(266 days)
CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, nano-crystalline hydroxyapatite (NCHA); is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Here's an analysis of the provided text regarding the CarriGen Bone Grafting Material and its acceptance criteria, structured as requested.
Important Note: The provided document is a 510(k) Summary and an FDA 510(k) clearance letter. It describes the device, its intended use, and substantial equivalence to predicate devices. It explicitly mentions "Testing data meeting the requirements of Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." However, the document itself does NOT contain the detailed acceptance criteria, the specific study design, or the performance results of such studies. It confirms that such data was submitted and found acceptable for 510(k) clearance, but the data itself is not presented here.
Therefore, for many of the requested points, the answer will be that the information is "Not Available in the provided document."
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available in the provided document. The document states that "Testing data meeting the requirements of Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." This implies specific performance criteria were met, but these criteria and the detailed performance results are not enumerated in this 510(k) summary or the clearance letter. | Not Available in the provided document. The document does not provide specific quantitative performance metrics beyond stating that testing data was submitted and accepted. |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Available in the provided document. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not Available in the provided document. The type of testing submitted would likely be animal studies or mechanical/chemical bench testing, rather than expert evaluation of images, given it's a bone grafting material. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Available in the provided document. This type of adjudication is typically for image-based diagnostic AI, which is not applicable to this physical bone grafting material. -
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. The CarriGen Porous Bone Substitute Material is a physical bone grafting material, not an AI or imaging diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As a physical bone grafting material, this device does not have an "algorithm-only" or "human-in-the-loop" performance. Its performance is related to its osteoconductive properties, resorption rate, and replacement by natural bone. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not Available in the provided document. For a bone grafting material, ground truth would typically be established through histological analysis (pathology) of tissue samples from animal or human studies to assess new bone formation, material resorption, and integration. -
The sample size for the training set:
Not Applicable / Not Available. For a physical medical device like a bone graft, there isn't a "training set" in the context of machine learning or AI. Performance data would come from pre-clinical (e.g., animal) and potentially clinical studies. -
How the ground truth for the training set was established:
Not Applicable / Not Available. As above, the concept of a training set ground truth is not relevant for this type of 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.