(265 days)
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Frequent / Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives: Reactive black 5, Titanium dioxide, Iron oxides, Solvent Yellow 18, Carbazole violet, Pigment Blue 36, Phthalocyanine green.
The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon).
In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties: Back vertex power -10.00D to 0.00D, step: 0.25D; Base curve 8.40 mm to 8.70 mm, step: 0.10 mm; Total diameter 13.80 mm to 14.50 mm, step:0.10 mm.
The physical properties of the proposed lens are: Specific gravity 1.124; Refractive index 1.437; Light Transmission 93% ± 5%; Surface character Hydrophilic; Water content 38%; Oxygen permeability 8.99x10^-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.
The provided document is a 510(k) Premarket Notification for a contact lens, the HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens. It details the device's characteristics, its comparison to a legally marketed predicate device, and the non-clinical tests performed to demonstrate its safety and effectiveness.
Based on the provided text, no information on a study proving the device meets acceptance criteria for an AI/ML powered device, specifically in the context of human-in-the-loop performance, standalone algorithm performance, or ground truth establishment by experts, is present.
The document specifically states in Section 8: "This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." This confirms that there was no clinical study, let alone one involving AI or expert human readers, to assess and prove the device meets acceptance criteria as envisioned in the prompt's requirements.
The "acceptance criteria" discussed in this document are related to the physical, chemical, optical, and biological safety and performance of the contact lens itself, not an AI/ML algorithm.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets acceptance criteria within an AI/ML context because the document is a 510(k) premarket notification for a contact lens and does not describe such a study.
However, I can extract the acceptance criteria and performance related to the contact lens itself from the document.
Acceptance Criteria and Reported Device Performance (Non-AI/ML Medical Device)
The document primarily focuses on demonstrating the substantial equivalence of the HPM38 contact lens to a predicate device (Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens, K142275) based on physical, optical, physicochemical, and biocompatibility properties. The "acceptance criteria" are implied by meeting the standards outlined in regulatory guidances and internationally recognized standards (e.g., ISO, ASTM).
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison table (Section 6) and lists performance tests (Section 7). Below is a summary of the key physical and optical properties and their reported values, which implicitly serve as the device's performance against industry and regulatory expectations for these parameters. The "acceptance criteria" are generally that these parameters fall within acceptable ranges for contact lenses and demonstrate equivalence to the predicate device.
Table: Acceptance Criteria (Implied) and Reported Device Performance for HPM38 Contact Lens
| Parameter | Acceptance Criteria (Implied / Predicate Range) | Reported Device Performance (HPM38) |
|---|---|---|
| Physical & Optical Properties | ||
| Back Vertex Power | Meets standard for vision correction (Predicate: -25.00D to +25.00D) | -10.00D to 0.00D, step: 0.25D |
| Base Curve | Within typical ranges for corneal fit (Predicate: 8.3 mm to 9.0 mm) | 8.40 mm to 8.70 mm, step: 0.10 mm |
| Total Diameter | Within typical ranges for corneal coverage (Predicate: 13.5 mm to 14.5 mm) | 13.80 mm to 14.50 mm, step: 0.10 mm |
| Center Thickness | Within typical ranges based on power (Predicate: 0.03 mm to 0.50 mm) | 0.050 mm to 0.090 mm |
| Specific Gravity | Consistent with polymacon material | 1.124 |
| Refractive Index | Consistent with polymacon material (Predicate: 1.428) | 1.437 |
| Light Transmission | >90% (Predicate: >90%) | 93% ± 5% |
| Surface Character | Hydrophilic | Hydrophilic |
| Water Content | 38% ± 2% (Predicate: 38% ± 2%) | 38% ± 2% |
| Oxygen Permeability | Sufficient for corneal health (Predicate: 9.77x10⁻¹¹ (cm²/s) [ml O₂/(ml·mmHg)]) | 8.99x10⁻¹¹ (cm²/s) [ml O₂/(ml·mmHg)] at 35°C |
| Modulus | Appropriate for handling and comfort (Predicate: 0.350 MPa) | 0.61 MPa |
| Tensile Strength | Adequate for durability (Predicate: 0.425 MPa) | 0.62 MPa |
| Elongation at Break | Adequate for material flexibility (Predicate: 127%) | 279% |
| Biocompatibility | No cytotoxicity, ocular irritation, skin sensitization, acute systemic toxicity | Passed all tests for lens and packaging |
| Sterilization | Sterility Assurance Level 10⁻⁶ | Validated per ISO 17665-1:2006 |
| Shelf Life | 5 years | Validated via accelerated aging per ISO 11987:2012 |
| Transportation | Withstands transportation stresses | Passed per ASTM D4169-22 |
| Compatibility with Lens Care | Compatible with marketed lens care regimens | Demonstrated per ISO 11981:2017 |
| Color Additive Leachability | Color additives are stable and do not leach | Demonstrated |
Since the document explicitly states that no clinical study was utilized and does not mention any AI/ML components, the remaining points of your request cannot be fulfilled as they pertain to such a study.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI/ML model or human reader study is described. The "test set" here refers to samples of contact lenses undergoing physical, chemical, and biological testing, not patient data for an AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in an AI/ML context (e.g., for image interpretation) is not established by experts in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established through physical measurements, chemical analyses, and biological assays (e.g., cytotoxicity tests).
8. The sample size for the training set: Not applicable. There is no mention of a training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.