Search Results

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:

• 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).

• 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.

Ask a specific question about this device

PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation

Filling of cystic defect

Filling of extraction sites

Filling of lesions of periodontal origin

Craniofacial augmentation

Filling of defects of endodontic origin

Mandibular reconstruction

Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

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 forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

The provided text is a 510(k) summary for a medical device called PROGENIX® Plus, a resorbable calcium salt bone void filler device. It is a Special 510(k) for a device modification, seeking to include a new formulation to an already cleared product line. The primary goal is to demonstrate substantial equivalence to predicate devices, not necessarily to prove a specific level of performance against quantitative acceptance criteria through a clinical study.

Therefore, the information typically requested in your template (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, specific ground truth types) is largely not applicable in this context, as a clinical study with such detailed parameters was not conducted or required for this type of submission.

Instead, the "acceptance criteria" and "study" are focused on demonstrating the osteoinductive potential and viral inactivation effectiveness of the product, primarily through non-clinical testing, and showing substantial equivalence to existing devices.

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of a 510(k) for a bone void filler, the "studies" refer to non-clinical tests rather than human clinical trials involving extensive statistical analysis of human performance.

1. Sample size used for the test set and the data provenance:

   • Osteoinductivity Assay: The sample size would refer to the number of athymic nude rats used in the in vivo assay. This information is not provided in the summary.
   • Viral Inactivation: Not applicable in terms of a "test set" like a clinical study. It refers to in vitro validation studies on the manufacturing process.
   • Data Provenance: Not explicitly stated, but typically these non-clinical studies are conducted in a controlled laboratory environment (e.g., manufacturer's labs or contract research organizations), likely in the country of manufacture (USA for Medtronic Sofamor Danek). All data would be prospective for the purpose of validating the new formulation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Osteoinductivity Assay: The "ground truth" for osteoinductivity would be established by histopathological evaluation of the rat tissue. The number and qualifications of the pathologists or histologists performing this evaluation are not provided.
   • Viral Inactivation: The ground truth is based on established virology assays to quantify viral reduction. The experts would be virologists and microbiologists within the testing facility. This information is not provided.

3. Adjudication method for the test set:

   • Osteoinductivity Assay: Adjudication methods for histological evaluation (e.g., multiple pathologists reviewing slides) are not specified. Standard practice may involve independent review, but it's not detailed here.
   • Viral Inactivation: Not applicable.

4. 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 device is a bone void filler, not an AI-powered diagnostic imaging device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Osteoinductivity: Histopathology (microscopic examination of tissue samples for the presence of osteoblasts, chondroblasts, and woven bone).
   • Viral Inactivation: Quantitative virology assays (measuring reduction in viral titers).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set in that sense. The "training" for the product refers to the development and manufacturing processes.

8. How the ground truth for the training set was established:

   • Not applicable. As above, it is not an AI/ML device.

Ask a specific question about this device