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The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.

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OdneClean is intended to prepare, clean, and irrigate teeth indicated for root canal therapy.

OdneClean is a dental device for the preparation of root canals during endodontic procedures. It achieves this by the creation of hydraulic cavitation inside the root canal. It consists of a console (control unit), an irrigation fluid reservor (saline solution bag or bottle), and a handpiece that is equipped with single-use OdneClean tips.

OdneClean delivers a stream of pressurized irrigation fluid (0.9 % NaCl) into the root canal. Upon leaving the narrow nozzle of the tip, it creates hydraulic cavitation inside the fluid stream, which enables the removal of organic matter from the root canal.

OdneClean features a user interface on its console and an on/off button on the handpiece. It provides automatic priming and disinfection programs to prepare the device for use and disinfect the internal fluid path after use. A waste container collects the fluid generated during priming and disinfection.

OdneClean is used after a conventional access cavity preparation, determination of the working length, and minimal shaping of the root canal. Following OdneClean treatment, root canals are to be disinfected using standard procedures.

I am sorry, but the provided text does not contain the specific details required to fulfill your request regarding acceptance criteria and study information for the OdneClean device. The text primarily focuses on regulatory approval (510(k) clearance) and general statements about compliance with standards and successful benchtop testing. It does not provide:

• A table of specific acceptance criteria and reported device performance values.
• Sample sizes for test sets, data provenance, or details on ground truth establishment.
• Information on expert qualifications or adjudication methods.
• Details on MRMC studies, effect sizes, or standalone algorithm performance.
• Training set details.

Therefore, I cannot generate the requested JSON output.

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Ultrasonic Scaler is used to remove dental plaque from teeth and remove stains on teeth during dental cleaning.

A device intended for use during dental cleaning and periodontal (gum) therapy to remove adherent plaque and food debris from the teeth to reduce tooth decay, potential stains in the gingival groove, the back of the tooth and the tooth and associated gingival line. The electronic oscillation circuit generates ultrasonic frequency electric pulse wave, which is amplified to a certain intensity and conveyed to the transducer. The electrical energy is converted into mechanical energy, and the working head tool is stimulated to produce vibration of the same frequency, so as to achieve the purpose of crushing calculus and loosening tartar.

The provided text is a 510(k) summary for an Ultrasonic Scaler (K240707). It describes the device's substantial equivalence to a predicate device and outlines performance data. However, it does not contain the acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, the document focuses on:

• Comparison of technological characteristics between the proposed device and a predicate device (K163414). This comparison highlights similarities and differences in design, operation controls, power supply, operating conditions, storage conditions, and electrical/EMC/biocompatibility standards.
• Performance data limited to biocompatibility testing and non-clinical testing of electrical safety and electromagnetic compatibility (EMC) according to various IEC standards.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/ML device, its reported performance, sample sizes, ground truth establishment, or specific AI/ML study details, because this information is not present in the provided document.

The document discusses acceptance criteria and performance data for a physical medical device (ultrasonic scaler), not an AI/ML component.

If this was a misunderstanding and you were expecting information related to a traditional medical device's performance, please clarify. Otherwise, the requested AI/ML specific information is absent from this document.

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Ultrasonic Applications for:

• All sub-gingival and supra-gingival scaling and routine prophylaxis procedures.
• Periodontal therapy

The BioSonic US200 Ultrasonic Scaler is an ultrasonic scaling unit that is used in sub-gingival and supra-gingival scaling and routing prophylaxis procedures, and periodontal therapy. The BioSonic US200 Ultrasonic Scaler includes the main unit, handpiece, footswitch, removable sheath, and a selection of scaler inserts. This device generates high frequency waves that cause the tip of the scaler insert to vibrate at 25kHz or 30kHz depending on the scaler insert used.

The provided document is a 510(k) Premarket Notification for a medical device called the BioSonic US200 Ultrasonic Scaler, which is an ultrasonic scaling unit for dental procedures. It is a Class II device (Regulation Number 872.4850, Product Code ELC).

This document does not contain the specific acceptance criteria and detailed study results for a device that uses a test set for performance evaluation in the way typically expected for AI/ML-driven devices. This is because the BioSonic US200 Ultrasonic Scaler is a hardware device, not an AI/ML software device.

The "studies" referenced are non-clinical performance tests conducted to ensure safety and effectiveness in comparison to a predicate device, focusing on electrical and mechanical aspects, and material compatibility. There are no mentions of "test sets", "ground truth", "experts", "adjudication methods", "MRMC studies", or "standalone performance" in the context of assessing an algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for items 1-9 based on the provided text, as those categories are not applicable to the type of device and submission described.

However, I can extract information about the type of tests performed and the general conclusion regarding acceptance criteria (though not specific numerical criteria for performance metrics).

Here's what I can extract regarding the device's testing and intended performance from the document:

General Acceptance Criteria and Reported Device Performance (as inferred from the document):

• Frequency testing (e.g., verifying 25kHz or 30kHz operation).
• Power testing.
• Tip displacement testing.
• Insert extraction testing. |
  | Material Compatibility | Materials compatibility testing with cleaning and disinfecting agents was performed. |
  | Substantial Equivalence to Predicate | The device's indications for use are identical to the predicate. Technological characteristics are substantially equivalent with minor differences (mechanism to change modes, automatic frequency detection, removable autoclavable sheath) that "do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate." This is the overarching acceptance criterion for 510(k) clearance. |

Why the other requested information cannot be provided from this document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device's non-clinical testing. "Test sets" in this context refer to electrical/mechanical measurements, not 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): Not applicable. "Ground truth" usually refers to diagnostic accuracy in AI/ML, not the physical properties of an ultrasonic scaler.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 for this hardware device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-only device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

This document solely concerns the FDA's 510(k) clearance of a traditional, non-AI medical device based on its physical and electrical performance and comparison to a predicate device.

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Scaling:

• Interdental junction treatment
• Tooth neck and subgingival treatment
• Treatment of large deposits
• Treatment of coating and tobacco stains
• Interproximal treatment
• Prosthesis conservative/restorative:
• Inlay/onlay condensation
• Amalgam plugging
• Loosening prostheses (bridge, crown, post, pivot ... )

Endodontics:

• Canal preparation
• Canal cleaning
• Canal filling
• Gutta percha condensation
• Treatment resumption
• Retro surgery
• Micro retro surgery
• Surface smoothing after burring

Periodontics:

• Root planning
• Initial therapy
• Treatment of periodontal pockets
• Treatment of furcations
• Maintenance therapy

The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System. The NEWTRON CAN A Module contains an Embedded Software. The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System manufactured by the American Company named A-DEC. The A-DEC Dental Delivery System provides different function to the NEWTRON CAN A Module such as Ultrasonic Power Setting, Light Command through a communication frame. The communication frame is designed and imposed by A-DEC, the Manufacturer of the Dental Delivery System. The values of Ultrasonic Power Setting and the Light Command are coded and communication frame. Ultrasonic Power Setting and the Light Command are driven by the user with a touch pad embedded in the A-DEC Dental Delivery System. The only parameters of the NEWTRON CAN A Module that can be modified by the A-DEC Dental Delivery System are the values of Ultrasonic Power Setting and the Light Command. The NEWTRON CAN A Module converts a low voltage Power Supply provided by the A-DEC Dental Delivery System into an Ultrasonic Electric Signal. The NEWTRON CAN A Module is intended to be used in combination with a SATELEC Dental Ultrasonic Handpiece and a SATELEC range of Dental Tips. The electrical signal emitted by the NEWTRON CAN A Module supplies the Dental Ultrasonic Handpiece equipped with SATELEC Dental Tip. The amplitude of the ultrasonic micro-vibrations depends on the electrical Signal provided by the NEWTRON CAN A Module (amplitude). The SATELEC Dental Ultrasonic Handpiece is connected to the Dental Delivery System via a Handpiece cord. Mechanical micro- vibrations are transmitted to a Dental tip attached to the end of the SATELEC Dental Ultrasonic Handpiece.

This document is a 510(k) summary for the SATELEC NEWTRON CAN-A ultrasonic scaler. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed independent study on specific acceptance criteria for device performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic AI devices.

Instead, the "acceptance criteria" here refer to conformity with established standards for medical devices and demonstration of similar performance characteristics to the predicate device. The "study" refers to the various tests and comparisons performed to prove this conformity and similarity.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria and device performance in a typical clinical metrics table (e.g., sensitivity, specificity). Instead, it demonstrates "substantial equivalence" to a predicate device (SP NEWTRON Module, K033764) by showing that the new device (NEWTRON CAN A) has equivalent technological characteristics and meets relevant safety and performance standards.

The acceptance criteria are implied by the "Result / Impact of the differences on Safety / Effectiveness" column in Table 01, which consistently states "Identical" or "No Impact." The "reported device performance" are the characteristics of the NEWTRON CAN A.

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

The document describes performance testing based on engineering bench tests and compliance with recognized standards rather than a clinical study with a "test set" of patients or data.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The "test set" would be the device itself and its components undergoing engineering validation.
• Data Provenance: The tests are likely performed by the manufacturer, SATELEC-ACTEON GROUP, based in France (Z.I DU PHARE, MERIGNAC, Gironde, FR). The data comes from the results of the specified engineering and biocompatibility tests. This is not retrospective or prospective clinical data but rather controlled laboratory test results.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information is not relevant for the provided document. The device is an ultrasonic scaler. Its performance is evaluated through compliance with electrical, mechanical, and biocompatibility standards, and comparison to a predicate device. "Ground truth" in the sense of expert consensus on medical images or patient outcomes, as would be relevant for an AI diagnostic device, is not established here. The "ground truth" for these tests are the objective measurement results compared against the requirements of the standards (e.g., maximum current, voltage, biocompatibility indices).

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of human expert review for establishing ground truth for a test set, as this is a physical device testing submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance in interpreting medical images or data. The device in question is an ultrasonic scaler, a therapeutic dental tool, not an AI diagnostic system.

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

Yes, in a way. The "performance data" described (Electromagnetic Compatibility, Electrical Safety, Software Verification and Validation, Biocompatibility Validation, Performance Testing bench) are all standalone tests of the device's technical specifications and compliance with standards, without human interaction as part of a clinical diagnosis or treatment decision process. The "algorithm" here refers to the embedded software and control systems of the device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Engineering Specifications: Objective measurements of electrical output (frequency, power, current), physical dimensions, voltage, current consumption, etc., that meet specified design parameters.
• Regulatory Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2), software (FDA guidance), and biocompatibility (ISO 10993 series).
• Predicate Device Equivalence: The characteristics and performance being substantially equivalent to the legally marketed predicate device (SP NEWTRON Module, K033764).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set of data for a machine learning model. The "NEWTRON Technology" and "feedback system" mentioned are likely traditional control algorithms, not AI that learns from data.

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

Not applicable, as there is no training set for an AI/ML model for this device.

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Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate.

It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.

The provided text is a 510(k) premarket notification for the EDS Calculus Softener (TURBO-CR™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication as one might see for a novel AI/imaging device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth establishment, adjudication methods, MRMC studies, or effect size of human reader improvement with AI assistance, are not applicable to this type of submission. This document describes a new medical device and demonstrates its equivalence to existing, legally marketed devices, primarily through bench testing and comparison of characteristics, rather than a clinical trial demonstrating a novel performance claim that would require an AI-style evaluation.

Here's an attempt to answer the questions based on the provided text, highlighting where information is N/A or not relevant to this submission type:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical targets (e.g., "softening of calculus by X%"). Instead, the performance objective is to demonstrate that the device is substantially equivalent to the predicate device in its ability to soften simulated dental calculus and meets relevant safety standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of human data or a specific "test set" for a novel algorithm. The testing described (bench and biocompatibility) is for the physical and chemical properties of the device itself. For example, for ASTM E384-22 (Microindentation Hardness), a sample of the material would be tested, not patient data. The document does not specify the number of material samples used for these bench tests.
• Data Provenance: Not applicable for device material testing. There is no patient data involved in the described equivalence testing.

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

• Number of Experts: Not applicable. Ground truth in this context is established through standardized laboratory tests (e.g., pH meter readings, viscometer measurements, hardness measurements) and adherence to international ISO and ASTM standards for biocompatibility and material properties. It does not involve human expert interpretation of images or clinical outcomes.
• Qualifications of Experts: N/A for human experts establishing ground truth. The testing is performed by laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As there are no human expert interpretations requiring consensus or adjudication, this step is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• MRMC Study: No. This type of study is typically performed for AI-assisted diagnostic tools where human reader performance is being evaluated with and without AI. This submission is for a physical/chemical dental product used by a hygienist, not an AI diagnostic tool.

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

• Standalone Performance: Not applicable. This is not an AI algorithm. The performance testing is for the physical and chemical properties of the gel.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for performance is established by objective measurements following standardized laboratory protocols (e.g., ASTM E384-22 for microindentation hardness, ISO 11609:2017 for pH, ISO 3219-2:2021 for viscosity) and biocompatibility testing against ISO standards (e.g., ISO 10993 series for cytotoxicity, irritation/sensitization). The foundational "ground truth" for the device's safety and effectiveness relies on the long history of safe clinical use of the predicate devices and the generally recognized as safe (GRAS) status of many of its components.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no training set.

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The ultrasonic scaler tips are intended for use by dental professionals to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Clean and irrigate root canals.

Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread.
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.

The provided text is a 510(k) summary for "Ultrasonic Scaler Tips" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with a defined test set, ground truth experts, and statistical outcomes.

The document discusses:

• Device Description and Intended Use: The device is an accessory for professional dental use to remove calculus and stain, and to clean/irrigate root canals.
• Comparison to Predicate Devices: It details similarities and differences in product code, regulation, intended use, device description, operating principle, tip shapes, composition, coatings, interaction with other products, sterilization, and mechanism of treatment to establish substantial equivalence.
• Performance Data: It lists bench performance testing (biocompatibility, reprocessing validation, conformity to ISO standards like ISO 18397 and ISO 3630-5) conducted to support substantial equivalence.
• Absence of Clinical Data: Critically, it explicitly states, "The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence."

Therefore, the information required to answer your detailed questions about acceptance criteria, test set, data provenance, number/qualifications of experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets is not available in this document. This document describes a 510(k) pathway, which often relies heavily on bench testing and comparison to legally marketed predicate devices rather than novel clinical performance studies, especially for devices like scaler tips.

To directly answer your request based on the provided text:

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

The document doesn't provide specific numerical acceptance criteria or clinical performance metrics for the device itself (e.g., how effectively it removes calculus). Instead, it states that tests were conducted to demonstrate conformity to applicable clauses of ISO standards and that biocompatibility and reprocessing validation were performed. The "performance" is implicitly deemed acceptable if it meets these bench test standards and allows for substantial equivalence to predicates.

• ISO 18397 Dentistry Powered scaler
• ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments (Implicitly passed) |
  | Clinical Performance | Not Applicable / Not Required. "did not require clinical studies to support substantial equivalence." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any "test set" in the context of clinical performance data, as clinical studies were not required. For bench testing (biocompatibility, reprocessing, ISO conformity), sample sizes would be determined by the specific test protocols and standards, but are not detailed here.
• Data Provenance: Not specified, as clinical data was not used. The document pertains to a Chinese manufacturer (Guilin Refine Medical Instrument Co., Ltd.) seeking FDA clearance in the US, so any bench testing would likely have been conducted by or for the manufacturer.

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 clinical test set requiring expert ground truth was performed or required for this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication was performed or required.

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 ultrasonic scaler tip, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned or relevant to its function.

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

• Not applicable. This device is an ultrasonic scaler tip, not an algorithm.

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

• Not applicable. No clinical ground truth was established or used, as no clinical studies were performed. Ground truth for the bench tests would refer to the validated methods and accepted reference standards of the specific physical, chemical, and mechanical tests conducted.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used or mentioned.

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

• Not applicable. No training set for an algorithm was used or mentioned.

In summary: The provided document is a 510(k) clearance letter and summary for an ultrasonic scaler tip, which falls under Class II medical devices. For such devices, particularly accessories, the FDA often relies on bench testing and substantial equivalence to existing predicate devices rather than requiring extensive clinical trials or AI-specific performance studies. The questions you've asked are highly relevant for AI/software as a medical device (SaMD) clearances, but not for this specific type of physical device and its associated 510(k) pathway.

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Drive unit with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

The Proxeo ULTRA is a drive unit including handpieces with a piezoceramic oscillating system, which moves the tip in a linear oscillation.

The drive unit is used for the removal of supragingival calculus and subgingival concretions and for endodontic application and preparation of tooth enamel.

The medical device consists of the following components that are also included in the scope of delivery:

• Control unit (PB-510, PB-520, and PB-530)
• Handpiece (PB-5 L, PB-5 L, S, and PB-5 L Q)
• Foot control (wired, wireless)
• A Power supply, instruction for use and other accessories

The scaler tips are moved with a piezo-scaler handpiece by converting electrical energy into mechanical vibration. The coolant (water) is directed to the treatment site via a solenoid valve and a control unit via the tip. The scaler tips are re-usable [diamond-coated tips are single use only] and delivered non-sterile. Tips for use with Piezo Scaler for the following dental applications:

• Scaling-tips
• Periodontic-tips
• Implant-cleaning-tips
• Endodontic-tips
• Tips for restoration and prosthetics

With the foot control, corresponding device functions can be operated with the foot. These functions include, for example, program selection (button), operation of coolant function (button), motor direction of rotation selection (button), motor speed level (variable with pedal), power piezo handpiece (variable with pedal).

Bluetooth Low Energy technology is used in the wireless foot controls (C-NW) to make this possible wirelessly as well. The foot controls are powered internally by a rechargeable battery (C-NW) or an external power source (C-NF).

This document is a marketing clearance (510(k)) for a dental device, the Proxeo ULTRA. It details the device's characteristics and its equivalence to previously cleared predicate devices. Since this is a 510(k) summary for a physical medical device (ultrasonic scaler), not a diagnostic or AI-powered software, the typical acceptance criteria and study designs that involve metrics like sensitivity, specificity, or reader studies with AI assistance are not applicable in the same way they would be for an AI/ML medical device.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, performance data (bench testing, biocompatibility, electrical safety, reprocessing validation), and adherence to relevant standards. It does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics for diagnostic or AI-based devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are not relevant or reported for this type of device clearance.

Instead, the "acceptance criteria" for a device like the Proxeo ULTRA are primarily met by demonstrating that it performs as intended (as shown by bench testing) and is as safe and effective as existing legally marketed devices.

Here's how the information would typically be presented if it were an AI/ML device, alongside an explanation of why it's not applicable here:

Based on the provided FDA 510(k) summary for the Proxeo ULTRA (an ultrasonic dental scaler), the requested information regarding acceptance criteria and study designs for AI/ML performance metrics is NOT applicable.

This document is for a physical medical device and demonstrates substantial equivalence through:

• Technical Characteristics Comparison: Showing similar design, operating principles, and materials to predicate devices.
• Performance Data: This primarily involves non-clinical testing to ensure the device functions as intended and meets safety standards, rather than diagnostic accuracy or clinical outcome studies in the context of AI.

Therefore, the following specific information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance (in terms of AI/diagnostic metrics): Not applicable. The "performance" is demonstrated through bench testing, biocompatibility, electrical safety, and reprocessing validation, ensuring the device operates as specified and is safe.
2. Sample sizes used for the test set and the data provenance: Not applicable. There isn't a "test set" of clinical data for diagnostic performance. Bench testing is mentioned, but specific sample sizes for its components are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not established for an ultrasonic scaler.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Instead, for this device, the "acceptance criteria" are implied by the demonstration of substantial equivalence, which includes:

• Manufacturing and Safety Standards Compliance: The device complies with relevant IEC standards (IEC 60601-1, IEC 80601-2-60, IEC 60601-1-2) for electrical safety and EMC.
• Biocompatibility: Evaluation according to ISO 10993 series.
• Reprocessing Validation: Validation per FDA Guidance for Medical Devices.
• Bench Testing: Functional testing (application, settings, features) per device specifications.
• Software Verification: Compliance with IEC 62304 and FDA guidance for software, given its moderate level of concern.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing (bench, biocompatibility, electrical safety, reprocessing, software verification) that demonstrates the device performs as intended and is as safe and effective as its predicate devices. The document explicitly states: "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device... and the reference device..."

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combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

• Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:

• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedure

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

The provided documentation describes the acceptance criteria and a study demonstrating that the Mectron S.p.A. "Combi Touch" device meets these criteria. The device is an ultrasonic scaler and air-polishing prophylaxis unit.

Here's the breakdown of the requested information:

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

The acceptance criteria are implicitly defined by the comparison to the predicate device and the adherence to various non-clinical performance standards. The "reported device performance" is essentially that the "combi touch" meets or is comparable to the predicate device in all measured aspects and complies with the listed standards.

Study Proving Acceptance Criteria:

The documentation states that:

"The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States."

And critically, regarding performance testing:

"The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above: 1) was effective in the removal of simulated plaque from dental surfaces. 2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment; 3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices." This implies that the testing for the "Combi Touch" device focused on non-clinical performance and engineering standard compliance rather than a traditional clinical study with patient data.

• Sample Size for Test Set: Not specified for any clinical data. For the non-clinical performance involving "simulated plaque from dental surfaces" and "examination of tooth surfaces morphology," the specific sample size of tested dental surfaces or teeth is not provided within this document.
• Data Provenance: Not specified, as it's primarily non-clinical testing.

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, as this was not a clinical study involving human ground truth assessment. The assessment of "simulated plaque" and "tooth surfaces morphology" would likely involve expert evaluation, but the number and qualifications are not detailed.

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

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

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 ultrasonic scaler/air-polisher, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.

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

Not applicable. This device does not feature an AI algorithm for standalone performance evaluation.

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

For the non-clinical performance tests mentioned (plaque removal, dental surface damage/erosion), the ground truth appears to be based on:

• Objective measurements of simulated plaque removal.
• Laboratory examination of tooth surface morphology (e.g., microscopy) to assess damage/erosion after treatment.
• Comparison against the performance of the predicate device under similar testing conditions.

8. The sample size for the training set

Not applicable. This device does not appear to employ machine learning or AI that would require a 'training set.'

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

Not applicable.

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For root canal cleaning. The instrument must only be used in hospital environments, clinics or dental offices, by qualified practitioners.

The Endo Ultrasonic Activator is mainly used for root canal cleaning.It mainly contain handpiece, sleeve, wrench, adapter and tip. The ultrasonic frequency generated by the CPU is driven by the drive circuit to drive the piezoelectric ceramic transducer, using the reverse piezoelectric effect to produce the ultrasonic vibration, motivating the working tip to produce the resonance, and using the cavitation and sound flow effect generated by the ultrasonic vibration to wash the root canal swing.

The provided text describes the regulatory clearance of a medical device, the "Endo Ultrasonic Activator," and its substantial equivalence to a predicate device. It contains a comparison table of characteristics and analysis of differences, but it does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical format one would expect for an AI algorithm's performance.

This document is a 510(k) summary for a physical medical device (an ultrasonic activator for root canal cleaning), not an AI/ML powered device. Therefore, the requested information components related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable and are not present in the provided text.

The "Non-Clinical Test Conclusion" and "Substantially Equivalent (SE) Comparison" sections describe how the device meets various safety and performance standards relevant to non-AI medical devices.

Here's an attempt to extract relevant information while acknowledging the non-AI nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical medical device, "acceptance criteria" are typically compliance with recognized standards. The "reported device performance" is demonstrated through testing against these standards and comparison to a predicate device.

2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This document refers to the testing of a physical medical device, not an AI/ML algorithm that would typically have a "test set" of data. The testing involved compliance with various engineering and safety standards, likely through bench testing and material evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. No ground truth establishment by experts for a test set is described as this is not an AI/ML device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
N/A. No test set or corresponding adjudication method is 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
N/A. This is not an AI/ML device, so no MRMC study or AI assistance effect size is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. No ground truth is described in the context of an AI/ML algorithm. The "truth" for this device's performance is its compliance with engineering, safety, and biocompatibility standards, and demonstrating the same fundamental operating principle as a legally marketed predicate device.

8. The sample size for the training set
N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established
N/A. This is not an AI/ML device.

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