(132 days)
MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can be used with autograft as a bone graft extender. MASTERGRAFT® Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral 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® Resorbable Ceramic Granules provides a bone void filler that resorbs and is replaced with bone during the healing process.
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.
The provided text describes a 510(k) submission for the Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules, seeking to expand its indications for use and size range. However, the document does not contain information about:
- Acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy).
- Any new study conducted to "prove the device meets the acceptance criteria" for the expanded indications.
- Sample sizes for test or training sets.
- Data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices.
Here's a breakdown based on the provided text, highlighting the missing information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as measurable performance metrics for the device itself in a study context. The "acceptance criteria" for the 510(k) approval process is typically demonstrating substantial equivalence to a legally marketed predicate device for the proposed indications.
| Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicates | The submission 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™ (K051774, SE 01/20/2006)." |
| Expanded Indication Performance | The document implies that the expanded indications (use with autograft as a bone graft extender, smaller size range) are also covered by the substantial equivalence argument, meaning the device's performance for these uses is considered comparable to the predicate devices. No new, quantitative performance data for these specific expanded indications are reported for a "study." |
| Device Composition | "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." This composition is presumably similar to or within the acceptable range of the predicate devices. |
| Biocompatibility/Safety (Implied) | While not explicitly detailed as acceptance criteria here, regulatory approval implies the device meets safety and biocompatibility standards, likely through similarity to predicate devices or prior testing. The document states it is "provided sterile for single patient use." |
| Functionality (Osteoconductivity) | "MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant." This characteristic is also shared with the predicate devices and is a fundamental aspect of its intended use. "provides a bone void filler that resorbs and is replaced with bone during the healing process." |
| Clinical Efficacy (Implied by Indication) | The indication for use (bone void filler, bone graft extender) implies an expected clinical outcome, which is considered met through substantial equivalence. There is no specific clinical trial data or performance metrics (e.g., rate of bone fusion, resorption time) presented as part of this 510(k) summary for a "study" conducted for this specific submission. |
Study Details (Information Not Provided in the Document)
- Sample size used for the test set and the data provenance: Not provided. The submission relies on substantial equivalence to predicate devices, not a new clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study with a test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/imaging device, and no such study is described.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bone void filler), not an algorithm.
- The type of ground truth used: Not applicable for this 510(k) summary. For bone void fillers, "ground truth" would typically relate to histological evidence of bone formation, clinical outcomes, or radiological assessment over time, none of which are described in the context of a new study in this document.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that uses training sets.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices for device approval and expanded indications, rather than reporting on a new performance study with explicit acceptance criteria and corresponding results for the device itself.
§ 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.