(298 days)
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:
| Acceptance Criteria Category | Specific Criteria (Implicit for S.E. to Predicate) | Reported Device Performance |
|---|---|---|
| Non-Clinical Bench Testing | ||
| Diameter and Tunnel Dimensions | Within specified tolerance | Met acceptance criteria |
| Implant Mass | Within specified tolerance | Met acceptance criteria |
| Sphericity | Within specified tolerance | Met acceptance criteria |
| Open Porosity | 40-60% | Met acceptance criteria |
| Resistance to Compression | Sufficient to withstand expected forces | Met acceptance criteria |
| Resistance to Traction | Sufficient to withstand expected forces | Met acceptance criteria |
| Biocompatibility | ||
| Chemical Characterization | No unacceptable leachables | Met acceptance criteria |
| Cytotoxicity | Non-cytotoxic | Met acceptance criteria |
| Sensitization | Non-sensitizing | Met acceptance criteria |
| Irritation | Non-irritating | Met acceptance criteria |
| Sterilization | Sterile (SAL 10^-6) | Sterilized by EO |
| Endotoxin | Meets endotoxin limits | Performed and met criteria |
| Shelf Life | 5 years, maintained functional performance and package integrity | Established at 5 years |
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.
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.