(83 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Osteoinductive Capacity (as per validated assay) | All DBM used in the preparation of PROGENIX™ DBM Putty must induce bone formation when evaluated in a validated athymic nude rat assay. The product has been shown to be osteoinductive in an athymic rat assay. (Note: "Although, findings from an animal model are not necessarily predictive of human clinical results.") |
| Osteoconductive Properties (as per animal model) | The product has been shown to be osteoconductive in an athymic rat assay, allowing for bony ingrowth across the graft site. |
| Resorption Rate (consistent with bony healing, as per animal model) | Resorbing at a rate consistent with bony healing in an athymic rat assay. |
| Biocompatibility (implied for components) | Contains human demineralized bone matrix (DBM) in a biocompatible carrier (mixture of bovine collagen with a natural polysaccharide (sodium alginate)). (Implied acceptance by using generally recognized biocompatible materials, no specific test data provided here). |
| Substantial Equivalence to legally marketed predicate devices | Explicitly claimed and accepted by the FDA. The submission provides documentation demonstrating substantial equivalence to several predicate bone void fillers (e.g., PROGENIX™ DBM Putty (K072265, K060794), DBX Demineralized Bone Matrix Putty and Paste (K040501), Accell Connexus™ DBM Putty (K060306), Intergo® Oral (K070147), and GRAFTON® DBM (K051188)). The FDA's letter (K080462) confirms this determination. |
Study Details (Based on available information)
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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.
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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.
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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.
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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 is a bone void filler product, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI assistance are not relevant.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable for the reason stated in point 7.
§ 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.