(174 days)
Medtronic Dental TCP is indicated as a bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure of the oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Medtronic Dental TCP provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.
Medtronic Dental TCP is intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects. Procedures include:
- Ridge augmentation
- Sinus augmentation
- Filling of cystic defects
- 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
Medtronic Dental TCP may be used alone, or in combination with saline, blood, bone marrow aspirate or platelet rich plasma (PRP).
Medtronic Dental TCP may be mixed with autograft as a bone graft extender.
Medtronic Dental TCP is a porous, resorbable, osteoconductive bone grafting material made of medical grade ß-tricalcium phosphate. Medtronic Dental TCP is supplied sterile for single patient use. The device is an osteoconductive, porous implant that allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing. The product is biocompatible.
This 510(k) premarket notification for Medtronic Dental TCP does not describe a study or acceptance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.
Therefore, many of the requested elements (like "number of experts," "adjudication method," "MRMC study," "training set size") are not applicable to this type of submission.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or present performance data in the way an AI/ML device submission would. Instead, it asserts substantial equivalence based on product description, intended use, and material composition.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided text. The "performance" is implicitly deemed equivalent to the predicate devices.
2. Sample size used for the test set and the data provenance
Not applicable. This submission doesn't detail a test set in the context of device performance evaluation. The substantial equivalence argument is based on the characteristics of the device itself compared to existing legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device and does not involve ground truth established by experts in the context of performance evaluation.
4. Adjudication method for the test set
Not applicable. No test set or adjudication process is described.
5. 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-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable. No ground truth in the context of AI/ML evaluation is relevant to this submission.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is present in the document relevant to its clearance:
- Substantial Equivalence: The primary method for demonstrating the device meets regulatory requirements is by proving its substantial equivalence to three predicate devices: MASTERGRAFT® Resorbable Ceramic Granules (K082917), Synthes (USA) chronOS™- B-TCP (K053022), and Cerasorb® Dental (K051443).
- Product Description: Medtronic Dental TCP is described as a "porous, resorbable, osteoconductive bone grafting material made of medical grade ß-tricalcium phosphate."
- Intended Use/Indications for Use: Detailed indications for use as a bone void filler in the oral and maxillofacial region are provided, including ridge augmentation, sinus augmentation, filling of cystic defects, extraction sites, periodontal lesions, craniofacial augmentation, endodontic defects, mandibular reconstruction, repair of traumatic defects, and filling of resection defects.
- Biocompatibility: The product is stated to be biocompatible.
- Mechanism of Action (Implied): It allows for bony ingrowth across the graft site while resorbing at a rate consistent with bone healing, being replaced by host bone.
The "acceptance criteria" for this specific 510(k) would be that the device's characteristics (material, indications, performance features) are sufficiently similar to the legally marketed predicate devices to establish that it is as safe and effective. The "study that proves the device meets the acceptance criteria" is the comprehensive comparison presented in the 510(k) submission, detailing how it is substantially equivalent to the predicates.
§ 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.