(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.
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K98 2593
0CT 2 2 1998 Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece
510(k) Summary
Company:
StarDental, Division of DentalEZ Group Owner/operator number 2520265
Contact Person:
Keith C. Peithmar , Director of Marketing StarDental, Division of DentalEZ Group 1816 Colonial Village Lane Lancaster, PA 176301 Phone: (717) 291-1161 (717) 29' -9742 Fax:
Device Trade Name:
Lybe Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece
Dental Handpiece and Accessories Common or Usual Name StarDental 430 Series High Speed Handpiece Predicate Device:
Intended Use/Description:
High-speed dents I 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 StarDental 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 StarDental Autochuck Turbine with Vortex Air Seal is to both provide the convenience of tool-free bur changing and to eliminate the necessity of lubrication of the turbine after use and before sterlization.
Substantial Equivalence:
The determination of substantial equivalence is based on the fact that the proposed StarDental device and the predicate StarDental device utilize substantially equivalent intended use, technology, design, manufacturing, and materials and so will be substantially equ valent in clinical performance.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human figures. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
OCT 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith C. Peithman Director of Marketing StarDental, Division of DentalEZ Group 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re : K982593 Trade Name: Lube Free Autochuck Turbine with Vortex Air Seal for Use with StarDental 430 Series Lube Free High Speed Dental Handpiece Regulatory Class: I Product Code: EFB Dated: July 21, 1998 Received: July 24, 1998
Dear Mr. Peithman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Peithman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cuenito flor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications of Use
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.
Prescription Use
per 21 CFR 801,109
Heald Shipman
(Division Sign-Off) Division of Demal, Infection Control, and General Hospital Devices 510(k) Number _
§ 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.