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TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.

Leader Italia's line of TiXos dental implants are titanium endosseous implants that are fabricated by a process called Direct Laser Metal Forming ("DLMF"). This fabrication process results in the production of an implant with a porous surface characterized by open intercommunicating cavities and networks. The implants are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient to provide support to be their fixed and/or removal prosthesis, and to restore their original dental and/or masticatory function. TiXos dental implants are permanent devices for single use and can support single tooth, multiple tooth, or total prosthesis restorations. These implants are designed to be used exclusively with Leader Italia's line of prosthetic abutments and surgical instruments. TiXos dental implants are gamma sterilized, have two basic model configurations called Cylindrical and S-Type, and a number of different sizes and diameters as shown below.

The provided text describes the submission of the TiXos Implant System for 510(k) clearance, asserting its substantial equivalence to the predicate IMPLUS Implant System. The document focuses on demonstrating that the new device does not raise new questions of safety and effectiveness, primarily through non-clinical bench testing and a summary of existing clinical literature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device in the form of specific quantitative thresholds for performance metrics. Instead, the approach is focused on demonstrating "substantial equivalence" to a predicate device (IMPLUS Implant System). The performance is shown by stating that the TiXos implants were "compared to the predicate device and found it to be similar" in fatigue testing and met other applicable standards.

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

• Test Set Sample Size: The document mentions that a "number of its dental implants" were submitted for fatigue testing. It also refers to a "prospective summary report, and radiographic images, to the FDA that were part of its European clinical study" and "201 Direct Laser Metal Forming Implants" in one of the cited clinical articles. However, specific sample sizes for each non-clinical bench test or the full clinical study report are not provided within this summary.
• Data Provenance:
  • Non-Clinical Data: Likely conducted in a laboratory setting, not explicitly stated as retrospective or prospective given it's bench testing.
  • Clinical Data: "European clinical study" and "prospective summary report." One cited article mentions a "1-Year Prospective Multicenter Study." This indicates some clinical data is prospective and originates from Europe.

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

The document does not describe the establishment of a ground truth for a "test set" in the context of an algorithm or AI performance. The clinical data cited are from existing peer-reviewed studies which would have had their own methods for diagnosis and outcome assessment, implicitly involving medical experts. However, the exact number and qualifications of experts for the purpose of establishing ground truth in this submission are not specified.

4. Adjudication Method for the Test Set

Since the document does not detail a process for establishing ground truth for an AI algorithm's test set, there is no mention of an adjudication method (like 2+1 or 3+1). The "ground truth" in the clinical studies cited would have been established through standard clinical practice for dental implant outcomes (e.g., radiographic analysis, clinical examination, histological analysis).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size

No MRMC comparative effectiveness study is mentioned. This submission is for a medical device (dental implant), not an AI algorithm intended for human-in-the-loop assistance for diagnosis or treatment planning. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, this document describes a physical medical device (dental implant), not an AI algorithm. Therefore, no standalone algorithm performance study was performed or is relevant to this submission.

7. The Type of Ground Truth Used

For the clinical data, the "ground truth" for the effectiveness and safety of the dental implants appears to be based on:

• Clinical outcomes: Restoration of original dental function and aesthetic features, osseointegration.
• Radiographic images: Used in the European clinical study.
• Histological reports: One cited study is titled "Early Human Bone Response to Laser Metal Sintering Surface Topography: A Histological Report."
• Histomorphometric studies: One cited study mentions "A Histomorphometric Study In Humans."
• SEM and X-Ray Dispersive Spectrometry Evaluation: Mentioned in a case series for surface and bone interface.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device and not an AI algorithm requiring a training set.

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

This question is not applicable as the document describes a physical medical device and not an AI algorithm requiring a training set.

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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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