Search Results

To be used in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.

The ProDrive line of high-speed air-driven dental handpieces includes two models - the ProDrive Mini and ProDrive Standard. These models are each available with one of a variety of quick couplings for use with: Sirona, KaVo, W&H, Bien-Air, NSK Mach and NSK QD-J connections. In addition, the PD Standard model comes in a fixed coupling format for MidWest handpiece users. The handpieces come supplied with a halogen light source of approximately 25,000 lux and a 3 jet spray for water. Every ProDrive handpiece is equipped with the previously-cleared ProDrive turbine as the standard drive mechanism. The ProDrive turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.

The provided document is a 510(k) Summary for a dental handpiece. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include detailed study results, acceptance criteria with reported performance, or specific information about ground truth establishment, expert adjudication, or sample sizes for testing or training sets in the way that would typically be presented for a diagnostic AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to performance standards for mechanical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The ProDrive line of dental handpieces meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization/use cycles the ProDrive handpiece continues to meet all performance requirements."

This is a general statement rather than a table with specific criteria and numerical performance results. Without the actual ISO 7785-1:1997(E) document, the specific acceptance criteria cannot be listed. The reported performance is a qualitative statement of meeting/exceeding standards after 250 cycles.

2. Sample size used for the test set and the data provenance
Not explicitly stated. The document mentions "Extensive testing," but does not provide details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set
Not applicable.

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
Not applicable. This is a mechanical device, not an AI/ML-driven diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device.

7. The type of ground truth used
For this type of mechanical device, "ground truth" would relate to objective performance metrics measured against engineering specifications and international standards (ISO 7785-1:1997(E)). It's not about clinical diagnostic ground truth like pathology or expert consensus.

8. The sample size for the training set
Not applicable. There is no AI/ML model for which a "training set" would be used.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device

To be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.

DO-ALL is a lubricant designed for use with air-powered dental handpieces. The product is intended to be used prior to handpiece sterilization to lubricate the moving parts inside of the air-powered turbine. The lubricant is not intended to come into contact with the patient and has no therapeutic function.

The provided document pertains to a 510(k) premarket notification for a dental handpiece lubricant and does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI/ML-driven diagnostics.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. The performance testing mentioned is for the lubricated dental handpiece to ensure it continues to meet existing performance standards after being lubricated with the new product. This is a different type of evaluation than what is usually described as "acceptance criteria" for a novel device's inherent performance.

However, I can extract information related to the closest equivalent of "acceptance criteria" and "study" based on the context provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device itself is a lubricant. The "performance" being evaluated is the ability of a dental handpiece lubricated with "DO-ALL" to continue performing according to established standards.

Note: The document states "DO-ALL performs as well as the predicate device in head-to-head comparisons" and that lubricated handpieces were "shown to meet or exceed all of the applicable performances standards outlined in ISO 7785-1:1997(E)." The specific quantitative acceptance criteria from ISO 7785-1:1997(E) and the FDA Guidance are not explicitly detailed in the provided text, nor are the specific numerical performance results for the lubricated handpieces. The key finding is the compliance with these standards.

2. Sample size used for the test set and the data provenance

• Test Set Description: The study involved testing "Dental handpieces lubricated with DO-ALL" and comparing their performance to those lubricated with the predicate device.
• Sample Size: The document mentions "Extensive testing illustrated that after 250 use/sterilization cycles the handpiece continued to meet all performance requirements." This implies that at least one or more handpieces were subjected to 250 cycles. The exact number of handpieces or the number of repeat tests for each characteristic is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "performance testing presented in the body of this submission." It is a prospective performance evaluation in a lab setting, not a retrospective analysis of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this type of device and study. The "ground truth" here is objective physical performance measurements of the handpiece against established engineering standards (ISO 7785-1:1997(E) and FDA Guidance), not expert consensus on an interpretation of data.

4. Adjudication method for the test set

This section is not applicable. No expert adjudication was involved as the assessments were objective physical measurements.

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

This section is not applicable. This study does not involve human readers, AI, or diagnostic image interpretation. It is a performance study of a mechanical lubricant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. There is no algorithm or AI involved. The study evaluated the mechanical performance of a dental handpiece with the lubricant.

7. The type of ground truth used

The "ground truth" was established by international standards (ISO 7785-1:1997(E)) and FDA Guidance Document on Dental Handpieces, which outline objective performance requirements for dental handpieces measuring various physical parameters (e.g., extraction force, torque, speed, noise level, resistance to corrosion, reprocessing, stall torque).

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is a performance evaluation of a physical product, not a machine learning model.

9. How the ground truth for the training set was established

This section is not applicable as there is no training set.

Ask a specific question about this device

To be used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces. The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance. Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way. With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture. ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.

This document describes the ProDrive Replacement Turbine, a dental device, and its conformity to established standards.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the ProDrive Replacement Turbine "meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E)." It then lists specific characteristics that this standard addresses.

Furthermore, the document states: "Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements."

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

The document does not explicitly state the numerical sample size used for the performance testing. It simply refers to "Extensive testing." The data provenance (country of origin, retrospective/prospective) is also not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a "ground truth" in the way it's typically understood for AI/diagnostic studies. The testing appears to be based on adherence to a recognized international standard (ISO 7785-1:1997(E)) and device-specific performance evaluations. Therefore, no information on the number or qualifications of experts is provided.

4. Adjudication Method

Since the testing is against a standard and doesn't involve subjective interpretation by multiple experts establishing a "ground truth" from complex data (like medical images), an explicit adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses on the device's technical performance against a standard and in comparison to a predicate device, not on diagnostic accuracy improvements with AI.

6. Standalone (Algorithm Only) Performance Study

No. The ProDrive Replacement Turbine is a mechanical dental handpiece component, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" in this context is defined by the performance requirements outlined in ISO 7785-1:1997(E) and the comparative performance against a legally marketed predicate device. This is a standards-based and objective measurement-based "ground truth," rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning algorithm.

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

Not applicable, as there is no training set mentioned or implied for an AI/ML algorithm.

Ask a specific question about this device