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The EZYPOR® orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.

EZYPOR® orbital implants are high density polyethylene (UHMWPE) implants designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation procedures. The polyethylene material has an open porosity structure of 40 to 60%. The implants are available in six diameter sizes, 12, 14, 16, 18, 20 and 22 mm. EZYPOR® orbital implants are supplied sterile and are sterilized by ethylene oxide.

This is a 510(k) summary for the EZYPOR® orbital implant, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving the device meets specific performance criteria through clinical trials. Therefore, much of the requested information about acceptance criteria for device performance in a clinical context, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable or available within this type of submission.

The document discusses non-clinical bench testing to ensure the device meets predefined specifications for its physical characteristics and biocompatibility.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for non-clinical bench testing. Standard engineering and material testing practices would imply a sufficient number of units were tested to ensure consistency and meet statistical requirements for demonstrating product specifications.
• Data Provenance: Not explicitly stated, but assumed to be from internal testing conducted by FCI S.A.S. (France Chirurgie Instrumentation SAS). The testing is non-clinical/bench-level, so concepts like "country of origin of the data" in a clinical sense or "retrospective/prospective" studies do not apply.

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

• Not applicable. Ground truth for non-clinical bench testing is established by engineering specifications, material standards, and validated test methods.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are typically for clinical studies where subjective interpretations might be involved. For bench testing, results are objectively measured against predefined specifications.

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 device is an orbital implant, not an AI-powered diagnostic tool requiring human reader studies.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For non-clinical bench tests (diameter, mass, sphericity, porosity, resistance, biocompatibility, sterilization, shelf life), the "ground truth" is defined by pre-established engineering specifications, material standards (e.g., ISO standards), and validated test methodologies.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set is used for this device.

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Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.

This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.

However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.

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The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of:

• Canalicular pathologies (stenoses, obstructions, lacerations),

• Congenital duct obstruction (Hasner valve stenosis),

• Dacryocystorhinostomy (conventional or laser).

The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called RITLENG®+ and RITLENG®+ PVP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the same way one might describe a novel diagnostic AI algorithm.

Therefore, the information about acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission, where the "study" is primarily a non-clinical comparison and testing against established specifications and predicate device characteristics.

Here's the breakdown based on the provided text:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The RITLENG®+ device is a bicanalicular lacrimal stent. For a 510(k) submission, the "acceptance criteria" are predominantly related to the device's technical specifications, safety, and functionality being comparable to a predicate device, as well as meeting relevant standards. The "study" refers to the non-clinical tests performed to demonstrate this equivalence and performance.

1. Table of Acceptance Criteria and the Reported Device Performance:

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

This document does not describe a "test set" in the context of clinical data for an AI/diagnostic device. The "tests" mentioned are non-clinical bench tests (e.g., cytotoxicity, chemical characterization, sterilization efficacy, material testing, package integrity, stability studies). Therefore, terms like "sample size," "data provenance," "country of origin," and "retrospective/prospective" are not applicable in the way they would be for a clinical study on human subjects or an AI product's performance. The "samples" for testing would be units of the device itself or its constituent materials. The provenance of this physical testing data is from the manufacturer (FCI SAS) and the testing laboratories they contracted.

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 is not applicable. The ground truth for non-clinical tests is based on scientific and engineering standards and validated test methodologies, not expert consensus in a medical diagnostic sense. For example, "ground truth" for cytotoxicity is determined by cell viability assays against established thresholds, not by a panel of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no "test set" requiring expert adjudication in the context of this 510(k) submission.

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. This is a conventional medical device (lacrimal stent), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable. This is a conventional medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's evaluation is primarily based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility), validated test methods, and comparison to the characteristics of the predicate device. For instance:

• Biocompatibility: Results of cytotoxicity, chemical characterization tests against established safety thresholds.
• Sterility: Absence of microorganisms to a sterility assurance level (SAL) of 10^-6, confirmed by validated sterilization processes.
• Physical Properties: Measurement of dimensions, material strength, etc., against predefined specifications.
• Intended Use: Direct comparison of the stated indications for use with the predicate device.

8. The sample size for the training set

This is not applicable. This is a conventional medical device, not an AI product that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable.

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LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.

LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.

LacriJet® is a monocanalicular intubation device, with self-retaining punctal fixation for the treatment of monocanalicular lacerations and stenoses. The silicone stent acts as a conformer. The shape of the fixation head keeps the probe from migrating and from expulsing.

The provided text is a 510(k) Pre-Market Notification from the FDA regarding the LacriJet® device. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical tests.

However, the document does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance. The LacriJet® is a physical medical device (a monocanalicular lacrimal stent), not a software or AI-based diagnostic/assessment tool.

Therefore, it is not possible to extract the requested information regarding acceptance criteria met by a study, sample size, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are not applicable to the type of device and submission described in the FDA document.

The document primarily focuses on establishing substantial equivalence based on:

• Intended Use: Similar to predicate devices (MASTERKA, Eagle Vision Monocanalicular Stent, Mini-Monoka).
• Technological Characteristics: Made of the same medical-grade silicone as a predicate, similar design for the stent and fixation head. The primary difference is in the delivery system, which the submission argues does not raise new safety or effectiveness concerns.
• Non-Clinical Testing: Confirms the device meets established specifications related to biocompatibility, sterilization, package integrity, and shelf-life, demonstrating equivalence to the predicate device in these aspects.

In summary, the provided text does not contain the information requested in your prompt as it pertains to a physical medical device clearance, not an AI/ML-driven device validation study.

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