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The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip air and water that help with removing debris from teeth cutting. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting.

The Vigor Series Low speed dental handpieces & Accessories are similar to other low-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are powered by either low speed air motor or electric micro-motor that are reusable and ergonomically shaped, and are provided without a fiber optic light system.

The Vigor C Low Speed Contra-Angle handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of these contra angle handpieces allows easy "snap-on" connection and removal from the motor. The contra-angle handpieces contain both chip air and water that help with removing debris from teeth cutting.

The Vigor S Low Speed Straight handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of the Low Speed Straight handpiece allows easy connection and removal from the motor. It can be used with a variety of different burrs that conform to the specifications stated in ISO 1797-1. These nose-cones contain both chip air and water that help with removing debris from teeth cutting.

The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle and straight handpiece that are manufactured in accordance with ISO 7785-2. The locking mechanism of the motor allows easy connection and removal of any add-ons. The motor contains chip air and water that help with removing debris from teeth cutting.

The devices are reused and can be sterilized by the steam autoclave method.

This document is a 510(k) summary for the Thunder Tiger Corp. Vigor Series Low Speed Dental Handpieces & Accessories. It does not describe an AI medical device or a study involving AI. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these concepts are not applicable to the provided text.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, function, and intended use, and adherence to relevant ISO standards, for non-AI medical devices.

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Tiger 500 Series High Speed Handpieces and Attachments are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

The Tiger 500 series High Speed Handpieces and Attachments are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices are supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single-use bag. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. According to IS07785-1:1997, Dental Handpiece-- Part 1: High-speed air turbine handpieces; and IS013485:2003, Medical Device Quality Management System to complete the device design steps.

The provided text is a 510(k) summary for the Thunder Tiger 500 Series High Speed Handpieces and Attachments. This document primarily focuses on establishing "substantial equivalence" to existing predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found in an AI/software as a medical device (SaMD) submission.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or extractable from this type of regulatory document for a traditional medical device.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or relevant to this type of submission:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" is demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and adherence to relevant standards. Performance is verified against mechanical and safety standards rather than clinical metrics.

Substantial Equivalence Table (from the document):

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

• Sample size: Not applicable. This is a traditional medical device (dental handpiece), not a software/AI device that undergoes testing with a "test set" of data samples. The evaluation is based on bench testing of the physical device and comparison to standards and predicate devices.
• Data provenance: Not applicable in the context of data samples. The device itself is manufactured in Taiwan, ROC (Thunder Tiger Corp., Taichung).

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

• Not applicable. There is no "test set" or "ground truth" established by experts in the context of clinical data for this type of device. Regulatory bodies (like the FDA) and standards organizations (like ISO) define the requirements, and the manufacturer performs testing to demonstrate compliance.

4. Adjudication method for the test set

• Not applicable. No "test set" (of data) or adjudication process regarding expert opinions is described.

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 physical dental handpiece, not an AI or diagnostic imaging device. An MRMC study is not relevant here.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is adherence to established international standards (ISO 7785-1:1997 for dental handpieces; ISO 13485:2003 for Quality Management Systems) and demonstrating substantial equivalence to legally marketed predicate devices. The "truth" is that the device meets these engineering specifications and performs comparably to existing, approved devices.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model that requires a training set of data.

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

• Not applicable. As above, this is not an AI/software device.

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The THUNDER TIGER Dental Air-Powered Handpiece is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N

This document is a 510(k) summary for a "Dental Air-Powered Handpiece". The information provided does not describe an AI/ML device or present a study that meets the acceptance criteria for such a device. Instead, it describes a traditional medical device (a dental handpiece) and the basis for its substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Here's why:

• No AI/ML Component: The document clearly identifies the device as a "Dental Air-Powered Handpiece." There is no mention of artificial intelligence, machine learning, software algorithms for diagnosis or analysis, or any other component that would classify it as an AI/ML device.
• Substantial Equivalence, Not Performance Study: The entire premise of the 510(k) summary is to demonstrate "substantial equivalence" to a predicate device (TIGER 100 series). This is a regulatory pathway for traditional devices, not typically for novel AI/ML performance validation studies.
• Performance Data Basis: The document states, "The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the THUNDER TIGER Dental Air-Powered Handpiece and its claimed predicate." This usually refers to engineering specifications, material comparisons, and basic function tests to ensure it operates similarly to the predicate, not clinical accuracy or diagnostic performance as would be relevant for an AI/ML device.

To directly answer your request based on the provided text, but acknowledging the device is not an AI/ML device:

1. Table of acceptance criteria and reported device performance:

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

• Not applicable for an AI/ML device. This document describes a mechanical dental handpiece. There is no "test set" in the sense of a dataset for evaluating an algorithm's performance. The "performance data" mentioned likely refers to engineering tests and comparisons to the predicate device's specifications.

3. Number of experts and qualifications for ground truth:

• Not applicable. Ground truth generation by experts is relevant for diagnostic or analytical AI/ML systems. This is a mechanical device.

4. Adjudication method:

• Not applicable. Adjudication is for resolving discrepancies in expert labeling or diagnoses for AI/ML training/test sets.

5. Multi reader multi case (MRMC) comparative effectiveness study:

• No, an MRMC study was not done. This type of study is for evaluating human performance alongside or with AI assistance in diagnostic tasks.

6. Standalone (algorithm only without human-in-the-loop performance) study:

• No, a standalone study was not done. This is for evaluating AI algorithm performance without human intervention.

7. Type of ground truth used:

• Not applicable. For a mechanical device, "ground truth" relates to its physical performance meeting specifications, not expert consensus on medical images or patient outcomes.

8. Sample size for the training set:

• Not applicable. No AI/ML model for training.

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

• Not applicable. No AI/ML model for training.

In summary, this document is solely for a traditional medical device (dental handpiece) and its regulatory clearance via substantial equivalence, not for an AI/ML device performance study.

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THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202

This submission refers to a 510(k) premarket notification for a Dental Air-Powered Handpiece (Models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202) by THUNDER TIGER CORP. The device's substantial equivalence is based on performance data comparing it to a predicate device, the CODENT Dental Air-Powered Handpiece (K033213).

However, the provided document does not contain the specific details required to describe acceptance criteria, the study proving the device meets those criteria, or most of the requested information (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results).

The document primarily focuses on:

• The 510(k) summary, identifying the applicant, device name, classification, predicate device, and intended use.
• A statement of substantial equivalence based on performance data comparison.
• The FDA's decision letter confirming substantial equivalence.
• The Indications for Use statement for the device.

Based on the provided text, I can only provide the following limited information:

1. A table of acceptance criteria and the reported device performance:

The remaining requested information (2-9) cannot be extracted from the provided text as it is not present in the 510(k) summary or FDA letter. This type of detailed study information is usually found in the full 510(k) submission, which is not included here. Substantial equivalence claims for Class I devices like this often rely on design, material, and operational similarity to a predicate device, with internal testing to ensure basic functionality and safety rather than extensive clinical efficacy studies.

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