Search Results

Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.

The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.

The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).

The subject device implants are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-BL). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The information primarily focuses on non-clinical performance data and a comparison of technological characteristics, rather than reporting on a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or human-AI effectiveness.

Therefore, many of the requested details, such as acceptance criteria for clinical performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not present in the provided document.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative clinical acceptance criteria for the Z5-BL device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance data and technological characteristics.

The "performance data" section lists the types of non-clinical tests performed and their respective standards. The implied acceptance criterion for these tests is conformance to the referenced international or national standards, which is then used to support the claim of substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission did not include clinical data or a "test set" in the context of clinical performance evaluation or AI model validation. The performance data listed are non-clinical, mechanical, and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set.

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 document describes a dental implant and does not involve AI or human reader improvement studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This document describes a dental implant and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical performance data, the "ground truth" is established by adherence to the respective international and national standards (e.g., ISO, ASTM, USP) for material properties, sterility, biocompatibility, and mechanical performance. These standards define the accepted methods and criteria for evaluating device properties.

8. The sample size for the training set:

• Not applicable. No training set for an AI model is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI model is mentioned.

In summary, this 510(k) submission for the Z5-BL dental implant relies on demonstrating substantial equivalence through comprehensive non-clinical testing according to established standards. It explicitly states, "No clinical data were included in this submission" (page 5). Therefore, the requested information pertaining to clinical studies, AI performance, ground truth, and expert evaluation for a test or training set is not present.

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

Zsmlb: Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z

The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z5mlb and Z5mlc are onepiece, root-form, threaded implants made from yttria-stabilized zirconia (Y -TZP). Zsmlb and 25mlc implants are designed for full or partial denture restorations. Z5mlb implants are provided in two diameters (3.6 and 4.0 mm) and two endosseous lengths (8 and 10 mm). Zsmlc implants are provided in one diameter (4.0 mm) and one endosseous length (10 mm).

The provided text describes the Z5mlb and Z5mlc dental implants and their substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in terms of effectiveness or accuracy.

Therefore, I cannot provide the requested table or answer most of the questions because the necessary data is absent from the provided 510(k) summary. This document primarily focuses on establishing substantial equivalence based on intended use, design principles, and material similarities to already marketed devices, rather than presenting a performance study with acceptance criteria.

Here's what I can extract based on the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance:

• Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., success rates, functional scores) and therefore does not report device performance against such criteria. The submission is a 510(k) for substantial equivalence, which relies on demonstrating similarity to predicate devices rather than proving performance against novel metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not applicable. No test set for performance evaluation is described in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set or ground truth establishment process for performance evaluation is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication method for performance evaluation is described.

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 device is a physical dental implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No test set or ground truth establishment process for performance evaluation is described. The "ground truth" for a physical implant's safety and efficacy is typically established through a combination of preclinical testing (mechanical, biocompatibility) and clinical data (which is not detailed in this 510(k) summary beyond the general claim of substantial equivalence).

8. The sample size for the training set:

• Not applicable. This device is a physical dental implant, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device is a physical dental implant, not an AI model requiring a training set.

Summary of available information:

The provided document is a 510(k) summary for dental implants (Z5mlb and Z5mlc). It asserts substantial equivalence to several predicate devices based on:

• Same intended use: Surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Also suitable for patients with metal allergies.
• Same operating principle: Implantation of a root-form, threaded implant.
• Same basic design: One-piece, root-form, threaded implants made from yttria-stabilized zirconia (Y-TZP).
• Same or very similar materials: Y-TZP.
• Similar packaging and sterilization processes.
• Similar physical dimensions: The subject device (Z5mlb: 3.6 & 4.0 mm diameter, 8 & 10 mm length; Z5mlc: 4.0 mm diameter, 10 mm length) falls within the range of predicate devices.

The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with defined acceptance criteria and performance studies. The "study" referenced in the prompt implicitly refers to the comparison done for substantial equivalence. The "proof" is the FDA's concurrence that the device is substantially equivalent, implying it meets safety and efficacy standards equivalent to the predicate devices.

Ask a specific question about this device