(83 days)
Hylashield® CL Lubricating Eye Drops are indicated for lubricating and wetting/rewetting rigid gas permeable contact lenses.
Hylashield® CL Lubricating Eye Drop is a sterile, isotonic, preservative-free, clear, elastoviscous, ophthalmic solution presented in a single-use container. It contains hylan fluid, a viscous, elastic and biocompatible substance derived from the natural polysaccharide, hyaluronan. It lubricates and wets/rewets your lenses, thereby providing prolonged relief from symptoms of ocular discomfort associated with the use of rigid gas permeable contact lenses.
The provided text describes a 510(k) summary for the Hylashield® CL Lubricating Eye Drop, which aims to demonstrate substantial equivalence to legally marketed predicate devices. The document focuses on preclinical safety studies and a clinical safety and efficacy study. However, it does not explicitly define acceptance criteria as numerical thresholds or metrics that the device had to meet. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence, meaning the device's performance should be comparable to the predicate devices.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit, quantitative acceptance criteria. The "reported device performance" is described in terms of its equivalence to the predicate device in a clinical study.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Clinical Safety: Well tolerated, low adverse event rate, comparable to predicate device. | The clinical study data showed "extremely low rate of adverse events in both treatment groups" (Hylashield® CL and Wet-N-Soak®), indicating that Hylashield® CL Lubricating Eye Drop is "well tolerated and safe when compared to Wet-N-Soak®." |
| Clinical Efficacy (Lubricating and Wetting/Rewetting): Similar performance to predicate device in minimizing daily discomfort. | The analysis of the clinical study data showed "substantial equivalence of Hylashield® CL Lubricating Eye Drop with Wet-N-Soak® with regard to slit lamp findings, symptom/problems/complaints, visual acuity, average wear time and lens replacement." The data "demonstrated that Hylashield® CL Lubricating Eye Drop is substantially equivalent to its predicate device, Wet-N-Soak with respect to safety and effectiveness as a lubricating and wetting/rewetting agent." |
| Biocompatibility: No new safety and efficacy issues compared to predicate devices, compatible with ocular structures. | Hylan has been shown to be "compatible with ocular structures and raises no new safety and efficacy issues." Extensive preclinical (in vivo animal and human use) studies are cited to support biocompatibility. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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Clinical Study (Comparative Effectiveness Study): The document states that the clinical study compared Hylashield® CL to Wet-N-Soak® in "minimizing daily discomfort associated with rigid gas permeable (RGP) contact lenses." It evaluated them "in conjunction with the two most commonly used RGP lens types."
- Sample Size: The exact sample size for the clinical study is not specified in the provided text.
- Data Provenance: The country of origin is not specified. The study appears to be a prospective clinical trial given the description of comparison and evaluation.
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Preclinical Safety Studies: A large number of preclinical studies are listed, many of which are in vivo animal studies.
- Sample Size: Specific sample sizes for each preclinical study are not detailed (e.g., number of rabbits, guinea pigs, mice, owl monkeys are mentioned in relation to the type of study, but not the count per study).
- Data Provenance: Given the nature of these studies (e.g., "in vivo animal and human use," "intracutaneous toxicity study in rabbit"), they would likely be prospective studies conducted in a laboratory setting. The country of origin is not specified, but the document itself is for submission to the U.S. FDA.
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)
Not Applicable. For this type of medical device (lubricating eye drop), ground truth is established through direct observation, patient reporting of symptoms, and clinical examinations (e.g., slit lamp findings, visual acuity measurements). There is no "test set" in the context of image analysis requiring experts to establish truth, nor is there a "device" in the sense of an algorithm whose output is compared to an expert's assessment. The clinical study compares direct patient outcomes and clinical measurements between two products.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. As explained above, this device does not involve a "test set" that requires adjudication by experts in the context of a diagnostic or image-analysis device. The clinical study likely involved standard clinical outcome measures and evaluations by clinicians, but no specific adjudication method for establishing a "ground truth" for algorithmic performance is mentioned or relevant here.
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
Not Applicable. This is a lubricating eye drop, not an AI-powered diagnostic or image-analysis device. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (lubricating eye drop), not an algorithm or software. Therefore, standalone performance of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" or primary endpoints were assessed through:
- Clinical Outcomes Data: Slit lamp findings, visual acuity measurements, average wear time, lens replacement.
- Patient-Reported Outcomes: Symptom/problems/complaints, daily discomfort.
For the preclinical safety studies, the "ground truth" was established through:
- Biological Tests: Such as irritation tests, sensitization assays, cytotoxicity, acute systemic toxicity, hemocompatibility, pyrogenicity, implantation studies, mutagenicity, subchronic toxicity, reproduction studies, and pharmacokinetics. These involve direct observation, histological analysis, biochemical analysis, and other laboratory methods to determine biological responses.
8. The sample size for the training set
Not Applicable. As this is not an AI/ML device, there is no "training set." The preclinical and clinical studies aim to demonstrate the safety and effectiveness of the physical product itself.
9. How the ground truth for the training set was established
Not Applicable. (Refer to point 8).
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”