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510(k) Data Aggregation
(317 days)
Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
The provided document is a 510(k) summary for the "Orthodontic Miniscrew for Absolute Anchorage" and focuses on demonstrating substantial equivalence to a predicate device, the "Aarhus Anchorage System K041527." It does not describe a study involving a comparison of device performance against detailed acceptance criteria in the manner typically seen for novel device efficacy. Instead, it relies on demonstrating equivalence through material properties, dimensions, intended use, and general performance characteristics.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as the submission primarily focuses on equivalence based on established standards and similarity to a predicate.
Here's an analysis based on the information available in the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by compliance with established material and sterilization standards, and by demonstrating performance comparable to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (conforms to surgical implant standards) | Titanium Alloy ASTM F 136 (same as predicate). Adheres to chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401). |
| Biocompatibility | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant (same as predicate). |
| Sterility | Gamma Radiation (same as predicate). Conforms to ISO 11137 (requirements for developing, validating, and routinely controlling sterilization process). Conforms to ASTM F1980-07 (addresses loss of sterile barrier system integrity). |
| Mechanical Safety/Performance | Tensile strength of material according to ASTM - F 136 is accepted for endosseous implants (same as predicate). Performance testing conducted to determine torque levels, forces, and insertion lengths. Measured performance is "comparable to the Aarhus Anchorage System K041527." |
| Dimensions (comparable to predicate) | Diameter ranges from 1.5 mm, length ranges from 6-10 mm. (Predicate: Diameter ranges from 1.5-2 mm, length ranges from 9-11 mm). The submission states "similar dimensions." |
| Performance Characteristics (comparable to predicate) | Self-trapping/Self-drilling (same as predicate). |
| Intended Use / Indications for Use | Threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. Used temporarily. (Identical to predicate). |
| Substantial Equivalence Conclusion | "in all respects based on Intended Use, Indications of Use, Construction Material, Performance and Bench Tests that the Orthodontic Miniscrew for Absolute Anchorage and the Aarhus Anchorage System K041527 are substantially equivalent." Specifically, "Potential adverse effects are identical." and "made from the same material ... and has similar dimensions and characteristics." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Performance Testing" which included "testing was done to determine the torque levels, forces and insertion lengths while inserting the Orthodontic Miniscrew for Absolute Anchorage." However, no specific sample sizes (N) for these tests are mentioned.
The data provenance is implied to be from bench testing conducted by Dental Morelli Ltda. The country of origin for the device manufacturer is Brazil. The data itself would be from laboratory experiments, not patient data, in this context of a 510(k) submission for mechanical equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. This submission is for a medical device (orthodontic miniscrew) and focuses on demonstrating substantial equivalence through material and mechanical properties, as well as adherence to standards. It does not involve a diagnostic algorithm or a scenario where expert-established ground truth is required in the context of a "test set" as one might find in an AI/ML medical device submission. The "ground truth" here is adherence to engineering standards and established performance of the predicate.
4. Adjudication Method for the Test Set
Not Applicable. See point 3. No clinical or diagnostic "test set" requiring expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This document does not mention any MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices to assess human reader performance with and without AI assistance. This device is a physical implant.
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 or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned (torque levels, forces, insertion lengths), the ground truth is based on instrumentation measurements comparing the new device against the performance characteristics of the predicate device. For material and sterilization claims, the ground truth is demonstrated by conformance to established international standards (ASTM F136, ASTM F1980-07, ISO 11137). There is no "expert consensus" or "pathology" in the typical sense for this submission regarding performance.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not Applicable. See point 8.
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