Search Results

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.

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.

Ask a specific question about this device

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.

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.

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.

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.

4. Adjudication Method for the Test Set

• Not Applicable. As there were no clinical studies involving human readers or expert consensus, no adjudication method was employed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The submission states: "No clinical studies were performed" (Section 5.21) and "No Animal studies were performed" (Section 5.20).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device is a physical medical implant (dental implant), not a software algorithm or AI device. Therefore, the concept of "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

• Standards-Based and Predicate Device Equivalence: The primary "ground truth" or reference for evaluating the W Zirconia Implants is compliance with recognized international and national standards (e.g., ISO 14801 for dynamic fatigue, ISO 10993-1 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices through comparable material properties, design features, and validated non-clinical performance.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Ask a specific question about this device

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:

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.

Ask a specific question about this device