(389 days)
TAV Medical Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."
Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:
| Test/Characteristic | Acceptance Criteria (Implicit from Standards/Statements) | Reported Device Performance |
|---|---|---|
| Premarket Equivalence | Substantial equivalence to predicate devices in: Indications for Use, technological characteristics, mode of operation, performance specifications. Minor differences justified by testing and reference devices. | TAV Medical Dental Implant System is stated to be substantially equivalent to predicate devices (MIS Dental Implant System, Hahn Tapered Implant System, Noris Medical Dental Implant System, SGS Dental Implants System, AB DENTAL Devices Ltd., Implant Direct, Ditron Dental Ltd.) in all device features, indications for use, materials, dimensions (with minor differences justified by other predicate devices or testing), prosthetic connection, device features, and sterilization method. Minor differences in implant diameter, packaging, healing cap dimensions, and abutment materials (Zirconia) and duration of use (PEEK abutments) were addressed by referencing other predicate devices or conducting specific mechanical/biological tests with "satisfactory results." |
| Material Biocompatibility | Conformance to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-18 (chemical characterization). FDA guidance "Use of International Standard ISO 10993-1" also followed. | "TAV Medical Dental Implant System products were tested and evaluated for materials biocompatibility... in order to demonstrate the biocompatibility of the system." (Implies successful demonstration). |
| Sterilization Validation | ANSI/AAMI/ISO 11137 parts 1 and 2 standards. Sterility Assurance Level (SAL) of 10^-6. All testing requirements met. | "Test results have demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met." |
| Pyrogenicity | Acceptance criteria as required by USP and . | "Tested using LAL method with satisfactory results that met the acceptance criteria." |
| Shelf Life | Successful accelerated aging validation, followed by real-time shelf-life validation for 5 years. | "Accelerated aging have been applied on the final packaging followed by a real time shelf life aging validation for 5 years shelf life." (Implies successful validation for 5 years). |
| Human Factors Study | Safe handling of the sterile single unit packaging, meeting study criteria. | "The study's criteria were met and passed successfully. Positive feedbacks received from the users participated in the study." |
| Performance Testing | Meets design specifications and performs as intended, similar to predicate devices. Includes: Implant to abutment compatibility, Static and Dynamic fatigue testing (ISO 14801:2007), Corrosion testing (ASTM F746-04), Surface finish analysis, Zirconia Material testing (ISO 13356:2008). | "Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate Tav Medical Dental Implant System meets its design specifications, performs as intended... The non-clinical testing results showed that the proposed dental implant system meet the device requirements and is considered equivalent to its predicate device." Specific tests mentioned performed with "satisfactory results" where material differences existed (e.g., Zirconia locker). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
- Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance
Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The Type of Ground Truth Used
The "ground truth" for the TAV Medical Dental Implant System is based on:
- Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
- Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
- Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
- Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
- Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML medical 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.