(101 days)
MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules 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® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.
MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.
This 510(k) premarket notification for Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules primarily focuses on expanding the indications for use to the oral and maxillofacial region, based on substantial equivalence to previously cleared devices. Therefore, the traditional "acceptance criteria" and detailed "study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, and confidence intervals, which are common in AI/Diagnostic device submissions, are not applicable here.
Instead, the "acceptance criteria" for this type of submission revolve around demonstrating substantial equivalence to predicate devices for the new indications. The "study" proving this involves a comparison of the device's characteristics (material composition, intended use, technological characteristics) to the predicate devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, for this 510(k) application, the acceptance criteria are not performance metrics but rather a demonstration of substantial equivalence.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Demonstration) |
|---|---|
| Material Composition Equivalence: Device material is equivalent to predicate devices. | MASTERGRAFT® Resorbable Ceramic Granules is made of a medical-grade combination of hydroxyapatite and b-tricalcium phosphate (60% HA, 40% b-TCP or 15% HA, 85% b-TCP). This composition falls within the established parameters of the predicate devices. |
| Intended Use Equivalence (for expanded indications): Device's intended use for oral and maxillofacial applications is equivalent to predicate devices. | The device is intended for use alone or combined with autograft as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure in the oral and maxillofacial region (e.g., periodontal defects, extraction sockets, cystic defects, sinus lifts, alveolar ridge augmentation, oral/maxillofacial augmentation or reconstruction). This expanded indication is argued to be substantially equivalent to the existing indications of the predicate devices. |
| Technological Characteristics Equivalence: Device shares similar technological characteristics with predicate devices. | The document states "Documentation is provided that demonstrates MASTERGRAFT® Resorbable Ceramic Granules to be substantially equivalent to the previously cleared MASTERGRAFT® Resorbable Ceramic Granules (K020986, SE 07/22/2002) and MBCP™ (K051885, SE 09/16/2005)." This implies that the design, manufacturing, and operational principles are similar. |
| Performance Data (if applicable for substantial equivalence): Any relevant performance data (e.g., biocompatibility) supports equivalence. | While not explicitly detailed as performance studies in this summary, the substantial equivalence claim inherently relies on the understanding that the device performs similarly to the predicates in terms of osteoconductivity and resorption characteristics, given the similar composition. The 510(k) process typically assumes that if a new device has similar technological characteristics and intended uses to a predicate, it will function similarly. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not describe a "test set" in the context of clinical performance or algorithm evaluation. This submission is for substantial equivalence based on material composition and intended use expansion, not for demonstrating clinical efficacy through a new trial with a distinct test set.
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)
Not applicable. There was no clinical "test set" requiring expert ground truth establishment for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical "test set" requiring adjudication for this 510(k) submission.
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 is not an AI/diagnostic device, and no MRMC study was conducted or referenced in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a clinical study for a diagnostic or AI device. The "ground truth" for this submission is embedded in the regulatory precedent set by the predicate devices (K020986 and K051885) and their established safety and effectiveness. The "truth" being established is that the new device is substantially equivalent to these already-approved devices.
8. The sample size for the training set
Not applicable. There was no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There was no "training set."
Summary of the Study for Substantial Equivalence:
The "study" for this 510(k) submission is a comparison to predicate devices (MASTERGRAFT® Resorbable Ceramic Granules K020986 and MBCP™ K051885). The manufacturer provided documentation demonstrating that the subject device shares the same material composition (hydroxyapatite and b-tricalcium phosphate) and similar technological characteristics, and that its expanded oral and maxillofacial indications are substantially equivalent to the existing indications of the predicate devices. The FDA reviewed this documentation and concurred with the substantial equivalence claim, allowing the device to be marketed for the specified expanded indications. This process does not involve new clinical trials or performance studies to establish "acceptance criteria" through statistical metrics.
§ 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.