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GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

GRAFTYS®BCP can be used with autograft as a bone graft extender.

In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies

GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute.

GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate.

Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process.

GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.

This document is a 510(k) summary for GRAFTYS®BCP, a resorbable bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in a clinical trial report or specific device performance testing section.

Therefore, I cannot fulfill your request using the provided text. The document focuses on regulatory approval (510(k) clearance) by demonstrating substantial equivalence to existing devices, rather than establishing and testing specific performance acceptance criteria for a new device study.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria Table & Reported Performance: The document does not define specific performance acceptance criteria for the device (e.g., a certain percentage of bone growth, resorption rate, or mechanical strength post-implantation). It relies on establishing substantial equivalence to predicate devices.
2. Sample Size and Data Provenance: No test set sample size or data provenance (country, retrospective/prospective) is provided because a specific clinical study with a distinct test set, as might be used to demonstrate performance against criteria, is not described. The document refers to "in vitro tests" but does not detail their methodology or results in terms of acceptance criteria.
3. Number of Experts & Qualifications: Not applicable, as there's no ground truth established by experts in a described study to assess device performance.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or conducted.
6. Standalone Performance Study: No detailed standalone performance study is presented. The document refers to "non clinical performance data" and "in vitro tests" to support substantial equivalence, but not to establish specific performance metrics against pre-defined criteria.
7. Type of Ground Truth: Not applicable, as no clinical or performance study with a defined ground truth (like pathology or outcomes data) is detailed.
8. Training Set Sample Size: Not applicable, as this is related to machine learning models, and this document is about a medical device made of calcium phosphate ceramic.
9. Ground Truth for Training Set: Not applicable for the same reason as above.

The core of this document is a regulatory submission demonstrating substantial equivalence to already approved devices (MBCP™ and VITOSS) based on technological characteristics (composition, porosity, osteoconductivity) and general in vitro tests. It does not involve setting new, specific performance acceptance criteria and then conducting a study to show the device meets those criteria in the way your request implies.

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