(181 days)
MasterGraft™ Matrix combined with autogenous bone marrow is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Matrix is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraff™ Matrix provides a bone void filler that resorbs and is replaced with bone during the healing process.
MasterGraft™ Matrix is made of medical grade combination of purified collagen and hydroxyapatite and B-tricalcium phosphate ceramic. The collagen is a highly purified bioresorbable lyophilized bovine tendon that is primarily Type I collagen. The ceramic portion of MasterGraft™ Matrix is provided in a 15 percent hydroxyapatite and 85 percent B-tricalcium phosphate formulation. The product is supplied sterile in a premixed strip form for single patient use. MasterGraft™ Matrix is a 3-dimensional, 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.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics, such as accuracy, sensitivity, or specificity.
Instead, the document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Matrix, which details:
- Product Description: Composition of the device (collagen, hydroxyapatite, B-tricalcium phosphate ceramic).
- Indications for Use: What the device is intended for (bony voids or gaps not intrinsic to stability, combined with autogenous bone marrow).
- Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to previously cleared predicate devices (Master Graft™ Resorbable Ceramic K020986 and K012506), not through a study demonstrating achievement of specific performance metrics against pre-defined acceptance criteria.
The FDA's 510(k) clearance process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring extensive clinical trials or performance studies with acceptance criteria in the way one might expect for a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information from the given text regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or its effect size.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.