(85 days)
MASTERGRAFT® Putty is combined with either sterile water and/or autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Putty is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include:
- . Filling of periodontal defects
- . Filling of dental extraction sockets
- . Filling of cystic defects
- . Sinus lifts
- . Alveolar ridge augmentation
- . Oral/maxillofacial augmentation or reconstruction.
MASTERGRAFT® Putty may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
MASTERGRAFT® Putty is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. The collagen component is Type I bovine collagen. The biphasic ceramic portion of MASTERGRAFT® Putty is provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. MASTERGRAFT® Putty is supplied as a sterile, dry, solid, construct that is hydrated for single patient use and is a moldable form of bone void filler. The device is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible. MASTERGRAFT® Putty has been shown to heal bone defects.
This document is a 510(k) summary for Medtronic Sofamor Danek MASTERGRAFT® Putty, indicating its clearance for use in oral and oral/maxillofacial regions. It asserts substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a direct response to your request, which expects explicit acceptance criteria and study results, cannot be fully provided from the given text.
Based on the information provided in the 510(k) summary:
- Acceptance Criteria and Reported Device Performance: This document does not specify quantitative acceptance criteria or provide a table of device performance against such criteria. The "acceptance" here refers to the FDA's determination of "substantial equivalence" to predicate devices, not meeting pre-defined performance metrics in a clinical study.
- Study Details (for a device proving equivalence): The document claims substantial equivalence based on comparisons to predicate devices (K071813, K010701, K030682, K062834, K051885).
- Sample size used for the test set and data provenance: No specific test set sample size or data provenance is mentioned as this is a substantial equivalence claim, not a de novo clinical study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts for a test set is typically part of a clinical trial or performance study, which is not detailed here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The document does not describe MRMC studies or human reader improvement with AI assistance, as this device is a bone void filler, not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a bone void filler product.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for "substantial equivalence" is the established safety and effectiveness of the predicate devices. The document implies that data from previous clearances (K071813, K010701, K030682, K062834, K051885) was used to support this claim.
- The sample size for the training set: Not applicable. This summary does not describe a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The "study" in this context is the comparison demonstrating "substantial equivalence" to previously cleared predicate devices, not a clinical trial designed to establish specific performance metrics against acceptance criteria.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared predicate devices for the expanded indications in oral/maxillofacial regions. | MASTERGRAFT® Putty was deemed substantially equivalent to: |
§ 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.