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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® 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.

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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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The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications:

· Scaling: Procedures for removal of supragingival and interdental calculus/plaque deposits:

· Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning:

· Endodontics: Treatments for root canal reaming irrigation, filling, gutta-percha condensation and retrograde preparation;

· Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

The Compact Piezo Led is a multipurpose piezoelectric ultrasonic scaler sub-assembly device intended to be supplied to manufacturers of dental unit devices and incorporated within such devices, to be used for ultrasonic treatment in scaling, periodontics and prosthetics dental applications.

The Compact Piezo Led uses ultrasonic energy to generate mechanical micro-vibration of the available tip inserts to perform the dental procedures defined in its intended use.

The Compact Piezo Led consists of an ultrasonic generator, a handpiece/cord incorporating a range of insert tips, a torque wrench, different wiring connection kits, and other minor accessories.

The range of tip inserts, handpiece and torque wrench are autoclavable.

The subject device is intended to be assembled inside a dental unit and connected to the dental unit's electrical supply by the wiring connection kit provided.

The handpiece/cord is connected directly to the device's ultrasonic generator, from which it receives the functional drive signals, including those for irrigation supply, from the dental unit. The ultrasonic power and water flow are simultaneously activated by pressing the footswitch of the dental unit. The power output and water flow are adjusted through the dental unit's controls.

The ultrasonic generator of the Compact Piezo Led 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 ultrasonic generator electronics search and locate the resonant frequency of the transducer/insert tip 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 Compact Piezo Led handpiece transducer and family of inserts are designed to resonate within this frequency range.

The Compact Piezo Led device complies with the electrical safety and electromagnetic compatibility requirements established by the standards IEC 60601-1 and IEC 60601-1-2.

This document describes the Mectron Compact Piezo LED, an ultrasonic scaler device. However, it does not contain a study that establishes acceptance criteria and proves the device meets them in the context of clinical performance or diagnostic efficacy.

The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to legally marketed predicate devices. This type of submission primarily focuses on comparing the new device's technological characteristics and safety with existing, cleared devices, rather than conducting new clinical performance studies with acceptance criteria for diagnostic accuracy or effectiveness.

Here's a breakdown of the information provided, specifically addressing the points in your request:

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

This document does not provide a table of acceptance criteria and reported device performance in terms of diagnostic or clinical efficacy (e.g., sensitivity, specificity, accuracy for a disease detection task). The device is an ultrasonic scaler, a therapeutic and dental hygiene tool, not a diagnostic imaging or AI-driven diagnostic device.

The "performance" discussed relates to technical specifications and compliance with safety and electromagnetic compatibility standards, which are:

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 is not a study evaluating a diagnostic device with a test set of patient data. The "testing" mentioned is non-clinical, focusing on engineering, electrical safety, and regulatory compliance.

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. There is no concept of "ground truth" as typically understood in diagnostic AI/imaging studies, as this is a dental scaling device undergoing technical and safety evaluation.

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

Not applicable. No expert adjudication for a test set is mentioned.

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

Not applicable. This device is an ultrasonic scaler, a physical tool used by dentists. It is not an AI diagnostic tool and does not involve "human readers" or AI assistance in the interpretation of information.

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

Not applicable. There is no standalone algorithm performance as this is a hardware device. The device has software that controls its functions, and this software was verified and validated.

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

Not applicable. As explained, the device is not being evaluated against a diagnostic "ground truth." The "truth" in this context refers to compliance with established engineering standards and functional specifications.

8. The sample size for the training set

Not applicable. This refers to a manufactured device and its components, not a machine learning model that undergoes training on a dataset.

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

Not applicable. See point 8.

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The Multipiezo Pro and Multipiezo are piezoelectric ultrasonic dental scalers intended for use, with the appropriate associated tip inserts, in the following dental applications:

• . 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: All general restorative procedures including cavity preparation, removal . of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning.

The Multipiezo Pro and Multipiezo devices are dental piezoelectic ultrasonic devices that use ultrasonic energy to generate mechanical micro-vibration of the inserts to perform the dental procedures defined in their intended use.

The Multipiezo Pro consists of a base control unit (console) with two integrated peristaltic pumps which deliver irrigation liquid, contained in two independent detachable 500 ml bottles, to two sterilizable ultrasonic handpieces with connecting cords. The selection of the irrigation fluid occurs automatically when the operator removes the handpiece from the support associated with the tank containing the liquid that the dentist wants to use for the treatment. Only one handpiece can be used at a time.

The Multipiezo device consists of a base control unit with a single integrated peristaltic pump which delivers the irrigation liquid contained in one detachable tank to one single ultrasonic handpiece with connecting cord.

The consoles of both devices are connected to mains power by an electrical cord, and include connectors for the hand piece/s and for the footswitch. The consoles incorporate peristaltic pump/s which provide/s the irrigation fluid contained in the tank/s to the operation site.

The handpiece contains a piezoelectric ultrasonic transducer which is connected to the ultrasonic generator (inside the console) by a cable at one end and to which tip inserts are attached at the other end.

The ultrasonic generator, identical in both devices, is microprocessor-based and uses electronics to generate and control the appropriate drive signal (power and frequency) for the transducer in the handpiece. A touch screen on the console of both devices allows the setting of treatment parameters, as follows:

• Four type of functions (Endo, Perio/Scaler, Restorative, Soft Mode) that can be adjusted through 6 power levels
• . Seven different levels of irrigation (from 0 to 6)
• . Insert tip illumination (on, off or auto)
• Flush function. .

The provided text is a 510(k) Summary for medical device clearance, not a study report detailing acceptance criteria and performance against those criteria. Therefore, the information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) is not present in the document.

This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with specific acceptance criteria that the device itself must meet against real-world data.

Here's what can be extracted, based on the type of document this is:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or report device performance against such criteria. Instead, the "acceptance criteria" for this 510(k) submission are met by demonstrating substantial equivalence to predicate devices, primarily through:

• Identical or very similar Indications for Use/Intended Use.
• Same Technological Characteristics (mechanism of action, piezoelectric technology, ultrasonic transducers, micro-vibration generation).
• Same accessories (insert tips, etc.).
• Same operative modes/signal information.
• Same parts to be sterilized and sterilization methods.
• Same performance (stated as a shared characteristic with the Multipiezo Pro and Multipiezo, implying performance comparable to the predicates, though not quantitatively detailed).
• Compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2).

The "reported device performance" in this context refers to the device's adherence to these characteristics, and compliance with the safety and EMC standards.

Summary of Information Not Found in the Document:

1. A table of acceptance criteria and the reported device performance: Not provided in the format requested as this is a substantial equivalence submission.
2. Sample size used for the test set and the data provenance: No "test set" in the context of a performance study is described. The assessment is comparative to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical dental device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state about testing:

• Non-clinical testing: Bench testing was conducted to confirm compliance with electrical safety (IEC 60601-1) and EMC requirements (IEC 60601-1-2). The details of these bench tests (e.g., specific parameters measured, number of units tested) are not provided in this summary.

In conclusion, this document serves as a regulatory submission demonstrating substantial equivalence to pre-existing devices, rather than a detailed report of a performance study designed to meet specific quantitative acceptance criteria of a novel device.

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