(213 days)
MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.
This document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a de novo study with specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for an AI/device performance evaluation is not applicable or present in this document.
Here's an breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This document does not describe specific performance acceptance criteria or report on performance metrics in the way one would for an AI or novel device study. The core of this 510(k) summary is to demonstrate "substantial equivalence" of the MasterGraft™ Bone Void Filler to existing, legally marketed bone void fillers.
The "performance" described is the product's intended function based on its composition and mechanism of action, which is assumed to be similar to its predicates.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No test set for performance evaluation is described. The document pertains to regulatory clearance based on substantial equivalence, not a clinical performance study with a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable. No test set or ground truth establishment by experts is described.
4. Adjudication Method for the Test Set
Not Applicable. No test set or adjudication method is described.
5. 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 document concerns a physical medical device (bone void filler), not an AI algorithm. Therefore, an MRMC study and AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This document concerns a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not Applicable. No ground truth for performance evaluation is mentioned as this is a substantial equivalence submission. The closest concept might be the established safety and efficacy of the predicate devices.
8. The Sample Size for the Training Set
Not Applicable. No training set is mentioned as this is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. No training set or ground truth establishment is described.
Summary of the Document's Content:
The document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It outlines:
- Product Description: A medical-grade combination of hydroxyapatite and β-tricalcium phosphate, supplied sterile, in two formulations (60% HA/40% β-TCP or 15% HA/85% β-TCP). It is described as an osteoconductive porous implant.
- Indications for Use: For bony voids or gaps not intrinsic to the stability of the bony structure, to be gently packed into skeletal voids (spine, pelvis, extremities). These defects can be surgically created or from traumatic injury. The product resorbs and is replaced by bone during healing.
- Substantial Equivalence: The primary assertion is that the MasterGraft™ Bone Void Filler is substantially equivalent to other previously cleared bone void fillers. This means the device is considered as safe and effective as a legally marketed predicate device, and thus does not require a de novo premarket approval application. The FDA letter confirms this finding of substantial equivalence (K012506).
§ 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.