(63 days)
indicated for use as a daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes.
Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version.
The provided text describes the substantial equivalence of tinted and untinted Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lenses. The "acceptance criteria" here refers to maintaining the physical and optical properties of the contact lens within specified tolerances after tinting, demonstrating that the tinted version is as safe and effective as the untinted predicate device.
Here's an analysis of the provided information, formatted as requested:
1. Table of Acceptance Criteria and the Reported Device Performance
| Property | Acceptance Criteria (Tolerance/Standard) | Reported Performance (Tinted vs. Untinted) |
|---|---|---|
| Light Transmittance (Visitint) | No adverse effect on light transmissibility | Max transmittance: 97.2% (tinted) vs. 96.9% (untinted). Min transmittance: 82.59% (tinted) vs. 82.5% (untinted). |
| Light Transmittance (Max Tint) | Not explicitly stated as "acceptance criteria", but notes "greatly reduced at the longer and shorter wavelengths" and "maximum intensity of dye should be avoided." | Max transmittance: 91.2% (tinted). Min transmittance: 1.75% (tinted). |
| Refractive Index | Within reproducibility of measurement | Untinted: 1.4041. Tinted (maximum intensity): 1.4052. (Difference is 0.0011, reported as "within the reproducibility of the measurement"). |
| Water Content | ±1.0%w | Untinted: 52.93%w. Tinted: 53.11%w. (Increase of 0.34%, "well within the tolerance specifications"). |
| Linear Swell | Within tolerance specification (not explicitly quantified but implied to accommodate ~1.0% increase) | Untinted: 34.41. Tinted: 34.8. (Increase of about 1.0%, "well within the tolerance specification"). |
| Optical Properties (Overall Rating) | Excellent (except for identified specific lens issues) | Untinted: excellent (except lens #1 rated fair). Tinted: still rated excellent (except lens #1 rated fair). |
| Oxygen Transmissibility (DK/L) | No adverse effect / maintain similar values | Untinted: 7.6 ± 0.69. Tinted: 7.7 ± 0.74. |
| Oxygen Permeability (DK x 10⁻¹) | No adverse effect / maintain similar values | Untinted: 16.7 ± 2.19. Tinted: 16.8 ± 2.00. |
| Refractive Power | ±0.25 diopters (for ±10.00D); ±0.50 diopters (for >±10.00D) | Same as untinted. |
| Cylinder Power | ±0.25 diopters (for <2.00D); ±0.50 diopters (for >2.00D) | Same as untinted. |
| Cylinder Axis | ±5° | Same as untinted. |
| Base Curve | ±0.02mm | Same as untinted. |
| Diameter | ±0.15mm | Same as untinted. |
| Center Thickness | ±0.10mm | Same as untinted. |
| Physical Appearance (Color) | Very light turquoise (visitint) to darker turquoise | Met by product (tinted version). |
| Physical Appearance (Surface Quality) | No defects (scratches, chips, gouges) | Implied to be maintained ("excellent optical properties"). |
| Physical Appearance (Edges) | Free of defects | Implied to be maintained ("excellent optical properties"). |
| Optical Quality | No bodies under 10X magnification | Implied to be maintained ("excellent optical properties"). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size:
- Light Transmittance: Not explicitly stated, refers to "the minimum tint, or Visitint" and "Ocu-Flex-53 Lenses, tinted with the maximum intensity of dye."
- Refractive Index: Not explicitly stated, refers to "Ocu-Flex-53 Tinted Lenses (maximum intensity)" and "the untinted version of the same lens."
- Water Content: Ten (10) Ocu-Flex-53 Contact Lenses, Lot IR.
- Linear Swell: Ten (10) Ocu-Flex-53 Contact Lenses, Lot IR.
- Optical Properties (Overall Rating): Ten (10) untinted Ocu-Flex-53 lenses, Lot IR (same lenses after tinting).
- Oxygen Permeability/Transmissibility: Not explicitly stated, but refers to "the untinted lenses first was established. The lenses were then tinted and the permeabilities determined again on the same lenses."
- Data Provenance: The studies cited (STS Final Report, Study No. GLP-1995-605, of 09/11/95 and STS Final Report, Study No. GLP-1995-324 of 06/08/95) indicate these were internal company reports or studies performed by a testing laboratory (STS). The document is a K960291 submission to the FDA in the US. This suggests the data is likely prospective for the purpose of demonstrating substantial equivalence, and originates from internal testing primarily in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document does not involve human expert consensus for "ground truth" in the way a diagnostic AI study would. The acceptance criteria for the contact lens properties are based on physical and optical measurements against established manufacturing specifications and performance standards for medical devices of this type. There are no "experts" establishing ground truth in the sense of medical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations. The data is based on direct physical and optical measurements.
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
Not applicable. This is not an AI-based device, nor a study on human reader performance.
6. 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 "performance" is the physical and optical characteristics of the lens itself.
7. The Type of Ground Truth Used
The "ground truth" is defined by established physical and optical specifications and regulatory standards for contact lenses. The untinted Ocu-Flex-53 lens, which has prior FDA approval (PMA P820051), serves as the predicate device against which the tinted version must maintain substantial equivalence in its performance characteristics. Thus, the performance of the untinted lens within its approved specifications implicitly defines the "ground truth" or acceptable range for the tinted version.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/machine learning study.
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MAR 2 5 1996
Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, CA 94564 (510) 724-0384
SUMMARY of SAFETY AND EFFECTIVENESS
The name of the device, Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is classified as a Class II device. It has been F.D.A. approved, see PMA P820051 an Amendments since March 7, 1984, and is indicated for use as a daily wear soft contact lens. Lens configurations include spherical, toric and aspherical for non-diseased eyes. The tinted version of the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens is substantially equivalent to that of the untinted version as demonstrated in this submission. Manufacturing and sterilization procedures have not been changed from the F.D.A. approved procedures already in place. The dye used in the tinted version. Reactive Blue 21, is F.D.A. approved for use with poly(hydroxyethyl methacrylate) copolymers. No technological differences between the predicate device, Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens (untinted) and the Ocu-Flex-53 (ocufilcon B) Soft (Hydrophilic) Contact Lens (tinted) were found. For example, all of the physical properties, such as refractive index, light transmission, water content, linear swell and oxygen permeability, are virtually identical for the untinted lens and the tinted version of the predicate device. As shown in the supporting attachments, there are no adverse effects on the physical or optical parameters of the Ocu-Flex-53 tinted lenses.
Overall, all of the performance data verify the substantial equivalence for the tinted and untinted version of the same lens.
Signed Charles McDermott
Charles R. Vermette, President
Date 2/16/76
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Physical and Optical Properties of Tinted Versus Untinted Lenses
Introduction
All physical, chemical and optical properties were determined at 25℃ ± 1ºC except for oxygen transmissibility, which was measured at 35ºC + 2ºC.
Color and Light Transmission
Color Index Code: Reactive Blue 21. Light transmittance was measured at various wavelengths in the visible region, i.e., from 350 to 700 mm. The minimum tint, or Visitint, showed a maximum transmittance of 97, 2% and a minimum transmission of 82.59%. The same untinted lens showed a maximum transmission of 96.9% and a minimum transmission of 82.5%. Ocu-Flex-53 Lenses, tinted with the maximum intensity of dye showed a maximum transmission of light of 91.2% and a minimum ot 1:75% See STS Final Report, Study No. GLP-1995-605, of 09/11/95 and STS Final Report, Study No. GLP-1995-324 of 06/08/95 for original data (Attachment 2).
These data suggest that low concentrations of Reactive Blue Dye 21, such as would be used in cosmetic tints, would have no adverse effect on light transmissibility but that the maximum intensity of dye should be avoided.
Refractive Index
The refractive index of Ocu-Flex-53 Tinted Lenses (maximum intensity) is 1.4052 with a standard deviation 0.0009. The untinted version of the same lens has a refractive index of 1.4041, which is within the reproducibility of the measurement. Consequently tinting of Ocu-Flex-53 Contact Lenses with Reactive Blue 21, even at the maximum intensity does not affect the refractive index, see Attachment 3.
Water Content
The average water content of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 52.93%w. After tinting with maximum concentration of dye the average water content of the same 10 lenses is 53.11%w. The increase of 0.34% is well within the tolerance specifications of + 1.0%w. See Attachment 4.
Linear Swell
The average linear swell of ten (10) Ocu-Flex-53 Contact Lenses, Lot IR, is 34.41. After tinting the same 10 lenses showed a linear swell of 34.8 or an increase of about 1.0%, which is well within the tolerance specification. See Attachment 4.
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Optical Properties
The optical properties of ten (10) untinted Ocu-Flex-53 lenses, lot IR, are considered to be excellent, except for Lens no. 1 which was rated only fair. After tinting the same ten (10) lenses were still rated excellent, except for lens #1. which was rated only fair before tinting. See Attachment 4. These results indicate the tinting with Reactive Dye 21 does not affect the excellent optical parameters of Ocu-Flex-53 Contact Lenses listed in Figure 3.
Oxygen Permeability at 35°C
Oxygen Permeabilities at 35°C were calculated from their respective transmissibilities that, in turn, were measured with the aid of a Rehder Development Polarographic Cell and a Schema Versatae Polarographic Amplifier. To minimize the number of uncontrolled variables the permeability of the untinted lenses first was established. The lenses were then tinted and the permeabilities determined again on the same lenses.
Attachment 5 illustrates quite clearly that tinting does not detract from the excellent transmissibility of Ocu-Flex-53 Lenses. For example the untinted Ocu-Flex-53 Lens showed an average transmissibility (DK/L), at 35°C, of 7.6, with a standard deviation of 0.69. After tinting the average transmissibility (DK/L), at 35°C, was 7.7 with a standard deviation of 0.74. Similarly the average permeability of the untinted lenses at 35°C was calculated to be 16.7, with a standard deviation of 2.19 while the same lenses after tinting had an average permeability (DK x 10-1) at 35°C, of 16.8 with a standard deviation of 2.00.
Optical Parameters of Ocu-Flex-53 Tinted Lenses Figure 3
The optical parameters of Ocu-Flex-53 Tinted Lenses and their tolerances are the same as those specified for Ocu-Flex-53 untinted lenses, namely:
Refractive Power: +10.00 diopters to -10.00 diopters with a tolerance of ±0.25 diopters. For powers with more than ±10.00 diopters the tolerance is +0.50 diopters.
Cylinder Power: for less than 2.00 diopters the tolerance is ±0.25 diopters. For more than 2.00 diopters the tolerance is + 0.5 diopters.
Cylinder Axis: tolerance of + 5° as stated on label.
Base Curve: measured in dry state, tolerance ±0.02mm.
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Diameter: within ±0.15mm of stated value on label.
Center Thickness: within ±0.10mm of thickness stated on label.
Physical Appearance:
Color: very light turquoise (visitint) to darker turquoise.
Surface Quality: there must be no defects such as scratches, chips or gouges.
Edges: free of defects.
Optical Quality: bodies, when viewed under 10X magnification, or greater, with an illuminated background.
In summary, tinting of Ocu-Flex-53 Contact Lenses with Reactive Blue 21 Dye has no adverse effects on either the physical or optical properties, even at relatively high intensities of color. It is noted, however, that at the maximum tint level, 181 ug per lens, light transmittance is greatly reduced at the longer and shorter wavelengths of the visible region. At low, or Visitint levels, however, there is essentially no reduction in light transmittance.
§ 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.