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The BioHorizons Maestro System 3.0 mm Diameter Implant may be used

• (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
• (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
• (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.

The BioHorizons Maestro System 3.0mm diameter dental implant is a machined titanium, screw-form implant supplied in lengths of 12mm, 15mm and 18mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The device is further processed by treating the surface with resorbable blast media (RBM). The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10 °, validated in compliance to ANSI/AAMI/ISO 11137, Sterlization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

The Maestro System™ 3.0mm Diameter Implant is a comprehensive system containing implants and surgical components.

This document is a 510(k) summary for a dental implant, not a study report for a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and adjudication methods is not present in the provided text.

Based on the provided text, here is what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document describes a medical device (dental implant) and its substantial equivalence to predicate devices for regulatory clearance. It does not detail specific acceptance criteria or performance metrics in the way a clinical or technical performance study would. It focuses on the device's characteristics and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. This document is not a study report. It does not mention any test sets, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No ground truth establishment for a test set is mentioned in this regulatory submission document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No adjudication method is mentioned as there is no test set or study 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

• Cannot be provided. This device is a dental implant, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This device is a dental implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No ground truth is described in the context of a performance study.

8. The sample size for the training set

• Cannot be provided. This document is not about an AI device with training sets.

9. How the ground truth for the training set was established

• Cannot be provided. Not applicable to this type of device and document.

Summary of what is present:

The document is a 510(k) Pre-market Notification for a dental implant, demonstrating substantial equivalence to previously cleared predicate devices. The focus is on the physical characteristics, materials, manufacturing processes, and intended use being similar to existing, legally marketed devices. The "study" here is essentially the comparison to predicate devices, asserting that its "Technological Characteristics" are "identical or very similar" and "substantially equivalent to all features of the predicate devices which could affect safety or effectiveness because of the similarities in design, material and intended use."

The regulatory body (FDA) reviewed this claim and, in the letter, indicated that the device is "substantially equivalent" for the stated indications for use. This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, implying that if the new device is as safe and effective as a legally marketed predicate, it can be marketed. No new clinical trials or performance studies against specific numerical acceptance criteria are detailed in this type of submission.

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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.

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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