(9 days)
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
| Acceptance Criteria | Reported Device Performance (or Demonstration) |
|---|---|
| Osteoinductivity Potential: All DBM (Demineralized Bone Matrix) used must induce bone formation when evaluated in a validated athymic nude rat assay. Raw material and final product screening must show histologic evidence of osteoinduction through the presence of osteoblasts, chondroblasts, and/or woven bone. | PROGENIX® Plus demonstrates histologic evidence of osteoinduction (presence of osteoblasts, chondroblasts, and/or woven bone) in the athymic nude rat assay. (This is implied by the statement that it "must induce bone formation" and the product being cleared). |
| Viral Inactivation: The processing steps for tissue and collagen must be validated to inactivate a panel of clinically relevant viruses. The cortical bone processing and additional DBM steps must demonstrate effectiveness in inactivating viruses. | The processing steps for PROGENIX® Plus are validated to inactivate a panel of viruses, and further steps demonstrate suitable viral inactivation potential for a wide range of potential human viruses. |
| Substantial Equivalence: The modified device (PROGENIX® Plus) must be substantially equivalent to previously cleared predicate devices for its intended use and technological characteristics. | The FDA deemed PROGENIX® Plus substantially equivalent to PROGENIX® DBM Putty (K080462) and GRAFTON® DBM Crunch (K051188). |
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.
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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.
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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.
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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.
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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.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
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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).
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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.
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How the ground truth for the training set was established:
- Not applicable. As above, it is not an AI/ML device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.