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510(k) Data Aggregation
(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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(156 days)
The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.
The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.
The Essential Cone implants are fitted with an internal octagonal conical connection.
The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.
Immediate loading is appropriate for the Essential Cone and Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading. Abutments can be used in single tooth replacements and multiple tooth restorations.
8mm Implants are not indicated for use as unitary implants and for immediate load.
The Klockner Essential implant system consists of a group of implants, implant accessories and additional material to restore the mastication system. The different EC, ES and ECK models are available in three different diameters: 3.5mm, 4.0mm and the range of lengths varies between 8mm and 16mm. They are internally connected.
This document (K080224) is a 510(k) premarket notification for the Klockner Essential Dental Implants System. It aims to demonstrate substantial equivalence to previously cleared devices. Based on the provided text, the submission focuses on asserting equivalence based on intended use, composition, endosseous surface treatment, and design principles, rather than presenting a study with acceptance criteria and performance data in the way a diagnostic AI device would.
Therefore, a table of acceptance criteria and device performance, as well as details about sample sizes, expert adjudication, MRMC studies, standalone performance, training data, and ground truth for a study proving the device meets acceptance criteria, cannot be extracted from this document. These types of studies are typically not required or presented for dental implant submissions that demonstrate substantial equivalence through comparison to predicate devices, especially concerning their physical and material properties.
The relevant sections of the document are primarily focused on:
- Device Identification: Name, manufacturer, contact.
- Device Description: Physical characteristics (diameters, lengths, connection types) of the Klockner Essential implant system (EC, ES, ECK models).
- Intended Use: Surgical insertion into bone to replace tooth roots, acting as support for dental implants, with specific indications for different diameters and bone types, and considerations for immediate loading.
- Predicate Devices: Listing of previously cleared Klockner dental implants and other manufacturers' implants used for comparison.
- Basis for Substantial Equivalence: Stating that "the intended use, the composition and the endosseous surface treatment are identical to the Klockner predicate devices. The design principles are the same as the Klockner predicate devices."
In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study demonstrating performance against those criteria because it's a 510(k) submission based on substantial equivalence to predicate devices, not a performance study of a novel diagnostic or AI-based device.
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