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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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To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

EVOCLEAN CLEANsert Ultrasonic Insert is used with EVOCLEAN Ultrasonic Scaler that was cleared under K201317. It is used by dental professionals for dental cleaning and periodontal (gum) therapy to remove calculus from the teeth. EVOCLEAN CLEANsert Ultrasonic Inserts are available in three models (ELITE IF-50 Universal Slim, PRO IF-50 Universal Slim and CLASSIC P-10 Universal). Each model has two oscillating frequencies (25KHz and 30KHz), three different grip sleeves and two water supply methods (internal/external). EVOCLEAN CLEANsert Ultrasonic Insert consists of a Tip, a Magnetostrictive stack, an Inner O-ring, a Grip sleeve and an Outer O-ring. CLASSIC P-10 Universal has an external water tube.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: EVOCLEAN CLEANsert Ultrasonic Insert

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This submission (K210832) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device (Hu-Friedy Satin Swivel Ultrasonic Insert, K012060). The bulk of the proof that the device meets acceptance criteria comes from non-clinical testing and a comparison of technical characteristics to the predicate device, rather than a traditional clinical study with human patients.

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of human subjects or cases for AI. The "test sets" here refer to samples of the device and its components used for engineering, material, and sterilization validation. Specific quantities of inserts or materials tested in these non-clinical studies are not provided in the summary.
   • Data Provenance: The tests were conducted by TTBIO CORP. or their contracted labs. The provenance is internal (Taiwan, where the company is located) and pertains to manufactured devices/materials, not patient data.

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

   • Not applicable in the context of establishing ground truth for a diagnostic AI model. The "ground truth" here is defined by the technical standards (ISO, AAMI, FDA guidance) and the performance of the predicate device. Expert involvement would be in the form of engineers, material scientists, and microbiologists conducting and interpreting the non-clinical tests. Their specific numbers and qualifications are not detailed in this summary.

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

   • Not applicable as this is not a diagnostic imaging study or a clinical trial requiring human expert adjudication of cases. The "adjudication" is based on meeting predefined engineering specifications, material biocompatibility standards, and validation protocols outlined in recognized international standards.

4. 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 MRMC study was done, as this device (an ultrasonic insert for dental scaling) does not involve AI assistance or human "readers" in the context of diagnostic interpretation.

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

   • Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is evaluated through its physical characteristics, material safety, and functional capabilities.

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

   • The "ground truth" is established by:
     • Industry Standards: ISO 18397:2016 (functions), ISO 10993-1, -5, -10 (biocompatibility), ISO 17665-1 (sterilization).
     • Regulatory Guidance: AAMI TIR30 and FDA Reprocessing Guidance (cleaning and sterilization validation).
     • Performance Equivalence: Demonstrating that the subject device's performance (e.g., flow of cooling liquid, extraction/insertion force, frequency, and amplitude) is comparable to or meets the requirements implied by the predicate device and safe clinical use.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI that would require a "training set."

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

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

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TTBIO EVOCLEAN Ultrasonic Scaler is designed for use during dental cleaning and periodontal debridement of periodontal diseases.

TTBIO EVOCLEAN Ultrasonic Scaler consists of an ultrasonic generator, a handpiece, a power supply, a foot pedal and other minor accessories. There are two models of TTBIO EVOCLEAN Ultrasonic Scaler, one is EVOCLEAN and the other is EVOCLEAN+. The specifications of these two models are almost the same; the major difference is the connection type, fix and plug in, between the handpiece and main unit. TTBIO EVOCLEAN Ultrasonic Scaler uses ultrasonic energy to generate mechanical micro-vibration of the available inserts to perform the dental procedures defined in its intended use. TTBIO EVOCLEAN Ultrasonic Scaler is a multi-frequency available device which is compatible with 25 KHz or 30 KHz inserts. The system will automatically detect the insert oscillation frequency, need not to operate it manually. The handpiece is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, search and locate the resonant frequency of the insert, which varies according to the insert in use.

The provided text is a 510(k) summary for a medical device called the TTBIO EVOCLEAN Ultrasonic Scaler. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details the substantial equivalence of an ultrasonic scaler to a predicate device, focusing on non-clinical performance and testing. Therefore, I cannot generate a response that includes acceptance criteria and a study proving an AI device meets those criteria based on the provided text.

Specifically, the document focuses on the following:

• Device identification: TTBIO EVOCLEAN Ultrasonic Scaler (K201317)
• Regulatory classification: Class II, Product Code ELC
• Intended Use: Dental cleaning and periodontal debridement.
• Comparison to predicate device (BONART ART-M3II Ultrasonic Scaler UNITS WITH ACCESSORIES, K052028): Demonstrates substantial equivalence through detailed comparisons of indications for use, contraindications, components, materials, treatment mechanism, power, frequency, etc.
• Non-clinical testing: Refers to testing according to ISO18397:2016, cleaning validation, biocompatibility evaluation (ISO 10993-1), software verification/validation, and electrical safety/EMC testing (IEC 60601-1-2:2014 and ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012).
• Absence of clinical testing: Explicitly states "No clinical testing was conducted for this submission."

Since the request is about acceptance criteria and a study for an AI device and the provided text is for an ultrasonic scaler with no AI component, I cannot fulfill the request directly.

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The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

The EVO 450 series High Speed Handpieces are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit.

This looks like a submission for a 510(k) premarket notification for a medical device. The document states that the EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device, Maxima PRO2 45L (K141576). It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format you requested, specifically regarding AI/algorithm performance.

The provided document describes a medical device (dental handpiece), not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically applied to AI/ML devices (e.g., performance metrics like sensitivity, specificity, AUC compared to a pre-defined threshold) is not present here.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device. This involves comparing the new device to a legally marketed predicate device in terms of:

• Intended Use: Both devices are high-speed, air-powered dental handpieces for specific dental procedures.
• Technological Characteristics: Comparison of physical attributes, materials, operating principles, and performance specifications.
• Safety and Effectiveness: Demonstrated through compliance with recognized standards and non-clinical testing.

Here's an analysis of the provided information in relation to your questions, noting the context of a non-AI medical device:

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

   • Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria here are that the proposed device (EVO 450 series) is substantially equivalent to the predicate device (Maxima PRO2 45L) in terms of safety and effectiveness, based on similar intended use and technological characteristics. This is demonstrated through direct comparison and adherence to standards.
   • Reported Device Performance: The "Summary Table of Substantial Equivalence" on pages 4 and 5 directly compares the proposed device's characteristics against the predicate device. This serves as the reported performance, showing that the device's specifications (e.g., speed, operation pressure, materials) are comparable or within acceptable ranges relative to the predicate and relevant standards.

   Table of Comparison (derived from the document):

   Descriptive Information	Proposed Device (EVO 450 series)	Predicate Device (Maxima PRO2 45L K141576)	Comparison/Comment
   Indication for use	Removal of carious material, cavities, crown preparations, surgical tool for impacted third molar removal and periodontal procedures.	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.	Substantially similar.
   Principle of operation	Air-powered turbine, cooling water, optional light system.	Air-powered turbine, cooling water, light system.	Identical mechanism.
   Water ports	Four	One	Differs but does not raise new safety or effectiveness questions.
   Fiber optics	With and without fiber-optic glass rod built-in light system	With built-in light system	Option for both, similar technology.
   Light intensity on input side	N/A	Approx. 25000 Lux	Not directly comparable, but presence of light system is noted.
   Head Dimensions	Φ10.5×H12.5mm	Φ12.5×H14.6mm	Slight dimensional difference, but within a functional range.
   Type of chuck	Push button locking chuck	Identical	Identical.
   Materials of body of the device	Stainless steel	Stainless steel	Identical.
   Bur retention force	Up to 24 N-cm	Identical	Identical (implied, as no difference noted).
   Operation pressure	2.0-3.0 bar	2.75±0.1 bar	Overlapping range.
   Speed	360,000~440,000 rpm	380,000~420,000 rpm	Overlapping range.
   Conformance with standards for shank	Ø1.59mm~1.60 mm	Identical	Identical (implied, as no difference noted).
   Head angle	45-degree	Identical	Identical.
   Compliance to Standards	ISO 14457:2017, ISO 9168:2009	ISO 14457:2012, ISO 9168:2009	Both comply with relevant standards (new device with updated version for one).
   Sterilization Method	Steam Autoclave (Moist Heat)	Steam Autoclave (Moist Heat)	Identical.
   Sterilization Standard	ISO 17665-1:2006	ISO 17665-1:2006	Identical.

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 and not provided in the context of a 510(k) submission for this type of device. The "testing" refers to non-clinical bench testing and adherence to standards, not a patient-based test set or clinical trial data collection.

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. This device is not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. Performance is assessed through engineering specifications and compliance with standards.

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

   • Not applicable. There is no "test set" in the sense of clinical cases or data requiring adjudication.

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 document is for a dental handpiece, not an AI-assisted diagnostic or therapeutic device.

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

   • Not applicable, as this is not an AI/ML algorithm.

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

   • Not applicable in the context of an AI/ML algorithm. For this device, "ground truth" relates to engineering specifications verified through testing and adherence to established industry standards (e.g., ISO for dental handpieces, sterilization, biocompatibility).

8. The sample size for the training set

   • Not applicable, as this is not an AI/ML algorithm development.

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

   • Not applicable, as this is not an AI/ML algorithm development.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental handpiece). It focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to non-clinical performance standards. It does not involve AI/ML technology, and therefore, the questions related to AI/ML specific acceptance criteria, study design, and ground truth establishment are not addressed or applicable in this context.

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Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

Thor 700 Electric Handpiece System is composed of a system unit, which is connected to a : power supply and a control tube, that system unit drives a dental drive device. The system unit converts pneumatic output from the dental treatment unit to control the torque, speed and directional rotation of the dental drive device. The dental drive device, in turn, provides the control for motorized dental handpieces. The inputs to the system unit are supplied by a dental treatment unit. Inputs can also be controlled by the foot pedal of the treatment unit.

This submission package for the Thor 700 Electric Handpiece System primarily focuses on demonstrating substantial equivalence to a predicate device (Siro Torque L, K031584) through a comparison of technical specifications and non-clinical performance testing. It does not describe an AI/ML-based device, therefore, many of the requested details concerning acceptance criteria and studies for AI performance metrics are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance (Table)

The document evaluates the Thor 700's performance against established standards and safety requirements, rather than against specific clinically relevant accuracy metrics typically associated with AI/ML devices. The "acceptance criteria" here are generally compliance with international standards and direct comparison of specifications to the predicate device.

Details for AI-Specific Questions (Not Applicable for this Device)

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. This is a hardware device (electric handpiece system) and does not involve an AI/ML component or a "test set" of data in the context of diagnostic or predictive performance. The testing involved
  • Electrical safety and EMC testing (IEC standards).
  • Software validation (internal process, not a clinical data set).
  • Performance testing (ISO 11498 for noise, likely empirical measurements of mechanical properties).
  • Sterilization validation (empirical testing in a lab).
  • Biocompatibility testing (animal studies - rabbits).

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. No ground truth in the context of AI/ML classification or prediction was established. "Ground truth" for this device relates to compliance with engineering standards and physiological safety, typically assessed by qualified engineers and toxicologists/biocompatibility experts with appropriate certifications, not medical specialists for diagnostic accuracy.

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

• Not Applicable. No test set requiring expert adjudication for ground truth was used.

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 an electric handpiece system, not an AI-assisted diagnostic or therapeutic tool for human readers. No MRMC study was conducted.

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

• Not Applicable. This is not an algorithm-only device. Software validation was performed, but it pertains to the control and operation of the hardware, not an AI for interpretation or diagnosis.

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

• Not Applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by compliance with established international standards (IEC, ISO, ANSI/AAMI) for electrical safety, EMC, mechanical performance (e.g., speed, torque, noise), software functionality, and biocompatibility. The predicate device's specifications also serve as a comparative benchmark.

8. The sample size for the training set

• Not Applicable. This device does not use an AI/ML model that requires a training set of data.

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

• Not Applicable. No training set was used.

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