(126 days)
HDS HI 1.54™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.
HDS HI 1.54™ rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. HDS HI 1.54™ toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters.
HDS HI 1.54™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
HDS HI 1.54™ contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery, in otherwise non-diseased eyes.
HDS HI 1.54 (pahrifocon A) rigid gas permeable contact lenses for daily wear are available as lathe cut contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior, or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.
The HDS HI 1.54 rigid gas permeable contact lens material is a thermoset copolymer derived from acrylate, silicone acrylate, and fluorosilicone acrylate monomers, dimers and oligomers.
The HDS HI 1.54 rigid gas permeable tinted lenses offer a handling aid for locating the lens and may be plasma treated.
Here's a breakdown of the acceptance criteria and the study details for the Paragon HDS HI 1.54 rigid gas permeable contact lens, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a formal table; instead, the submission focuses on demonstrating "substantial equivalence" to the predicate device (FluoroPerm 30) through comparative performance data and clinical outcomes. The device performance is generally presented by comparing the HDS HI 1.54 to the predicate or demonstrating acceptable clinical observations.
Given the information, I've constructed a table highlighting key properties and clinical outcomes where performance comparison implicitly serves as the acceptance criterion (i.e., being comparable to or better than the predicate, or within expected clinical ranges).
| Property/Clinical Outcome | Acceptance Criteria (Implied) | Reported HDS HI 1.54 Performance (Un-irradiated) | Reported FluoroPerm 30 Performance (Predicate) |
|---|---|---|---|
| Material Properties | |||
| Specific Gravity | Comparable to predicate | 1.12 | 1.14 |
| Refractive Index | Comparable to predicate | 1.54 | 1.466 |
| % Light Transmittance | Comparable to predicate (for blue tinted material) | 93 | 94 |
| % Water Content | Comparable to predicate | 1 | 0.20 logMAR decrease (measurement error) |
| Lens Wearing Time | Stable over 13 hours/day, comparable to control | Over 13 hours/day | Over 13 hours/day |
| Lens Replacements | Reasons predominantly for deposits/parameter, discomfort comparable to control | 49 replacements (deposits, parameter change, discomfort) | N/A (historical control, reasons for discontinuation specified) |
| Overall Equivalence | Substantial equivalence to predicate demonstrated | Achieved | N/A |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 76 subjects (152 eyes) were enrolled. 64 subjects (84.2%) completed the study.
- Data Provenance: The study was a multi-site, randomized, double-masked clinical study. The country of origin is not explicitly stated, but the submission is to the US FDA, implying that the study was likely conducted in the US or under ICH GCP guidelines applicable to US submissions. The study was prospective as it involved enrolling subjects and following them with the investigational device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a clinical study involving patients wearing contact lenses, with outcomes measured by eye care practitioners. The text does not specify the number of individual "experts" used to establish ground truth in the sense of adjudication for, for example, image interpretation. However, the study was conducted by clinicians/investigators at multiple sites, presumed to be qualified eye care practitioners. Their qualifications (e.g., ophthalmologists, optometrists, years of experience) are not detailed in this summary.
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Adjudication method for the test set:
- The document describes a "multisite, randomized, double masked clinical study." This suggests that the investigators assessing patient outcomes were masked to whether the patient was using the investigational or control lens where possible, reducing bias in assessment. There is no mention of a formal adjudication panel (e.g., 2+1, 3+1) specifically for reviewing clinical outcomes or discrete "ground truth" events. Clinical findings (e.g., slit lamp evaluation, comfort ratings, visual acuity) would have been recorded by the examining clinicians.
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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 study is for a physical medical device (contact lens) and does not involve AI or human readers interpreting cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a contact lens and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this contact lens study, the "ground truth" for evaluating performance and safety was derived from clinical outcomes data directly observed and recorded by eye care practitioners during patient visits, supplemented by patient-reported comfort and wearing time. This includes:
- Slit lamp findings (e.g., injection, staining)
- Keratometry changes
- Manifest refraction changes
- Visual acuity measurements
- Patient comfort ratings
- Wearing time
- Reports of adverse events and complications.
- For this contact lens study, the "ground truth" for evaluating performance and safety was derived from clinical outcomes data directly observed and recorded by eye care practitioners during patient visits, supplemented by patient-reported comfort and wearing time. This includes:
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The sample size for the training set:
- This is a contact lens, not an AI/ML device, so there is no "training set" in the context of machine learning. The non-clinical tests involved laboratory characterization of the material.
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How the ground truth for the training set was established:
- Not applicable as there is no training set for an AI/ML algorithm. Material properties were established through standard laboratory testing methods (e.g., ISO, ANSI methods for Dk, transmittance, wetting angle, hardness, modulus, etc., and USP/ISO methods for biological reactivity, toxicity).
§ 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.