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The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.

Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.

The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.

Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
2. Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
3. Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
4. MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
5. Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
6. Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
7. Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.

In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.

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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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