(78 days)
The CONTAFLEX GM3 58 (acofilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism off75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Evecare practitioners may prescribe the lenses for 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.
The CONTAFLEX GM3 58% Spherical Soft Contact Lenses are fabricated from acofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (acofficon A) is a terpolymer based on high purity Glycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The acofilcon A name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (acofilcon A) soft hydrophilic contact lens has a spherical back 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 and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight.
This 510(k) premarket notification for the CONTAFLEX GM3 58% (acofilcon A) Spherical Soft Contact Lens focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting de novo acceptance criteria. Therefore, the information provided relates primarily to the comparison with the predicate device and the safety and efficacy of the new device.
Here's an analysis of the provided text, addressing your points where applicable based on the available information:
Acceptance Criteria and Device Performance
There are no explicit "acceptance criteria" in the format of specific thresholds for performance metrics (e.g., minimum visual acuity improvement, maximum adverse event rate) that the device must meet independently. Instead, the study aims to show substantial equivalence to the predicate device, the "BENZ 55G" contact lens. This means the new device is considered acceptable if its safety and efficacy are no different than the legally marketed predicate device.
The "device performance" is reported through preclinical and clinical studies demonstrating this equivalence.
Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Metric/Characteristic | Acceptance Criteria (Demonstrate Equivalence to Predicate) | Reported Device Performance (CONTAFLEX GM3 58%) |
|---|---|---|---|
| Preclinical | Toxicology | Equivalent to predicate device (Benz 55G) in terms of in-vitro cytotoxicity, systemic toxicity, and acute ocular irritation. | In-Vitro Cytotoxicity: Meets ISO 10993-5 requirements (Agarose Overlay Method). |
| Systemic Toxicity: Meets requirements of systemic injection test and is considered non-toxic. | |||
| Acute Ocular Irritation: No ocular irritation produced. | |||
| Conclusion: Demonstrated safety equivalent to Benz 55G. | |||
| Shelf Life | Equivalent to predicate device (Benz 55G). | Referenced data granted to Contamac Ltd. for 510(k) 973597. Supports substantial equivalence to Benz 55G. | |
| Solution Compatibility | No significant changes to lens parameters after 30 cycles of cleaning and conditioning with recommended care regimen. | Lenses subjected to 30 cycles of cleaning and conditioning. No significant changes to base curve, back vertex power, total diameter, and overall physical appearance observed. | |
| Material Properties | Substantially equivalent material properties to predicate device. | Intended Use: Identical to predicate. | |
| Functionality: Identical to predicate. | |||
| Indications: Identical to predicate. | |||
| Production Method: Identical to predicate (Lathe-cut). | |||
| FDA Group #: Identical to predicate (Group # 2 >50% Water, Nonionic Polymers). | |||
| USAN name: Acofilcon A (differs from predicate: Hioxifilcon A). | |||
| Water Content: 58.0% (identical to predicate). | |||
| Oxygen Permeability: 25.5 x 10^-11 (cm^2/sec)(ml O2/ml x mm Hg @ 35°C) (predicate: 23.0 x 10^-11). | |||
| Specific Gravity: 1.103 (predicate: 1.045). | |||
| Clinical | Safety | Equivalent to predicate device (Benz 55G) in adverse events, slit lamp findings, symptoms/complaints, and keratometry changes. | Not explicitly reported with numerical performance metrics for CONTAFLEX vs. Benz 55G. The summary states: "The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G." Specific data like adverse event rates are not provided in this summary. |
| Efficacy | Equivalent to predicate device (Benz 55G) in refractive changes, lens visual acuity, lens VA line changes, comfort, vision, and average wearing time. | Not explicitly reported with numerical performance metrics for CONTAFLEX vs. Benz 55G. The summary states: "The sponsor concludes that CONTAFLEX GM3 58 Soft Contact Lens material is equivalent in safety and efficacy to the predicate device, the Benz 55G." Specific data like visual acuity measures are not provided in this summary. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 122 eyes (61 patients) were enrolled in the clinical study. 100 eyes (50 patients) completed the study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions "CONTAMAC Ltd." with an address in "Saffron Walden, Essex England CB11 4JX," which suggests the study or at least the sponsor is based in the UK. The study is described as a "clinical study carried out." It is a prospective study as patients were "entered into the study" and followed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: 5 investigators were involved in the clinical study.
- Qualifications of Experts: Their specific qualifications (e.g., "ophthalmologist with X years of experience") are not provided in the document. They are referred to as "investigators," implying medical professionals involved in clinical eye care.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any specific adjudication method for the clinical study data (e.g., for adverse events or efficacy assessments). It simply lists the safety and efficacy measures that were tracked.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a contact lens and does not involve AI assistance or human readers interpreting medical images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm. The "standalone" performance here would refer to the lens's physical and optical properties, and its performance in daily wear, which was assessed in the preclinical and clinical studies.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the preclinical studies, laboratory testing and standardized methods (e.g., ISO 10993-5, revised Fatt method) were used to determine material properties and toxicity.
- For the clinical study, the "safety and efficacy measures" (Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints, Keratometry Changes, Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time) are essentially clinical outcomes data and clinical assessments by the investigators. These assessments, presumably based on established ophthalmological practices, serve as the "ground truth" for the lens's performance in vivo.
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The sample size for the training set:
- Not applicable in the context of this device. This is a medical device (contact lens), not an AI algorithm requiring a "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design, based on established material science and ophthalmological principles.
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How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.
§ 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.