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510(k) Data Aggregation
(592 days)
Dental Electric Motor
Dental Electric Motor NL400-1 is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces.it is for use in general dental applications with use of a straight, right-angle, ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed. This system is designed for use by a trained professional in the field of general dentistry.
Dental Electric Motor NL400-1 is a system attached to dental treatment center to operate electrically driven low speed handpieces. It consists of the components Control Unit, Micromotor, Motor Cable, and AC Adaptor. The common gear ratio is 1:1, 16:1 and 1:5, the speed range is from 2000 to 40,000 rpm.
The Control Unit provides the operation panel to achieve different operation functions, such as turn on/off the motor, adjust the motor speed, select memory setting, choose the motor work ratio, and the motor rotate direction.
The Motor Cable is connected to the Control Unit and the Micromotor, and contains lead wires to power the motor and tubing to transmit air/water/spray provided and controlled by the dental treatment center.
The Micromotor is built in with a three-phase DC motor and an LED light, and contains air and water outlet, which can drive the electrically-driven handpiece with the set output parameters and transmits the air/water/spray and lights.
The provided text is a 510(k) summary for a "Dental Electric Motor." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/ML powered medical device. Therefore, the information required to answer your questions regarding acceptance criteria and supporting studies for an AI device is largely not present in this document.
Here's an attempt to answer based on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
This document does not define specific performance acceptance criteria or report performance in the typical sense for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it conducts a comparison to predicate devices, where "performance" is implicitly evaluated by demonstrating that the subject device meets relevant safety and performance standards (like IEC 60601-1, IEC 60601-1-2, ISO 14457).
The closest to "acceptance criteria" for this conventional device are the general safety and performance standards it was tested against. The "reported device performance" would be that it complies with these standards.
| Acceptance Criteria (Implied from testing standards) | Reported Device Performance (Implied from Summary) |
|---|---|
| Compliance with IEC 60601-1 (Medical electrical equipment basic safety and essential performance) | Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Device has been evaluated for safety and performance by lab bench testing according to IEC 60601-1-2. |
| Compliance with ISO 14457 (Dentistry Handpieces and motors) | Device has been evaluated for safety and performance by lab bench testing according to ISO 14457. Additionally, specific features like speed and gear ratio are stated to comply with ISO 14457. |
| Moderate level of software documentation and verification | Performed (stated as "Moderate level of software documentation and verification per the FDA Guidance Document for Software Contained in Medical Devices"). |
| Sterilization and cleaning validation | Performed per ISO 17665-1 and FDA Guidance Document for Reprocessing of Medical Device. |
| Biological evaluation (in vitro cytotoxicity) | Performed per ISO 10993-5:2009. |
| Biological evaluation (irritation and skin sensitization) | Performed per ISO 10993-10:2010. |
| Substantial Equivalence to Predicate Device (in terms of design, intended use, indications for use, functions, material and applicable standards) | Concluded as substantially equivalent, with minor differences not affecting safety and effectiveness. |
| Speed Range (2000-40000rpm) | Achieved 2000-40000rpm (Subject Device, Technical Specifications). |
| Speed Ratio (16:1, 1:1, 1:5) | Achieved 16:1, 1:1, 1:5 (Subject Device, Technical Specifications). |
| Maximum Torque (4.20 N*cm) | Achieved 4.20 N*cm (Subject Device, Technical Specifications). |
| Torque Range (1-3.0 N*cm) | Achieved 1-3.0 N*cm (Subject Device, Technical Specifications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because the submission describes testing of a physical device against standards, not an AI/ML model for which "test sets" of data are typically defined in this manner. The testing described is lab bench testing of the physical hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there is no AI/ML model and thus no "ground truth" establishment in the context of expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device substantial equivalence submission.
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 electric motor, a piece of hardware, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in the device description.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device, compliance with standards and functional specifications constitutes the "truth" or verification of its performance.
8. The sample size for the training set
Not applicable. This document pertains to a physical dental electric motor, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or training set discussed.
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(391 days)
Dental Electric Motor
The MT2 dental electric motor consists of main unit, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment. The Dental Electric Motor can be used with ISO E-type a straight, right-angle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.
The contra-angle handpieces (model: WJ-15, WJ-15L) are driven by a micro-motor to rotate at a specified speed, so as to drive the dental bur. It is applicable to drilling and grinding in dental surgery.
The MT2 dental electric motor consists of main unit, motor, motor tail, power adapter and power cord. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, rightangle or contra-angle handpiece attachment of equal, gear-reducing, or gear increasing speed.
Dental Electric Motor (model: MT2) is a control unit, which is connected to an AC power supply and a handpiece hose, that drives a DC electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. The foot switch is not included in the control unit. It is used together with a handpiece attachment. It provides a low voltage DC power supply for the handpiece attachment with light.
The device is for prescription use.
The provided text describes a 510(k) premarket notification for a Dental Electric Motor (model MT2). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive trials. Therefore, the information typically requested in your prompt (e.g., effect size with AI assistance, expert qualifications for ground truth in a test set, MRMC studies) is generally not applicable to this type of regulatory submission for this device.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present acceptance criteria in a table format with corresponding device performance metrics in the way you might expect for a diagnostic or AI-powered device. Instead, substantial equivalence is claimed based on comparing the technological characteristics of the subject device to predicate and reference devices, and conformity to recognized standards.
The "acceptance criteria" for this submission are primarily demonstrating that the device meets relevant safety and performance standards and that any differences from a predicate device do not raise new questions of safety or effectiveness.
Table: Comparison of Subject Device to Predicate/Reference Devices (from text, modified for clarity to show "acceptance criteria" indirectly)
| Item | Subject Device (MT2 Dental Electric Motor) | Primary Predicate Device (K163131: A-dec NLZ electric motor system) | Reference Device (K182999: General Cutting Contra Handpiece) | "Acceptance Criterion" (Implied: Demonstrated Substantial Equivalence) |
|---|---|---|---|---|
| Product Code | EBW, EGS | EBW | EGS | Identical to predicate/reference codes |
| Regulation No. | 872.4200 | 872.4200 | 872.4200 | Identical to predicate/reference |
| Class | I | I | I | Identical to predicate/reference |
| Indications for Use | General dental applications (cutting, preparation, finishing, inlay, filing, polishing, prophylaxis, endodontic treatment); usable with ISO E-type handpiece attachments. Contra-angle handpieces for drilling/grinding. | General dental applications (cutting, preparation, finishing, inlay, filing, polishing, prophylaxis, endodontic treatment); usable with ISO E-type handpiece attachments. | General dentistry (cutting, grinding, cavity preparations, finishing, trimming, material removal). | Similar (Differences discussed and justified not to affect equivalence) |
| Drive | Electric-micromotor | Electric-micromotor | NA | Identical to predicate |
| Components | Main unit, DC adapter, DC cord, motor, motor tail | Motor controller, Electric micromotor, Motor tubing | NA | Identical principle of operation |
| Power source | AC/DC Adapter: 100-240Vac; Output: DC30V, 3.0A | --- | NA | Meets relevant electrical safety standards |
| Size | Main unit: W165.5 x D129.7 x H77.6mm; Motor: DΦ22 x H76.7mm; Motor tail: 1800mm | Motor controller: D78.5 x W148.0 x H43.0mm; Motor: Length: 31mm, Diameter: Φ20.1(Front), Φ22.1(Rear); Motor tubing: 1600mm/2080mm | NA | Different but justified not to affect principle of operation or new risk |
| Material of Motor exterior | Aluminum alloy | Titanium | NA | Different but justified not to affect principle of operation or new risk |
| Light | LED | LED | NA | Identical to predicate |
| Rotation Speed | 2,000-40,000 rpm | 1,000 - 40,000 rpm | NA | Similar (Discussion 2 states differences do not affect identical principles) |
| Rotation direction | Forward and reverse | Forward and reverse | NA | Identical to predicate |
| Coolant mechanism | Coolant air | Coolant air | NA | Identical to predicate |
| Available Handpiece type | E-type (ISO 3964) | E-type (ISO 3964) | NA | Identical to predicate |
| Usage environment | Temperature: 5-40°C, Humidity: 30-75% | Temperature: 0 - 40°C, Humidity: 30-75% | NA | Similar (Discussion 2 states differences do not affect identical principles) |
| Operational modes (Handpiece) | Air-power | NA | Air-power | Identical to reference |
| Optical fiber (Handpiece) | WJ-15: without, WJ-15L: with light | NA | With light, without light | Identical to reference |
| Type of chuck (Handpiece) | Mechanical type chuck | NA | Mechanical type chuck | Identical to reference |
| Coupling dimensions (Handpiece) | Middle (ISO 3964-2016) | NA | ISO 3964 Standard Coupling | Identical to reference |
| Material of handpiece | Copper, Stainless steel | NA | Titanium | Different but justified not to affect principle of operation or new risk |
| Shanks for rotary instruments | Type3,Φ1.6mm drill ( ISO 1797-1-2011) | NA | Type 1, Type 3 | Identical to reference |
| Gear Ratio Max rotation speed (handpiece) | 1:5 Increasing- 200,000 min-1 | NA | 16:1, 10:1, 4:1 Reduction; 1:1 Direct; 1:5 Increasing | Identical to reference |
| Lubricant | NSK Pana-Spray (K052700) | NA | NSK PANA SPRAY Plus (K163483) | Identical to reference |
| Sterilization | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Sterilized by user (Steam sterilization) | Identical to predicate/reference |
| Sterilization Validation Standard | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | ANSI/AAMI/ISO 17665-1:2006 | Identical to predicate/reference |
The "Remarks" column (e.g., "Identical," "Similar," "Different") from the original table serves as the performance outcome relative to the implied acceptance criterion of substantial equivalence. Where "Different" or "Similar" is noted, the document explicitly states in "Discussion 2" that these differences do not affect the identical principles of operation or cause new risks.
Non-clinical Tests Performed:
- Biocompatibility testing (ISO 10993-5, ISO 10993-10)
- Electric safety and EMC testing (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60)
- Bench testing (implied by the comparison and discussion of differences not affecting performance)
- Sterilization validation (ANSI/AAMI/ISO 17665-1:2006 and FDA Reprocessing Guidance)
- Software validation (per FDA Software Guidance for Moderate level of concern)
- Conformity to Dentistry-Handpieces and motors standard (ISO 14457: 2017)
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the submission is for a traditional 510(k) for a mechanical dental device, not a diagnostic device or an AI/ML product typically requiring test sets of patient data. The "tests" mentioned are non-clinical engineering and bench tests, not clinical studies with patient samples. The manufacturer is Guilin Woodpecker Medical Instrument Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth experts are typically used for diagnostic or AI/ML device evaluations. This document details non-clinical testing against engineering standards and a comparison to predicate devices, not clinical ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for clinical trials or diagnostic studies, not for the non-clinical engineering tests performed for this 510(k).
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
This information is not applicable. This device is a dental electric motor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the clinical sense. For the non-clinical tests, the "ground truth" is defined by the requirements of the cited international and national standards (e.g., IEC, ISO, ANSI/AAMI), which specify test methods and acceptable performance limits for parameters like electrical safety, biocompatibility, and sterilization effectiveness.
8. The sample size for the training set
This information is not applicable. This device is a mechanical dental instrument, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, no AI/ML system or training set is involved.
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