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TRIHA+ is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. TRIHA+ is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. TRIHA+ should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

TRIHA+ is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

TRIHA+ is an osseo-conductive macroporous implant made of synthetic béta tri calcium phosphate (_-TCP (Ca(PO).) indicated for bone void filler. It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60-80% and the size of pores is 200-500μm. TRIHA+ implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone. The progressive resorption of TRIHA+ is intended to prevent premature resorption.

This document is a 510(k) premarket notification for the TRIHA+ bone void filler device. It is a regulatory submission to the FDA, demonstrating substantial equivalence to previously marketed devices. Such submissions typically do not contain detailed acceptance criteria or study results of the type you are asking for.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is primarily done by comparing technological characteristics and intended use, rather than by presenting extensive clinical trial data or performance metrics against pre-defined acceptance criteria, especially for Class II devices like this bone void filler.

Therefore, based on the provided text, I cannot extract the specific information you requested. The document clearly states that TRIHA+ is equivalent in material, indications, and use to two predicate devices: BIOSORB (K021763) and Vitoss™ Scaffold (K994337). The "Summary of Technological Characteristics Compared to Predicate Device" states that TRIHA+ is similar in composition, porosity, pore size, and resorption. This comparison is the basis for its clearance, not a new study demonstrating performance against acceptance criteria.

Here's why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The review is based on substantial equivalence, not novel performance data against set criteria.
2. Sample size used for the test set and the data provenance: Not applicable, as a new test set/clinical study is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 device is a bone void filler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no new study data is presented.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is an FDA clearance letter based on a 510(k) submission, not a scientific publication detailing a study with acceptance criteria and performance metrics. The clearance is granted because the FDA deemed the device substantially equivalent to existing, legally marketed predicate devices.

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