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For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).

The provided document is a 510(k) Premarket Notification for a Dental Handpiece. This type of submission is focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy through clinical studies or setting and meeting specific acceptance criteria for performance as would be done for a novel device or a device requiring a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of diagnostic or actionable performance (e.g., accuracy, sensitivity, specificity for a diagnostic AI). The "acceptance criteria" discussed in this document refer to adherence to established safety and performance standards for dental handpieces, and "study" refers to non-clinical tests verifying compliance with these standards.

Here's why the requested information isn't available in this document:

• Device Type: A "Dental Handpiece" is a physical tool used for mechanical dental procedures (cutting, grinding, polishing). It's not a diagnostic device, an AI algorithm for image analysis, or a device that generates a patient-specific "result" that would require performance metrics like sensitivity or specificity.
• Regulatory Pathway (510(k)): The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, technological characteristics, and intended use, and running non-clinical tests to show adherence to relevant performance and safety standards. It generally does not require large-scale clinical trials or MRMC studies that would describe the kind of acceptance criteria you've outlined.
• No Clinical Testing: The document explicitly states: "Clinical testing was not included in the submission." This immediately tells us that there will be no data on human reader improvement with AI assistance, standalone algorithm performance, or ground truth established from clinical outcomes.
• "Ground Truth" irrelevant: For a dental handpiece, the concept of "ground truth" (e.g., for a diagnosis) is not applicable. Its "performance" is measured by its physical characteristics, safety, and ability to perform its mechanical function according to engineering standards.
• No AI component: There is no mention of an AI component in this device.

Based on the available document, I cannot fulfill your request as it pertains to a diagnostic/AI device. The document describes a traditional medical device (dental handpiece) and its regulatory clearance via a 510(k) pathway, which focuses on substantial equivalence and compliance with engineering and safety standards, not clinical performance metrics relevant to AI or diagnostic accuracy.

However, I can extract information related to the standards and non-clinical tests that were performed to demonstrate the device's adherence to established safety and performance requirements, which are the "acceptance criteria" in this context.

Summary of Acceptance Criteria and Device (Non-Clinical) Performance:

Here's why the other points of your request cannot be answered from this document:

1. Sample size used for the test set and data provenance: Not applicable in the context of diagnostic/AI performance. The "tests" are engineering and safety verification tests on physical units of the device. The provenance of the device under test would be "Guangdong JINME Medical Technology Co., Ltd., China."
2. Number of experts used to establish the ground truth... and qualifications: Not applicable. There is no diagnostic "ground truth" to establish for a dental handpiece.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Explicitly stated "Clinical testing was not included in the submission." Therefore, no MRMC study, no human reader improvement data.
5. Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable, as there is no algorithm component.
6. Type of ground truth used: Not applicable.
7. Sample size for the training set: Not applicable, as there is no AI or machine learning component that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.

This FDA 510(k) summary (K240340) for the Surgical Drive System (Model: ES70, ES90, E8) describes a device that is not an AI/ML-driven medical device. The document focuses on establishing substantial equivalence to a predicate device based on technical design, intended use, and conventional performance and safety testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, cannot be extracted from this document because it does not involve AI/ML.

However, I can provide a summary of the non-clinical performance testing that was conducted to support the substantial equivalence claim for this medical device, which addresses the "study that proves the device meets the acceptance criteria" in a general sense, but not for AI/ML specific criteria.

Non-AI/ML Related Acceptance Criteria and Study Summary (Based on Provided Document):

The acceptance criteria for this non-AI/ML device are primarily related to safety, electromagnetic compatibility, and reprocessing effectiveness, demonstrated through adherence to recognized international standards.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

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

• Test Set Sample Size: Not explicitly stated in terms of number of devices / units. Testing would typically involve a statistically relevant sample of devices or components to demonstrate compliance with standards.
• Data Provenance: Not explicitly stated, but testing is implied to be conducted by the manufacturer (Guangdong Jinme Medical Technology Co., Ltd.) or a contracted testing facility. The nature of these tests (safety, EMC, reprocessing validation) implies prospective testing on manufactured devices to meet specific engineering and regulatory requirements.

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

• This concept is not applicable as this is a non-AI/ML device. "Ground truth" established by expert consensus is typically relevant for evaluating the diagnostic or classification performance of AI/ML algorithms. For this device, compliance is measured against engineering specifications, industry standards, and regulatory requirements, which do not rely on expert "ground truth" in the same way.

4. Adjudication method for the test set:

• Not applicable for a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or performance evaluations for diagnostic devices to resolve discrepancies in expert interpretations, particularly for establishing ground truth for AI model training or testing.

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 as this is a surgical drive system, not an AI-driven diagnostic or assistive imaging device involving human readers.

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

• Not applicable as this is a hardware-based surgical drive system, not an AI algorithm.

7. The type of ground truth used:

• For this device, "ground truth" is established by:
  • Engineering Specifications: The device is designed to meet specific performance parameters (e.g., motor speed, power output, operating mode).
  • International Standards: Compliance with established safety (e.g., IEC 60601-1), EMC (e.g., IEC 60601-1-2), and reprocessing (e.g., ISO 17665-1) standards, where the standard itself defines the acceptable criteria and test methods.
  • Software Design Requirements: For the device's control software, compliance is against its own validated design requirements and IEC 62304.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of AI/ML.

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

• Not applicable.

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Dental Low-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:

The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));

The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.

The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply; refer to section 2.3 for details.

The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.

This document is a 510(k) summary for a "Dental Low-speed Turbine Handpiece." It's a submission to the FDA seeking clearance for a new medical device by demonstrating its substantial equivalence to a legally marketed predicate device.

The provided text does not contain any information about a study based on artificial intelligence (AI), machine learning, or software performance evaluation for diagnostic purposes. The device in question is a physical dental instrument. Therefore, it's impossible to extract the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment in the context of AI/ML.

The "Test Summary" section (page 5 of the document) refers to:

• Performance test according to ISO 14457 standard: This standard relates to the mechanical and physical performance of dental handpieces.
• Biocompatibility test according to ISO 10993-1: This standard relates to the biological safety of medical devices in contact with the body.
• Reprocessing and Sterilization test according to ISO 17665:2006 and ISO 11134:2003 standards: These standards relate to the sterilization and resterilization of medical devices.
• Reprocessing validation according to FDA guidance document Dental Handpieces - Premarket Notification [510(k)] Submissions: This relates to the validation of cleaning and sterilization protocols for dental handpieces.

These are all standard engineering and biocompatibility tests for a physical medical device, not a software or AI/ML diagnostic.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The Dental High-speed Turbine Handpiece is the dental treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and and efficiency can be improved. Cartidges have high precision when rotating, cartiridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

The provided document describes a 510(k) premarket notification for a Class I medical device, the Dental High-speed Turbine Handpiece. The document details the device's substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not applicable in this context.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't provide specific numerical acceptance criteria for performance in a clinical sense. Instead, it compares the subject device's specifications and performance to predicate devices and adherence to relevant standards.

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

• Sample Size for Test Set: Not applicable. This is not a clinical study assessing patient outcomes or device performance on a test set of data/patients. The "test set" here refers to the physical device being tested against engineering standards.
• Data Provenance: Not applicable in the context of clinical data. The performance claims are based on engineering tests and comparisons to predicate devices, not clinical data sets.

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

• Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnostic images) is not relevant for this type of device submission. The "ground truth" for this device is established through compliance with recognized standards and successful engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no clinical adjudication of results for a test set.

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 handpiece, not an AI-assisted diagnostic tool.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The "ground truth" for the device's safety and effectiveness is established through adherence to ISO standards (ISO 14457 for performance, ISO 10993-1 for biocompatibility, ISO 17665:2006 and ISO 11134:2003 for sterilization), and reprocessing validation according to FDA guidance. It is also based on demonstrating substantial equivalence to existing legally marketed devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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