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510(k) Data Aggregation
(200 days)
RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.
RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.
O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act as a refracting medium to focus light rays on the retina.
Here's an analysis of the provided text regarding the O->PERM 30A (sterafocon A) contact lens, structured to address your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Criteria) | Reported Device Performance |
|---|---|---|
| Safety | Adverse Reactions (none reported) | "There were no lens related Adverse Reactions reported in the study." |
| Slit Lamp Findings (typical, no treatment required) | "All Slit Lamp Findings were typical... No slit lamp findings required treatment." | |
| Bioburden Level (<100 CFU/lens for alternate site manufacturers) | Not directly assessed in the clinical study, but a quality control measure for manufacturing. | |
| Effectiveness | Visual Acuity (20/30 or better for majority) | Trial Lens: 94.4% (68 out of 72 eyes) achieved 20/30 or better. Control Lens: 88.2% (30 out of 34 eyes) achieved 20/30 or better. |
| Wearing Time (typical for daily wear: 10-14 hours/day) | "The average wearing time for all patients participating in the Study was typical of daily wear patients generally: 10 to 14 hours per day." | |
| Discontinuations (normal for contact lenses) | Trial Cell: 16.7% (6 out of 36) Control Cell: 17.6% (3 out of 17) | |
| Symptoms/Complaints (no unanticipated, no treatment required) | "There were no unanticipated observations... and none... required treatment..." | |
| Lens Replacements (mostly for fitting/loss, normal reasons) | "Lens replacements during the study were mostly for fitting related reasons, or other normal contact lens wearing related reasons (such as loss)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- The study aimed for approximately 15 patients per investigator.
- The study had a "random distribution of 2:1 in the trial lens : control lens."
- Based on reported visual acuity data:
- Trial lens: 72 eyes (likely 36 patients, assuming 2 eyes per patient)
- Control lens: 34 eyes (likely 17 patients, assuming 2 eyes per patient)
- Total participants in effectiveness assessment: Approximately 53 patients (106 eyes).
- In the discontinuation section, it states: "6 out of 36 (16.7%) in the trial cell, and 3 out of 17 (17.6%) in the control cell," reinforcing the approximate patient count.
- Data Provenance: The data is from a prospective clinical study conducted in the USA (specifically mentioning "Salvatori Ophthalmics Manufacturing Inc. of Sarasota, Florida" as a collaborator and "The South West Independent TRB" for IRB approval).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical study. It refers to "Investigators" who conducted the patient examinations and followed the protocol established by Optical Polymer Research, Inc. (OPR). Given the context of a contact lens study, these investigators would typically be ophthalmologists or optometrists experienced in fitting and evaluating contact lens wear.
4. Adjudication Method for the Test Set
The document does not mention a specific adjudication method (e.g., 2+1, 3+1). The study design appears to be focused on individual investigator assessments against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a medical device (contact lens) and not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is a study for a physical medical device (contact lens), not an algorithm or AI. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The ground truth used in this study is based on clinical observations and measurements by qualified healthcare professionals (Investigators), combined with patient-reported outcomes. This includes:
- Visual acuity measurements.
- Slit lamp examination findings.
- Patient wearing time.
- Reports of adverse reactions, symptoms, and complaints.
- Reasons for lens replacements or discontinuations.
8. The Sample Size for the Training Set
This document describes a clinical study for a physical medical device. There is no mention of a training set in the context of machine learning or AI. The term "training set" is not relevant to this type of device submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI or algorithm in this submission, this question is not applicable.
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