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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:

1. Bench Testing: Mechanical, chemical, and biocompatibility testing to ensure the device meets established standards for dental implants.
2. 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.
3. 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.

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The T.B.R.® ide@ conic 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.

Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.

The provided document is a 510(k) summary for a medical device (T.B.R.® ide@ conic endosseous dental implant) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Mechanical testing: This was done in accordance with FDA guidance for root-form endosseous dental implants and abutments. It showed "sufficient mechanical static and dynamic strength."
2. Biocompatibility testing: Conclusions demonstrate the safety and effectiveness of the implant system.
3. Technological characteristics: A comparison table is provided highlighting similarities in type, lengths, diameters, connection, shape, materials, and surface with predicate devices.

Therefore, I cannot provide the requested information for an AI/ML device's acceptance criteria and study, as the input document describes a traditional medical device (dental implant).

The following information cannot be extracted from the provided document as it pertains to a traditional medical device submission, not an AI/ML device:

1. A table of acceptance criteria and the reported device performance (for an AI/ML algorithm).
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device