(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) | 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.
§ 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.