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PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender. substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial 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.

The PROGENIX® products contain 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. 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 readyto-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 the Medtronic Sofamor Danek PROGENIX® device. It describes the product, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain the kind of information requested regarding acceptance criteria and studies that prove the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, etc.

The 510(k) process for devices like PROGENIX® (a bone void filler) typically relies on demonstrating substantial equivalence to a predicate device based on similar materials, intended use, technological characteristics, and performance data (which often includes biocompatibility, mechanical properties, and osteoinductivity/osteoconductivity in animal models). It usually does not involve "acceptance criteria" in the sense of predictive algorithm performance (e.g., sensitivity, specificity) against a ground truth, as might be found for AI/ML-driven diagnostic or image analysis devices.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with acceptance criteria for statistical metrics.

Here's why the information isn't available in the provided text:

• Type of Device: PROGENIX® is a medical device (bone void filler) composed of human demineralized bone matrix (DBM) and a biocompatible carrier. It's a biological/material product, not a software algorithm or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or rely on human expert consensus for "ground truth" in the way an AI diagnostic device would.
• 510(k) Process for this device: The 510(k) summary confirms "substantial equivalence" to previously cleared predicate devices (other DBM products). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This determination relies on demonstrating similar intended use, technological characteristics, and performance data (e.g., osteoinductivity in rats, osteoconductivity, resorption rate). It does not typically involve human reader studies or comparison to an AI algorithm.
• Missing Information: The document does not discuss:
  • Specific quantitative acceptance criteria (e.g., statistical thresholds for performance).
  • Clinical studies designed to measure such criteria in humans (beyond showing it is resorbed and replaced by host bone).
  • Test sets, training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies. These are concepts relevant to AI/ML or diagnostic device evaluations, not directly to a bone graft material's regulatory submission as presented here.

In summary, the provided document is a regulatory clearance for a medical device (bone void filler) based on substantial equivalence, not a clinical study report for an AI/ML or diagnostic device with performance metrics and acceptance criteria as outlined in your request.

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