Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery. It is also usable in the placement of screws.

The Stryker Oral Max System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories.

This document describes a 510(k) premarket notification for the Stryker Oral Max System, a device intended for surgical procedures involving bone and bone-related tissue. The provided text is a summary of safety and effectiveness for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML device submission.

The document states that the Stryker Oral Max System is "equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment" and to devices distributed by Aeseptico. This indicates a substantial equivalence (SE) claim, which is a regulatory pathway for devices that are as safe and effective as legally marketed predicate devices.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details because the provided text does not describe an AI/ML device or a study designed to establish detailed performance metrics against pre-defined acceptance criteria. It relies on the substantial equivalence principle rather than demonstrating de novo performance.

To reiterate, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as it describes a traditional medical device submission based on substantial equivalence, not an AI/ML device with performance studies.

Ask a specific question about this device