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High Speed Air Turbine Handpiece series: This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece Series: This device is an air-powered hand-held device. intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.

High Speed Air Turbine Handpiece series: There are two series (total 12 models) handpieces in this high speed hanhpiece series as A and B series. A series means the initial of model is "A", which include Quick Coupling, B series means the initial of model is "B", which doesn't include Quick Coupling. The High Speed Air Turbine Handpiece series device is reusable device, but they should be sterilized before use. In the A series, there are 2 models (AZL-4 and ADZ-4) device have one especial different from other model. These two model device have illumination function implemented via LED, the power supply of which is 3.3V d.c. and supplied by Therapy Machine. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series: This series devices is the low speed handpiece device which includes 2 air motors (model 0222 is two hole motor; model 0224 is four hole motor), one straight head (model 043) and one contra angle head (model 058E). the two air motor can be matched with the straight or contra angle head discretional for different condition. The Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series device is reusable device, but they should be sterilized before use. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

This submission details the K093971 Premarket Notification for High Speed Air Turbine Handpiece series and Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series. The document asserts substantial equivalence to predicate devices based on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "The performance of device following [relevant ISO and IEC standards] were conducted."

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

Not applicable. The ground truth was established through compliance with recognized international and national standards for device performance, not through expert human evaluation of outcomes.

4. Adjudication Method for the Test Set

Not applicable. Device performance was assessed against established technical standards, not through a process requiring human adjudication.

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

Not applicable. This device is a dental handpiece, not an AI/imaging diagnostic device that would typically involve an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states that "The performance of device following [relevant ISO and IEC standards] were conducted," implying that the device's technical specifications and functional capabilities were assessed independently against these standards. This is a standalone evaluation of the device's adherence to engineering and safety benchmarks.

7. Type of Ground Truth Used

The ground truth used was compliance with established international and national standards for dental handpieces:

• ISO7785-1:1997
• ISO9168:1991
• IEC 60601-1 (for specific models with illumination)
• IEC60601-1-2 (for specific models with illumination)
• ISO7785-2:1995
• ISO13294:1997

8. Sample Size for the Training Set

Not applicable. This device is a mechanical dental instrument, not a machine learning or AI-driven device that requires a training set.

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

Not applicable. There is no training set for this type of device.

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The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.

All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.

The provided text is for a 510(k) summary for a "Dental Unit with Chair" (K080438). This type of device is a Class I product, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device based on common design principles, adherence to recognized standards, and safety considerations. It does not involve a study proving performance against specific acceptance criteria in the way a medical imaging AI or diagnostic device would.

Therefore, many of the requested categories (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and demonstration of substantial equivalence.

Here's a breakdown based on the available information:

Acceptance Criteria and Device Performance for K080438 (Dental Unit with Chair)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This is a hardware device submission focused on compliance with recognized standards and substantial equivalence, not performance against clinical test data. No specific "test set" in the context of clinical or algorithmic performance data was used.

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

• Not Applicable. See point 2. Ground truth in the context of clinical data is not relevant here. Compliance with standards is assessed through engineering tests and documentation.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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 device is a dental unit and chair, not an AI or diagnostic tool that would involve human readers or image interpretation.

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

• Not Applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used:

• Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission is based on the requirements of recognized international and national standards (ISO, IEC, FDA guidance) and the specifications/performance of a previously cleared predicate device.

8. The sample size for the training set:

• Not Applicable. See point 2.

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

• Not Applicable. See point 2.

Summary Explanation:

This 510(k) submission (K080438) for a "Dental Unit with Chair" is a Class I medical device. For such devices, particularly those that are not complex diagnostic tools or AI-driven, the regulatory pathway primarily involves demonstrating substantial equivalence to an existing legally marketed predicate device. This demonstration is achieved by showing that the new device has the same intended use, similar design principles, and, crucially, complies with relevant recognized national and international consensus standards for safety and effectiveness (e.g., ISO, IEC).

The "study that proves the device meets the acceptance criteria" in this context refers to the manufacturer's internal testing and documentation verifying that the device (and its components, including software where applicable) meets the specifications outlined in the standards (e.g., electrical safety, biocompatibility, mechanical properties) and aligns with the design and features of the predicate device. There is no clinical trial, performance study with patient data, or AI algorithm validation involved.

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