(128 days)
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are available in violet color. The violet tinted lenses contain D & C Violet # 2 and D & C Red #17. The lenses have the following dimensions and characteristics: Material: Paflufocon E, Indication: Daily wear, Water content:
Here's a breakdown of the acceptance criteria and the study details for the PVS BASICS™ (paflufocon E) rigid gas permeable contact lenses, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a clinical trial that established the PVS BASICS™ (paflufocon E) material as safe and effective against a predicate device (paflufocon A / FluoroPerm 92™). Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in the provided text. Instead, the study's goal was to demonstrate "equivalence" between the new material and the predicate device for several clinical variables.
The tables below summarize the findings related to safety and symptoms, which implicitly serve as the performance data to demonstrate equivalence, meaning the PVS BASICS™ performed comparably to the established predicate.
Assumed Acceptance Criteria (based on predicate equivalence and safety profile):
- No statistically significant difference in Visual Acuity compared to predicate.
- No statistically significant difference in Comfort compared to predicate.
- No statistically significant difference in Lens-Eye Relationship compared to predicate.
- No statistically significant difference in Movement compared to predicate.
- No statistically significant difference in Slit Lamp Findings compared to predicate.
- No statistically significant difference in Functional Wetting compared to predicate.
- Low incidence of adverse events, similar to or better than the predicate.
- No serious ocular complications (corneal ulcers, iritis).
- Low incidence of staining, edema, injection, or neovascularization exceeding Grade 2.
- Patient reported symptoms and complaints comparable to the predicate.
Reported Device Performance (PVS BASICS™ (paflufocon E)) vs. Predicate (Paflufocon A):
| Parameter | PVS BASICS™ (paflufocon E) Performance | Predicate (Paflufocon A) Performance | Implicit Finding (Equivalence) |
|---|---|---|---|
| Safety | |||
| Discontinued Eyes | 2 eyes (out of 70) | 0 eyes (out of 22) | Comparable (low incidence) |
| Average Wearing Time | 13.58 (no unit provided, likely hours) | 14.09 (no unit provided) | Comparable |
| All Adverse Reactions | 0 | 0 | Equivalent (no adverse reactions) |
| All Corneal Ulcers | 0 | 0 | Equivalent (no ulcers) |
| All Iritis | 0 | 0 | Equivalent (no iritis) |
| Staining Reports > Grade 2 | 0 | 0 | Equivalent |
| Edema Reports > Grade 2 | 0 | 0 | Equivalent |
| Injection Reports > Grade 2 | 0 | 0 | Equivalent |
| Neovascularization Reports > Grade 2 | 0 | 0 | Equivalent |
| Symptoms/Complaints (Final Visit) | |||
| None | 66.2% | 63.6% | Comparable |
| Discomfort | 11.8% | 27.3% | PVS BASICS™ lower |
| Itching/Burning | 2.9% | 18.2% | PVS BASICS™ lower |
| Variable Vision | 7.4% | 18.2% | PVS BASICS™ lower |
| Blurred Vision | 2.9% | 36.4% | PVS BASICS™ lower |
| Lens Needs Cleaning | 5.9% | 9.1% | PVS BASICS™ lower |
| Dryness | 8.8% | 27.3% | PVS BASICS™ lower |
| Total Positive Reports | 29 (Number of positive reports, not %) | 24 (Number of positive reports, not %) | Individual symptoms lower for PVS |
Study Details
-
Sample Size used for the test set and the data provenance:
- Test Set (Clinical Study):
- PVS BASICS™ (paflufocon E) ("Trial Eyes"): 70 eyes enrolled, 68 completed.
- Predicate (Paflufocon A / FluoroPerm 92™) ("Control Eyes"): 22 eyes enrolled and completed.
- Data Provenance: The document does not explicitly state the country of origin, but the submission is to the U.S. FDA, suggesting the study was likely conducted in the U.S. or under U.S. regulatory standards. The study appears to be prospective, described as a "randomized double-masked controlled trial."
- Test Set (Clinical Study):
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The term "ground truth" as typically used in AI/Machine Learning doesn't directly apply here, as this is a clinical trial involving human subjects and direct observation.
- The "ground truth" or clinical data collection was based on direct patient experience and examination by "eye care practitioners" or clinical investigators. The document doesn't specify the number or qualifications of these practitioners.
-
Adjudication method for the test set:
- The study is described as a "randomized double-masked controlled trial." This means:
- Randomized: Subjects were randomly assigned to either the test or control lens group.
- Double-masked: Neither the patients nor the clinical investigators (those examining the patients and collecting data) knew which lens material the patient was wearing. This masking serves to minimize bias in observations and patient-reported outcomes.
- The process for resolving discrepancies in clinical findings (if any) or adverse event reporting is not explicitly detailed as an "adjudication method" in the provided text.
- The study is described as a "randomized double-masked controlled trial." This means:
-
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:
- No. This was a clinical trial comparing a new contact lens material to a predicate device in humans, not an AI or imaging-based diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance is not applicable here.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a contact lens, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the "ground truth" (or primary outcome measures) used a combination of:
- Patient-reported outcomes: Comfort, symptoms, and complaints (e.g., discomfort, dryness, blurred vision).
- Clinical observations/measurements: Visual Acuity, Lens-Eye Relationship, Movement, Slit lamp Findings, Functional Wetting, and detailed adverse event reporting (staining, edema, injection, neovascularization, corneal ulcers, iritis).
- For biocompatibility, the ground truth was based on established ISO guidelines for ocular irritation (rabbit model), in vitro cytotoxicity (L-929 mouse fibroblast cells), and guinea pig maximization test for sensitization.
- For the clinical study, the "ground truth" (or primary outcome measures) used a combination of:
-
The sample size for the training set:
- This is a clinical trial for a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The "training" for the device's development would involve material science, manufacturing, and preclinical testing.
-
How the ground truth for the training set was established:
- As there is no AI/ML training set, this question is not applicable. The development relied on established scientific principles, pre-clinical testing (biocompatibility and irritation studies mentioned), and comparative analysis against the predicate device.
§ 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.