(72 days)
The CORE Spherex Implant is intended to be used as a corrective prosthesis for the anophthalmic socket.
The GORE Spherex Implant is an expanded polytetrafluoroethylene (ePTFE ) and fluorinated ethylene propylene ( FEP ) laminate which is intended to be used as a space filling, corrective prosthesis for the anophthalmic socket. The open microstructure of the ePTFE material allows for host tissue ingrowth. The device is machined to create a smooth, spherical structure which is provided in a variety of sizes.
The provided text is a Premarket Notification Summary for a medical device (GORE Spherex Implant) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where the device meets specific acceptance criteria based on performance data.
Therefore, I cannot complete the table of acceptance criteria and reported device performance, nor can I answer questions related to a study proving the device meets acceptance criteria.
The document details the device's description, intended use, and technological characteristics in comparison to predicate devices, but does not describe an analytical validation, clinical validation, or a clinical study with acceptance criteria and corresponding performance metrics.
However, I can extract information regarding non-clinical data and general statements about safety and effectiveness if that is helpful. But it will not fulfill the request to describe acceptance criteria and a study proving their fulfillment.
Missing Information/Cannot Answer based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes the device's characteristics and compares it to predicate devices, but does not state specific performance metrics or acceptance criteria for those metrics.
- Sample sized used for the test set and the data provenance: No test set or clinical study supporting performance is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no such study is detailed.
- 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 not an AI-based diagnostic tool, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no such study is detailed.
- The sample size for the training set: Not applicable as no such study where a training set would be relevant is detailed.
- How the ground truth for the training set was established: Not applicable as no such study is detailed.
Information provided in the document (but not directly answering the prompt's specific questions about acceptance criteria and a performance study):
The "Nonclinical Data" section states:
- "The evaluation of the GORE Spherex Implant reveals that the use of this device as a corrective prosthesis for the anophthalmic socket did not demonstrate any abnormal effects."
- "The biological response was very similar to the response elicited elsewhere in the face when the material has been used in other applications as a plastic and reconstructive prosthetic."
- "The foreign-body tissue response is minimal and there is extensive cellular migration laterally, posteriorly and anteriorly into the material. Vascularization into the eveball is evident with numerous capillaries within the device's interstices."
- "The nonclinical data reveal that the material functioned safely and effectively in this application."
This "nonclinical data" appears to be from pre-clinical (e.g., animal or in-vitro) studies, but no specific methodology, sample sizes, or acceptance criteria the data was measured against are provided in this summary. The purpose of this section is to support the overall claim that "no new safety and effectiveness questions are posed."
{0}------------------------------------------------
96224
3 722
Premarket Notification Summary
| Applicant: | W. L. Gore and Associates, Inc.3750 W. Kiltie LaneFlagstaff, Arizona 86002Phone: 520-779-2771FAX: 520-779-1456 |
|---|---|
| Contact: | John W. Nicholson, Associate |
| Date of Preparation: | 8/16/96 |
| Applicant Device : | |
|---|---|
| Trade Name: | CORE Spherex Implant |
| Common Name: | Eye Shphere Implant |
| Classification Name: | Eye Shphere Implant |
Predicate Devices:
For the purposes of determining substantial equivalence, GORE cites the following as predicate devices:
- SAM Reinforced Facial Implant .
- Porex MEDPOR Biomaterial, Conical Volume Augmentation (CVA) Implant ●
- Porex MEDPOR Biomaterial, Preformed Craniofacial Implant ♥
Applicant Device Description:
The GORE Spherex Implant is an expanded polytetrafluoroethylene (ePTFE ) and fluorinated ethylene propylene ( FEP ) laminate which is intended to be used as a space filling, corrective prosthesis for the anophthalmic socket. The open microstructure of the ePTFE material allows for host tissue ingrowth. The device is machined to create a smooth, spherical structure which is provided in a variety of sizes.
Intended Use:
The CORE Spherex Implant is intended to be used as a corrective prosthesis for the anophthalmic socket. This is the same intended use as the predicate Porex CVA implant.
{1}------------------------------------------------
Technological Characteristics:
The GORE Spherex Implant is constructed of the same raw materials, undergoes the same manufacturing processes and is subject to the same quality control evaluations as the predicate SAM Reinforced Facial Implant. The devices are configured for their specific applications whether for rhinoplasty, malarplasty, maxilloplasty, orbital reconstruction or as corrective implants for the anophthalmic socket; the only difference is in the shape of the device. Design, material composition and intended performance reveal that the applicant and this predicate device incorporate identical technological characteristics.
The POREX CVA Implant is configured for the same indication as the applicant device. They both create the same therapeutic effect and, though they are not constructed of identical materials, they fulfill their equivalent clinical functions by providing the physician with a synthetic, biocompatible corrective prosthesis. The applicant device components, ePTFE and FBP, have established a successful clinical history in facial plastic reconstruction individually and combined and their use as a corrective prosthesis for the anophthalmic socket poses no new questions regarding safety and efficacy.
Nonclinical Data:
The evaluation of the GORE Spherex Implant reveals that the use of this device as a corrective prosthesis for the anophthalmic socket did not demonstrate any abnormal effects. The biological response was very similar to the response elicited elsewhere in the face when the material has been used in other applications as a plastic and reconstructive prosthetic. The foreign-body tissue response is minimal and there is extensive cellular migration laterally, posteriorly and anteriorly into the material. Vascularization into the eveball is evident with numerous capillaries within the device's interstices. The nonclinical data reveal that the material functioned safely and effectively in this application.
Conclusion:
This submission demonstrates that the applicant device and predicate CVA Implant device have the same indication. The applicant device incorporates the identical technological characteristics as the predicate GORE device and the only difference with the predicate POREX device is in the selection of materials. The successful clinical history of the applicant's components, singly and in combination, and the positive nonclinical implant data reveal that no new safety and effectiveness questions are posed by the use of these materials in this application.
§ 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.