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510(k) Data Aggregation
(306 days)
MASTERGRAFT® Strip is to be combined with autogenous bone marrow and is indicated for bony voids or qaps that are not intrinsic to the stability of the bony structure and can be used as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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. The device resorbs and is replaced with bone during the healing process.
MASTERGRAFT® Strip is made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic. In the MASTERGRAFT® Strip device, the collagen is a highly purified (s95%) Type I bioresorbable lyophilized collagen. The biphasic ceramic portion of all devices is provided in a 15% hydroxyapatite and 85% b-tricalcium phosphate formulation.
MASTERGRAFT® Strip is supplied sterile in a premixed strip form for single patient use.
MASTERGRAFT® Strip is a biocompatible, osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The device readily absorbs bone marrow aspirate and has been shown to heal bone defects.
This document is a 510(k) Summary for the Medtronic Sofamor Danek MASTERGRAFT® Strip, a resorbable calcium salt bone void filler device. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance data in the way you've outlined for AI/diagnostic devices.
Therefore, the requested information categories are largely not applicable to this type of regulatory submission. The document explicitly states: "Documentation is provided that demonstrates MASTERGRAFT® Strip to be substantially equivalent to the previously cleared..."
Here's a breakdown of why many of your categories cannot be filled from this text:
- Acceptance Criteria & Device Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics for the MASTERGRAFT® Strip. Its purpose is to demonstrate equivalence based on material composition, intended use, and general safety/effectiveness features.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): There is no mention of a clinical study designed to test the device's performance against specific acceptance criteria. This implies that the substantial equivalence was likely demonstrated through non-clinical testing (e.g., biocompatibility, material characterization, mechanical properties) and comparison to predicate devices, rather than a prospective clinical trial with human subjects for performance evaluation in the context of imaging or diagnostic tasks.
- Ground Truth: Since there's no clinical performance study described, there's no "ground truth" established in the way it would be for a diagnostic tool (e.g., confirming disease presence). The "ground truth" for a bone void filler is ultimately successful bone healing and integration, which would be assessed in clinical use, but not typically as part of a 510(k) summary for substantial equivalence.
- Training Set: As no AI or algorithm is involved, there is no training set.
Summary of available information based on the provided text:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance against specific numerical acceptance criteria.
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Sample Size Used for the Test Set and Data Provenance: Not applicable. No clinical "test set" in the context of performance metrics (like for a diagnostic device) is described. Substantial equivalence is based on comparison to predicate devices and material characteristics.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth as typically defined for diagnostic or AI studies is not relevant here.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI or diagnostic device that would typically undergo such a study.
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Standalone Performance Study: Not applicable. This is not an algorithm, so "standalone performance" for an algorithm is not relevant. The device itself is "standalone" in its physical form.
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Type of Ground Truth Used: Not applicable in the traditional sense of a diagnostic study. The "ground truth" for a bone void filler is successful bone healing and integration, which is assessed clinically but not detailed as a "ground truth" method for this 510(k) summary.
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Sample Size for the Training Set: Not applicable. This is not an AI/ML device.
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How the Ground Truth for the Training Set was Established: Not applicable.
Key information from the provided text:
- Device Name: MASTERGRAFT® Strip
- Product Description: Made from a combination of medical grade purified collagen and biphasic calcium phosphate ceramic (15% hydroxyapatite, 85% b-tricalcium phosphate). It is biocompatible, osteoconductive, porous, absorbs bone marrow aspirate, and resorbs while being replaced with bone.
- Intended Use/Indications: To be combined with autogenous bone marrow for bony voids or gaps not intrinsic to bony structure stability, and as a bone graft extender. Packed into bony voids/gaps of the skeletal system (posterolateral spine, pelvis, ilium, extremities), which can be surgically created or due to traumatic injury.
- Regulatory Pathway: 510(k) Premarket Notification, seeking substantial equivalence.
- Predicate Devices:
- Conclusion of the 510(k) Summary: The documentation demonstrates MASTERGRAFT® Strip to be substantially equivalent to the listed predicate devices.
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