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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).

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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.

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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.

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