(307 days)
The ONSIJ-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray, or blue-violet tinted varieties and blue tint with UV-blocker. Each is a shell of the following dimensions.
Spherical Contact Lens:
Horizontal Lens Size: 6.5 mm to 11.50mm
Base Curve: 6.50mm to 9.50mm
Distance Powers: +12.00D to -20.00D
Center Thickness:
for low minus 0.05mm to 0.30mm
for plus 0.10mm to 0.70mm
Aspheric Lens
Eccentricity 0 to 1.5
Peripheral Curves 0.1 to 1.0mm
Toric Lens
Axis 1 to 180 degrees in 1 degree steps
Cylinder power 0.50 to 4.00D
Translating Bifocal Contact Lens:
Horizontal Lens Size: 8.00mm to 10.50mm
Base Curve: 6.50mm to 8.50mm
Distance Power: +12.00D to -20.00D
Add Power 1.00 to 4.00D
The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
Here's a summary of the acceptance criteria and study findings for the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list "acceptance criteria" for the clinical study in a quantitative manner (e.g., minimum visual acuity improvement, maximum complication rate thresholds). Instead, it describes general safety and efficacy findings. The tables below summarize the product's physical properties compared to a predicate device and the clinical study findings:
Comparison to Predicate Device (Oxycon (wilofocon A))
| Characteristic | Predicate Device (Oxycon) | ONSI™-56 (onsifocon A) |
|---|---|---|
| Water Content | 95% T | |
| Light Transmittance (Tinted) | 93% (green), 87% (gray) | >70% T (blue, green, gray, blue-violet, blue UV) |
| Light Transmittance (Blue UV) | (not specified) | >70% T (400-780nm), 0% T (200-380nm) |
Clinical Study Findings (Safety and Efficacy)
| Finding / Metric | Initial (Baseline) | Final (3 Months) | General Observation / Interpretation |
|---|---|---|---|
| No Findings (Slit Lamp) | 90.5% (eyes) | Not directly comparable (table shows "वेरे '8") - Likely a typo, assuming "reported as high" based on conclusion | High percentage of eyes with no adverse slit lamp findings. |
| Edema | 0.0% | 0.0% | No incidence of edema related to the lenses. |
| Neovascularization | 1.4% | 0.0% | Slight decrease in pre-existing neovascularization. Good safety. |
| Staining | 5.4% | 3.2% | Decrease in corneal staining incidence over time. |
| Hyperemia | 1.4% | 0.0% | Elimination of hyperemia during the study. |
| Palpebral Abnorm. | 1.4% | 0.0% | Elimination of palpebral abnormalities during the study. |
| Adverse Events | N/A | 0 (zero) | No unanticipated adverse device effects observed during the study. |
| No Symptoms (Scheduled visits) | N/A | 75.7% (eyes) | A high percentage of eyes reported no symptoms. |
| Lens Awareness | N/A | 5.7% | Low incidence of lens awareness. |
| Reading Problems | N/A | 5.5% | Low incidence of reading problems. |
| Need for Cleaning | N/A | 5.2% | Low incidence of need for cleaning. |
| Dryness | N/A | 4.6% | Low incidence of dryness. |
| Discontinuations | N/A | 1 subject (3%) | Very low discontinuation rate, indicating good patient tolerance. |
| Visual Acuity | Baseline | Final | All eyes had a final visual acuity within 1 line of the initial best corrected acuity. (Efficacy met) |
| Wear Time | Baseline | 3 Months | Remained essentially unchanged, indicating continuing comfort and cleanliness. (Efficacy met) |
| Lens Replacements | N/A | 10 (6 for VA) | Low number of replacements, mostly for VA in the first month, supporting efficacy for myopia. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 37 subjects.
- Data Provenance: The 510(k) summary does not explicitly state the country of origin. It is a clinical trial, implying prospective data collection.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not explicitly stated, but the study involved "Three (3) investigators." These investigators would have been responsible for clinical assessments (e.g., slit lamp findings, visual acuity measurements), and thus contributed to establishing the "ground truth" through their clinical observations and measurements.
- Qualifications of Experts: Not explicitly stated, but for a contact lens clinical trial, these investigators would typically be ophthalmologists, optometrists, or other eye care professionals experienced in contact lens fitting and evaluation, often with significant clinical experience.
4. Adjudication Method (Test Set)
- The 510(k) summary does not describe any formal adjudication method (e.g., 2+1, 3+1). The findings are reported as collected by the investigators.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The clinical study compared the ONSI™-56 device to "historical controls wearing wilofocon A," rather than a concurrent study with human readers comparing AI-assisted vs. non-AI-assisted performance. This is a direct device performance study.
- Effect Size: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance
- No, a standalone (algorithm only) performance study was not done. This device is a physical contact lens, not a software algorithm. Therefore, "algorithm only" performance is not applicable. The study evaluated the lens's performance in human subjects.
7. Type of Ground Truth Used
- The ground truth for the clinical study was established through expert clinical assessment and objective measurements by the investigators. This included:
- Slit lamp findings (presence/absence and severity of conditions like edema, neovascularization, staining, hyperemia, palpebral abnormalities).
- Visual acuity measurements.
- Patient-reported symptoms, problems, and complaints.
- Wear time.
- Lens replacements.
8. Sample Size for the Training Set
- Not applicable. This study is for a physical medical device (contact lens) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device submission.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.