Search Results

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.

PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.

The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).

The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.

The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.

The provided text is a 510(k) Summary for the PIEZOTOME CUBE, an ultrasonic surgical system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics for clinical efficacy. Therefore, much of the requested information regarding an acceptance criteria table, sample sizes for test and training sets, number and qualifications of experts, adjudication methods, multi-reader multi-case studies, and specific ground truth types for a clinical performance study cannot be found or directly inferred from the provided text.

The document primarily relies on comparisons of technical characteristics and performance testing to the predicate device, PIEZOTOME SOLO.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a table of explicit acceptance criteria with corresponding performance results for clinical efficacy. Instead, it compares the technical characteristics and performance of the PIEZOTOME CUBE to its predicate device, PIEZOTOME SOLO, arguing that the differences have no impact on safety or effectiveness.

Below is a summary of the technical performance comparisons, which serve as the "reported device performance" in the context of demonstrating substantial equivalence, effectively meeting the "acceptance criteria" of being similar to the predicate.

The acceptance criterion, in essence, is that the new device's performance is either identical to the predicate or that any differences have no impact on safety or effectiveness.

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 refers to "Performance Testing bench" and various validation tests (Electrical Safety, EMC, Software V&V, Sterilization, Cleaning, Biocompatibility). These are bench tests or validation processes, not clinical studies with human patient data or specific "test sets" in the context of AI/ML performance evaluation. Therefore, sample size and data provenance (country, retrospective/prospective) in the clinical sense are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The device is a physical ultrasonic surgical system, not an AI/ML diagnostic tool that requires ground truth established by medical experts for image interpretation or diagnosis.

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

Not applicable, as this is related to expert consensus for ground truth establishment in studies involving interpretation, which is not the case for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was mentioned or performed, as the PIEZOTOME CUBE is a surgical tool, not an AI-assisted diagnostic or interpretation system for human readers.

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

This is not applicable, as the device is an ultrasonic surgical system, not an algorithm. Performance testing was primarily bench testing and direct comparison to a predicate device's technical specifications.

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

Ground truth in the context of this submission refers to the established technical specifications and performance characteristics of the predicate device, as well as compliance with recognized standards (e.g., IEC 60601-1, ISO 10993-1). For the validation tests performed (sterilization, cleaning, biocompatibility), the "ground truth" would be the successful adherence to the requirements of the specified standards and guidance documents. There is no mention of clinical outcome data or pathology reports for ground truth.

8. The sample size for the training set

Not applicable. 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.

Ask a specific question about this device

Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.

PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.

PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips.

The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values).

The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.

The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.

The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.

The provided document is a 510(k) Premarket Notification for a medical device called PIEZOTOME M+, issued by the FDA. It declares the device to be "substantially equivalent" to legally marketed predicate devices.

This document describes a medical device (PIEZOTOME M+, an ultrasonic surgical system) and its performance data to demonstrate substantial equivalence to existing devices. Therefore, the questions related to acceptance criteria and study design for an AI/algorithm-based device (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this document.

The "performance data" discussed in the document refers to typical engineering and safety tests for a physical medical device, not an AI/algorithmic system. The information provided is about electrical safety, electromagnetic compatibility, software verification (specifically stating the software is identical to a predicate device, not a new algorithm), and performance testing bench (meaning physical tests to confirm the device functions as intended, not AI model performance).

Here's how the provided information relates to the request, focusing on what can be extracted and what is not applicable:

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

The document does not present "acceptance criteria" in the typical format for an AI/algorithm where specific metrics (e.g., accuracy, sensitivity, specificity) and thresholds are defined. Instead, it demonstrates equivalency through a comparison of technological characteristics and verification against established electrical and safety standards.

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 document pertains to a physical medical device. The "performance data" refers to engineering and safety tests of the device itself and its components (e.g., electrical safety, EMC, sterilization, biocompatibility), not an AI/algorithm dataset. There is no mention of a "test set" in the context of data used for an algorithm.

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 document does not describe an AI/algorithm that requires expert-established ground truth from medical images or clinical data.

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

• Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-assisted diagnostic or clinical decision support device. It's an ultrasonic surgical instrument.

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

• Not Applicable. There is no standalone algorithm. The "software" mentioned is identical to a predicate device's software, suggesting a control system for the physical device, not an analytical algorithm.

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

• Not Applicable. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., IEC, ISO) and benchmarks against predicate devices' physical characteristics and function.

8. The sample size for the training set

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

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

• Not Applicable. See point 8.

Ask a specific question about this device

The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009). The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria for the PIEZOTOME SOLO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Size: Not explicitly stated. The document mentions "test bench" evaluations.
• Data Provenance: Not explicitly stated, however, the tests were "internal" and conducted by SATELEC, a French company. It is implied the data is prospective as the evaluations were done for the purpose of a 510(k) submission.

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

• Not applicable. The ground truth was established through direct comparison to the performance of a predicate device rather than expert review of clinical data.

4. Adjudication Method for the Test Set:

• Not applicable. The study involved direct performance comparison to a predicate device on a test bench, not human interpretation of results requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on technical performance equivalence to a predicate device, not clinical effectiveness with or without AI assistance.

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

• Yes, a standalone performance study was done. The "Performances of the New Device have been evaluated on test bench" comparing its technical outputs (currents, frequencies, irrigation flows, leakage currents) directly against the predicate device. This is a standalone evaluation of the device's technical specifications.

7. Type of Ground Truth Used:

• Predicate Device Performance: The "ground truth" for the new device's performance was established by directly comparing its measured technical parameters (currents, frequencies, irrigation flows, leakage currents) to the established performance values of the legally marketed predicate device (Satelec IMPLANT CENTER 2, K091252).

8. Sample Size for the Training Set:

• Not applicable. This device is an operative unit, not an AI/algorithm-driven device requiring a training set in the typical sense for machine learning. The comparison is based on the technical characteristics and performance of the Piezotome Solo against a predicate device.

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

• Not applicable. As above, this is not an AI/algorithm-driven device that uses a training set for model development.

Ask a specific question about this device

The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

This 510(k) premarket notification is for the Satelec PIEZOTOME 2, a dental operative unit. This submission is a declaration of substantial equivalence to a predicate device, the Satelec PIEZOTOME (K060274). As such, it relies on the safety and effectiveness established for the predicate device rather than presenting new clinical study data to meet acceptance criteria.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. Substantial equivalence claims do not typically involve setting new acceptance criteria or reporting new performance data. Instead, the claim is that the new device performs as safely and effectively as the predicate device.

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

Not applicable. There is no new test set or clinical study for this 510(k) submission. The device is claimed to be substantially equivalent based on similarities to a previously cleared device.

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

Not applicable. No new ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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

Not applicable. This is not a comparative effectiveness study. It's a substantial equivalence submission for a new version of an existing device.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

Not applicable. This device is a physical dental operative unit, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established for this submission. The "ground truth" for the device's safety and effectiveness relies on the predicate device's clearance.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. No training set was used.

Summary of the 510(k) Document:

• Device: Satelec PIEZOTOME 2
• Predicate Device: Satelec PIEZOTOME (K060274)
• Claim: Substantial Equivalence
• Differences: "Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2."
• Indications for Use: To supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

In essence, the "study" proving the device meets acceptance criteria in this context is the FDA's review and determination that the PIEZOTOME 2 is substantially equivalent to the previously cleared PIEZOTOME. This implies that the new device meets the same safety and effectiveness standards that were established for the predicate device, without requiring a new clinical study or the specific metrics you've requested for AI/algorithm-based devices.

Ask a specific question about this device

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.

Ask a specific question about this device

The Piezotome™ device is a bone cutting instrument intended for use in oral surgery.

The Piezotome™ is a bone cutting instrument intended for use in oral surgery.

The Piezotome™ device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue, The device is supplied with bone surgery, sinus lift, and ligament cutting tips for use in dental surgery, including osteotomy, osteoplasty, periodontal surgery, and implantology.

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.

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.

The provided text is a 510(k) Summary for a medical device called the Piezotome™. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain acceptance criteria, a study proving the device meets those criteria, or any of the detailed study information regarding sample sizes, ground truth establishment, or expert involvement that you've requested.

The FDA's 510(k) clearance process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that define and meet specific performance acceptance criteria like those often seen for novel devices or PMAs.

Therefore, I cannot fulfill your request with the provided input because the necessary information is not present in the document. The document confirms that the device is substantially equivalent to a predicate, meaning its safety and effectiveness are considered to be at least as good as the predicate device, but it doesn't detail a specific study with acceptance criteria.

Ask a specific question about this device