(220 days)
The T.B.R.® Zirconnect endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The T.B.R.® Zirconnect dental implant system consists of root form, screw-type implants (made from Ti-6Al-4V ) and restorative components with many options such as Ti-6Al-4V abutments, conical abutments. castable abutments and ball abutments. The system also includes surgical and laboratory accessories. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.
This 510(k) summary does not contain information typically found in a study proving a device meets acceptance criteria. Instead, it describes a dental implant system and asserts its substantial equivalence to previously marketed predicate devices. Therefore, I cannot provide a detailed answer to your request in the format you specified.
Here's why and what information is available:
What is available from the provided text:
- Device Name: T.B.R.® Zirconnect
- Intended Use: Surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices (artificial teeth) and restore chewing function.
- Predicate Devices: 3i Osseotite Certain NT (K031475) and T.B.R.® ide@ conic (K050956)
- Performance Statement: "Test conclusions demonstrate the safety and effectiveness of T.B.R.® Zirconnect implant system." and "The overall design and characteristics of the T.B.R.® Zirconnect implants are similar to the predicated devices and as safe, as effective and as performs as well or better than the legally predicate devices."
Why a full answer in your requested format isn't possible:
The provided text is a 510(k) summary, which is a document submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. For this type of device (endosseous dental implant), the primary demonstration of safety and effectiveness often relies on:
- Bench Testing: Mechanical, chemical, and biocompatibility testing to ensure the device meets established standards for dental implants.
- Comparison to Predicate Devices: Showing that the new device has similar technological characteristics (materials, design, dimensions, surface treatment, sterility) and performs similarly to devices already cleared by the FDA.
- Clinical Data (Less Common for 510(k)s for this type of device): While some 510(k)s may include summary clinical data, especially for novel features or higher-risk devices, root-form dental implants often do not require new clinical studies if they are substantially equivalent to existing devices. The focus is usually on engineering and material equivalence.
Therefore, the document does not contain the following information that you requested:
- A table of acceptance criteria and reported device performance: While the document states the device performs as well or better than predicates and test conclusions demonstrate safety and effectiveness, it doesn't provide specific quantitative acceptance criteria or detailed performance metrics. These would typically be found in detailed test reports, not a 510(k) summary.
- Sample size and data provenance for a test set: This implies a clinical study evaluating the device's performance in patients, which is not detailed here. The "test conclusions" likely refer to bench testing.
- Number of experts and qualifications for ground truth: Not applicable as there's no mention of a human-read clinical study requiring a ground truth panel.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned. The comparison is between the new device's characteristics and those of predicate devices, not human reader performance.
- Standalone (algorithm only) performance: Not applicable; this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable as there's no clinical study described that would establish such a ground truth. The "ground truth" for a device like this would be established through engineering specifications, material standards, and successful long-term clinical use of similar predicate devices.
- Sample size for the training set & how ground truth for training set was established: Not applicable, as this refers to AI/machine learning models, which is not the subject of this 510(k) submission.
In summary, the provided 510(k) is a regulatory document focused on demonstrating substantial equivalence, not a detailed study report with specific performance metrics and clinical trial data in the way you've outlined for AI/diagnostic devices.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.