(109 days)
The Salvin Bone Tack System is designed to stabilize a barrier membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial, or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.
The Salvin Bone Tack System consists of 3mm and 5mm Titanium (Ti-6Al-4V) bone tacks and associated instrumentation. The devices are provided non-sterile.
This document describes a 510(k) premarket notification for the Salvin Dental Specialties Bone Tack System. A 510(k) submission seeks to demonstrate that a new device is "substantially equivalent" to one or more legally marketed predicate devices, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on this substantial equivalence rather than explicit acceptance criteria and a study proving device performance against those criteria in the way one might see for a novel device.
Given the nature of a 510(k) for this type of device, the acceptance criteria are not explicitly numerical performance metrics but rather a demonstration of equivalence in design, materials, and intended use to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to other devices cleared by the agency for commercial distribution. |
| Design Equivalence | Engineering drawings demonstrated substantial equivalence, if not identical, to predicate devices in terms of design. |
| Material Equivalence | Detailed inspectional analysis demonstrated substantial equivalence, if not identical, to predicate devices in terms of materials of composition (Titanium (Ti-6Al-4V)). |
| Indications for Use Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of indications for use (stabilize a barrier membrane onto a region of cortical plate in craniofacial, maxillofacial, or mandibular bone). |
| Associated Characteristics Equivalence | Demonstrated substantial equivalence, if not identical, to predicate devices in terms of other characteristics as may be associated with the manufacture of any medical device. |
| Non-Sterile Presentation | Devices are provided non-sterile. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No "test set" in the traditional sense of a clinical or performance study was used. The submission relies on engineering equivalency and comparison to a predicate device.
- Data Provenance: Not applicable. The data primarily consists of engineering drawings and inspectional analysis of the device itself, compared to the known characteristics of the predicate device (IMTEC Bone Tac, K973180). This is internal manufacturer data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of clinical expert review is not relevant for this 510(k) submission, which relies on engineering and regulatory assessment of equivalence.
4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.
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 tack system, not an AI-powered 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 device is a physical medical device, not an algorithm.
7. The type of ground truth used
For a 510(k) submission for a device like this, the "ground truth" is established through:
- Reference to the predicate device's known characteristics and regulatory clearance.
- Engineering specifications and material science data for the proposed device, demonstrating it meets the same functional and safety profiles as the predicate.
- Intended Use statements that align with those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.