(108 days)
The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Si-Hy Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
The Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are about 2.2% (
The provided document is a 510(k) premarket notification for a soft contact lens device. It describes the device, its intended use, and comparative information with predicate devices, including nonclinical and clinical study summaries.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in the format of a table with specific thresholds for device performance. Instead, it states that "the physical, optical and chemical properties of the lens are within established specifications for the lenses" and that "the clinical study provided data to establish substantial equivalence with the predicate, control lens." The reported performance is primarily compared to the predicate device to demonstrate substantial equivalence, rather than meeting predefined numerical acceptance criteria for specific metrics.
However, we can infer some performance metrics from the device characteristics and the clinical study summary.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Study Purpose) | Reported Device Performance |
|---|---|---|
| Physical/Optical/Chemical Properties | Within established specifications and comparable to predicate devices. | Si-Hy (olifilcon B) lens characteristics are detailed (e.g., Water Content: 47%, Oxygen Permeability (DK): 120, Refractive Index: 1.410, Light Transmittance: 94%). The document states that these properties "are within established specifications for the lenses" and are "as safe, as effective and performs as well as the predicate device" in comparison. |
| Material Composition | Substantially equivalent to predicate lenses (Silicone Hydrogel). | Olifilcon B (53% olifilcon B and 47% water) - Silicone Hydrogel. Compared to olifilcon A and narafilcon A. |
| Biocompatibility/Toxicity | Non-toxic and acceptable in ocular environment. | "Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment." |
| Visual Acuity (VA) | Mean VA similar to predicate and correctable to 0.1 (log MAR) or better. | "The mean VA for both lenses [device and predicate] was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better." |
| Slit Lamp Findings | No significant findings (Grade 3 or Grade 4) and no significant differences between groups. | "No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups." |
| Adverse Reactions | Not explicitly quantified as an acceptance criterion, but implies a safe profile comparable to the predicate. | Measured, but specific rates are not provided in this summary. The overall conclusion is that the device is "as safe" as the predicate. |
| Symptoms, Problems, Complaints | Not explicitly quantified, but taken into account for safety and effectiveness. | Measured, but specific details are not provided in this summary. |
| Lens Wearing Time | Not explicitly quantified, but taken into account for safety and effectiveness. | Measured, but specific details are not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "At least 50 evaluable subjects were participated."
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical studies conducted for regulatory submission for a new device are almost always prospective. The manufacturer is based in Taiwan, so the study was likely conducted there or in a region convenient for the manufacturer.
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. The clinical study describes "parameters measured," implying a quantitative assessment by clinical investigators, but it does not specify the number or qualifications of experts involved in establishing a "ground truth" in the way one might for diagnostic accuracy studies (e.g., radiologist consensus). For contact lens clinical trials, "ground truth" is typically established by measurements and observations made by trained optometrists or ophthalmologists during eye examinations.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods (like 2+1 or 3+1 consensus) are common in studies where expert interpretation is subjective and needs consensus, such as pathology or imaging reads. For contact lens clinical evaluations, direct measurements and clinical findings by investigators typically serve as the primary data, and formal adjudication by multiple independent experts might not be a standard practice unless there are highly subjective or ambiguous outcomes.
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 involving AI assistance was not done. This device is a contact lens, not an AI-powered diagnostic tool. The clinical study performed was a direct comparison of the new contact lens ("Si-Hy (olifilcon B)") against a legally marketed predicate contact lens ("Vistakon (narafilcon A) Contact Lens").
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. As mentioned, this is a physical medical device (contact lens), not an algorithm.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was established through:
- Clinical Measurements and Observations: This includes objective measurements (e.g., visual acuities) and subjective observations/assessments by investigators (e.g., slit lamp findings, adverse reactions, symptoms, complaints).
- Comparison to a Predicate Device: The study's primary goal was to demonstrate substantial equivalence to a legally marketed control contact lens for safety and effectiveness. The "ground truth" for what constitutes an acceptable contact lens performance is implicitly tied to that of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The concept of a "training set" typically applies to machine learning models. For a physical medical device like a contact lens, there isn't a "training set" in the computational sense. The device underwent manufacturing and quality control processes, and then was tested in nonclinical and clinical studies.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this device in the context of AI/machine learning. For the manufacturing and design of the contact lens, the "ground truth" for its properties and performance would have been established through extensive material science research, engineering specifications, and validated in vitro testing to meet performance standards.
§ 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.