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510(k) Data Aggregation
(328 days)
The Bicortical Screw is intended for surgical placement in edentulous anterior regions of the maxillary and/or mandibular arch to support crowns, bridges, or overdentures. In many cases the Bicortical Screw is inserted immediately after extraction.
The Bicortical Screw is a self-tapping, single-stage titanium implant that enjoys maximum primary support in the bone, i.e., bicortical support. The high degree of initial stabilization on insertion ensures undisturbed healing for this free-standing implant site is prepared with a small diameter pilot bur and the screw implant cuts its own thread configuration, leaving only a very small wound. The implant is intended for sale in the United States with a square head and round head in two thread diameters each (3.5 mm and 4.5 mm major diameter). The square head version is bendable at the head whereas the round head version is not bendable.
The provided document describes a 510(k) premarket notification for the Bicortical Screw dental implant, focusing on its substantial equivalence to previously marketed devices rather than a study against a specific set of acceptance criteria for algorithm performance.
Therefore, many of the requested sections about acceptance criteria, device performance, ground truth, and training an algorithm are not applicable to this submission.
However, I can extract information related to the device's performance and the clinical data used to support its safety and effectiveness in the context of the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a novel algorithm. Instead, the performance is demonstrated through comparison to predicate devices and clinical results highlighting safety and effectiveness.
| Performance Metric | Reported Device Performance (Bicortical Screw) | Comparison/Context |
|---|---|---|
| Clinical Survival Rate | 93.9% after five years (Center A) | Demonstrated clinical success. |
| 97.9% after five years (Center B) | ||
| Osseointegration | Fully osseointegrated, no evidence of fibrous tissue layer (Primate study) | Demonstrated successful bone integration. |
| Histological evidence of osseointegration, compact bone, good bone contact (Human explants) | ||
| Static Bending Compression Strength | Nearly twice as strong as Pin Implant | Superior mechanical strength compared to a predicate device. |
| Fatigue Limit (5 million cycles) | More than twice that of Pin Implant | Superior mechanical durability compared to a predicate device. |
| Biocompatibility | Made from commercially pure titanium (ASTM F67 Grade 2) | Widely accepted biocompatible material for implants. |
2. Sample Size Used for the Test Set and the Data Provenance
- Clinical Study (Retrospective Analysis):
- Total Patients: 276 (148 from Center A, 128 from Center B)
- Total Implants: 559 (247 from Center A, 312 from Center B)
- Data Provenance: Retrospective analysis of consecutive patients from two centers treated between 1984 and 1997. The country of origin is not explicitly stated but implied to be regions where these clinical centers operate, given Oraltronics' German origin.
- Animal Testing: A primate study was conducted, but the sample size (number of primates) is not specified.
- Human Explant Histopathology: Data from two patients (one implant removed due to trauma, six implants due to death).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The clinical studies used general criteria for success (lack of mobility for free-standing implants, freedom from pain, generalized radiolucency, uncontrolled bone loss), which would typically be assessed by treating clinicians/dentists. Histopathological evaluation would be done by pathologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable in the context of this 510(k) submission. The clinical data appears to be based on observed outcomes and clinical assessments by the treating teams at the respective centers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or mentioned, as this is a premarket notification for a physical medical device (dental implant), not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Clinical Study:
- Survival: Based on observed device presence and functionality over time, using Kaplan-Meier analysis.
- Success criteria: Clinical assessment (lack of mobility, freedom from pain, absence of generalized radiolucency or uncontrolled bone loss).
- Animal and Human Explant Studies: Histopathological evidence of osseointegration (observing compact bone, absence of connective tissue, bone remodeling, no fibrous tissue layer).
- Mechanical Testing: Measured physical properties (static bending compression, fatigue limit) of the implants.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an algorithm, so there is no "training set" in the machine learning sense. The device design and materials are based on established engineering principles and prior knowledge of biocompatible materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no algorithm being trained, there's no "ground truth for the training set." The design and material choices are based on existing standards (ASTM F67, ISO 11137, EN 552, CE Mark, ISO 9001, EN 46001) and known successful approaches in dental implantology, as well as comparative mechanical testing against predicate devices.
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