(210 days)
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper eye insertion. The approximately 1mm flat packaging system is easily opened and reinforces the single-use factor. The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycero) Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifileon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive 'Reactive Blue # 19', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the eve covering the corner and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in a quantitative or pass/fail format beyond demonstrating substantial equivalence to the predicate device. Instead, it focuses on showing that the new packaging system does not negatively impact the established properties and safety of the contact lens. The "reported device performance" is essentially a comparison of the key physical and material properties of the lens in the new Flat Pack packaging versus the predicate device (Clear 1-Day - blister pkg.).
| Property/Characteristic | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (One Day Flat Pack) | Predicate Device Performance (Clear 1-Day - Blister Pkg.) |
|---|---|---|---|
| Lens diameter | Equivalent to predicate | 14.2 | 14.2 |
| Lens base curve | Equivalent to predicate | 8.6 | 8.6 |
| Lens power | Equivalent to or within established ranges of predicate | +5D ~ -10D | +10D ~ -20D |
| Refractive index | Equivalent to predicate | 1.4011 | 1.4011 |
| Light transmittance | Equivalent to or exceeding predicate | >95% | >95% |
| Surface character | Equivalent to predicate | Hydrophilic | Hydrophilic |
| Specific gravity | Equivalent to predicate | 1.086 | 1.086 |
| Oxygen permeability | Equivalent to predicate | 25.38 | 25.38 |
| Sterility | Sterile | Sterile | (Implied Sterile for Predicate) |
| Packaging material toxicity | Not toxic | Not toxic | (Implied Non-toxic for Predicate) |
| Packaging material irritation | Not irritating | Not irritating | (Implied Non-irritating for Predicate) |
| Lens orientation upon opening | Anterior side up | Anterior side up | Unknown (Predicate) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) involved a series of non-clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" (which in this context refers to the samples used in the non-clinical studies). It refers to "a series of in vivo preclinical toxicology and biocompatibility tests," "packaging integrity tests, stress tests, and simulations tests."
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical study data. It can be assumed it was conducted as part of the manufacturer's (Menicon Co., Ltd., Japan) R&D processes. The studies are described as retrospective in the sense that they are presented as completed tests rather than ongoing 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. Given that the studies are non-clinical (toxicology, biocompatibility, packaging integrity, physical/material properties), the "ground truth" would be established by the results of validated laboratory tests and analyses, not by expert consensus on observational data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human interpretation of medical images or patient outcomes requires a standardized method to resolve discrepancies between readers. This submission relies on objective laboratory measurements and tests for its non-clinical 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 was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might use AI assistance. The device in question is a contact lens and its packaging, which does not involve AI or human readers in a diagnostic context.
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 is also not applicable to a contact lens and its packaging.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical studies is based on:
- Objective laboratory measurements: for physical and material properties (e.g., refractive index, light transmission, water content, oxygen permeability, lens diameter, base curve, power, specific gravity).
- Validated toxicology and biocompatibility test results: to ensure the materials and extracts are not toxic or irritating.
- Packaging integrity, stress, and simulation test results: to confirm the robustness and integrity of the packaging system.
- Sterility testing: to confirm the lenses are sterile.
8. The Sample Size for the Training Set
Not Applicable. This submission details the substantial equivalence of a medical device (contact lens packaging) and does not involve AI/machine learning, therefore there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.