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After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.

Smartburs

This document is a 510(k) premarket notification letter from the FDA for a dental device called "Smartburs". It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex AI/ML-based medical devices.

Therefore, I cannot provide the requested information for the following reasons:

• No Acceptance Criteria or Performance Study: The provided text is a regulatory clearance letter, not a scientific study report. It states that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a performance validation against specific acceptance criteria.
• Device Type: "Smartburs" is a dental bur, a mechanical instrument for removing decay. It is not an AI/ML-based device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance, nor would it involve training sets, test sets, or expert adjudication for ground truth.

Because the document does not contain the specifics of a performance study for an AI/ML device, I cannot fill in the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

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The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece.
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.

CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth. The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy.

This is a submission for a 510(k) premarket notification for a dental device, specifically a bone-cutting instrument. These types of devices generally rely on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials as typically seen for novel medical devices or diagnostic algorithms. Therefore, the information provided focuses on non-clinical performance and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The submission does not specify a "test set" in the context of an AI/ML algorithm or a diagnostic test with patient data. Instead, it refers to non-clinical tests conducted on the CeraDrill devices themselves to evaluate their physical and biological characteristics. The data provenance is internal testing by the manufacturer (Gebr. Brasseler GmbH & Co. KG), and the studies are prospective in the sense that they were designed and executed to test the characteristics of the new device. No geographical origin of patient data is relevant here as it's not a clinical study involving patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study that involves expert review for ground truth in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured physical and biological properties of the device, assessed using established engineering and laboratory standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission describes non-clinical performance data, not a study evaluating human interpretation or a diagnostic outcome requiring adjudication.

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

No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the evaluation of the CeraDrill's performance is based on engineering and laboratory test results for mechanical stability, thermal safety, corrosion resistance, material composition, and biocompatibility, as determined by internal testing and adherence to relevant standards (e.g., ISO 7405 for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

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Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.

Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.

The provided submission for K061383, "TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification," does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.

The submission is a 510(k) for a modified dental implant system (sterile dental drills kit/abutments and caps). The primary focus of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria for a novel device and then prove those criteria are met through a dedicated study.

Here's a breakdown of why this information is absent, based on the provided text:

• Substantial Equivalence Approach: The submission explicitly states, "The modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510(k) K022258 on Sep 11, 2003 and 510(k) 053355 on Mar 14, 2006." This indicates that the core approval strategy relies on comparing the new device to existing, already approved devices, rather than establishing de novo performance criteria.
• Lack of Performance Data: The document describes the device, its intended use, and its classification, but it does not present any specific performance metrics (e.g., bone cutting efficiency, abutment stability, wear resistance) that would typically have acceptance criteria. Consequently, there is no study described that would aim to "prove" such criteria were met.
• Focus on Design, Material, and Function: The "CONCLUSION" reiterates: "The modified BTT Dental Implant System is considered to be substantially equivalent in design, material and function to BTI Dental Implant System." This further emphasizes that the evaluation was a comparison of attributes rather than a measurement against new, independent performance benchmarks.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a proving study, as this information is not present in the provided 510(k) submission.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size for test set and data provenance: Not applicable, as no specific performance test data is presented.
3. Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone (algorithm only) performance study: Not applicable (this is a physical medical device, not an algorithm).
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

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