(133 days)
PROGENIX® Plus 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® Plus provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. The device may either be use alone or mixed with autograft bone and used as a bone graft extender.
PROGENIX® 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® is available in two versions: Putty and Plus. PROGENIX® Plus is a putty containing two different sized demineralized bone particles. PROGENIX® 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® 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.
This is a 510(k) premarket notification for a medical device called PROGENIX® Plus, a bone void filler. This document is not a study report or clinical trial. It is a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device.
Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set details are not applicable in this context.
Instead, the document focuses on demonstrating that PROGENIX® Plus is substantially equivalent to previously cleared devices based on its composition, intended use, and pre-clinical testing, primarily in an athymic rat assay for osteoinductivity and viral inactivation studies.
Here's a breakdown of what is available in the document related to some of your points:
1. A table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Implicit for Substantial Equivalence):
- Osteoinductivity: "All DBM used in the preparation of PROGENIX® Plus must induce bone formation when evaluated in a validated athymic nude rat assay. Additionally, PROGENIX® must also induce bone formation in this assay system prior to being released for use." (Page 2)
- Histologic evidence: "The raw material and final product screening must show histologic evidence of osteoinduction through the presence of osteoblasts, chrondoblasts and/or woven bone." (Page 2)
- Viral Inactivation: Processing steps must be "validated to inactivate a panel of viruses representative of those that are clinically relevant." (Page 2)
- Intended Use, Technology, Performance: Demonstrate equivalence to predicate devices (PROGENIX® DBM Putty and GRAFTON® DBM Crunch) in terms of intended use, technological characteristics, and performance characteristics (as supported by pre-clinical data).
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Reported Device Performance (as stated in the document):
- Osteoinductivity: "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." (Page 1) and "Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects." (Page 2)
- Viral Inactivation: "The viral inactivation testing demonstrates suitable viral inactivation potential of the processing methods for a wide range of potential human viruses." (Page 2)
2. Sample sized used for the test set and the data provenance:
- Not applicable for clinical studies. This document refers to an "athymic nude rat assay" for osteoinductivity. The sample size for this assay is not provided, nor is the provenance of data as it's a pre-clinical, lab-based assay.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to clinical studies with expert reviewers, which is not the nature of this document.
4. Adjudication method for the test set:
- Not applicable. This relates to clinical studies with expert reviewers, which is not the nature of this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This is a regulatory submission based on substantial equivalence, not a clinical effectiveness trial in human subjects. The document explicitly states: "Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects." (Page 2)
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/algorithm-based device. It is a biological product (bone graft substitute).
7. The type of ground truth used:
- Pre-clinical animal model (athymic rat assay) for osteoinduction: Histologic evidence (presence of osteoblasts, chondroblasts, and/or woven bone) was used to assess osteoinductivity.
- Laboratory-validated viral inactivation studies for viral safety.
8. The sample size for the training set:
- Not applicable. This refers to AI/machine learning models, which is not relevant to this device.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI/machine learning models.
In summary: The provided document is a 510(k) summary demonstrating substantial equivalence for a bone graft substitute, relying on pre-clinical animal and lab testing to support claims of osteoinductivity and viral inactivation. It does not involve clinical studies with human subjects, AI models, or the associated methodologies for evaluating such technologies.
§ 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.