(90 days)
TAV Medical's W Zirconia Implants are intended for surgical placement in the patient's upper and 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 for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.6mm reduced diameter implants are recommended for central and lateral incisors only.
TAV Medical's W Zirconia Implants are dental implants, composed of the following implant models: W One Piece - monotype implant with integrated abutment. W Two Piece – implant for screw retained Abutment. The implants are tissue level designed and includes a body portion and a neck (1.8mm). The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone level. TAV Medical's W Zirconia Implants are made of Yttria stabilized tetragonal zirconia (Y-TZP). This material conforms with ISO 13356:2015 standard for Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The Titanium abutments are going through anodizing process using an electrolytic process that adjusts the oxide level of the metal surface. This adjustment changes the spectrum of light, resulting in perceived color. By controlling the surface oxide level, an entire range of colors can be achieved. The Subject Device includes the following dimensions: W One-Piece implants: Diameter of 3.6mm for lengths of 8mm, 10mm, 12mm and 14mm and; Diameters of 4.1mm and 4.8mm for length of 14mm. W Two-Piece implants: Diameters of 4.1mm and 4.8mm for lengths of 8mm, 10mm, 12mm and 14mm. Cover Screw are screwed into the implant to protect the inner configuration of the implant during the healing phase in cases of submucosal healing protocol. Cover screws are made of Titanium alloy Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Titanium Healing Caps are intended to protect the 2-piece implants during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. The healing caps are available in different geometrical features such as height and diameter. The Titanium Healing Caps manufactured from Ti 6Al 4V ELI & Anodize and are available in diameters of 4.1mm and 4.8mm. Each diameter is provided with height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Healing Caps are designed to protect the two-piece implant during the healing phase. The healing caps also support the emergence profile and keep the implant shoulder ideal for the impression phase. Peek healing caps are available in different geometrical features such as height and diameter and available in 2 different designs, one design for the one-piece implant and second design for the two-piece implant. Both designs are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK healing caps are available in diameters of 4.1mm and 4.8mm and height dimensions of 1mm, 2mm, 3mm and 4mm. PEEK Temporary Caps serves as a basis for temporary restoration. TAV Medical temporary restoration caps available in two configurations, temporary Cap for Crown and Temporary Cap for Bridge. The caps are manufactured from PEEK material and are indicated to be placed in patients' mouth for a maximum duration of 180 days. The PEEK temporary caps are available in diameter of 3.6mm. Titanium Abutments for the W Two Piece Zirconia Implants are intended for use as an adapter between the implant and the crown. The abutments are characterized by distinct geometrical features such as length and angulation. The titanium abutments are manufactured from ASTM F136-13 compatible Titanium Ti 6Al 4V ELI & Anodize. TAV Medical abutments are intended to be connected to 2-piece W Zirconia implants with titanium screw, to provide support for prosthetic reconstructions. The abutments are available in the following dimensions: Length of 5.0mm and 6.0mm and Angles of 0°, 5°, 10° and 15°. The 0º serves also for bridges.
The provided document is a 510(k) Premarket Notification for the TAV Medical Ltd. W Zirconia Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth in the way one might evaluate a diagnostic AI system.
However, I can extract the information related to performance testing that supports the claim of substantial equivalence.
Here's an analysis of the "acceptance criteria" (which are more akin to performance benchmarks against predicate devices and regulatory standards in this context) and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are implicitly meeting the performance of predicate devices and adherence to relevant ISO standards and FDA guidance documents. The document doesn't explicitly list numerical acceptance criteria with pass/fail thresholds in the same way a diagnostic AI study would. Instead, it states that the subject device's performance was "substantially equivalent" to the predicate devices and conformed to standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Conformance | Material (Yttria stabilized tetragonal zirconia, Y-TZP) conforms with ISO 13356:2015. |
| Biocompatibility | Established through identical manufacturing methods, facility, raw materials as the primary predicate device (K172668), |
| and compliance with ISO 10993-1, 10993-5 and FDA Guidance for Use of ISO 10993-1. No additional tests were conducted, as it was concluded biocompatibility was already established. | |
| Sterilization (Implants) | Validation leveraged from primary predicate K172668, conducted in accordance with ANSI/AAMI/ISO 11137-2:2013. Achieved SAL of 10^-6. |
| Sterilization (Abutments) | Steam heat sterilization validation performed in compliance with FDA Guidance (Jan 21, 2016) and ANSI/AAMI/ISO 17665-1:2006. Achieved SAL of 10^-6. |
| Shelf Life | Accelerated aging applied to final packaging, followed by real-time aging validating implants packaging. (No specific duration or results reported in this summary, but implies positive validation). |
| Mechanical Performance (Fatigue Testing) | Performed according to FDA guidance (May 2004) and ISO 14801:2016. Results indicated substantial equivalence to the primary predicate device. |
| Mechanical Performance (Implant-to-Abutment Connection Wear) | Bench tests conducted after fatigue testing to assess wear of implant body, abutment, and fixation screw, and screw loosening. Data concluded 'comparable behavior' to reference devices. |
| Overall Equivalence | Same intended use, indications for use, mode of operation, materials, manufacturing technology, and body contact as predicate devices, demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (dental implants), not an AI algorithm. Therefore, the concept of a "test set" for an AI model (like images with ground truth labels) does not directly apply.
- Mechanical Testing: While not explicitly stated as "sample size," mechanical tests (like fatigue testing and wear assessment) would involve a certain number of physical implant samples. This information is typically detailed in the full test reports, which are not included in this 510(k) summary. The summary only states that tests were performed according to ISO standards, which define methodologies including sample numbers.
- Data Provenance: Not applicable in the context of an AI test set. The provenance of the device components (materials, manufacturing) is Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as this is a physical medical device, not a diagnostic AI system requiring expert-established ground truth for a test set. Evaluation relies on established engineering principles, material science, and bio-compatibility standards through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device. Decisions are based on objective measurements against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
For a physical medical device, "ground truth" refers to established scientific and engineering principles, validated test methodologies, and regulatory standards.
- Material Properties: Conformance to ISO 13356:2015.
- Biocompatibility: Demonstrated through adherence to ISO 10993-1, 10993-5, and FDA guidance.
- Sterilization: Demonstrated through adherence to ANSI/AAMI/ISO 11137-2:2013 and ANSI/AAMI/ISO 17665-1:2006, and FDA guidance.
- Mechanical Performance: Demonstrated through adherence to FDA guidance (May 2004) and ISO 14801:2016. Testing involved objective measurements of fatigue life, wear, and screw loosening.
The underlying "ground truth" is that the device must meet the performance and safety requirements outlined in these standards and guidance documents, demonstrating substantial equivalence to legally marketed predicate devices.
8. The Sample Size for the Training Set
This is not applicable as this is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as this is a physical 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.