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One Day Flat Pack (hioxifilcon A) Spherical Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.00 diopter (D) or less of astigmatism that does not interfere with visual acuity.

One Day Flat Pack (hioxifilcon A) Multifocal Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.00 D or less of astigmatism that does not interfere with visual acuity.

One Day Flat Pack (hioxifilcon A) Spherical and Multifocal Lenses are intended to be worn once and then discarded at the end of each wearing period on a daily basis. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are daily wear disposable soft contact lenses available as spherical and multifocal lens designs. 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 insertion. The non-ionic lens material. (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 43 % hioxifilcon A and 57 % 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.

This document describes a 510(k) premarket notification for a new soft contact lens, the Menicon One Day Flat Pack (hioxifilcon A) Multifocal Daily Disposable Soft Contact Lens. The information largely focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving performance against explicit acceptance criteria for the new multifocal design.

Based on the provided text, the device meets acceptance criteria primarily by demonstrating substantial equivalence to predicate devices based on material, manufacturing process, and performance characteristics.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for the new multifocal lens beyond what is inherent in demonstrating substantial equivalence. Instead, it relies on a comparison of characteristics to predicate devices. The implicit acceptance criteria are that the new device should perform as safely and effectively as the predicate devices.

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

• Test set for the new multifocal lens: No specific test set or clinical study was conducted for the new multifocal lens design to assess its direct performance against new acceptance criteria. The document explicitly states: "Clinical studies were unnecessary for this application."
• Data Provenance: The device relies on existing data from predicate devices and the known properties of the hioxifilcon A material. This would be retrospective in the sense of leveraging historical data. The origin of this historical data (e.g., country of origin) is not specified in this document.

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

Not applicable. No new clinical trials or specific test sets requiring expert ground truth establishment for the new device's performance are described. The evaluation relies on the known safety and effectiveness of the material and previous designs.

4. Adjudication Method for the Test Set

Not applicable. As no specific test set or clinical study was performed for the new multifocal device, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study was not conducted as no clinical studies were deemed necessary for this application.

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

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

7. The Type of Ground Truth Used

The "ground truth" implicitly used for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices and the hioxifilcon A material, which has been reviewed in multiple prior 510(k) applications (1998-2016). This relies on prior clinical data (from the predicates) and material characterization data.

8. The Sample Size for the Training Set

Not applicable. This is 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 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.).

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.

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