Search Results

Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants. The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used. The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.

This document is a 510(k) Pre-Market Notification from the FDA for a dental implant system. It focuses on demonstrating the substantial equivalence of the "Implacil Implant System" to existing legally marketed devices, rather than presenting a study to prove acceptance criteria for a new device's performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study are not fully available or directly applicable to this type of regulatory submission.

However, I can extract the information that is present in the document that relates to performance and equivalence:

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

The document does not present specific acceptance criteria in the typical format of a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, it demonstrates "substantial equivalence" to predicate devices based on shared technological characteristics and mechanical performance.

Differences and Discussion

• Design - presence of chambers: The subject device has chambers on its external surface, while the primary predicate does not. The document states this difference does not alter the external surface area with bone and expects no impact on mechanical performance. This is acknowledged as a "Difference" but mitigated by an analysis.
• Implant diameter/lengths: The subject device's range of diameters and lengths is within the range of dimensions of the primary predicate and reference devices, leading to an "Equivalent" determination.

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

• Test Set Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) and does not involve a new clinical or laboratory "test set" for a performance study.
• Data Provenance: Not applicable for a new performance study. The data referenced is primarily existing regulatory clearances and standards.

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)

• Not applicable. Ground truth establishment by experts for a test set is not part of a substantial equivalence claim for a dental implant's mechanical properties, as opposed to, for example, an AI diagnostic device. The FDA reviewers and the submitters are the "experts" in assessing regulatory compliance and technical equivalence.

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

• Not applicable. Adjudication methods are not used in this type of 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

• Not applicable. This is not an AI/software device; it's a physical dental implant.

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

• Not applicable. This is not an AI/software device.

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

• Ground Truth: For a physical medical device like this, the "ground truth" for its safety and effectiveness is established through adherence to recognized performance standards (e.g., ISO 14801 for dynamic fatigue testing), biocompatibility testing, material specifications (e.g., ASTM F67), and comparability to predicate devices with a history of safe and effective use. The "truth" is based on established engineering principles, material science, and regulatory precedent.

8. The sample size for the training set

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

Study Proving Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which demonstrates substantial equivalence to legally marketed predicate devices. The document explicitly states:

• "Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024." (K183024 is the primary predicate device).
• "No clinical data were included in this submission."

This means that the device meets implied "acceptance criteria" by showing that its materials, manufacturing processes, intended use, and relevant performance characteristics (like mechanical strength assessed via ISO 14801) are either identical or acceptably similar to devices already cleared by the FDA. The submission effectively leverages the prior clearance of the predicate device (K183024) to support the safety and effectiveness of the new device, arguing that any differences (like the presence of chambers) do not raise new questions of safety or effectiveness.

Ask a specific question about this device

Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.

The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.

If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.

Ask a specific question about this device