Search Results

The Piezosurgery White 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, revision, 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 White uses ultrasonic energy to generate mechanical micro-vibration of the available insert tips designed with different morphologies/shapes to perform the dental procedures defined in its intended use.
The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard.

The provided text is a 510(k) summary for a medical device called "Piezosurgery White." It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The device in question ("Piezosurgery White") is a surgical instrument that uses ultrasonic energy for bone cutting and other dental procedures. It is not an AI-powered diagnostic or assistive device that would typically involve acceptance criteria related to accuracy metrics (e.g., sensitivity, specificity, AUC), human reader performance, ground truth establishment by experts, or MRMC studies that are common for AI/ML medical devices.

The "Performance Data" section states:
"A features comparison and risk analysis of the modified devices was performed. The results demonstrate that the modifications do not alter the operating principle or mechanism of action of the inserts. The tuning frequency and vibration amplitude of each insert was evaluated via performance bench testing. The results demonstrated that the W1-W6 met the stipulated acceptance criteria and so are substantially equivalent to the predicate inserts."

This indicates that a bench test was performed to ensure the new inserts (W1-W6) met specific performance criteria (tuning frequency and vibration amplitude) to demonstrate substantial equivalence to existing inserts for a physical surgical device.

Therefore, I cannot extract the requested information from the provided text because the device and the nature of its evaluation are different from what the prompt is asking about (which seems to be tailored towards AI/ML device performance studies).

Ask a specific question about this device

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® Plus is an ultrasonic surgical system consisting of handpieces and associated tips for osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

• Otolaryngology
• Oral/maxillofacial
• Hand and foot
• Neurosurgery
• Spine
• Plastic/reconstructive, and
• Orthopedic surgery.
  The device may also be used with endoscopic visual assistance to perform the above listed procedures.

The Piezosurgery Plus device is a surgical system that uses ultrasonic energy to generate mechanical micro-vibration of associated inserts, to perform cutting of bony structures in the procedures defined by its intended use.
The Piezosurgery Plus system consists of a control unit which provides control and power functions, two different detachable surgical handpieces which provide the ultrasonic mechanical energy, two peristaltic irrigation pumps, two irrigation tubing systems, a range of single use insert tips, torque wrenches, and a foot-pedal.
The control unit has a color LCD touch screen user interface for the selection/visualization of device functional parameters. Inside the control unit are located two ultrasonic generators which drive the two handpieces, the electrical power supply modules and the microprocessor electronic board that controls and supervises the functional parameters of the device.
The two piezoelectric ultrasonic handpieces available for the Piezosurgery Plus are identified as 'Piezosurgery Medical' and 'Piezosurgery Medical +'. The handpieces are reusable and capable of being reprocessed by autoclaving.
The handpiece labeled 'Piezosurgery Medical +', uses identical technology to the 'Piezosurgery Medica' handpiece but differs from it as it contains larger piezoceramic rings in its transducer, allowing more efficient cutting of thick bony structures, and also use with extended reach for minimally invasive bone surgery in long narrow access path, in small cavities and other hard to reach areas.
The two peristaltic pumps, which provide, through the two single-use irrigation tubing sets, sterile fluid to the surgical site, are mounted on the two lateral panels of the control unit.
The control unit includes connectors for the handpieces and for the foot-pedal. Each handpiece receives the functional drive signals from the control unit.
Each irrigation tubing set connects each handpiece irrigation connector to a sterile fluid bag (not supplied with the device) via the associated peristaltic pump.
The user may select either of the two handpieces for activation from the LCD touch-screen. Ultrasonic power and irrigation flow are simultaneously activated for the selected handpiece by pressing the foot-pedal.
The ultrasonic generator(s) provides electrical energy at a specific range of frequency. The generator must drive the transducer at or near its anti-resonance frequency for optimal operation. A key function of the generator is to locate the anti-resonant frequency and drive the output at this frequency.
In particular, the generator conducts an automatic frequency sweep across a frequency interval of 36 kHz - 24 kHz to locate and lock the electrical resonance frequency of the transducer/insert system. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery Plus handpieces transducers and family of inserts are designed to resonate in this range of frequencies.
The ultrasonic signal can be modulated in amplitude, generating a sinusoidal signal with alternative amplitudes of high and low value that creates a hammer effect that enhances cutting and minimizes insert stalling.
The Piezosurgery Plus complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

The provided text describes the Mectron Piezosurgery Plus device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device numerically meets specific criteria as typically seen in AI/ML device submissions.

This document is a 510(k) summary for a traditional surgical instrument, not an AI/ML powered device. The "performance testing" section focuses on demonstrating the device's functionality, safety, and equivalence to predicate devices based on well-established non-AI engineering principles and physical testing.

Therefore, many of the requested items (e.g., sample size for test sets, data provenance, number of experts, MRMC studies, standalone performance, ground truth types for training/test sets, training set size) are not applicable to this type of device and submission.

Here's a breakdown of the information that can be extracted from the document, acknowledging the non-AI nature:

Acceptance Criteria and Device Performance (Non-AI Device)

Since this is a traditional surgical instrument, the "acceptance criteria" are generally framed around demonstrating functional equivalence to predicate devices and compliance with relevant safety standards, rather than numerical performance against a specific metric (like sensitivity/specificity for AI). The "reported device performance" refers to the results of engineering tests confirming these aspects.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

Information Regarding the Study (or lack thereof for AI/ML specific aspects):

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

   • Test Type 1 (Osteotomy/Osteoplasty Efficiency): "cow femur or rib samples" were used. No specific number of samples is provided.
   • Test Type 2 (Bone Safety): Performed on "bone surfaces derived from the above test type 1." Same samples, no specific count.
   • Test Type 3 (Device Safety - Insert Breakage): "Five samples were tested for each investigated insert type."
   • Data Provenance: In vitro testing (cow bone), not human data.

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

   • Not applicable in the context of this engineering performance testing. "Ground truth" was established by direct measurement (cutting speed, volume removed) or visual inspection (microscope for necrosis). The document does not mention external experts for ground truth establishment.

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

   • Not applicable as this is not an AI/ML diagnostic or prognostic study requiring multi-reader adjudication.

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

   • No MRMC comparative effectiveness study was done. This is a traditional surgical instrument, not an AI-assisted device for diagnostic or prognostic purposes.

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

   • Not applicable. This device is a console and handpiece system, always used with a human operator. The performance testing describes the device's physical capabilities.

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

   • For mechanical testing, the "ground truth" was direct physical measurement and observation:
     • Cutting speed measurement.
     • Volume of bone removed measurement.
     • Microscopic visual inspection for bone necrosis.
     • Observation of insert integrity after stress cycles.
   • For safety and software, it was compliance with recognized standards and guidance.

7. The sample size for the training set:

   • Not applicable; this is not an AI/ML device that requires a training set. The software mentioned is for device control and functionality, validated through traditional software V&V.

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

   • Not applicable as there is no training set mentioned for an AI/ML algorithm.

Ask a specific question about this device

The Piezosurgery White 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.

The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use. The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. The device 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. Inside the console are located the ultrasonic generator, the electrical power supply module and the microprocessor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the footswitch. One external peristaltic pump, intended for delivery of saline solution to the point of use, is attached to the console. The console is equipped with a keyboard that allows the surgeon to set/control the functions of the device. The keyboard also provides monitoring information, by means icons, in case of malfunction of the device. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch. The ultrasonic generator of the Piezosurgery White is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the ultrasonic transducer, which is housed inside the handpiece. The touch panel of the console allows setting of the following treatment/operative parameters: Six different types of treatment (IMPLANT, CORTICAL, CANCELLOUS, SPECIAL, PERIO, ENDO): Seven different levels of irrigation (from 0 to 6); The "pump/flush" function. The Piezosurgery White uses piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the tip insert 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 and locates the resonant frequency of the transducer/insert combination, which varies according to the geometry/morphology of the tip insert in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. The Piezosurgery White handpiece transducer and family of inserts are designed to resonate in this range of frequencies.

This document is a 510(k) summary for the MECTRON S.p.A. Piezosurgery White device. It highlights the device's equivalence to a predicate device rather than providing acceptance criteria for a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details for a medical device that uses AI/ML is not available in the provided text.

The document focuses on demonstrating substantial equivalence to an existing predicate device (Piezosurgery Touch) for regulatory approval, which is a different type of evaluation than setting and meeting performance criteria for novel AI/ML functionalities.

Here's a breakdown of what is available in the document, framed against the requested items, to illustrate why the specific AI/ML performance criteria are not present:

Context of the Document:
This is an FDA 510(k) summary for a medical device called "Piezosurgery White." The purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, thereby not requiring a new premarket approval (PMA).

Piezosurgery White Device Description:
The Piezosurgery White is a piezoelectric ultrasonic device used for various oral surgical procedures (bone cutting, osteotomy, drilling) and scaling applications (calculus removal, periodontal therapy, endodontics, restorative/prosthetic procedures). It uses ultrasonic energy to generate mechanical micro-vibrations in its tip inserts.

Comparison to Predicate Device (Piezosurgery Touch):
The document extensively compares the Piezosurgery White to its predicate device, the Piezosurgery Touch (K122322). The key takeaway is that both devices use identical piezoelectric ultrasonic technology, have similar components, intended uses, operational characteristics, and output parameters. The main differences noted are minor cosmetic changes to the external design and the introduction of ten new inserts, for which specific functional and design verification was performed.

Addressing the specific categories requested, based on the provided text:

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

   • N/A. The document does not describe acceptance criteria and reported performance in the context of an AI/ML device's diagnostic or predictive capabilities. Instead, it demonstrates "substantial equivalence" to a predicate device.
   • The "performance" discussed relates to compliance with recognized standards and similarity to the predicate device's operational characteristics (e.g., operational vibration frequency: 24 kHz to ~36 kHz, Max. Output: 25 Watt for both subject and predicate devices). This is about technological specifications rather than a performance metric against a disease state or outcome.

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

   • N/A. The document does not describe a "test set" in the context of an AI/ML algorithm's performance evaluation against a dataset. The testing was primarily non-clinical (bench tests, compliance with safety and EMC standards, sterilization validation, software verification) to demonstrate the device's physical and functional equivalence to the predicate.
   • For the new inserts (PR1 and PR2), "Functional bench tests conducted on inserts PR1 and PR2 when attached to the Piezosurgery White handpiece verify that the operative resonant frequency of the inserts is within the functional ultrasonic frequency range of the Piezosurgery White." No specific sample size for these bench tests is given, nor is "data provenance" relevant 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):

   • N/A. Ground truth, in the context of expert consensus for AI/ML evaluation, is not applicable here as the device does not make diagnostic or predictive assessments. The evaluation is against engineering specifications and comparison to a predicate device.

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

   • N/A. Not applicable, as there's no diagnostic "test set" and no expert adjudication process 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 device does not involve "human readers" or "AI assistance" in a diagnostic or interpretive capacity. It is a surgical tool. Therefore, an MRMC study is not relevant.

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

   • N/A. This device is a surgical instrument, not an AI/ML algorithm that operates standalone. Its "performance" is its ability to meet physical and functional specifications.

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

   • N/A. The "ground truth" for demonstrating substantial equivalence for this type of device primarily relies on engineering specifications, compliance with international standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 17665-1, ISO 14937), and direct comparison of its technological characteristics and intended use to a legally marketed predicate device. For new inserts, Finite Element Analysis (FEA) and functional bench tests were used to verify resonant frequency.

8. The sample size for the training set:

   • N/A. This document does not describe an AI/ML algorithm with a training set. The "software" mentioned (Page 8, Item 8) refers to the device's internal control software, which underwent "verification and validation in accordance with FDA guidance," not training on a dataset for learning tasks.

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

   • N/A. Not applicable, as there is no AI/ML training set.

Ask a specific question about this device

The Piezosurgery FLEX 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 paalstic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

Piezosurgery FLEX is a piezoelectric ultrasonic device that uses ultrasonic energy to generate mechanical micro-vibration of tip inserts intended for bone cutting. The device consists of a base control unit with intearated peristaltic pump, a sterilizable handpiece with connecting cord, a range of sterile, single use tip inserts, a torque wrench, a foot-pedal, an irrigation set, and other minor attachments.

The console is equipped with a touch panel that allows the surgeon to control device operation. The control panel also provides monitoring information, by means icons, in case of malfunction of the device. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to mains power by an electrical cord, and includes connectors for the handpiece and for the foot-pedal. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the foot-pedal. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

The touch panel of the console allows the operator to set the treatment parameters, as follows:

• Seven levels of power: .
• Six levels of irrigation: .
• Three ultrasonic output modes; .
• · The pump function.

The Piezosurgery FLEX uses piezoelectric ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.

This 510(k) summary describes a traditional submission for the Mectron Spa Piezosurgery FLEX, an ultrasonic surgical system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical testing focused on compliance with electrical safety and electromagnetic compatibility (EMC) standards. It does not contain information about a "test set" in the context of clinical performance evaluation (e.g., patient data). The testing performed was related to device characteristics.

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

Not applicable. The document describes compliance testing against established engineering standards (IEC 60601-1, EN 60601-1-2), not a study requiring expert-established ground truth for a clinical dataset.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human interpretation or performance, which is not described here.

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 surgical system, not an AI-based diagnostic or assistive technology that would involve human "readers" or an MRMC study.

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

Not applicable. This device is a surgical instrument. "Standalone" performance testing would relate to its engineering specifications and functionality, which are covered by the non-clinical testing mentioned (IEC and EMC standards compliance).

7. The Type of Ground Truth Used

For the non-clinical testing: The "ground truth" was defined by the requirements and specifications outlined in the international standards IEC 60601-1 (medical electrical equipment safety) and EN 60601-1-2 (electromagnetic compatibility).

8. The Sample Size for the Training Set

Not applicable. The Piezosurgery FLEX is a hardware surgical device, not a machine learning or AI model that requires a training set.

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

Not applicable. As noted above, this device does not utilize a "training set" in the context of machine learning.

Ask a specific question about this device

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 Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts.

This is a 510(k) premarket notification for a medical device (Piezosurgery Touch), not a study report. Therefore, much of the requested information about device performance and ground truth establishment from a study is not present in this document.

However, I can extract information related to the device name, classification, and intended use.

Here's a breakdown of what can be inferred or explicitly stated:

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

This document describes a premarket notification for a medical device, not a performance study result. Acceptance criteria and reported device performance from a clinical study are not provided. The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the regulatory acceptance criteria for 510(k) clearance.

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 is a regulatory approval notice, not a study report.

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 is a regulatory approval notice, not a study report.

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

Not applicable. This document is a regulatory approval notice, not a study report.

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 bone cutting instrument and ultrasonic scaler, not an AI-powered diagnostic device that would involve human readers for comparative effectiveness.

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

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

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

Not applicable. This document is a regulatory approval notice, not a study report. The "ground truth" for 510(k) clearance is substantial equivalence to a predicate device, which is based on similar technological characteristics and intended use, not necessarily comparison to a 'ground truth' in a clinical study sense.

8. The sample size for the training set

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

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

Not applicable. This document is a regulatory approval notice, not a study report involving a training set for an algorithm.

Ask a specific question about this device

The OSSTEMPiezo is intended for use in the following dental applications:

• Bone cutting for use in oral surgery
• 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 3 is intended for use in the following dental applications:

• Bone cutting for use in oral surgery
• 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 OSSTEMPiezo 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 rer smoothing and blunt insert tips for use in oral surgery, including implantology, periodontal surgery, endodontic surgery and surgical orthodontics.

The device uses piezoeledric ultrasonic technology to generate mechanical microvibrations of insert tips for cutting mineralized structures with minimal trauma to soft tissue and for ultrasonic scaling.

The provided text does not contain specific acceptance criteria or a detailed study proving that the OSSTEMPiezo device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance evaluations.

Here's a breakdown of the information that is available and what is missing, structured according to your request:

1. A table of acceptance criteria and the reported device performance
   • No explicit acceptance criteria (e.g., "The device must achieve a cutting depth of X mm with Y pressure") are provided in the document.
   • The "performance evaluations" section describes qualitative outcomes rather than measurable performance statistics against defined criteria.

2. Sample size used for the test set and the data provenance

   • The document does not provide details on a specific "test set" sample size or its provenance (e.g., country of origin, retrospective/prospective). The performance evaluations are described in general terms, implying a summary of observations rather than a detailed study protocol.

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

   • No information is provided regarding the number of experts, their qualifications, or their role in establishing "ground truth" for any test set. The 'evaluations' appear to be based on general observation of device functionality.

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

   • No adjudication method is mentioned, as there is no described formal test set requiring such a process.

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 MRMC study was conducted or mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool for "human readers."

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

   • The device is a human-operated surgical instrument, so the concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable in this context.

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

   • No formal "ground truth" in the sense of a definitive reference standard (like pathology or clinical outcomes) is described for the performance evaluations. The evaluations appear to be based on observations of physical effects (e.g., incision quality, tissue preservation).

8. The sample size for the training set

   • The document does not describe a "training set" as this is not a machine learning or AI-based device.

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

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

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 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

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

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

The Piezosurgery device, indicated as a bone cutting instrument for oral surgery, underwent performance evaluations primarily based on clinical and histologic data.

Here's an analysis of the provided information in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "clinical and histologic data," implying a study involving patients or tissue samples, but no specific numbers are provided for either human subjects or tissue samples.
• Data Provenance: Not explicitly stated. The clinical and histologic data are likely retrospective, as no prospective study design is mentioned. The country of origin is not specified, but the submitter and contact person are associated with Italy, suggesting the data could be from Italy or Europe, though this is not confirmed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The evaluation focuses on the device's intrinsic performance characteristics rather than comparing human reader performance with and without AI assistance. This device is a surgical tool, not an AI diagnostic system.

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

• Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm or AI system. Its performance inherently involves a human operator.

7. The Type of Ground Truth Used

• Ground Truth Type: Clinical observations and histologic findings. These are considered direct evidence of the device's effects on tissue and surgical outcomes.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. As this is a medical device and not an AI or machine learning model, there is no "training set" in the conventional sense. The "training" for such devices typically involves design, engineering, and iterative testing, sometimes using preclinical or basic science data, and ultimately clinical data serves as validation.

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

• Ground Truth Establishment: Not applicable, as there is no training set mentioned for an algorithm. The development of the device would have relied on engineering principles, material science, and possibly cadaveric or animal studies to refine its design and operational parameters.

Ask a specific question about this device