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510(k) Data Aggregation
(420 days)
The Hydron ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters.
Eyecare practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
The ActiFresh 400 soft contact lens is a hemispherical shell manufactured of a high water content (73%), polymerised material of n-vinyl pyrrolidone (nVP) and methy methacrylate (MMA) and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eye. A UV filter has been incorporated into the lens material. The lens is visibility tinted with a minute amount of poly (2-hydroxyethyl methacrylate and Reactive Blue Dye #4 copolymer. The lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness) and hyperopia (farsightedness). The lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. The lens is designed with a spherical lenticulated front surface and spherical bicurve back surface. The lens is manufactured by cast molding.
The provided document describes the ActiFresh™ 400 Soft (hydrophilic) Contact Lens and its application for 510(k) clearance, asserting substantial equivalence to the predicate device, Hydron Omniflex SofBlue. The document does not describe acceptance criteria in the typical sense of a table with specific thresholds for performance metrics. Instead, it presents a comparative study against a predicate device and notes the absence of adverse events and comparability of clinical findings.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a table format with numerical thresholds for clinical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (Hydron Omniflex SofBlue) through a combination of non-clinical (physical, chemical, mechanical properties, toxicology, microbiology, stability) and clinical studies. The "acceptance criteria" are implicitly met if the ActiFresh 400 performs comparably to the predicate device and does not raise new questions of safety or effectiveness.
Here's a summary of the comparative performance as presented, alongside the predicate device, which can be interpreted as demonstrating "meeting acceptance criteria" by being comparable:
| Property | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (ActiFresh 400) | Predicate Device Performance (Omniflex SofBlue) |
|---|---|---|---|
| Non-Clinical | |||
| USAN | lidofilcon A | lidofilcon A | lidofilcon A |
| Monomers | nVP, MMA | nVP, MMA | nVP, MMA |
| Manufacturing Process | - (Different permitted if equivalent performance) | Cast Molding | Lathe-cut |
| Diameter (mm) | 14.3 | 14.3 | 14.3 |
| Center Thickness (mm) | 0.12 | 0.12 | 0.12 |
| Base Curves (mm) | - (Within specified range) | 8.4, 8.8 | 8.10 to 9.30 |
| Refractive Index | Comparable | $1.37 \pm 0.0003$ | $1.39 \pm 0.0007$ |
| Water Content (%) | Comparable | $73 \pm 0.3$ | $69 \pm 0.5$ |
| Oxygen Permeability (Dk) | Comparable | $28 \times 10^{-11}$ | $24 \pm 2.7 \times 10^{-11}$ |
| Light Transmittance | Comparable | $94.11\pm14.68%$ | $95.24\pm3.42%$ |
| Modulus (N/mm²) | Comparable | $0.31 \pm 0.04$ | $0.52 \pm 0.065$ |
| Tensile Strength (N/mm²) | Comparable | $0.48 \pm 0.14$ | $1.01\pm0.338$ |
| Elongation at Break (%) | Comparable | $126 \pm 27$ | $213\pm63$ |
| Toxicology | Non-toxic (according to ISO standards) | All results provide reasonable assurance of non-toxicity | Not explicitly stated but assumed for predicate |
| Microbiology | Sterilizable to SAL of 10⁻⁶ | Efficacy of sterilization checked, bioburden < 10 cfu/ml | Not explicitly stated but assumed for predicate |
| Lens Stability | 8-year shelf life | Demonstrated up to 8 years | Not explicitly stated but assumed for predicate |
| Clinical | |||
| Adverse Reactions | Absence of | Absent | Not explicitly stated but implied low incident in predicate |
| Clinically Significant Slit-lamp Findings | Low incidence, comparable to predicate | Low incidence, one subject discontinued with positive findings | Comparable to predicate |
| Changes in Keratometry, Refraction, BCVA | Very low incidence | Very low incidence | Not explicitly stated but assumed low incident in predicate |
| Efficacy (Visual Acuity) | High incidence of BCVA within one line of initial | High incidence | Not explicitly stated but assumed for predicate |
| Acceptability (Completion Rate, Discomfort) | High completion rate, low incidence of discomfort | High completion rate, low incidence of symptoms of discomfort | Comparable to predicate |
| Average Daily Wear Time | - (Relevant for daily wear claim) | 12.1-12.7 hours per day | Not explicitly stated but assumed for predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study):
- Enrolled: 39 subjects (78 eyes)
- Dispensed lenses: 38 subjects (76 eyes)
- Completed full 3 months: 33 subjects (66 eyes)
- Data Provenance: The study was conducted by Hydron Ltd., a company based in Farnborough, UK ("Hawley Lane, Famborough, Hants, GU14 8EQ, U.K."). The report itself is a submission to the FDA for market clearance in the US, but the studies were likely conducted in the UK or a similar location accessible to the company. The document does not explicitly state the country of origin for the clinical data in detail, beyond the company's location.
- Retrospective or Prospective: The clinical studies described (e.g., "Clinical Evaluation of Cast-Moulded ActiFresh 400 During a 3-month Period of Daily Wear," "High Power ActiFresh 400 Study," "Comparative Clinical Evaluation") appear to be prospective clinical trials. The description "3-month, 39 subject, open-label, uncontrolled, daily wear, dispensing study" confirms this.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify human experts establishing a "ground truth" for the test set in the sense of independent review of images or data. The "ground truth" is derived directly from clinical observations and measurements by the study investigators (presumably ophthalmologists, optometrists, or trained clinical staff) during the prospective clinical trials. The qualifications of these investigators are not provided.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The clinical study results are reported as direct observations and measurements from the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study, as typically understood for AI-assisted diagnostic devices, was not done.
- This device is a contact lens, not a diagnostic imaging AI. The "study" is a clinical trial evaluating the safety and efficacy of the contact lens itself, comparing its performance to a predicate device (Omniflex SofBlue) and demonstrating substantial equivalence, rather than comparing human readers with and without AI assistance. Therefore, no effect size of human readers improving with AI is reported.
6. Standalone Performance
- Yes, a standalone performance evaluation was conducted for the device. The clinical studies (LIDF-219, LIDF-220, DISP-203) evaluate the safety, efficacy, and acceptability of the ActiFresh 400 lens itself, independent of human interpretation nuances that would be present in an AI diagnostic device. However, "standalone" in this context refers to the device's inherent physical, mechanical, and clinical performance when worn by subjects, not an algorithm's performance.
7. Type of Ground Truth Used
The ground truth for the clinical studies was established through:
- Expert Clinical Observation and Measurement: Slit-lamp findings (e.g., corneal staining, palpebral follicles), keratometry, refraction, best-corrected visual acuity (BCVA), and patient-reported symptoms (discomfort) were directly assessed by clinical investigators.
- Patient Outcomes Data: Completion rates, discontinuation reasons, and daily wearing times.
For non-clinical properties, the ground truth was via laboratory measurements using standard industry methods (e.g., Abbe refractometer for refractive index, gravimetric determination for water content, Fatt method for oxygen permeability, UV/visible spectrophotometer for light transmittance, tensile measurements for mechanical properties).
8. Sample Size for the Training Set
- Not applicable in the AI sense. This submission is for a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" for machine learning. The "training" in the context of device development would refer to manufacturing process optimization and material formulation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI algorithm, there is no ground truth established for an AI training set. The clinical and non-clinical data collected serve to validate the performance of the manufactured device.
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(162 days)
The Hydron ActiToric(ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
The ActiToric soft contact lens is a hemispherical shell manufactured of polymerised material of HEMA and other monomeric incredients crosslinked with EGDMA and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eve. This lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (near-sightedness), hyperopia (farsightedness) and astigmatism (multiple foci). The lens provides corrective power which is to correspond to the refractive power of the eve to which it is being treated. The lens has an aspheric base curve that is formed in the free surface during the spinning process. Secondary and tertiary curves as well as bevelled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mould to provide consistent optics. Onentation marks are moulded into the front surface as part of the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort. Axis stabilisation is action of the action of the lids on the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hydron ActiToric contact lens:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with novel acceptance criteria and extensive clinical trials. Therefore, many of the requested elements for a study proving device meeting acceptance criteria (like sample size for test sets, expert qualifications, effect size with AI assistance, MRMC studies, etc.) are not applicable (N/A) in this context, as the primary method of demonstrating safety and effectiveness is through comparison to the predicate device.
The "acceptance criteria" here are largely implicit in the comparison to the predicate device, meaning the new device must perform comparably to the predicate across various properties.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (ActiToric) |
|---|---|
| Material: USAN | ocufilcon A |
| Material: Group | 3 (ionic) |
| Material: Monomers | 2-HEMA, MA, EGDMA |
| Manufacturing: Process | Spun-cast |
| Manufacturing: Diameter (mm) | 14.5 |
| Manufacturing: Center Thickness (mm) | 0.15 |
| Manufacturing: Base curve (mm) | 8.95 (equivalent to 8.90 of predicate) |
| Physical Properties: Refractive Index | 1.43 ± 0.001 |
| Physical Properties: Water content % | 45 ± 0.00 |
| Physical Properties: Oxygen Permeability | $11.9 \pm 1.85 \times 10^{-11}$ (cm² x ml O₂)/(sec x ml x mmHg) |
| Physical Properties: Light Transmittance % | 98 ± 0.4 |
| Mechanical Properties: Modulus (N/mm²) | 0.32 ± 0.045 |
| Mechanical Properties: Tensile strength (N/mm²) | 0.32 ± 0.116 |
| Mechanical Properties: Elongation at break (%) | 208 ± 94 |
| Toxicology: Within normal limits | All necessary toxicology studies were undertaken and results were within normal limits. |
| Microbiology: Relevant test procedures | Relevant test procedures have been undertaken and are included. |
| Compatibility: (No specific requirement if similar material and approved care products) | Compatibility testing not required as recommended lens care products have been approved for the same lens material (ocufilcon A). |
| Lens Stability: (Determined lifespan without adverse effect) | Indicates storage for up to 8 years with no adverse effect. |
| Clinical Safety: (Comparability to predicate) | Not required due to same USAN and manufacturing method as predicate device. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for a clinical trial. The comparison is based on product specifications and laboratory testing of the ActiToric lens, which are then compared to the specifications of the predicate device.
- Data Provenance: The manufacturing process, material, and testing would originate from Hydron Limited, United Kingdom. The document implies these are measurements from their own product and comparisons to established data for the predicate.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in this context is established by objective laboratory measurements of physical, chemical, and mechanical properties, not expert consensus on interpretations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective assessments or when discrepancies arise in expert interpretations, which is not the primary method of demonstration here.
-
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:
- N/A. This device is a contact lens and does not involve "readers" or "AI assistance."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Measurements / Objective Product Specifications. The ground truth for equivalency is derived from direct measurements of the lens's physical, optical, and mechanical properties, toxicology results, microbiology tests, and stability data.
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The sample size for the training set:
- N/A. No "training set" in the machine learning sense is relevant for this type of device submission. The device is characterized through laboratory measurements of its properties.
-
How the ground truth for the training set was established:
- N/A. No training set for an algorithm is involved. The ground truth for the device's properties is established through standard manufacturing quality control and laboratory testing methodologies.
Summary of the Study:
The "study" presented here is a substantial equivalence demonstration for a 510(k) premarket notification. It primarily relies on a side-by-side comparison of the physical, optical, and mechanical properties, material composition, manufacturing processes, and established safety tests (toxicology, microbiology, lens stability) of the new device (ActiToric) against a legally marketed predicate device (Specialty UltraVision Specialty T).
The acceptance criteria are effectively met if the new device exhibits equivalent properties and performance characteristics to the predicate device, as detailed in Table 2.1. Clinical safety data was not required because the device used the same USAN (ocufilcon A) and method of manufacture as the predicate, which implies that their clinical safety profiles are expected to be similar.
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