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Spherical: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or lyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.
Toric: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.
The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for wither single use disposable wear.
The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are available with ultraviolet absorbing additive (benzophenone based):

in the power range of -10.00 to +6.00 diopters for sphere
in the cylinder power range pl to -6.00D cylinder .
with center thickness from 0.025mm to 0.27mm
with base curves of 8.00mm to 9.20mm .
. with diameter of 12.00mm to 18.00mm.
This lens material, design, cast molding manufacturing and sterilization process is equivalent to BIOMEDICS® 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses described in submission 52 PMA890023/S4,S6 and S7, 510(K) K003136.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BIOMEDICS® 52 1-Day contact lens, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device and assuring safety and efficacy after a manufacturing process change. Therefore, the "acceptance criteria" are largely framed as demonstrating non-inferiority or equivalence to the control lens and meeting general safety expectations for contact lenses.

Acceptance Criteria (Stated Goal / Benchmark)	Reported Device Performance (BIOMEDICS® 52 1-Day - "Test Lens")
Safety - Absence of significant adverse events/complications:
1. No permanent decreases in Best Corrected Visual Acuity (BCVA) (no 2-line decreases).	No reports of 2-line decreases in BCVA for any Test cohort eyes. (Equivalent to Control)
2. No persistent corneal staining of Grade 3 or 4 at two or more follow-up visits.	No reports of Grade 3 or 4 staining for any Test cohort eyes. (Equivalent to Control)
3. No neovascularization more than 1.5mm and/or more than 1.0mm in 3 or more quadrants.	No neovascularization reported of greater than 1.5mm in any quadrant. Incidence remained stable. (Equivalent to Control)
4. No persistent hyperemia of Grade 3 or 4 at two or more follow-up visits (limbal or bulbar).	No Grade 3 or 4 limbal or bulbar hyperemia reported. (Equivalent to Control)
5. No peripheral or central ulcerative keratitis.	No peripheral or central ulcerative keratitis reported. (Equivalent to Control)
6. No infiltrates of Grade 2 or worse.	No infiltrates reported. (Equivalent to Control)
7. Subjective symptoms (e.g., discomfort, blurred vision) not indicating safety issues when compared to Control.	Discomfort: Reported more frequently (12.5% of follow-ups) with greater severity (avg 2.1/4.0) vs. Control (7.3% of follow-ups, avg 1.1/4.0). Blurred vision: Reported less frequently (1.6% of follow-ups) with lower severity (avg 1.0/4.0) vs. Control (6.3% of follow-ups, avg 1.7/4.0). Conclusion: No safety issues indicated for Test lenses.
Efficacy - Visual Acuity Performance:
1. Similar visual acuity performance to Control lens at final examination.	Both Test and Control lens visual acuities were "essentially the same" at the final examination.
2. Proportion of subjects successfully completing the study duration.	100% of Test cohort subjects completed the 1-month study period. (Equivalent to Control)
3. Percentage of lens visual acuities of 20/20 or better at final visit.	84.8% for Test cohort eyes (vs. 83.3% for Control cohort eyes). Both > measured at study start.
4. Percentage of lens visual acuities of 20/30 or better at final visit.	100% for Test cohort eyes (vs. 100% for Control cohort eyes). Both met expectations.
Other Performance Characteristics (Equivalence to Control):
- Average Wearing Time	Test cohort: 12.8-13.2 hours/day. Control cohort: 13.1-13.3 hours/day. (Acceptable and similar)
- Lens Deposits	Test: 12.5% with deposits (1.4% medium). Control: 11.1% with deposits (only light). (Similar rates, with Test having some medium deposits).
- Material properties (chemical composition, water content, refractive index, Dk permeability, light transmittance)	Material property data generated on BIOMEDICS® 52 and BIOMEDICS® 52 1-Day lenses processed with manufacturing changes showed they were "substantially equivalent." (Specific values are listed in Table 1 and are identical to predicate).
- Toxicology (cytotoxicity, acute systemic injection, ocular eye irritation)	Cytotoxicity: Not cytotoxic. Acute Systemic Injection: No evidence of systemic toxicity. Ocular Eye Irritation: No evidence of ocular irritation. 22-Day Ocular Eye Irritation: Eyes treated with test lenses similar to untreated control eyes. (All met safety requirements for toxicological tests).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 36 subjects (72 eyes) were enrolled.
- Test Cohort: 48 eyes (from 24 subjects, assuming 2 eyes per subject)
- Control Cohort: 24 eyes (from 12 subjects)
- Note: The text states "All of the 36 subjects were determined to be eligible... and were dispensed either the Test or the Control lenses." And later "Female Subjects: Test 19, Control 10; Male Subjects: Test 5, Control 2; Totals: Test 24, Control 12." This implies 24 subjects in the Test group and 12 in the Control group, totaling 36 subjects. It then refers to 48 "Completed Test Eyes" and 24 "Completed Control Eyes," which aligns with 2 eyes per subject.
Data Provenance: Prospective, concurrent cohort control, randomized clinical trial conducted at three (3) investigational sites. The country of origin of the data is not explicitly stated, but the contact person is in Maryland, USA, and the applicant is in California, USA, suggesting a US-based study, although international marketing is mentioned elsewhere.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The study involves clinical observations and examinations by healthcare professionals during "scheduled follow-up visits" and "laboratory observations." However, the text does not explicitly state the number of experts used to establish ground truth nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that licensed eye care practitioners (optometrists or ophthalmologists) at the investigational sites conducted the examinations, as these are standard roles in contact lens clinical trials.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the clinical findings. Clinical trials for contact lenses typically rely on the observations and assessments of the examining clinician(s) at each site.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens, and the study is a clinical trial comparing a new manufacturing process of a contact lens to a predicate contact lens, not an AI-powered diagnostic device involving human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical contact lens, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established through a combination of:

Clinical Observations: Daily health observations, macroscopic eye examinations, weekly biomicroscopic slit-lamp examinations, body weight observations by investigators.
Subjective Symptoms and Complaints: Self-reported by subjects.
Measurements: BCVA, wearing time, lens deposits.
Toxicology Studies: Conducted in a laboratory setting (e.g., cell cultures for cytotoxicity, animal models for systemic and ocular irritation).

Essentially, the ground truth is derived from expert clinical assessment and objective measurements within a controlled clinical trial setting, supported by pre-clinical laboratory results.

8. The Sample Size for the Training Set

This submission is for a physical medical device (contact lens) and describes a clinical trial (human subject-based study) and non-clinical (laboratory/animal) studies. There is no "training set" in the context of an AI/algorithm. The sample sizes mentioned (36 subjects, 72 eyes) pertain to the clinical test set.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/algorithm in this context, this question is not applicable. The clinical study was designed to evaluate the safety and efficacy of the contact lens itself through direct observation and measurement, not to train a predictive model.

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