(90 days)
WMT- TCP Bone Graft is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. The WMT-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. WMT- TCP Bone Graft Substitute can be combined with autogenous bone marrow aspirate and/or blood. The product resorbs and is replaced with bone during the healing process.
The WMT- TCP Bone Graft Substitute is provided sterile for single use only and should not be resterilized.
Apatight-TCP Bone Graft Substitute is a porous calcium phosphate resorbable bone graft substitute for the repair of bony defects. Apatight is an osteoconductive implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. Apatight-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site. When placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant. filling the pores with new bone. As Apatight-TCP Bone Graft Substitute resorbs. bone grows into the space it previously occupied.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called WMT-TCP Bone Graft Substitute, submitted by Wright Medical Technology, Inc. It aims to establish substantial equivalence to a previously cleared device. Therefore, it does not contain the type of study data and acceptance criteria you've requested for a device performance study involving accuracy metrics like sensitivity, specificity, or AUC, as it's not evaluating an AI/diagnostic device.
The information provided describes the device's intended use and demonstrates its substantial equivalence to a predicate device (APATIGHT™- TCP Bone Graft Substitute, K013966) based on material composition and design features.
Here's how to interpret the available information in the context of your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria for device performance in the way a diagnostic or AI device would, nor does it report performance metrics like sensitivity, specificity, or AUC. The "acceptance" in this context is the FDA's determination of substantial equivalence to an existing legally marketed device.
Therefore, for this submission, the implicit "acceptance criterion" is generally:
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| The device (WMT- TCP Bone Graft Substitute) is as safe and effective as a legally marketed predicate device (APATIGHT™- TCP Bone Graft Substitute, K013966), and does not raise different questions of safety and effectiveness. This is demonstrated through similar intended use, material composition, and design features. | Substantial Equivalence Achieved: The FDA has determined the WMT-TCP Bone Graft Substitute is substantially equivalent to the predicate device (K013966) for the stated indications for use. |
The document explicitly states: "The intended use, material composition, and design features of the WMT- TCP Bone Graft Substitute are substantially equivalent to the intended use, material composition, and design features of the previously submitted APATIGHT™- TCP Bone Graft Substitute (K013966)."
Furthermore, it states: "The safety and effectiveness of the WMT- TCP Bone Graft Substitute with the expanded indication is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification." |
The remaining points (2-9) are not applicable or cannot be answered with the provided submission as it is not a study reporting on diagnostic accuracy, AI performance, or clinical trial outcomes in the way your questions are framed.
Here's why:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of evaluating diagnostic performance from images or other data. The evaluation is based on a comparison of device characteristics to a predicate device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No ground truth establishment for a test set of diagnoses or classifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication.
- 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 is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, which the new device is compared against.
- 8. The sample size for the training set: Not applicable. There is no "training set" for an algorithm.
- 9. How the ground truth for the training set was established: Not applicable. There is no training set.
In summary, this document is an FDA 510(k) clearance summary for a bone graft substitute, aiming for substantial equivalence to a predicate device. It does not involve a performance study with acceptance criteria related to diagnostic accuracy, nor does it concern an AI or image-based diagnostic device.
§ 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.