Search Results

The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.

Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

Here's an analysis of the provided text regarding the Hylasine™ device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (Based on Clinical Safety and Efficacy Study Summary):

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 30 patients.
   • Data Provenance: The study was a clinical evaluation conducted at three centers. It involved comparing treatment in one sinus with no treatment in the contralateral sinus of the same patient. This indicates prospective, multi-center clinical data. The country of origin is not explicitly stated, but the submission is to the US FDA, implying data may be from the US or internationally recognized clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical study's endpoints (synechiae/adhesions, middle meatal stenosis, mucosal status, bleeding control). It only mentions that the product was judged as effective for bleeding, implying clinical assessment by the physicians involved in the study.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct comparisons within each patient (treated vs. untreated contralateral sinus).

4. 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, an MRMC study was NOT done. This device is a medical product (gel stent), not an AI diagnostic or assistance system that would involve human readers interpreting images.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a medical device (gel) and not an algorithm or AI system.

6. The type of ground truth used:

   • Clinical observation and assessment. The ground truth for the clinical study outcomes (synechiae, stenosis, mucosal status, bleeding) would have been established through direct clinical examination and assessment by the treating surgeons/clinicians during the follow-up period.

7. The sample size for the training set:

   • Not applicable. This device is a physical product (gel), not a machine learning model, so there is no concept of a "training set" in the context of data used for algorithm development. The safety and performance data came from preclinical animal studies and a human clinical trial.

8. How the ground truth for the training set was established:

   • Not applicable. As a physical device, there is no "training set" or "ground truth" established for algorithm training. The preclinical and clinical studies provided evidence for safety and effectiveness. For the preclinical studies, ground truth for endpoints like irritation, toxicity, and implantation was established through standard laboratory and histological analyses. For the clinical study, it was clinical observation.

Ask a specific question about this device

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.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• 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.

• 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).

Ask a specific question about this device