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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K172668

Device Name

W Zirconia Implants

Manufacturer

TAV Medical Ltd.

Date Cleared

2018-11-06

(427 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K120793,K132881,K163043,K132585,K994119,K170131,K151328

Intended Use

Device Description

W Zirconia Implants are suitable for one or two stage endosseous form of dental implants. One Piece and Two-Piece implants are available. The abutments are used in conjunction with the endosseous dental implant in order to support in the prosthetic rehabilitation. The implantation procedure can be accomplished, for the One-piece implant in a one stage and for the two piece implant in a one or two stage surgical procedures. TAV Medical's W Zirconia Implants are composed of the following implant models: W One Piece – monotype implant with integrated abutment. W Two Piece –implant for screw retained Abutment. In both implants the endosteal region is provided with a roughness with a Ra value of 2.3 µm. The implants and abutments are tissue level designed and includes a body portion (implant body diameter 4.1 mm with a 4.8 mm platform, and implant body diameter 4.8 mm with a 6.0 mm platform) 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). Each Two piece implant is accompanied with a standard titanium cover screw.

AI/ML Overview

This document, K172668, describes the substantial equivalence determination for TAV Medical's W Zirconia Implants. It is a 510(k) Premarket Notification to the FDA, which means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device. This is not a de novo application or a PMA, and therefore, the study information described below primarily focuses on non-clinical testing to demonstrate equivalence, rather than extensive clinical efficacy studies to establish new performance criteria.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices. The "reported device performance" demonstrates that the new device meets those equivalent characteristics through non-clinical testing. The document highlights various aspects, but direct quantifiable acceptance criteria with a single reported value for "reported device performance" are not presented in a concise table format in the provided text for all features.

However, based on the non-clinical testing section (5.19.3 Performance Testing) and the substantial equivalence tables (5.18), we can infer some key comparisons.

Feature	Acceptance Criteria (Predicate)	Reported Device Performance (W Zirconia Implants)
Biocompatibility	Complies with ISO 10993-1 and FDA guidance for medical devices.	Testing performed according to ISO 10993-1 and FDA guidance; results demonstrated biocompatibility.
Sterility Assurance Level (SAL)	SAL of 10^-6 (Standard for terminally sterilized devices).	Achieved SAL of 10^-6 through validation according to ANSI/AAMI/ISO 11137 (Gamma Irradiation).
Shelf Life	Demonstrated shelf life for packaging. (Implied by predicate standards and FDA expectations).	Accelerated aging applied to packaging, followed by real-time aging, validating a 1-year shelf life.
Dynamic Fatigue Strength	Meets or exceeds the fatigue strength of predicate devices, as per ISO 14801.	Testing performed according to ISO 14801; results showed the implant system meets device requirements and is equivalent to predicate devices.
Implant-Abutment Compatibility	Compatible with intended abutments. (Implied by predicate and design).	Evaluated through design verification testing. Results indicate compliance.
Surface Finish	Acceptable surface roughness and characteristics. (Implied by predicate and design specifications).	Surface finish analysis performed. Endosteal region has a roughness with a Ra value of 2.3 µm, similar to predicate characteristics.
Zirconia Material Wear	Acceptable wear characteristics for zirconia. (Implied by predicate and specific material standards).	Testing performed. Results indicate compliance.
Manufacturing Technology	Predicate uses turning technology (Institute Straumann AG) or CIM (COHO Technology Co. Ltd.).	CIM (ceramic injection molding). Deemed equivalent due to reference predicate (K132585) also using CIM.
Implant Outer Diameter (One-Piece)	Referenced predicate diameters (e.g., K120793, K132585) 3.6, 4.0, 5.0 mm.	4.1, 4.8 mm. Minor dimensional differences deemed covered by reference predicate devices (K120793 and K132585).
Implant Outer Diameter (Two-Piece)	Referenced predicate diameters (e.g., K132881, K163043) 4.0, 5.0 mm and 3.3, 4.1, 4.8 mm respectively.	4.1, 4.8 mm. Minor dimensional differences deemed covered by reference devices (K132881 and K163043).
Prosthetic Connection (Two-Piece)	Internal connection type (Z-Systems AG K132881, Dentalpoint AG K163043).	Internal Hex screw retained connection. Deemed equivalent as reference predicates have internal connection types covering the screw retained feature.
Sterilization Method	Plasma (Primary Predicate) or Steam (Reference Predicates).	Gamma Irradiation. Validated to assure SAL of ≥10^-6, a common sterilization method.
Sterile Package	Sterile barrier sealed blister (Primary Predicate).	Sterile barrier sealed tube. Bridged using TAV Medical's packaging system cleared under 510(k) K170131.
PEEK Healing Caps Use Period	Up to 6 months (Primary Predicate K151328).	Up to 180 days (similar to 6 months).
PEEK Temporary Caps Use Period	Up to 30 days (Primary Predicate K151328) with PMMA material.	Up to 180 days with PEEK material. Justified by prior clearance of PEEK components for 180 days under K170131.

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

Sample Size for Test Set: The document does not specify exact sample sizes for the non-clinical bench testing (e.g., number of implants tested for fatigue). It generally states that "testing and evaluation" were performed and "validation results have demonstrated" adherence to standards.
Data Provenance: All testing appears to be non-clinical bench testing performed by or for TAV Medical Ltd. The country of origin of the data is not explicitly stated beyond TAV Medical Ltd. being located in Israel. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

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

Not Applicable. Since no clinical studies were performed (Section 5.21), there was no "ground truth" established by human experts in a clinical setting for the performance of the device on patients. The "ground truth" for the non-clinical tests is established by the specified ISO/ASTM standards and the performance of the predicate devices.