Search Results

PROGENIX™ DBM Putty is 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™ 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. All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. Although, findings from an animal model are not necessarily predictive of human clinical results.

PROGENIX™ DBM Putty is a single use product intended for use in the oralmaxillofacial region. 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

The provided text is a 510(k) premarket notification for a medical device called PROGENIX™ DBM Putty. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections about explicit acceptance criteria, detailed study design, and performance metrics are not directly found in the provided text. The submission is a regulatory filing for market clearance, not typically a detailed report on clinical trial outcomes with specific statistical thresholds.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a bone void filler, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices and demonstrating the device's ability to induce bone formation and be osteoconductive. No specific numerical performance metrics are provided in the context of clinical acceptance criteria.

The key "performance" mentioned is in an animal model:

Study Details (Based on available information)

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

   • The primary "test set" described for performance is an athymic nude rat assay. The exact number of animals (sample size) is not specified in this document.
   • Data Provenance: Animal model data (athymic nude rat assay). The location of the assay or the origin of the facility is not stated, but it's part of the product development for a US company. This would be considered prospective data generation for the purpose of demonstrating device characteristics.

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

   • Not applicable in the context of this animal model. The "ground truth" for the animal assay (e.g., presence/absence of bone formation, rate of resorption) would be determined by standard histological and imaging analyses conducted by trained veterinary pathologists or researchers, but specific details about their number or qualifications are not provided as it's a foundational biological assay.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human clinical assessments or image interpretation where expert agreement is needed to establish a "ground truth" diagnosis. This document references an animal assay where outcomes are generally assessed objectively through histological examination.

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 is a bone void filler product, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not applicable. This device is a bone void filler, not an algorithm. Performance is evaluated on its biological effects (osteoinduction, osteoconduction, resorption) within a biological system.

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

   • For the animal assay, the ground truth for osteoinduction, osteoconduction, and resorption rate would be established through histopathology (microscopic examination of tissue samples) and potentially imaging techniques appropriate for small animal models.

7. The sample size for the training set:

   • Not applicable. This product is a physical bone void filler, not a machine learning model, so there is no "training set" in the context of AI.

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

   • Not applicable for the reason stated in point 7.

Ask a specific question about this device

PROGENIX™ DBM Putty is intended for use as a bone graft substitute, and bone void filler in bony voids or gaps of the pelvis, ilium and extremities not intrinsic to the stability of the bony structure. 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.

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. All DBM used in the preparation of Progenix DBM Putty must induce bone formation when evaluated a validated athymic nude rat assay. Additionally, every lot of PROGENIX DBM PUTTY must also induce bone formation in this assay system prior to being released for use. Findings from an animal model are not necessarily predictive of human clinical results. PROGENIX™ DBM Putty is a single use product intended for use in filling bony voids or gaps of the skeletal system 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™M 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.

This document is a 510(k) summary for a medical device (PROGENIX™ DBM Putty), which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and comparative effectiveness is not typically found in such a submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size: Not specified for the athymic nude rat assay. Clinical human trial data, or a 'test set' in the typical sense for medical imaging or AI, is not mentioned for performance evaluation. The substantial equivalence relies on comparison to predicate devices, not de novo clinical testing of this specific device's efficacy in humans.
• Data Provenance: The athymic nude rat assay is an animal model. No country of origin is specified for the animal data. The study is prospective in the sense that each lot and all DBM used must undergo this testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable. The primary performance evaluation cited is an animal model (athymic nude rat assay) and demonstration of substantial equivalence. There is no mention of a human 'test set' requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set

• Not applicable as there is no human 'test set' requiring adjudication described in this document. The animal assay results would likely be evaluated by laboratory personnel or veterinarians, but no specific adjudication method is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic devices (e.g., AI in radiology) comparing human reader performance with and without AI assistance. This document describes a bone void filler device and its regulatory clearance based on substantial equivalence and animal model performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical product (DBM Putty), not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the performance claims (osteoconductivity, osteoinductivity, resorption), the ground truth is based on observations and measurements from the athymic nude rat assay. The assay itself is a validated model designed to assess bone formation.
• For viral inactivation, the ground truth refers to the results of validated laboratory processing steps demonstrating viral inactivation.

8. The Sample Size for the Training Set

• Not applicable. There is no mention of a 'training set' in the context of an AI/machine learning model. The product's development and testing would involve R&D and quality control procedures, but not a "training set" like in AI development.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no 'training set' in the AI sense.

Ask a specific question about this device