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510(k) Data Aggregation
(252 days)
High-speed air turbine 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.
High-speed Turbine Air Handpiece is an instrument for drilling, grinding, repairing utilized in dental clinics. It composed of a head, a handle and a connector.
The subject device is intended to be used for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). The user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
N/A
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(216 days)
High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L. The cooling system includes air/water spray or only water spray. The head types include standard head and miniature head. The angle of the head and shaft include 45℃ and 90°. High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit.
The provided text describes the regulatory clearance of a dental handpiece and references a non-clinical study to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and performance data for a device that typically accompanies a study proving the device meets those criteria, as one would expect for an AI/ML powered device.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was tested per ISO 14457:2017 Dentistry - Handpieces and motors and that "the test result demonstrated that the proposed device complies with the standard requirements." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text.
The text lists the following parameters that were evaluated, implying these are the areas where acceptance criteria from ISO 14457:2017 were applied:
| Parameter Evaluated (Implied Acceptance Criteria from ISO 14457:2017) | Reported Device Performance (Not provided in the text) |
|---|---|
| Noise level @ Background noise level 56 dB(A) | "complies with the standard requirements" |
| Flow rate of air supply @ 400kPa | "complies with the standard requirements" |
| Flow rate of spray air @ 200kPa(2.0 bar) | "complies with the standard requirements" |
| Flow rate of water supply @ 200kPa(2.0 bar) | "complies with the standard requirements" |
| The force required to extract the test mandrels from the chuck system for Type 5 test mandrels | "complies with the standard requirements" |
| Torque @ Type 5 test mandrels | "complies with the standard requirements" |
| Speed of handpiece @ 0.22MPa | "complies with the standard requirements" |
| Dynamic eccentricity | "complies with the standard requirements" |
| Stall torque | "complies with the standard requirements" |
| The light at the output side of the handpiece (for models with optic light guide) | "complies with the standard requirements" |
Missing Information: The specific numerical acceptance limits for each parameter as defined by ISO 14457:2017 and the actual measured performance values of the device for each of these parameters are not detailed in this document.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "the proposed device" was tested, implying at least one unit of each of the 11 models (G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800, G800L). However, the specific number of units tested for each parameter is not disclosed.
- Data Provenance: Not explicitly stated, but based on the applicant's address (Zhongshan, Guangdong, China), the testing was likely performed in China. The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as this is a non-clinical performance test for a mechanical dental device, not an AI/ML powered device requiring expert ground truth for interpretation. The "ground truth" for this device's performance comes from physical measurements against an international standard (ISO 14457:2017).
4. Adjudication method for the test set
- This information is not applicable for the same reasons as point 3.
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
- No, a MRMC comparative effectiveness study was not done. This is a clearance for a physical dental handpiece, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI/ML software device.
7. The type of ground truth used
- For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the international standard ISO 14457:2017 Dentistry - Handpieces and motors. The device's performance is measured against these established engineering and safety standards.
8. The sample size for the training set
- This information is not applicable as this is a physical device, not an AI/ML "algorithm" that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as this is a physical device, not an AI/ML "algorithm."
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(77 days)
The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Dental Air-Powered Handpiece
The provided text is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it concludes equivalence based on comparison of "formulations and intended uses."
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states:
"The claim of substantial equivalence is based on comparisons of formulations and intended uses of the PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series and its claimed predicate."
This implies that detailed performance data, specific acceptance criteria, or a standalone study with human readers and ground truth, as typically required for demonstrating device performance against specific metrics, were not part of this 510(k) submission as presented. The FDA's letter also confirms that the determination is based on substantial equivalence to a legally marketed predicate device, not necessarily on a de novo performance study against defined acceptance criteria.
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(70 days)
The PAR-4HEX/4HX series handpiece is for use by authorized persons in the practice of the dentistry.
TWIN POWER TURBINE 4 H is a dental handpiece. Through the tube connected to a dental unit, the handpiece of this device receives the air for high speed turbine, the cooling water for cutting treatment through pouring holes and light for illumination source. The PAR-4HEX/4HX series includes ten types of models as is shown below at Table-1, and they are be able to be connected to the coupling of the other manufacturers than J.MORITA.
This 510(k) summary (K061701) describes a dental handpiece, the J. Morita USA Inc.'s TWIN POWER TURBINE 4H (PAR-4HEX/4HX series). The submission claims substantial equivalence to a previously cleared device (K043498), rather than providing a new study with acceptance criteria and performance data. Therefore, many of the requested details about a new study are not present in the provided text.
Here is the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance for a new study are provided in this 510(k) submission. The submission asserts substantial equivalence based on similar intended uses, technological characteristics, and operating principles to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No new study with distinct acceptance criteria presented) | Not applicable (No new study data presented for performance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a new study with a test set.
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)
Not applicable. Ground truth establishment for a test set is not mentioned as part of this substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods for a test set are not mentioned as part of this substantial equivalence claim.
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 (a physical tool), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental handpiece (a physical tool), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth is not relevant for demonstrating the safety and effectiveness of a dental handpiece through a substantial equivalence claim. The equivalence is based on physical and operational characteristics compared to an existing device.
8. The sample size for the training set
Not applicable. This device is a dental handpiece and does not involve AI/machine learning, thus no training set is relevant.
9. How the ground truth for the training set was established
Not applicable. As noted in point 8, there is no training set for this device.
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