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510(k) Data Aggregation
(124 days)
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
The Intelliwave4 with HPT, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Intelliwave4 with HPT, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The Intelliwave4 with HPT, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4 with HPT, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (safrofilcon A) is a daily wear silicone hydrogel contact lens that is characterized by high water content. The lens material is composed of silicone monomers cross linked with other monomers, and it optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom Ry. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
The Intelliwave4 with HPT, Silicone Hydrogel Soft Contact Lenses are treated to incorporate Hydra-PEG Technology (HPT)-which is a thin polyethylene glycol (PEG)-based polymer that is covalently (permanently) bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with HPT, the underlying material (safrofilcon A) is completely encapsulated in a thin layer of polymer that results in measurable improvement of the surface characteristics, compared to untreated lenses, including: wettability (dynamic contact receding angle), lubricity (coefficient of friction), and water film stability (WBUT). The resulting layer is hydrophilic and approximately 30nm in thickness.
This document (K152046) is a 510(k) premarket notification for a new class II medical device, the Intelliwave4 with HPT (Hydra-PEG Technology) Silicone Hydrogel Daily Wear Soft Contact Lens. It is not an AI/ML medical device and therefore does not include the detailed information requested in the prompt regarding AI model performance, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (IntelliWave4, K142641) by showing that the addition of Hydra-PEG Technology (HPT) to the contact lens surface, while enhancing certain physical properties, does not change the core functionality, intended use, or safety profile of the device.
However, based on the provided document, I can extract and infer some information relevant to the concept of acceptance criteria and the study that proves the device meets them, specifically concerning the physical and material properties, and clinical performance for equivalence.
Here's an attempt to structure the information based on your prompt, acknowledging the limitations due to the nature of the document:
Device: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
This device is not an AI/ML driven diagnostic or assistive tool, but rather a physical medical device (contact lens). Therefore, many of the specific criteria related to AI performance, such as MRMC studies, expert adjudication for ground truth of an algorithm, and effect sizes of AI assistance, are not applicable here. The "acceptance criteria" discussed are related to the physical properties, safety, and effectiveness of a contact lens compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds in the same way an AI model might have for metrics like AUC or sensitivity/specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device, particularly that the new HPT treatment does not negatively impact safety or core performance, and ideally improves certain physical properties of the lens surface.
The table below summarizes the enhanced surface properties of the new device compared to the predicate device, which implicitly serve as a form of "performance acceptance" in the context of demonstrating improvement while maintaining safety. Clinical performance is evaluated for "similar overall performance."
| Acceptance Criteria Category (as inferred) | Specific Metric/Property | Predicate Device Performance (IntelliWave4, K142641) | Reported Device Performance (IntelliWave4 with HPT) | Performance Outcome against "Acceptance" (Improvement or Equivalence) |
|---|---|---|---|---|
| Surface Properties | Wettability - captive bubble contact angle (degrees) (advancing contact angle) | 103 | 46 | Improved (123% reduction) |
| Inclined Plane Friction/Lubricity (degrees) | 35 | 19 | Improved (46% reduction) | |
| Water Break Up Time – WBUT (seconds) | 1.57 | 5.69 | Improved (262% increase) | |
| Friction/Lubricity at human eyelid – contact lens biointerface ($μ$ kinetic) | 0.059 | 0.043 | Improved (27% reduction) | |
| Physical Properties (Material) | Refractive Index (wet) | 1.3841 | 1.3841 (Same as predicate) | Equivalent |
| Visible Light Transmission | >98% | >98% (Same as predicate) | Equivalent | |
| Surface Character | hydrophilic | hydrophilic (Same as predicate) | Equivalent | |
| Water Content (%) | 65% | 65% (Same as predicate) | Equivalent | |
| Specific Gravity | 1.102 (hydrated) | 1.102 (hydrated) (Same as predicate) | Equivalent | |
| Oxygen Permeability | 46.46 x 10-11 | 46.46 x 10-11 (Same as predicate) | Equivalent | |
| Clinical Performance | Overall performance (vision, health, comfort, fit) | - | "similar overall performance" to predicate control | Equivalent |
| Safety | Biocompatibility/Toxicology | Acceptable | Acceptable | Met (non-toxic, non-irritating) |
| Sterility | Sterile | Sterile for indicated shelf-life | Met |
Note: The "acceptance criteria" for improved properties are implicitly that the new device performs significantly better than the predicate for beneficial characteristics, and for other properties (like water content, oxygen permeability), the criterion is to be substantially equivalent.
2. Sample Size and Data Provenance for Test Set (Clinical Study)
- Sample Size for Test Set: 30 patients
- Data Provenance: The document does not specify the country of origin. It describes a "bilateral, open-label, parallel group, and randomized daily wear study." It is a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth
- Applicability for this device: Not directly applicable in the typical AI/ML sense of establishing ground truth for image interpretation or diagnosis.
- Context for this device: The clinical study evaluated safety and efficacy. The "experts" would be the eye care practitioners supervising the study and assessing clinical outcomes (vision, health, comfort, fit). The document does not specify the number or qualifications of these practitioners, but they would be licensed professionals involved in contact lens prescribing and care.
4. Adjudication Method for the Test Set
- Applicability for this device: Not explicitly stated as an adjudication method for a "test set" in the AI/ML context.
- Context for this device: The clinical study's design (open-label, parallel group, randomized) implies standard clinical trial methodology for data collection and analysis to ensure unbiased assessment of patient outcomes. Decisions on "ground truth" (e.g., whether a lens fits well, or whether vision is adequate) would be made by the trained clinicians participating in the study as part of their standard practice.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is specifically designed for evaluating the impact of AI on human reader performance for diagnostic tasks.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance
- Applicability for this device: Not applicable. This device is a physical contact lens, not a software algorithm. Its "performance" is inherent in its physical and material properties, and its clinical performance when worn by a human.
7. Type of Ground Truth Used
- For physical/material properties: Quantitative measurements derived from in vitro tests (e.g., contact angle, friction, WBUT, water content, oxygen permeability). These are objective measurements from laboratory equipment.
- For clinical safety and effectiveness: Patient-reported outcomes (comfort), clinician assessments (vision, health, fit), and observations during a clinical study. This is essentially outcomes data and clinical assessment.
8. Sample Size for the Training Set
- Applicability for this device: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.
- Context for this device: The device development would involve R&D, material science, and manufacturing process development, but not a "training set" as understood for AI.
9. How Ground Truth for the Training Set Was Established
- Applicability for this device: Not applicable for an AI/ML context.
- Context for this device: For physical and material properties, the "ground truth" for development and manufacturing is established through standard laboratory testing methods and material science principles, ensuring the lens meets specified manufacturing tolerances and material compositions. For safety and biocompatibility, this is established through pre-clinical toxicology and biocompatibility tests conducted according to GLP regulations.
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(117 days)
Intelliwave4
The Intelliwave4, sphere (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The Intelliwave4, toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The Intelliwave4, multifocal (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4, multifocal toric (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave4, irregular cornea (safrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
IntelliWave4 UV lenses help protect against transmission of harmful UV radiation to the eye.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Intelliwave4 Silicone Hydrogel Soft Contact Lenses are fabricated from safrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material (safrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates Reactive Blue 246 (21 CFR 73.3106) as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 35% safrofilcon A and 65% water by weight when immersed in a buffered saline solution. The (safrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (safrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
In the Intelliwave4 Contact Lens with UV Blocker and center thickness of 0.18mm, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV Blocker is 2-(4-Benzoyl-3-hydroxyphenoxy)ethyl acrylate. The UV blocking for Intelliwave4 lenses averages > 99% in the UVB range of 280nm - 315nm and >77% in the UVA range of 316 - 380mm.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 65% water by weight. The lenses will be manufactured in spherical, aspherical, toric, and multifocal configurations with the following features and properties.
The provided text describes the Intelliwave4 contact lens and its substantial equivalence to a predicate device, IntelliWave3. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This type of regulatory submission does not typically involve detailed acceptance criteria tables or studies designed to "prove" a device meets acceptance criteria in the way a novel device might. Instead, it relies on demonstrating equivalence through comparison of design, materials, and clinical performance.
However, based on the information provided, I can extract the closest parallels to your requested categories:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for specific performance metrics in a table. Instead, it compares the new device (Intelliwave4) to a predicate device (IntelliWave3) to demonstrate substantial equivalence. The "performance" is described in terms of safety and efficacy being "similar overall performance" to the predicate.
Here's a table reflecting the comparative properties and a summary of performance as reported:
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Intelliwave4) |
|---|---|
| Similar Safety & Effectiveness | "Clinical evaluation demonstrated similar overall performance to the concurrent predicate control in the clinically relevant areas of vision, health, and comfort and fit when worn for daily wear." |
| "The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses." | |
| Physical and Material Properties Consistency | "Lens physical and material properties are consistent with currently marketed lenses." |
| (Specific properties are listed, but no explicit "acceptance criteria" for these, rather they are presented as characteristics.) | |
| Refractive Index (wet): 1.3841 | |
| Visible Light Transmission: >98% | |
| Surface Character: hydrophilic | |
| Water Content: 65 % | |
| Specific Gravity: 1.102 (hydrated) | |
| Oxygen Permeability: 46.46 x 10-11 (cm²/sec) (ml O2/ml x hPa @ 35°C). (revised Fatt method). | |
| UV Blocker: > 99% in UVB (280nm - 315nm), >77% in UVA (316 - 380mm) | |
| Sterility & Shelf-Life | "Lenses supplied in glass vials are sterile for the indicated shelf-life" |
| Packaging Material & Extracts Safety | "The packaging material and extracts are not toxic and not irritating" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: 60 patients
- Data provenance: Not explicitly stated regarding country of origin, but the study was a "bilateral, open-label, parallel group, and randomized daily wear study" which indicates a prospective design. Given the FDA submission, it implicitly refers to data relevant for US regulatory purposes, likely with US or internationally recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The clinical study details are very brief. It mentions "Clinical evaluation demonstrated similar overall performance," but it does not specify the number or qualifications of clinicians involved in assessing "vision, health, and comfort and fit."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool. The clinical study compares the new contact lens to a predicate contact lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the clinical study was the clinical evaluation of 60 patients over three months, assessing "vision, health, and comfort and fit." This falls under outcomes data or clinical assessments by potentially multiple clinicians, although the specific number and qualifications are not detailed.
8. The sample size for the training set
This is not applicable in the context of this device. A training set is typically for machine learning algorithms. The Intelliwave4 contact lens is a physical medical device. The "training" for its development would involve material science, engineering, and manufacturing, not a data-based training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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