(213 days)
The Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending on indication the user choose the matching screw, prepares the pit hole and inserts the screw. The screws are intended for single use only.
The Meisinger Dental Bone Screws consist of Titanium alloy Grade 5 with 1.1mm, 1.3mm and 1.5mm diameter and with lengths between 7mm - 16mm. The bone screws have a self-fapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile.
The Meisinger Dental Bone Screws are a Class II medical device (product code DZL) intended for fixation of bone segments, such as for horizontal or vertical augmentative grafts. The 510(k) summary states that a performance test was conducted to demonstrate that the device's design and function are equivalent to predicted devices. This indicates that the primary acceptance criteria for this device are focused on equivalence to existing predicate devices, rather than specific numerical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design and function equivalent to predicate devices. | "A performance test has been performed with the result that the design and function are equivalent to the predicted devices." |
| "The Meisinger Dental Bone Screws have the same intended use and are substantially equivalent to the legally marketed predicate devices in the United States." | |
| "The screws use the same biocompatible materials meeting the requirements from ASTM F136 as the predicated devices. The design is similar, at least equivalent to predicated devices: All products have comparable dimensions and design and the intended use is equivalent." | |
| Biocompatibility requirements met. | "The screws use the same biocompatible materials meeting the requirements from ASTM F136 as the predicated devices." (ASTM F136 is a standard specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications). |
| Compliance with relevant standards. | "The following standards have been followed for the development, production, performance and safety testing of Dental Bone Screws: AAMI ST79, ISO 17664, ISO 11607-1, ISO 2832-3, ASTM F136, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 17665-1, ASTM F543." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The submission focuses on comparison to predicate devices and adherence to standards rather than a specific clinical test set for performance. The "performance test" mentioned likely refers to bench testing rather than a clinical study with a defined patient sample size.
- Data Provenance: Not applicable in the context of clinical data for performance. The data provenance described is related to the materials and design characteristics compared against established standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The submission does not describe a clinical study requiring expert-established ground truth. The evaluation is based on technical equivalence and compliance with standards.
4. Adjudication method for the test set:
- Not applicable. There is no mention of a human-adjudicated test set in the context of this 510(k) submission.
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:
- No. This device is a bone screw and does not involve AI or human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation lies in the established engineering principles, material specifications, and performance characteristics of legally marketed predicate devices as well as compliance with recognized international and national standards (e.g., ASTM F136 for materials, ISO and AAMI standards for sterilization and risk management). The performance is benchmarked against these established norms for similar devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The development and testing adhere to traditional engineering and quality management system approaches.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish in this context.
§ 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.