(426 days)
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.
| Acceptance Criteria (Implicit / Demonstrated by Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: Not cytotoxic. | IMPLUS Implants were tested and found to be not cytotoxic according to standard UNI EN ISO 30993 part 5 of September 2000 by "BIOLAB" laboratory (report nº SAM1282 dated 11th February 2003). |
| Material Use: Use of medical-grade titanium. | Implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67). Abutments are made of Titanium grade 5 (ASTM F136-96). This material is commonly used and widely recommended for contact with human tissue. |
| Mechanical Strength & Durability: Demonstrated stiffness and durability. | Mechanical and fatigue tests performed by "Politecnico di Milano" - Structural Engineering Department - demonstrated stiffness and durability of Leader Italia implants and abutments. These tests were performed on IMPLUS implants diam.4 with 25° angled abutment (report 01/014/rel of 17th December 2001). Further Fatigue Tests are presently running according to standard ISO 14801 (foreseen completed April 2007). |
| Sterilization Effectiveness: Effective sterilization procedure. | Performance test and biological analysis demonstrated effectiveness of the sterilization procedure with gamma rays (report by BIOSTER laboratory issued on January 1998). New tests for validation performed (Report by BIOSTER laboratory issued on February 2nd 2007). |
| Packaging Duration: Specified duration of sterility. | Packaging duration (5 years) demonstrated according to results of report issued by BIOSTER on October 2003. New tests for validation performed (Report by BIOSTER laboratory issued on December 2006). |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.