Search Results

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