(108 days)
FLOSI (willofocon A) Rigid Gas Permeable Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for dally wear correction of refractive ametropla (myopla, hyperopla, astigmatism and presbyopla) In aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
The FLOSI (wilofocon A) Rigid Gas Permeable Contact Lons Is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, willofocon A, is sphencer, asphonour, and assigment which contains D & C Green No: 6 as a color additive. The FLOS (willofocon A) Contact Lens is a hemispherical shell.
Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:
Device: Flosi (wilofocon A) Rigid Gas Permeable Contact Lens (Spherical, Aspheric, Toric, and Bifocal)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in the provided document. Instead, the study's findings are presented as being "within expecteds" or demonstrating "no significant issues," implying that the performance met acceptable clinical standards for this type of device. Based on the clinical study summary, the implied acceptance criteria revolve around the safety and efficacy of the contact lens, specifically related to potential adverse reactions, visual acuity, slit-lamp findings, and refractive changes.
| Acceptance Criteria Category (Implied) | Specific Performance Metric (Implied Target) | Reported Device Performance |
|---|---|---|
| Safety - Adverse Reactions | No adverse reactions requiring treatment | None reported |
| Safety - Slit-Lamp Findings (SLFs) | SLFs within expected range for RGP lenses | 99 Grade 1 SLFs (mostly corneal staining, 18% of visits); 5 Grade 2 SLFs (staining, resolved by lens changes). "were within expecteds for wearers of an RGP contact lens." |
| Safety - Symptoms/Complaints (SPCs) | SPCs within expected range for RGP lenses | 135 reports (largest: variable vision 8.7%, lens awareness 6.2%). "All symptoms, problems or complaints were reduced over time. None... can be considered outside of the normal expecteds." |
| Efficacy - Visual Acuity | No drop in visual acuity greater than one line | "No patients experienced a drop of visual acuity that was greater than one line." |
| Efficacy - Keratometry | Minimal change in corneal curvature | 90.4% showed no change to 0.50 D change; 98.6% showed 1.00 D or less change. Average change: 0.08 D flattening. "generally low and may be attributed to adaptation to a new lens type or usual clinical measurement variation." |
| Efficacy - Refraction | Minimal change in refractive error | 99.1% showed no change to 1.00 D change. Average change: near zero. "generally low and may be attributed to a better fitting lens or usual clinical measurement variation." |
| Wear Time | Clinically acceptable daily wear time | Average wearing time: 14.9 hours |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study: 122 eyes enrolled, with 110 eyes completing a minimum of three months of contact lens wear. 12 eyes were discontinued.
- Preclinical Studies:
- Systemic Injection Test: Animals (number not specified, but typically small groups)
- Eye Irritation Test: Rabbits (number not specified, but typically small groups)
- Tissue Culture-Agar Overlay Cytotoxicity Assay: In vitro (not applicable for animal count)
- Data Provenance: The document does not specify the country of origin for the clinical study data. Given the submission to the FDA (United States), it is highly probable the study was conducted in the USA or a region with comparable clinical standards. The study appears to be prospective, as it describes enrolling patients and following them over a three-month period of contact lens wear.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth for the clinical test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, clinical studies for medical devices like contact lenses are typically overseen and evaluated by ophthalmologists or optometrists who are experienced in contact lens fitting and management. The observations (slit-lamp findings, keratometry, refraction, visual acuity) would have been performed and recorded by these clinical professionals.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the clinical test set. The clinical findings collected (SLFs, SPCs, keratometry, refraction, visual acuity) are typically direct observations or measurements made by the treating clinician during the study visits. It is implied that the clinical investigators made these assessments and their findings were recorded and aggregated for analysis. There is no mention of a separate panel or process for resolving discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly done. The clinical study described focuses on the performance of the Flosi contact lens on its own, not in comparison to human readers or with AI assistance. It evaluates the device's safety and efficacy in a standalone clinical setting.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Yes, a standalone study was done, if we interpret "standalone" as the device performing its intended function without human intervention beyond fitting and wear. The clinical study specifically evaluates the Flosi contact lens as the standalone device. The lens is placed in the eye, and its performance (visual acuity correction, impact on eye health) is assessed. There is no AI component or algorithm described in this submission; the "device" is the physical contact lens itself.
7. Type of Ground Truth Used
For the clinical study, the "ground truth" was established through direct clinical observations and measurements by eye care professionals. This includes:
- Clinical Examination Findings: Slit-lamp examinations for corneal and conjunctival health.
- Patient-Reported Outcomes (PROs): Symptoms, problems, and complaints (SPCs).
- Objective Measurements: Keratometry (corneal curvature), Refraction (visual correction needed), Visual Acuity (measured using standard charts like Snellen).
- Adverse Event Monitoring: Tracking any adverse reactions or significant clinical issues.
For the preclinical studies, the ground truth was based on established laboratory assays and animal model observations (e.g., signs of toxicity, ocular irritation).
8. Sample Size for the Training Set
- Not applicable / Not explicitly stated. This device is a physical contact lens, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would reside in the historical data and scientific principles used during its design and material formulation, but this is not a data set in the sense of AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, there is no AI/ML training set defined for this physical device. The "ground truth" for the development of any medical device comes from scientific understanding, clinical experience with similar devices, regulatory standards, and extensive pre-clinical and clinical testing, which includes the safety and efficacy data presented in this 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.