(294 days)
WMT Composite DBM resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
The WMT Composite DBM paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
The WMT Composite DBM Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced by bone during the healing process. The bone void filler included in the WMT Composite DBM Core Decompression Kit is not intended to be used as a load bearing device.
WMT Composite DBM is provided sterile for single use.
WMT Composite DBM consists of a calcium sulfate, calcium phosphate, and demineralized bone matrix bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions.
The provided text is a 510(k) summary for the WMT Composite DBM device, a bone void filler. It describes the device's intended use, composition, and claims about its performance, primarily in comparison to other bone graft materials. However, the document does not describe a study involving "acceptance criteria" for device performance in the typical sense of a pre-defined threshold that the device needs to meet for regulatory approval.
Instead, the document details "Non-Clinical Performance/Marketing Claims" which are based on comparative studies. These studies aim to demonstrate the device's effectiveness and safety, primarily by showing it is comparable to or, in some aspects, superior to, existing predicate devices or autograft. The document does not contain information about:
- A table of acceptance criteria and reported device performance against those criteria.
- Sample sizes used for a test set in the context of typical AI/software performance evaluation.
- Data provenance for a test set.
- Number of experts or their qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm.
- The type of ground truth used in an AI/software context.
- Training set sample size or how ground truth was established for a training set.
The document discusses biological and mechanical performance metrics from animal studies, which are used to support the claim of substantial equivalence to predicate devices and to justify its intended use. Here's a breakdown of the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not define explicit "acceptance criteria" in the form of numerical thresholds for device performance to be met for regulatory approval. Instead, the performance claims are comparative, aiming to show non-inferiority or superiority to predicate devices or autograft.
Reported Device Performance:
| Performance Claim / Comparison | Reported Device Performance (WMT Composite DBM) |
|---|---|
| Accelerated healing vs. PRO-DENSE® | At 6 weeks, similar percentage of new bone formation, but less residual material in WMT Composite DBM defects. Showed accelerated and more complete healing as evidenced by new bone formation across the width of the defect. |
| Accelerated healing vs. Autograft | At 13 and 26 weeks, showed accelerated new bone formation (slightly higher stiffness, greater amount of newly formed bone, statistically significantly greater compressive strength). At 26 weeks, no statistically significant differences in percentage of new bone, compressive strength, and modulus of elasticity compared to autograft. Clinical, contact radiographs, and gross/histological images showed little to no apparent differences between WMT Composite DBM and autograft at 26 weeks. |
| Bone remodeling to normal bone at 13 weeks | From 6 to 13 weeks, increased new bone formation; material had substantially remodeled. From 13 to 26 weeks, sustained new bone formation, continued decrease in residual material. At every time point, WMT Composite DBM compared to normal bone showed no significant differences for percentage new bone, compressive strength, and modulus of elasticity. |
| Osteoinductivity | Confirmed to be osteoinductive, following the same test design as the predicate ALLOMATRIX®. |
Note: All of these claims are based on a "critically sized canine proximal humerus defect model." The document explicitly states: "It is unknown how results from the canine model compare with clinical results in humans."
2. Sample size used for the test set and the data provenance
The studies described are animal studies.
- Sample Size for Test Set: Not explicitly stated in the provided text. The claims refer generally to "WMT Composite DBM defects," "PRO-DENSE® treated defects," "autograft," and "normal bone" within a canine model, implying groups of animals were used, but specific numbers are not given.
- Data Provenance: Critically sized canine proximal humerus defect model (animal study, prospective in design for the purpose of evaluating the device). Country of origin is not specified, but the submission is to the US FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The evaluation of bone formation, residual material, stiffness, and compressive strength would typically be performed by veterinary pathologists, histologists, and biomechanical engineers, but their specific numbers or qualifications are not detailed.
4. Adjudication method for the test set
This information is not provided. The objective nature of some measurements (e.g., compressive strength, modulus of elasticity) might not require complex adjudication, while histological assessments might involve consensus or reviews, but no details are given.
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
No such study was conducted or described. This type of study is relevant for AI or imaging interpretation devices, not for a bone void filler product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used
The ground truth was established through histological analysis, biomechanical testing (stiffness, compressive strength, modulus of elasticity), and possibly radiographic imaging (clinical and contact radiographs, gross cross-sectional images). This is a combination of direct biological and mechanical measurements on the animal model.
8. The sample size for the training set
Not applicable. This is not an AI/software device relying on a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.