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The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.

W&H's reciprocating/oscillating handpieces were developed as dental contra-angle handpieces that are powered by either an air motor or an electric micromotor. The internally mounted gearing elements transmit the supplied rotational movement up to the head-side assembly holding the clamped tool and generating its reciprocal movement. Because of being designed for two different manufacturers´ files/tips (tools), the following types have been developed: the Synea Profin handpieces WG-67 LT and WG-67 A, intended to be provided with tips/files offered by the Swedish company Dentatus AB (Establishment Reg. No. 8030870) and the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A (incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be provided with tips/files offered by the Swiss manufacturer Intensiv SA (Establishment Reg. No. 8030958). All these devices´ application is intended in dentistry.

The provided text is a 510(k) Premarket Notification summary for dental handpieces. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the new Synea Fusion Handpieces to a legally marketed predicate device (K082827) based on non-clinical testing for mechanical, material, and reprocessing characteristics, as well as biocompatibility.

Here's what can be extracted based on the provided text, and what cannot:

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

The document does not provide a specific table of acceptance criteria with reported performance values in the way one would for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, it states that "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K082827)."

The acceptance criteria are implied by the standards applied and the successful completion of the tests:

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 applicable and therefore not provided in the document, as the testing was non-clinical (laboratory/bench testing) of physical devices, not data from patients for an AI/ML diagnostic system. There were no "test sets" of patient data.

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 as typically understood for AI/ML diagnostic devices (e.g., radiologist reads, pathology) was not established for this type of device (dental handpieces). The "truth" for the performance criteria established was based on engineering specifications and adherence to international standards.

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

Not applicable, as this was not a human-reader based study for diagnostic accuracy.

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. No MRMC study was conducted, as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical performance testing was not conducted."

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

Not applicable. This is not an AI algorithm.

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

For this device, "ground truth" refers to the established engineering specifications and validated test methods defined by the applied ISO standards and internal procedures. For example:

• Mechanical/Functional: Compliance with force, speed, and dimensional tolerances as defined by ISO 14457.
• Biocompatibility: Absence of toxic or adverse biological reactions based on validated assays defined by ISO 10993-1 and ISO 7405.
• Reprocessing: Successful elimination of microbial load and retention of functional integrity after reprocessing cycles, validated according to ISO 17664, ANSI/AAMI ST79, and ISO 17665-1.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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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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High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.

The provided text is a 510(k) Summary for dental handpieces, which focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance directly from this document. The document primarily highlights that the proposed device met design specifications and performed as well as the legally marketed predicate device based on non-clinical tests compliant with various ISO and IEC standards. It explicitly states, "No clinical study is included in this submission."

Given this, I am unable to provide a response that directly answers your request for acceptance criteria and device performance from a clinical study, sample sizes for test sets, expert involvement, adjudication methods, MRMC study details, standalone performance, or training set specifics, as these are details typically found in clinical performance studies, not in this type of 510(k) submission.

The document focuses on non-clinical testing for safety and effectiveness, and comparability to a predicate device.

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Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.

Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.

During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.

The provided text is a 510(k) summary for a dental device, the "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)". It outlines the device's indications for use, technological comparison to predicate devices, and non-clinical tests performed to support substantial equivalence.

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance claims related to effectiveness measured by clinical outcomes or diagnostic accuracy (e.g., sensitivity, specificity, accuracy, effect size with human readers).

The non-clinical tests mentioned are related to:

• Performance Test: Compliance with standards like ISO 20608:2018 (Dentistry - Powder jet handpieces and powders) and sterilization/reprocessing standards (ISO 17665-1, ISO 17664-1, ISO 17664-2), and FDA guidance documents related to dental handpieces and reprocessing. These tests confirm the device's functional and safety attributes, not direct clinical efficacy metrics.
• Biocompatibility Test: Compliance with ISO 10993-1:2018 and FDA guidance on biological evaluation for devices with limited contact with surface medical devices and breached or compromised surfaces. This ensures the material safety of the device.

Based on the provided text, the following points can be addressed:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: The document refers to compliance with ISO standards (e.g., ISO 20608:2018 for powder jet handpieces and powders, various ISO standards for sterilization and biocompatibility) and FDA guidance documents. Specific numerical performance acceptance criteria (e.g., specific thresholds for removal efficiency of deposits, or clinical outcomes) are not detailed in this summary.
   • Reported Device Performance: The summary states that "The tests demonstrate compliance with the requirements of the following standards and guidance." and "The test results demonstrate compliance with the requirements of the following standards and guidance". It doesn't provide specific quantitative performance metrics beyond stating compliance with these standards.

2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical, primarily for engineering performance, biocompatibility, and reprocessing validation against international standards, not clinical studies with patients or image data.

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 studies involving AI or clinical diagnostic accuracy is not relevant here as the tests are non-clinical.

4. Adjudication method for the test set: Not applicable for the non-clinical tests 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 dental handpiece, not an AI or diagnostic imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical dental tool, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" is defined by the requirements and test methods outlined in the cited ISO standards and FDA guidance documents (e.g., for sterilization efficacy, material compatibility, or functional parameters of the handpiece).

8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices through non-clinical testing for performance against recognized standards (engineering, sterilization, biocompatibility) rather than clinical efficacy studies with specific acceptance criteria that would yield metrics like sensitivity, specificity, or reader improvement.

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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:

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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Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.

The provided document is a 510(k) premarket notification for a dental air motor. The core of this document is a comparison of the subject devices (Air Motor FX204 M4 and Air Motor M205) against predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device against acceptance criteria in the typical sense of AI/ML performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for AI/ML devices are not applicable in this context. The document focuses on performance testing to demonstrate safety and effectiveness for a mechanical device.

However, I can extract the information relevant to how the device's technical specifications and performance were evaluated against established standards and predicate devices.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in a table format for each specific performance metric in the way you might see for an AI algorithm (e.g., AUC > 0.90). Instead, the acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices by showing that the subject devices perform similarly and meet relevant safety and performance standards.

The closest we have to "reported device performance" and "acceptance criteria" are the comparison tables (Table 1 for FX204 M4 and Table 2 for M205) and the "Judgement" column, which indicates if the subject device is "Same," "Similar," or "Different" to the predicate. For "Different" or "Similar" aspects, further testing or justification is provided to demonstrate that the difference does not raise new questions of safety or effectiveness.

Below are tables summarizing the key performance and safety aspects evaluated and how the subject device's performance compared to the predicates, along with the implicit "acceptance criteria" through this comparison.

For Air Motor, FX204 M4 (model without spray) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-1")

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

• Sample Size for Test Set: The document mentions "Statistical calculation of sample size" under performance testing, but does not provide specific numbers for units tested for each type of test. The nature of these tests (e.g., drop test, reprocessing resistance, water leakage, vibration, sterilization validation) typically involves testing a representative sample of devices, but the exact number isn't quantified in the provided text.
• Data Provenance: Not explicitly stated, however, the applicant is "NAKANISHI INC." based in "700 Shimohinata Kanuma Tochigi, 322-8666, Japan". It's highly probable the testing was conducted in Japan or through certified testing facilities used by the manufacturer. The data would be prospective in the sense that these tests are performed on the manufactured devices to ensure they meet specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This concept typically applies to clinical studies or studies involving human interpretation (e.g., radiology expert review for AI algorithms). This submission is for a mechanical dental device.
• The "ground truth" here is compliance with engineering standards (e.g., ISO 14457 for dental handpieces), safety standards (e.g., ISO 10993 for biocompatibility), and the performance characteristics of the predicate devices.
• No "experts" in the sense of clinical reviewers establishing ground truth for individual cases are mentioned. Instead, the evaluations are based on technical testing by qualified personnel in accredited laboratories.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in AI/ML performance evaluation where ground truth is based on expert consensus.
• This is not applicable here as the evaluation is based on objective measurements against engineering standards and comparison with predicate device specifications.

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

• Not applicable. This is a submission for a mechanical dental motor, not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device does not involve a software algorithm in the context of an AI/ML device requiring this type of performance evaluation.

7. Type of Ground Truth Used

• The "ground truth" for this submission is primarily technical specifications/performance derived from engineering standards (e.g., ISO 14457, ISO 10993) and comparison to the known and established safety and effectiveness of legally marketed predicate devices.
• For example, passing ISO 14457 test methods indicates the device performs as expected for a dental handpiece. Biocompatibility is "ground-truthed" by adherence to ISO 10993.

8. Sample Size for the Training Set

• Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable, as there is no "training set" for this type of device.

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High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Straight Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Geared Angle Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Air Motors:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The proposed device is used to hold rotary instruments such as burs and drills for cutting, grinding, and drilling operations. The dental handpieces are hand-held instruments driven by air motor, thus driving the rotation of dental attachments for the purpose of drilling and tooth cutting. Some models include an electric connection to power an LED light

This document describes the regulatory submission for dental handpieces (High-Speed Air Turbine, Straight, Geared Angle Handpieces, and Air Motors). The goal of the submission is to prove the substantial equivalence of the proposed device to existing predicate devices, not to prove clinical safety or effectiveness for a new medical device. Therefore, a traditional "acceptance criteria" and "study that proves the device meets acceptance criteria" as one might see for a diagnostic AI device is not applicable here.

Instead, the submission focuses on non-clinical testing and comparison to predicate devices to demonstrate that the new device is as safe and effective as those already on the market.

Here's an analysis based on the provided document, addressing the prompt's points where applicable, and explaining why others are not relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental handpiece), "acceptance criteria" are typically defined by compliance with recognized international standards and performance benchmarks relative to the predicate devices. The document does not present a formal "acceptance criteria table" with specific thresholds for outcomes related to a diagnostic or therapeutic AI. Instead, it demonstrates compliance through non-clinical testing against standards and comparison to predicate device specifications.

The "performance" of the device is implied by its adherence to these standards and functional similarity to the predicate.

Here's a table summarizing the differences identified and the justification for substantial equivalence, which acts as the "performance" verification in this context:

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

• Test Set: Not applicable for a traditional "test set" in the context of an AI/diagnostic algorithm. The "testing" here refers to bench testing (non-clinical) of physical devices against engineering specifications and international standards. The sample size would refer to the number of physical units tested, but this detail is not provided in a P(K) summary, as it's standard engineering verification.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering measurements and tests performed on the physical dental handpieces.

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

• Not applicable. Ground truth, in this context, is established by adherence to international engineering standards (e.g., ISO, IEC, ANSI/AAMI) and direct comparison of physical properties with legally marketed predicate devices. No human expert consensus on medical image interpretation or clinical outcomes is needed for this type of device.

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

• Not applicable. This concept pertains to expert review and consensus in diagnostic studies, which is not relevant here.

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 mechanical dental instrument, not an AI or diagnostic tool that assists human readers. No MRMC study was performed. The "Clinical Test Conclusion" (Page 6, Section 8) explicitly states: "No clinical study is included in this submission."

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

• Not applicable. This is not an algorithm; it's a mechanical device.

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

• The "ground truth" for this submission is based on:
  • International Standards: Adherence to established standards such as ISO 14457 (Dentistry - Handpieces and motors), IEC 60601 series (Medical electrical equipment), ISO 10993 series (Biological Evaluation of Medical Device), etc.
  • Predicate Device Specifications: Direct comparison of the proposed device's specifications and performance to those of the legally marketed predicate devices (K181691 and K202786). The argument for "Substantial Equivalence" is built on demonstrating that any differences do not raise new questions of safety or effectiveness.
  • Bench Testing Results: Data derived from physical performance tests (e.g., bur extraction force, speed measurements, biocompatibility tests).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. No training set for an AI model.

In summary:

This FDA 510(k) submission for dental handpieces is a pre-market clearance based on substantial equivalence to existing devices. The "acceptance criteria" are met by demonstrating compliance with recognized performance standards and by showing that any differences from the predicate devices do not introduce new safety or effectiveness concerns, primarily through non-clinical bench testing and adherence to international engineering and safety standards. Clinical studies or AI-specific performance metrics (like MRMC, standalone algorithm performance, or expert ground truthing) are not required or relevant for this type of device submission.

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The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.

EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.

EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.

This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.

EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.

The provided text is a 510(k) summary for the EVO 700 series High Speed Handpiece. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a report of a study proving the device meets specific performance acceptance criteria through clinical trials or comprehensive algorithmic validation studies.

The document primarily focuses on demonstrating that the new device (EVO 700 series) is substantially equivalent to a previously cleared predicate device (EVO 500 series) based on similar indications for use, principle of operation, and technological characteristics.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details for AI/ML validation studies is not present in this document. This document is for a Class I dental handpiece, which typically does not require extensive clinical or AI/ML performance studies for 510(k) clearance, especially when demonstrating substantial equivalence to an existing predicate.

The "study" referenced in the document is effectively the comparison of the new device to the predicate device and verification that it meets relevant consensus standards (ISO 14457:2017, ISO 9168:2009, ISO 14971:2019, ISO 10993-1:2018).

Here's a breakdown of what is available and why the requested information is absent:

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

• Acceptance Criteria (Implied): The acceptance criteria are implicitly that the EVO 700 series handpiece's characteristics (e.g., rotation speed, drive air pressure, bur retention force) are either identical or appropriately justified as similar to the predicate device and comply with relevant international standards (ISO 14457:2017).
• Reported Device Performance: The table on page 4-5 compares the subject device (EVO 700 series) to the predicate device (EVO 500 series) across various technical specifications. There are no performance metrics reported in terms of clinical outcomes or diagnostic accuracy, as this is a mechanical dental tool.
  • Example from the document's comparison table (page 4-5):

    Characteristic	Acceptance Criteria (Predicate)	Reported Performance (Subject Device)
    Rotation speed (rpm)	T≥300,000, M≥350,000	T: 300,000360,000, M: 350,000430,000
    Drive air pressure (bar)	2.6~3.0	2.6~3.0
    Bur retention force	Up to 24 N-cm	Up to 24 N-cm
    Device standard	ISO 14457:2012, ISO 9168:2009	ISO 14457:2017, ISO 9168:2009

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

• Not applicable/Not provided. This is a comparison of device specifications and compliance with standards, not a clinical study or AI/ML performance test on a specific dataset. "Test set" in the context of AI/ML validation studies is not relevant here.

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

• Not applicable/Not provided. No "ground truth" to establish in the AI/ML sense. The "truth" is established by engineering specifications and compliance with recognized standards.

4. Adjudication method for the test set

• Not applicable/Not provided.

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 is a mechanical device, not an AI-powered diagnostic tool.

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

• Not applicable. This is a mechanical device.

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

• Not applicable in the AI/ML sense. The "ground truth" for this device's safety and effectiveness is established through adherence to engineering standards (ISO 14457:2017, ISO 9168:2009) and the results of specific tests for biocompatibility (ISO 10993-1:2018) and risk management (ISO 14971:2019).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of what the document does describe as its "study":

The study to prove the device meets acceptance criteria is primarily a comparison and verification study based on engineering standards and design control activities.

• Comparison to Predicate: The document explicitly compares the EVO 700 series to the predicate EVO 500 series across numerous parameters (indications for use, principle of operation, rotation speed, pressures, bur dimensions, etc.).
• Compliance with Standards:
  • ISO 14457:2017 Dentistry - Handpieces and motors: The device's design and performance are stated to be in accordance with this standard to ensure safety and effectiveness. The document addresses manufacturing tolerances for rotation speed as per the standard (Analysis 2).
  • ISO 9168:2009: Also cited as a standard the device complies with.
  • ISO 13485:2016 Medical devices – Quality management systems: Followed for internal design change control.
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices: Used for identifying and evaluating risks through Failure Modes and Effects Analysis (FMEA).
  • ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process: Used to confirm biocompatibility of materials (specifically PEEK).
• Sterilization Validation: The document mentions the specified sterilization parameters (gravity-displacement and dynamic-air-removal methods) imply that these parameters have been validated to ensure the device can be properly sterilized for reuse.

In essence, for this Class I medical device, "acceptance criteria" are met by demonstrating substantial equivalence to a cleared predicate and compliance with relevant, recognized international consensus standards for safety and performance of dental handpieces. No clinical trial or AI/ML validation study, as detailed in your prompt, was conducted or required for this type of device clearance.

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The Titanium Turbine is intended for the following applications:

Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment.

Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.

The provided text describes the 510(k) premarket notification for a dental handpiece called "Titanium Turbine." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

However, the information requested regarding acceptance criteria and a study proving the device meets the acceptance criteria (specifically related to AI/algorithm performance and human reader studies) is not present in the provided document. This document pertains to a Class I dental handpiece, which is a mechanical device, not an AI or algorithm-driven medical device. Therefore, the concepts of sensitivity, specificity, MRMC studies, human-in-the-loop performance, and ground truth establishment for AI models are not applicable to the information given.

The document focuses on demonstrating substantial equivalence to predicate dental handpieces based on:

• Mechanical and operational characteristics: Head size, weight, head angle, rotation speed, torque, noise level, chuck design, bur type, power, device features (Clean Head System, Quick Stop System).
• Material properties: Coating (DURAGRIP vs. Sand blasting finish/Plasmatec coating), direct/indirect patient contacting materials (Titanium vs. Stainless Steel).
• Sterilization and lubrication: Methods and compatible products.
• Performance testing against established standards: ISO 14457:2017 ("Dentistry Handpieces and motors") and ISO 17665-1:2006 ("Sterilization of health care products - Moist heat").
• Biocompatibility testing: According to ISO 10993-1:2018.

Therefore, I cannot populate the requested table and study details as they are outside the scope of this FDA submission for a mechanical dental device.

Summary regarding the absence of requested information:

• No AI/Algorithm Component: The device, "Titanium Turbine," is a mechanical dental handpiece. It does not involve any artificial intelligence, machine learning algorithms, or image analysis components.
• Acceptance Criteria: The "acceptance criteria" for this device are its compliance with recognized performance standards (ISO 14457, ISO 17665-1) and biocompatibility standards (ISO 10993-1), and demonstrating substantial equivalence to predicate devices based on its physical and functional characteristics. These are not performance metrics like sensitivity/specificity for AI.
• Study Proving Acceptance: The "study" proving acceptance is the series of non-clinical performance and biocompatibility tests conducted according to the listed ISO standards. No clinical study was required for this 510(k).
• Irrelevant Metrics: All the specific points requested (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set ground truth establishment) are relevant to the validation of AI/ML-based medical devices, not mechanical devices like a dental handpiece.

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This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.

Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.

The provided document is a 510(k) premarket notification for a dental handpiece (TRAUS Air Dental Handpiece) and does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document discusses the substantial equivalence of the TRAUS Air Dental Handpiece to a predicate device (Maxima PRO 45L) based on technical characteristics and non-clinical performance data. It explicitly states: "No clinical performance testing was performed."

Therefore, I cannot provide the requested information, such as:

1. Table of acceptance criteria and reported device performance: This document does not establish performance criteria in the way an AI/ML device study would (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and operational principles of the new device to a predicate device.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance: These are all concepts relevant to clinical or AI/ML performance studies, which were explicitly stated as "not performed."
3. Type of ground truth: Not applicable as it's a mechanical device with no AI component requiring ground truth.
4. Sample size for training set, how the ground truth for the training set was established: Not applicable as there is no training set for an AI/ML model.

The "Non-clinical Performance Data" section (page 6) details bench tests conducted to ensure conformity to ISO standards (ISO 14457, ISO 17665-1, ISO 9168) and demonstrate substantial equivalence. These are engineering and sterilization validation tests, not performance studies as typically understood for AI/ML devices.

In summary, the provided text describes a 510(k) submission for a conventional dental handpiece, and thus does not contain the information requested about acceptance criteria and a study for an AI/ML driven device.

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