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IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions. Implus implant fixtures are indicated for permanent use. Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.

Leader Italia IMPLUS implants are available in cylindrical or tapered shape, with different dimensions; connection to abutments is made by internal or external hexagon. All implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67) with a modified surface for optimum ostheointegration. The implants are all provided sterile in a packaging complete with mount transfer.

This document is a 510(k) summary for the LEADER ITALIA S.r.l. IMPLUS Endosseous Dental Implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data in the format of a typical medical device study.

Therefore, providing a direct answer to all points of your request is not possible, as the provided text does not describe a study to prove acceptance criteria for a device. Instead, it outlines the device's characteristics and references tests performed to support its safety and effectiveness for substantial equivalence.

However, I can extract the relevant information regarding the tests performed to demonstrate safety and effectiveness.

Here's a breakdown of the existing information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would expect for a specific performance study (e.g., "sensitivity must be > X" or "fatigue life must exceed Y cycles at Z load").

Instead, the performance of the IMPLUS device is demonstrated through adherence to material standards, biocompatibility testing, and mechanical/fatigue testing, with the implicit "acceptance criterion" being that these tests confirm safety and effectiveness comparable to legally marketed predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

• The document does not specify sample sizes for the test set in the context of a clinical trial or algorithm validation study.
• The tests mentioned (biocompatibility, mechanical, fatigue, sterilization, packaging) are laboratory-based.
• Data Provenance:
  • Biocompatibility: BIOLAB laboratory, Vimodrone, Milano, Italy.
  • Mechanical and Fatigue Tests: "Politecnico di Milano" - Structural Engineering Department.
  • Sterilization and Packaging: BIOSTER laboratory.
  • The overall context is for CE Mark and FDA 510(k) submission, suggesting the data is intended for regulatory purposes. The country of origin for the testing appears to be primarily Italy.
  • The data would be considered prospective with respect to the intent of the device submission, even if some tests were conducted retrospectively from prior dates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications

• This is not applicable as the document describes laboratory tests for device components/properties, not a diagnostic device or a study requiring human expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable for laboratory performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, this document does not describe an MRMC study. The device is an implant, not an imaging or diagnostic AI tool that would involve human readers.

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

• Not applicable. This is a physical medical device (dental implant), not an algorithm or software-as-a-medical-device (SaMD).

7. The Type of Ground Truth Used

• The "ground truth" for the tests performed are laboratory standards and measurements:
  • Biocompatibility: ISO 30993 part 5 (presumably against a control for cytotoxicity).
  • Material Composition: ASTM F67, ASTM F136-96 (material specifications).
  • Mechanical & Fatigue: Standard ISO 14801 (implied as ongoing/completed), and internal methods detailed in a specific report (01/014/rel). This would involve physical measurement of force, cycles, and structural integrity.
  • Sterilization: Performance against accepted microbiological sterility standards.
  • Packaging: Performance against accepted standards for maintaining sterility over time.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

Summary of Limitations in the Provided Document for Your Request:

The provided text is a 510(k) Summary, which is designed to demonstrate "substantial equivalence" of a new device to predicate devices already on the market. It does not typically contain the detailed information of a full clinical trial or a detailed AI/ML performance study as implied by your request. It focuses on:

• Device description
• Comparison to predicate devices
• Indications for use
• Summary of key safety and effectiveness tests (often laboratory-based for implants)

Therefore, many of your questions, especially those related to "test sets," "expert ground truth," "adjudication," "MRMC studies," "standalone performance," and "training sets" are not applicable to the type of information presented here for an endosseous dental implant.

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