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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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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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The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.

The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes the EndoPilot2, a dental device, for which the manufacturer, Schlumbohm GmbH & Co. KG, sought 510(k) clearance from the FDA. The submission (K202906) claims substantial equivalence to predicate devices: EMS-200 and SUPRASSON P5 NEWTRON. The document details the non-clinical performance data used to support this claim.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against which specific quantitative numerical performance metrics of the EndoPilot2 are directly compared. Instead, it describes various non-clinical performance tests conducted and states that the device "PASSED required testing" or "all requirements were met."

Therefore, I will extract the performance specifications and the stated outcome for the most relevant functional components where quantitative values are mentioned, and then for other types of tests, I will summarize the general pass/fail outcome.

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This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM or NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).

The provided text describes the regulatory submission for the Satelec NEWTRON P5 and NEWTRON P5 B.LED ultrasonic scalers, focusing on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through novel performance data.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state quantitative "acceptance criteria" for the new device, nor does it present device performance against a pre-defined set of criteria in a table format. Instead, it relies on demonstrating similarity to legally marketed predicate devices.

The performance data that is reported is in the context of similarity:

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 states, "Clinical Data is not needed for this 510(k) process." Performance data was primarily based on bench testing. Therefore, there is no sample size for a clinical test set, nor is there information on data provenance in terms of country of origin or retrospective/prospective nature for clinical data. The bench tests involved comparing measured values, so the "sample size" would relate to the number of units tested during the bench comparison. This specific number is not provided, but it would typically be a small N for engineering verification.

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. Since no clinical data or human-in-the-loop performance study was conducted, there are no experts establishing ground truth for a test set in the traditional sense of medical image analysis or clinical outcomes. The "ground truth" for the performance evaluation appears to be the measured physical parameters from the predicate device.

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

Not applicable. As no clinical test set requiring expert interpretation or adjudication was used, there is no mention of an adjudication method.

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 an ultrasonic scaler. The submission focuses on demonstrating substantial equivalence based on technological characteristics and bench performance, not on AI assistance or human reader performance.

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

Not applicable. This is a medical device (ultrasonic scaler), not an AI algorithm. The performance evaluation was done through bench testing of its physical characteristics (irrigation flow, current) by comparing it to a predicate device.

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

The "ground truth" for the performance evaluation in this 510(k) submission is the measured physical properties and performance characteristics of legally marketed predicate devices. The new device aims to be "similar" in these aspects. specifically:

• Bench Test Measurements: Irrigation Flow and Current delivered in the Piezoelectric Handpiece (for K050895).
• Technological Characteristics: Piezoelectricity Technology, materials (self-extinguishing material UL94V-0), user interface principles, energy sources, output energy, and light function principles (for K071424).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or corresponding ground truth establishment process.

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The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.

The provided text is a 510(k) Summary for the NEWTRON BOOSTER, an ultrasonic scaler. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing new clinical study data to prove safety and effectiveness for novel devices.

Therefore, the document explicitly states that no new clinical studies were conducted to establish acceptance criteria or demonstrate device performance. Instead, the device's characteristics and performance are compared to those of already cleared predicate devices.

Here's a breakdown of why the requested information about acceptance criteria and studies cannot be fully provided from the given text:

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

• This information is not present. The submission focuses on demonstrating similarity in technological characteristics, materials, design, and energy sources to predicate devices. There are no specific performance metrics or acceptance criteria presented in a table format.

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 as no new test set or study was conducted to generate performance 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 as no new test set was created or evaluated by experts for ground truth establishment.

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

• Not applicable as no new test set.

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, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is hardware (ultrasonic scaler), not an algorithm. Its performance is demonstrated through substantial equivalence to existing devices.

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

• Not applicable as no new ground truth was established for a new study. The "ground truth" in this context is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable as no new training set was used.

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

• Not applicable.

Summary of the document's approach:

The submission for the NEWTRON BOOSTER relies entirely on demonstrating substantial equivalence to two predicate devices:

• SUPRASSON P5 NEWTRON (K020892, cleared April 20, 2005)
• ProUltra Piezo Ultrasonic (K113430, cleared February 23, 2012)

The manufacturer asserts that the New Device is substantially equivalent by comparing the following:

• Intended Use: "The Satelec New Device Indications for Use is similar to the Satelec Predicate Devices."
• Technological Characteristics:
  • Uses the same Piezoelectricity Technology.
  • Casings are made of the same self-extinguishing material (UL94V-0).
  • Same Principle of User interface.
  • Uses the same or a derivated Dental Ultrasonic Handpiece (Satelec NEWTRON and NEWTRON SLIM Handpiece, which are based on the predicate device handpieces).
• Energy Source:
  • Uses the same input energy source (Electric Power Supply).
  • Delivers the same output energy source (ultrasonic micro-vibration).
  • Delivers the same Handpiece Current Values.
  • Delivers similar irrigation Flow values.
• External Structure: Very similar, made from the same raw material (UL94-V0) and uses a single function footswitch.
• Patient Contact Materials: The materials in contact with the patient are the same.

Conclusion stated in the document:
"Because of the used technologies, characteristics and performances are similar to the Satelec Predicate Devices, the characteristics of the Satelec New Device do not affect the Safety or the Effectiveness of the Predicate Devices, the Safety and Effectiveness is the same as of the Predicate Devices."

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Periodontics
Endodontics
Scaling
Prosthesis

Please refer to the attached listing for a detailed description.

Periodontics:

• Root planing .
• Initial therapy .
• Treatment of periodontal pockets .
• Treatment of furcations .
• Maintenance therapy .
• Implant maintenance

Endodontics:

• Canal preparation ●
• Canal cleaning .
• Canal filling .
• Gutta percha condensation .
• Treatment resumption .
• Retro Surgery ●
• Micro Retro Surgery

Scaling (prophylaxis):

• 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 ... ) .

The Piezotome™ is an ultrasonic scaler for use by dental practitioners.

The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.

In Newtron® function, it can be used for mechanical ultrasound treatment in prophylaxis, periodontics, endodontics or prosthesis.

This device is fitted with two handpiece cord connectors. Depending on the application, the practitioner may connect two handpieces at the same time.

The Piezotome™ function offers four utilization modes at pre-set ultrasound power settings. In Newtron® function, the power of the ultrasound can be finely adjusted by the user.

The user regulates the flow rate of the irrigation fluid.

The practitioner controls the device using a keyboard and a multi-function footswitch.

The irrigation fluid flow rate and the ultrasound power are monitored on a screen. For enhanced efficacy, the last settings are memorized by the machine.

This document is a 510(k) Summary for the SATELEC Piezotome™ ultrasonic scaler, which seeks to prove substantial equivalence to a predicate device, the Suprasson® P5 Newtron (K050895). As such, it does not contain the information requested for a detailed study description with acceptance criteria, sample sizes, expert qualifications, and comparison to AI performance. This type of regulatory document primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing a detailed scientific study with defined acceptance criteria and performance metrics in the way you've outlined.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. The basis for clearance is "substantial equivalence" to a predicate device.

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. This is a regulatory submission for substantial equivalence, not a clinical study with a test set of 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. No ground truth establishment from experts for a test set is mentioned.

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

Not applicable. No test set or adjudication method is mentioned.

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; it is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. No such ground truth data is presented. The "ground truth" for regulatory clearance is the performance and safety established for the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

Summary of available information related to the device and its regulatory clearance:

• Device Name: Piezotome™
• Device Type: Ultrasonic scaler
• Predicate Device: Suprasson® P5 Newtron (K050895) by Satelec
• Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Piezotome™."
• Operating Modes/Power Settings:
  • Green: Low (Periodontics mainly)
  • Yellow: Medium (Endodontics mainly)
  • Blue: High (Prophylaxis mainly)
  • Orange: Very high (Prosthesis or Specific treatment modalities)
• Indications for Use (from Enclosure):
  • Periodontics: Root planing, initial therapy, treatment of periodontal pockets, treatment of furcations, maintenance therapy, implant maintenance.
  • Endodontics: Canal preparation, canal cleaning, canal filling, gutta percha condensation, treatment resumption, retro surgery, micro retro surgery.
  • Scaling (prophylaxis): 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).

In conclusion, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed study report with the specific metrics and study design elements you requested.

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