themselves, given their identical nature to the predicate.
§ 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.