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510(k) Data Aggregation
(399 days)
The Z7 Zirconia Implant System is 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 ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. 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. The implants come in corresponding diameters of 3.7 and 4.3 mm.
The provided text describes the Z7 Zirconia Implant System, a dental implant device, and its compliance with FDA requirements for substantial equivalence to a predicate device. However, the information you've requested regarding acceptance criteria and study details in the context of an AI/ML device is not present in this document.
The document is a 510(k) clearance letter for a medical device manufactured from Zirconia (an endosseous dental implant), not an AI/ML-driven medical device. Therefore, it does not contain information about:
- Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
- Sample size for test sets in an AI context
- Data provenance for AI training/testing
- Number/qualifications of AI ground truth experts
- Adjudication methods for AI ground truth
- MRMC studies for AI assistance
- Standalone AI algorithm performance
- Type of ground truth used for AI
- Training set sample size for AI
- Ground truth establishment for AI training
The performance testing summarized in the document (Page 7) is related to the physical and material properties of the dental implant itself:
- Material Performance Testing: Per ISO 13356:2015 for Yttria-stabilized tetragonal zirconia (Y-TZP).
- Fatigue Testing: Per ISO 14801:2016 for dynamic loading of endosseous dental implants.
- Implant Surface Roughness and Chemical Analysis Validation: Through 3D Scanning Electron Microscope (SEM) Imaging and Energy Dispersive Spectrometry (EDS Analysis).
- Biocompatibility: According to ISO 10993-1 and ISO 10993-5 (cytotoxicity).
- Endotoxin Testing: Following USP and USP.
- Sterilization Validation: Per ISO 11135:2014 (Ethylene Oxide) and ISO 17665 (Moist Heat) for sterility assurance level (SAL) of 10^-6.
- Shelf-Life Validation: Accelerated aging followed by real-time aging.
For these physical device tests, all results are reported as "PASS" and "Device met all predetermined acceptance criteria" or "Substantially equivalent fatigue strength to reference device."
To reiterate, this document does not contain the information you are looking for regarding AI/ML device acceptance criteria and study details.
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(427 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.
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.
| 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.
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.
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