(50 days)
The TYRO™-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyoptic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
The TYRO ™ -97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear are available in spherical, aspherical and toric designs in the clear untinted or blue, green and gray tinted varieties with and without 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 -1.5 to 1.5 Oblate to prolate
Peripheral Curves 0.1 to 1.0mm
Toric Lens
Axis 1 to 180 degrees in 1 degree step
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 1.00D to 4.00D
The lens material, hofocon A, is a polymer of trifluoroethyl methacrylate and silicone methacrylate, with no methyl methacrylate. 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-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 breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
This device is a contact lens, and as such, the "acceptance criteria" are related to the physical properties of the lens material and its safety and efficacy for daily wear. The "study" refers to the clinical trials conducted to demonstrate this.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (TYRO™-97) |
|---|---|
| Water Content: -11 Fatt Units (1990) | 97.98 ANSI units (Note: Different units, but likely a higher value indicating better oxygen permeability, which is generally desired for contact lenses) |
| Refractive Index: 1.44 | 1.440 |
| Hardness: D/89 (Shore) | D/82 (Shore) |
| Specific Gravity: 1.25 | 1.087 |
| Residual Monomers: Implied acceptable levels | No leachable monomers detected |
| Wetting Angle: 23.0±2° (CLMA method) | 23.3° (sessile drop technique) |
| Mechanical (flexural) Strength: Not explicitly stated for predicate in comparison table, but a property evaluated. | 3952psi |
| Light Transmittance (clear): 93% | >95% T |
| Light Transmittance (blue): 87% | >70% T |
| Light Transmittance (green): Not explicitly stated for predicate in comparison table. | >70% T |
| Light Transmittance (Blue-UV): Not explicitly stated for predicate. | >70% T (400-780nm), 0% T (200-380nm) |
| Non-toxic as per cytotoxicity, systemic toxicity, and acute ocular irritation tests. | Non-toxic in all tests (Agar Overlay Cytotoxicity, Systemic toxicity, Acute Ocular irritation). |
| Safety of daily wear for correction of visual acuity in not-aphakic persons with non-diseased eyes (myopic, hyperopic, presbyopic, and corneal astigmatism). | Clinically demonstrated safety for daily wear for the stated indications. |
Study Information
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. The document mentions "clinical trials" but does not give a specific number of participants or eyes.
- Data Provenance: Not explicitly stated. The document refers to "clinical trials" and implies that the data was collected in accordance with a "Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses (May 1994)," which would suggest a prospective study methodology. No country of origin is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of contact lens clinical trials for safety and efficacy. "Ground truth" for contact lenses typically refers to the objective measurements of the lens properties and the clinical outcomes (e.g., visual acuity, adverse events, comfort) observed in subjects by eye care professionals. The clinical study would have involved ophthalmologists or optometrists assessing these outcomes, but they are not establishing a "ground truth" in the same way experts would for image interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in studies involving expert interpretation of medical images. Clinical trials for contact lenses would involve clinical examinations and assessments by the study investigators.
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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:
- Not applicable. This is a contact lens, not an AI-powered diagnostic device.
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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. Physical and chemical properties are tested standalone, but clinical performance always involves human subjects.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the material properties, the "ground truth" would be established by standardized laboratory testing methods (e.g., specific gravity, hardness, light transmittance).
- For clinical efficacy and safety, the "ground truth" is based on outcomes data from the clinical trial, including measurements of visual acuity, adverse events, comfort, and signs of ocular health observed by qualified eye care professionals during the study.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. (See #7)
§ 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.