(90 days)
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM come in the form of a kit with a premeasured powder, TCP and/or CBM chips, premeasured mixing solution, and the tools necessary to mix the components. emps, premeasured himmy all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
The provided text describes a 510(k) summary for ALLOMATRIX® Putty Products, which are bone void fillers. The submission focuses on demonstrating substantial equivalence to predicate devices and includes information on product performance testing.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|
| Osteoinductivity Potential | DBM in product possesses osteoinductive potential. | Each lot of DBM is assayed in vitro for a native protein (surrogate marker) correlated to the athymic rat model. This assures only DBM with osteoinductivity potential is used. | In vitro immunoassay and correlation to athymic rat model (for DBM alone and ALLOMATRIX Putty Products). |
| Viral Inactivation | Processing method effectively inactivates potential human viruses. | Processing method demonstrated suitable viral inactivation potential for a wide spectrum of model human viruses. | Viral inactivation validation study of the processing method. |
| Product Performance | Device exhibits expected performance in a biological model (e.g., bone formation, integration). | Evaluated in a canine model using radiographic and histological methods. | In vivo canine model study. |
| Substantial Equivalence | Device is as safe and effective as identified predicate devices. | Found to be substantially equivalent to predicate devices. Supported by substantial equivalence info, materials data, and testing results. | Comparison to predicate devices, materials data, and various testing (including those listed above). |
2. Sample Sizes and Data Provenance
- Osteoinductivity: "Each lot of DBM" is tested. The athymic rat model (Lindholm & Urist, 1980) is referenced, likely for validation of the surrogate marker, but specific sample sizes for this correlation study within the submission are not provided. The study by Lindholm and Urist itself would describe its sample sizes and methodology.
- Viral Inactivation: A "panel of model potential human viruses" was evaluated. Specific sample sizes (e.g., number of replicates, viral titers) are not provided.
- Product Performance Testing (Canine Model): The document states "evaluated in a canine model." No specific sample size (number of canines or defect sites) is mentioned.
- Data Provenance: The document implies the studies were conducted by or for Wright Medical Technology, Inc. ("Data on file at Wright Medical Technology, Inc."). The canine model is an in vivo animal study, and the osteoinductivity and viral inactivation tests are laboratory-based studies. All studies appear to be prospective in nature, designed to evaluate the product.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human experts to establish ground truth for a test set in the context of an AI/algorithm-based device. The ALLOMATRIX® Putty Products are physical medical devices, and their performance is assessed through biological and laboratory testing, not through interpretation of digital data by human readers.
4. Adjudication Method
Not applicable, as this is not a study involving human readers or interpretation of data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/software device that would involve human readers making diagnoses or assessments. It is a bone void filler, and its effectiveness is determined through biological performance.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI/algorithm device.
7. Type of Ground Truth Used
- Osteoinductivity: The ground truth for osteoinductivity potential is established by correlating the in vitro immunoassay results to the athymic rat model, which is a widely accepted in vivo model for evaluating bone formation and osteoinduction. The immunoassay itself serves as a surrogate for this biological activity.
- Viral Inactivation: The ground truth is the actual viral inactivation observed in the laboratory setting using model viruses and the processing method.
- Product Performance (Canine Model): The ground truth for bone healing and integration is established through radiographic and histological analysis of the treated bone defects in the canine model. These are direct biological observations.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The product undergoes manufacturing quality control and specific performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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.