(131 days)
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.
The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that directly proves the device meets such criteria. The document describes a 510(k) summary for a medical device (Cytoplast™ GBR Non-Absorbable Barrier Membrane) and primarily focuses on comparing it to predicate devices to establish substantial equivalence.
Here's a breakdown of why I cannot fulfill your request with the given input:
- Acceptance Criteria and Device Performance: The document states that the device is "identical in composition, function, and intended use to legally marketed predicate devices" and "performs at least as well." However, it does not provide specific quantitative acceptance criteria (e.g., "device must achieve X % success rate" or "device must have Y MPa tensile strength") or any reported device performance data against such criteria.
- Study Details: There is no mention of any specific study (clinical trial, bench test, in-vitro study) with details about sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods. The comparison is based on the characteristics of the device being similar to already approved predicate devices.
- MRMC, Standalone, Training Set: These concepts are relevant to studies involving AI algorithms or diagnostic devices. The Cytoplast™ GBR is a physical barrier membrane, and the provided document does not indicate any AI component, diagnostic function, or a multireader assessment.
Therefore, I cannot populate the requested table or answer the specific questions about study design, ground truth, or training sets from the information given. The provided text is a summary for a 510(k) submission focused on substantial equivalence to existing devices rather than a detailed report of a performance study with specific acceptance criteria.
{0}------------------------------------------------
MAR 1 1 1997
510 (k) SUMMARY
ADMINISTRATIVE 1.
Osteogenics Co. Submitter: 3234 64th Street Lubbock, TX 79413 (806) 792-2311
Contact Person: Barry K. Bartee, DDS
Date of Preparation: January 29, 1997
DEVICE NAME 11.
Proprietary Name: Cytoplast ™ GBR
Common Name: Non-Absorbable Barrier Membrane
Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation.
PREDICATE DEVICES =============================================================================================================================================================================
Gore-Tex™ Regenerative Material (K922627; W.L Gore & Associates, Inc.) TefGen-FD (K935137; American Custom Medical) Imtec Biobarrier Membrane (K950306; Imtec Corporation)
IV. DEVICE DESCRIPTION
The Cytoplast™ GBR Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film with a nominal thickness of 250 microns and supplied in a variety of shapes and sizes. Membranes are supplied sterile in sealed pouches.
The biocompatibility of polytetrafluoroethylene (PTFE) has been established through a long history of use in a variety of long-term PTFE implant devices, such as PTFE vascular prostheses and cardiovascular patches. The Cytoplast™ GBR Non-Absorbable Barrier Membrane has been shown to be non-cytotoxic.
V. INTENDED USE
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
{1}------------------------------------------------
VI. COMPARISON TO PREDICATE DEVICES
The Cytoplast ™ GBR Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material, TefGen-FD, and the Imtec Biobarrier Membrane.
Accordingly, Osteogenics Co. concluded that the Cytoplast™ GBR Non - Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.