(144 days)
TricOs T is indicated for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs T is a bone void filler without initial mechanical properties, therefore rigid fixation techniques may often be recommended.
TricOs T is intended to be packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, TricOs T is resorbed and replaced with bone during the healing process.
Fibrin matrix without the HA/TCP granules is not indicated for use as a bone void filler.
TricOs T is a resorbable bone substitute that is replaced over time by newly formed bone. TricOs T consists of an inorganic calcium phosphate scaffold (HA/TCP granules) combined with a heterologous human fibrin matrix. The fibrin matrix acts as a 3D matrix and enhances the handling of the product by making it moldable and allows it to hold its shape.
This appears to be a 510(k) summary for a medical device called TricOs T Bone Void Filler, submitted to the FDA in 2005. It describes the device's intended use, technological characteristics, and claims substantial equivalence to predicate devices, but does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria.
Specifically, the document states:
- "Nonclinical tests: TricOs T has been tested in in vivo and in vitro studies that document safety and effectiveness equivalent to that of the predicate devices."
- "Substantial Equivalence Information: The intended use, composition, biocompatibility and select performance properties of TricOs T are substantially equivalent to commercially available predicate bone void filler products. The product is adequately supported by the substantial equivalence information, materials data, and testing results provided or referenced to in the Premarket Notification."
However, the provided text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details or effect size.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (expert consensus, pathology, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission summary that asserts the device's safety and effectiveness based on nonclinical tests and substantial equivalence but does not provide the detailed study results, acceptance criteria, or ground truth methodology you're asking for. Such details would typically be found in the full premarket notification (510(k)) document, not just the summary.
§ 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.