(93 days)
The ORI is intended for augmentation or restoration and to separate tissues. The Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.
The ORI is a non-absorbable, inert, sterile, porous, surgical implant composed of silicone elastomer and expanded polytetrafluoroethylene (ePTFE). If desired, the thickness of the ORI can be augmented by adding a small volume of saline prior to implantation. This polymeric implant is available in a range of lengths, widths and thicknesses to accommodate the surgical application and the needs of the individual surgeon practicing medicine.
The provided text describes a 510(k) submission for the Orbital Reconstructive Implant (ORI), which is a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.
Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document states:
- "The safety and effectiveness evaluations based on biocompatibility and biomechanical performance data provided in this 510(k) demonstrate that the ORI is substantially equivalent to the cited predicate devices."
- "The results of these evaluations of the ORI support the conclusion that it is safe and effective for its intended use and that it is sub- stantially equivalent to the cited predicate device(s) with regards to its safety and effectiveness."
This indicates that the submission relies on demonstrating similarity to already approved devices (predicates) in terms of materials, intended use, and general characteristics, along with biocompatibility and biomechanical performance data, rather than a clinical study establishing specific quantitative or qualitative performance metrics against predefined acceptance criteria for a new clinical application or diagnostic capability.
To answer your specific questions:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence, not on meeting specific quantitative or qualitative performance acceptance criteria from a clinical trial.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical "test set" study is described in this document. The evaluations mentioned are likely pre-clinical (biocompatibility, biomechanical).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 medical implant, not an AI-assisted diagnostic or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an implant, not an algorithm.
- The type of ground truth used: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is the regulatory acceptance of the predicate devices.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.