(90 days)
High-speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate 430 Series Lube Free High Speed Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing. The intended use of the Star Autochuck Turbine with Vortex Air Seal is to both provide the convenient:e of tool-free bur changing and to eliminate the necessity of lubrication of the turbin a after use and before sterilization.
Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing.
This device, the "Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece," is a dental accessory. The provided 510(k) summary and FDA clearance letter do not contain any information about acceptance criteria or a study demonstrating the device meets such criteria.
The 510(k) process for this device relies on substantial equivalence to a predicate device, the "StarDental 430 Series Lube Free High Speed Handpiece." This means the manufacturer argued that their new device is as safe and effective as a device already legally marketed, without needing to perform extensive clinical studies to establish new performance metrics.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
Here's a breakdown of why and what information would typically be needed for such a report:
Why the information isn't available in the provided text:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves comparing technological characteristics, intended use, materials, and safety/effectiveness profiles. It does not necessarily require new clinical trials or the establishment of new, specific acceptance criteria for performance, especially for devices like dental handpieces which are well-understood.
- Device Type: A dental handpiece and its components are mechanical devices. Performance is more often assessed through engineering benchmarks (e.g., rotational speed, torque, durability, vibration, noise) rather than complex diagnostic accuracy metrics as seen with AI/imaging devices.
- Date of Submission (1998): Regulatory expectations for device testing, particularly for software/AI components or complex diagnostic devices, have evolved significantly since 1998. The focus for this type of device at that time was primarily on demonstrating equivalence established through technical comparison and compliance with relevant standards.
What would be expected for a device with acceptance criteria and a study:
If this were a device where such information was required and provided, the report would look like this (with hypothetical data for illustration):
Hypothetical Report (as if the information were present in the 510(k) submission):
This report describes the acceptance criteria and the study that proves the device meets these criteria for [Device Name - hypothetical example: "AI-Powered Caries Detection System"].
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Sensitivity (Caries Detection) | ≥ 90% (for lesions ≥ 1mm) | 92.5% | Met |
| Specificity (Caries Detection) | ≥ 85% | 87.8% | Met |
| Accuracy (Caries Detection) | ≥ 88% | 90.1% | Met |
| False Positive Rate | ≤ 10% | 7.2% | Met |
| Time to Diagnosis | Reduction of 20% compared to unassisted readers | 25% reduction | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 500 dental radiographs (250 with confirmed caries, 250 caries-free).
- Data Provenance: Retrospective data collected from 3 dental clinics in the United States and 2 in Germany.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 3
- Qualifications: All were board-certified radiologists specializing in oral and maxillofacial radiology with an average of 15 years of experience in dental imaging interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: 2+1 (Two experts independently reviewed each image. In cases of disagreement, a third senior expert adjudicated the final ground truth).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes.
- Effect Size: Human readers (dentists and dental hygienists) showed an average improvement of 22% in sensitivity and 15% in diagnostic accuracy when using AI assistance compared to reading without AI assistance. The time taken for diagnosis decreased by an average of 20%.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes. The performance metrics in the table above (Sensitivity, Specificity, Accuracy, False Positive Rate) represent the standalone performance of the AI algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: A combination of expert consensus (as described in section 4) and correlative pathology reports where available for a subset of the carious lesions. Patient outcome data (e.g., confirmed restoration due to active caries) was used to validate equivocal cases.
8. Sample Size for the Training Set
- Training Set Sample Size: 20,000 dental radiographs.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Ground truth for the training set was established through a combination of:
- Automated Labeling: Leveraging existing clinical reports and structured data fields from electronic dental records.
- Expert Review (Subset): A random subset of 10% of the training data was independently reviewed and labeled by 5 dental professionals (dentists and experienced dental hygienists). Discrepancies were resolved by a lead radiologist.
- Pathology Correlation: For a portion of the confirmed carious lesions, histopathological reports provided definitive ground truth.
Conclusion for the original prompt based on available data:
The provided 510(k) summary for the "Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece" does not include details on specific acceptance criteria or a study demonstrating the device meets such criteria. The submission focuses on establishing substantial equivalence to a predicate device based on identical intended use, technology, design, manufacturing, and materials, which is a common pathway for mechanical dental devices.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.