(288 days)
Inclusive® Tapered Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
The Inclusive® Tapered Implants are manufactured from biocompatible Titanium alloy. The implant is designed with an internal hex connection and a tapered body to replace one or more missing teeth. The surface is blasted with Hydroxyl Apatite and acid etched to facilitate osseointegration. The Implants are available in the following diameters: 3.7mm. 4.7mm. and 5.2mm, and each diameter is available in the following lengths: 8mm, 10mm, 11.5mm, 13mm, and 16mm. The dental implants are provided sterile (gamma).
The provided document describes the PRISMATIK DENTALCRAFT, INC. Inclusive® Tapered Implant System, a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the results of a standalone study against specific acceptance criteria in the format requested. However, it does reference performance data and biocompatibility tests conducted to meet acceptance criteria.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Implant to Abutment Compatibility) | FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801: 2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. This included fatigue testing on 30° Multi-Unit Abutments and evaluated the worst-case scenario. | "All testing conducted met the acceptance criteria and evaluated the worst-case scenario." |
| "performance testing data indicated the compatibility, and the safety and the effectiveness of the proposed device which meets the mechanical properties." | ||
| Biocompatibility | 1. Irritation (applying ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization) | "reports for the results indicated satisfactory and meeting the acceptance criteria" |
| 2. Media (MEM) Elution test to determine the Cytotoxicity (applying ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | "reports for the results indicated satisfactory and meeting the acceptance criteria" | |
| 3. Sensitization Tests for Irritation and Skin Sensitization (applying ISO 10993-10: 2010 Tests for Irritation and Skin Sensitization) | "reports for the results indicated satisfactory and meeting the acceptance criteria" | |
| Sterilization | Gamma sterilization process conforming to ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, and ANSI/AAMI/ISO 11137-2: Sterilized of Health Care Products - Radiation - Establishing the sterilized dose. | The implant packages are "sterilized by a gamma sterilization process that conforms to ISO 11137-1... and ANSI/AAMI/ISO 11137-2." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the mechanical performance testing (fatigue tests) or the biocompatibility tests (irritation, cytotoxicity, sensitization). It only states that worst-case scenarios were evaluated. There is no information regarding data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The tests described are laboratory-based mechanical and biological evaluations, not studies requiring human interpretation or expert ground truth for a test set in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable for the types of tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for substantial equivalence based on mechanical and biological performance, not a study involving human readers or AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
No. This device is a physical dental implant, not an algorithm or AI system. The performance data relates to the physical properties and biocompatibility of the implant itself.
7. Type of Ground Truth Used:
For the mechanical performance, the "ground truth" or standard was established by the specified FDA guidance and ISO 14801: 2007 standard for dynamic fatigue testing. For biocompatibility, the "ground truth" was established by the relevant ISO 10993 standards. These are internationally recognized standards and guidance documents for medical device testing.
8. Sample Size for the Training Set:
Not applicable. This device is a physical implant and does not involve AI or machine learning algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.