Search Results

Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for:

• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
• Scaling applications, including:
• Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
• Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning;
• Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation:
• Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tor:

• Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures;
• Scaling applications, including:
• Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
• Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning:
• Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation:
• Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

The Piezosurgery Touch and Piezosurgery White use ultrasonic energy to generate mechanical microvibrations of the available tip inserts to perform the dental procedures defined in its intended use.

They consist of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. They also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use.

The table-top units use piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the insert tip attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip.

The ultrasonic generator electronics searches and locates the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the insert tip in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz.

Each of the insert tips is available separately.

The purpose of this 510(k) is to add additional insert tip designs to the PIEZOSURGERY TOUCH and PIEZOSURGERY WHITE to extend the number of insert tips already cleared for sale in the US under K122322 and K151248.

This FDA 510(k) summary describes the submission for new insert tips for the Piezosurgery Touch and Piezosurgery White devices. The purpose of the submission is to add these new tips and establish their substantial equivalence to already cleared devices and tips.

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

1. Table of acceptance criteria and the reported device performance:

The document outlines acceptance criteria implicitly through the non-clinical testing performed and the conclusions drawn regarding substantial equivalence. The "acceptance criteria" are essentially that the new inserts perform comparably to predicate devices in specific areas.

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

• Sample Size for Test Set: Not explicitly stated as a number of devices or tips. The text refers to "the subject inserts (SLC, SLO-H, SLS, SLE1 and SLE2)" for comparative performance bench testing, which implies at least one of each listed subject insert. For reprocessing and biocompatibility, it refers to "a typical worst case reprocessed insert tip," suggesting one or a representative sample.
• Data Provenance: The manufacturer is MECTRON S.p.a, located in Carasco - (GE) - ITALY. The tests were performed to support a U.S. FDA 510(k) submission, suggesting the data originates from tests conducted by or on behalf of the Italian manufacturer. The data is most likely from prospective bench testing and laboratory analyses.

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 in the document. The evaluations are based on non-clinical, bench-top testing, and biocompatibility studies, which are typically performed by engineers, technicians, and laboratory scientists rather than clinical experts establishing "ground truth" in terms of patient outcomes or diagnoses.

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

This information is not applicable and therefore not provided. "Adjudication method" usually refers to a process for resolving discrepancies among multiple human readers or experts, which is relevant for clinical studies or image interpretation. The studies described here are non-clinical bench tests.

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:

This information is not applicable and therefore not provided. An MRMC study involves human readers, typically in the context of diagnostic performance or AI-assisted workflows. This submission is for new surgical device inserts, and the studies are non-clinical bench tests evaluating physical properties and performance characteristics, not diagnostic effectiveness or human reader performance.

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

This information is not applicable and therefore not provided. The devices (Piezosurgery Touch and Piezosurgery White) are physical medical devices (ultrasonic instruments and tips) used in surgery, not software algorithms or AI systems. The "standalone" performance here refers to the device's inherent physical characteristics, which were evaluated through the non-clinical tests described.

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

The "ground truth" for the non-clinical tests is based on engineering specifications and established scientific methodologies.

• For tuning frequency and vibration amplitude: "Ground truth" is the empirically measured values compared against the expected operational range (24-36 kHz) and predicate device values.
• For reprocessing: "Ground truth" is the successful outcome of sterilization and cleaning protocols as per validated methods.
• For biocompatibility: "Ground truth" is the absence of cytotoxic effects, determined by a standardized in vitro test (ISO 10993-5:2009).

8. The sample size for the training set:

This information is not applicable and therefore not provided. "Training set" refers to data used to train machine learning models. The devices in this submission are physical instruments with no machine learning or AI components described.

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

This information is not applicable and therefore not provided. As there is no training set for an AI model, the method for establishing its "ground truth" is irrelevant.

Ask a specific question about this device

The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing.

The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console.

The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

This looks like a 510(k) premarket notification for a medical device called Piezosurgery Medical. It's a submission to show substantial equivalence to already marketed devices, not a study demonstrating performance based on acceptance criteria in the way you've described for an AI/ML device.

Therefore, many of the specific questions about acceptance criteria, study design, sample sizes, ground truth, experts, and AI performance cannot be directly answered from the provided text. This document is focused on regulatory clearance based on equivalence, not a clinical performance study with specific metrics and acceptance criteria for a new algorithmic device.

However, I can extract what is provided related to "performance data" which, in this context, refers to the device's operational characteristics rather than clinical outcomes measured against statistical targets.

Here's an attempt to address your request based only on the provided text, highlighting where information is not applicable or missing for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not present "acceptance criteria" in the context of specific quantitative efficacy or diagnostic performance targets, nor does it provide a direct "reported device performance" against such criteria. The "Performance Data" section describes the device's operational capabilities.

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

• Sample Size for Test Set: Not applicable. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable for a clinical test set. The manufacturer is Mectron Spa, Italy, and the 510(k) owner is Piezosurgery SRL, Italy.

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) submission.

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

• Not applicable. No test set requiring adjudication 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 a surgical instrument (Piezosurgery Medical), not an AI/ML diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

• Not applicable. The Piezosurgery Medical is an ultrasonic surgical system, a physical instrument operated by a surgeon ("human-in-the-loop" by design), not a standalone algorithm.

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

• Not applicable. The submission focuses on the device's functional and technological characteristics and its intended use, demonstrating equivalence to predicate devices. It does not present a clinical performance study that would require a defined "ground truth" in the context of diagnostic accuracy or treatment success.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device where a "training set" would be used.

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

• Not applicable. As above, there is no training set for this type of device.

Summary of what is provided regarding performance and regulatory rationale:

The "Performance Data" section describes the device's operational flexibility (four cutting modalities, five irrigation levels, seven power levels) and its inherent technological features like ultrasonic frequency modulation and automatic tuning to achieve the desired surgical effect (a "hammering effect" for cutting action).

The conclusion of the 510(k) submission states that: "Based on the information contained within this submission, it is concluded that the Piezosurgery Medical device is substantially equivalent to the predicate devices already in interstate commerce within the USA." This statement, along with the FDA's clearance letter, indicates that the device met the regulatory standard of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission – meaning it is as safe and effective as a legally marketed predicate device. The information supporting this includes the device description, intended use, and technological characteristics, as well as the operational "performance data" detailed above.

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

The Piezosurgery® device is intended for use in the following dental applications:

• Bone cutting for use in oral surgery (K043408) -
• Removing supra and subgingival calculus deposits and stains from teeth -
• Periodontal pocket lavage with simultaneous ultrasonic tip movement -
• Scaling and root planing -
• Retrograde preparation of root canals

The Piezosurgery® device uses piezoelectric ultrasonic technology to generate mechanical microvibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue. The device is supplied with sharp, smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.

The provided text is a 510(k) summary for the Piezosurgery® device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than providing a detailed study report with specific acceptance criteria and performance data as one might find for a novel AI/ML medical device.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission, as it describes a traditional medical device (an ultrasonic scaler) and its performance evaluation for established indications.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it's not applicable:

1. Table of acceptance criteria and the reported device performance

• Removing supra and subgingival calculus deposits and stains
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Retrograde preparation of root canals | Technical, clinical, and histologic comparisons supported a finding of substantial equivalence to the predicate device. |
  | For Bone Cutting: Substantial equivalence to a predicate device (K043408, though the specific predicate for bone cutting is only referenced by K-number, not name) for bone cutting in oral surgery. | Performance and safety evaluations demonstrated:
• Precisely delineated tissue cutting
• Reduced risk of adjacent tissue damage
• Needed limited pressure on the handpiece to achieve desired cutting action
• Improved surgical control
• Reduced possibility of trauma to soft tissue |

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

• Sample Size for Test Set: Not specified in the provided text. The submission mentions "clinical data," but no numbers are given for patient or case count.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

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

• Number of Experts/Qualifications: Not specified. The summary refers to "clinical data" and "histologic comparisons" but does not detail how these assessments were conducted or by whom.

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

• Adjudication Method: Not specified.

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

• MRMC Study: Not applicable. This is a traditional medical device, not an AI/ML diagnostic tool, so an MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This is a traditional medical device that requires human operation; it is not an algorithm.

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

• Type of Ground Truth: The performance evaluations were based on "clinical data on the characteristics of the inserts in vibration, cutting precision, and on the risk of adjacent tissue damage." It also mentions "histologic comparisons." These suggest a combination of clinical observation, physical measurements of device performance (vibration, cutting), tissue damage assessment, and potentially histopathological analysis to confirm tissue effects.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a traditional medical device, not an AI/ML model, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable. (See #8)

Summary of Key Findings from the Document:

The Piezosurgery® device achieved 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (EMS Piezon® Master 600 for ultrasonic scaling and K043408 for bone cutting). This equivalence was supported by "technical, clinical and histologic comparisons." The performance evaluations specifically highlighted precise cutting, reduced risk of adjacent tissue damage, and improved surgical control with limited pressure. The document, being a 510(k) summary, does not provide detailed study methodologies, sample sizes, or expert qualifications as typically found in comprehensive clinical trial reports.

Ask a specific question about this device