(117 days)
MasterGraft™ Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraff™ Resorbable Ceramic is to be gently packed into bony voids 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. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.
MasterGraft™ Resorbable Ceramic is made of medical grade combination of hydroxyapatite and ß-tricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ß-tricalcium 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™ Resorbable Ceramic. A 510(k) submission is a premarket notification demonstrating that a device is at least as safe and effective as a legally marketed predicate device. This type of submission generally does not include detailed studies on performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel, high-risk device might.
Based on the provided text, the submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a standalone study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth details, training set size) is not present in this type of document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. This document does not describe specific numerical acceptance criteria (e.g., a certain percentage of bone regeneration, or a specific mechanical strength) or report performance against such criteria. The entire premise of a 510(k) is to demonstrate substantial equivalence, not to prove novel performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No test set or associated sample size is mentioned. The submission is based on demonstrating equivalence, likely through material characterization, predicate device literature review, and potentially some in-vitro or animal testing (though not detailed here).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing. Not applicable for a substantial equivalence submission of this nature. There is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. Not applicable.
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
- Missing. Not applicable. This device is a bone void filler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. Not applicable. This device is a bone void filler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. While the device is intended to be replaced by bone during healing, the 510(k) summary does not describe specific studies that established "ground truth" using pathology or outcomes data in the context of a clinical performance study. The ground truth for substantiating equivalence would be data supporting the properties and efficacy of the predicate devices.
8. The sample size for the training set
- Missing. Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Missing. Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k)):
The "study" described in this document is a demonstration of Substantial Equivalence to legally marketed predicate devices, not a study proving the device meets specific (new) performance acceptance criteria.
- Substantial Equivalence Claim: The documentation "demonstrated the MasterGraft™ Resorbable Ceramic to be substantially equivalent to itself and Interpore Cross International ProOsteon 500R (K990131)."
- Purpose of Submission: The specific purpose of this particular submission was to:
- Increase the granule size of the MasterGraft™ device.
- Expand the indications to include the ilium.
- Implied Acceptance Criteria (for substantial equivalence): The implied acceptance criteria are that the modifications (larger granule size, expanded indication to ilium) do not alter the fundamental safety and effectiveness profile of the device such that it is no longer substantially equivalent to its own previous version or the identified predicate device ProOsteon 500R, for its stated indications. This would typically involve demonstrating similar material properties, biocompatibility, and intended function. The FDA's letter confirms that the review found the device to be substantially equivalent for the stated indications for use.
In conclusion, this regulatory document does not contain the level of detail requested concerning specific acceptance criteria and detailed study methodology because it is a 510(k) submission focused on demonstrating substantial equivalence rather than a detailed performance study against novel, quantitative acceptance criteria.
§ 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.