(147 days)
PROGENIX™ DBM Putty is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (i.e. spine, pelvis and extremities). The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX™ DBM Putty provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. When used in the extremeties or pelvis, the device is used by itself. When used in the spine, the device must be mixed with autograft bone and used as a bone graft extender.
PROGENIX™ DBM Putty contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX™ DBM Putty is a single use product intended for use as a bone graft substitute, bone graft extender, and bone void filler in bony voids or gaps of the skeletal system (i.e. spine, pelvis and extremities) not intrinsic to the stability of the bony structure. Additionally, this product is not designed to impart any mechanical strength to the surgical site. PROGENIX™ DBM Putty is provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. This product has been shown to be osteoconductive as well as osteoinductive in an athymic rat assay, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.
Acceptance Criteria and Device Performance for Medtronic Sofamor Danek PROGENIX™ DBM Putty
This document describes the acceptance criteria and the study used to demonstrate the performance of the PROGENIX™ DBM Putty, as outlined in the provided 510(k) summary (K072265).
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the expanded indication of PROGENIX™ DBM Putty (use as a bone graft extender in spinal fusion procedures) were based on demonstrating its effectiveness in producing spinal fusion.
| Acceptance Criterion | Reported Device Performance (as demonstrated in the rabbit study) |
|---|---|
| Spinal Fusion Effectiveness | |
| Radiographic fusion | Effectiveness in producing spinal fusion by radiographic criteria |
| Manual palpation for fusion | Effectiveness in producing spinal fusion by manual palpation |
| Osteoconductivity | Demonstrated |
| Osteoinductivity | Demonstrated (in an athymic rat assay) |
2. Study Design and Data Provenance
The study that demonstrated the expanded indication for PROGENIX™ DBM Putty was a rabbit study.
- Sample Size: Not explicitly stated in the provided text, but the study was conducted on a sufficient number of rabbits to "suggest that PROGENIX™ DBM Putty is effective."
- Data Provenance: The study was conducted in a pre-clinical animal model (rabbit). No country of origin is specified for the study location. The study is prospective as it evaluates the device's performance in a controlled environment.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not specify the number of experts used or their qualifications for establishing the ground truth of the rabbit study. However, the assessment of spinal fusion (radiographic and manual palpation) would typically involve trained veterinary radiologists and/or surgeons.
4. Adjudication Method
The adjudication method used for the rabbit study is not explicitly stated. However, given the nature of radiographic assessment and manual palpation, it is likely that the evaluation was performed by one or more trained individuals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed as this is a pre-clinical animal study for a bone graft substitute, not a diagnostic imaging device.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a bone graft substitute, not an algorithm or software. Its performance is assessed through biological outcomes in vivo.
7. Type of Ground Truth Used
The ground truth used in the rabbit study was based on direct observation and objective assessments of fusion in an animal model:
- Radiographic criteria: Imaging evidence of spinal fusion.
- Manual palpation criteria: Physical assessment of spinal fusion.
8. Sample Size for the Training Set
Not applicable. This is a biological device, not an AI/ML algorithm that requires a training set. The "study" refers to the pre-clinical validation for the expanded indication.
9. How Ground Truth for Training Set Was Established
Not applicable. See point 8.
§ 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.