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MT-Bone 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.

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery.
MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts.
This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces.
The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

The provided text describes the MT-Bone device and its substantial equivalence to a predicate device (PIEZOSURGERY TOUCH, K122322). However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or details of a study proving the device meets said criteria in the way typically found for AI/ML-based medical devices.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics, indications for use, and general safety/performance testing. There is no mention of an algorithm, AI, or machine learning in the context of device function.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this document, as they pertain to a different type of device or evaluation method.

Here's a breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:

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

The document states that a series of non-clinical bench performance tests were conducted to evaluate the efficacy and safety of the device. The "acceptance criteria" are implied by the statement "All tests passed successfully" or "The testing showed that..." without quantitative metrics.

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 for any of the non-clinical tests. For the cadaver lab, it refers to "clinicians" but no number of cadavers or specific cases is given.
• Data Provenance: Not explicitly stated for any of the tests. It's internal testing by the manufacturer (Mectron S.p.A., Italy).

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):

• Number of Experts: For Usability Testing, it mentions "KOLs feedback and evaluations" (Key Opinion Leaders) but does not specify the number or their qualifications. For the Cadaver Lab, it states "clinicians" but again, no number or qualifications are provided.
• Qualifications of Experts: Not specified.

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

• Not applicable as the tests described are primarily bench, software, and usability/cadaver lab evaluations, not diagnostic accuracy studies requiring adjudication of ground truth by multiple experts.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device described is a surgical instrument (piezoelectric ultrasonic device), not an imaging or diagnostic AI/ML device that assists human readers.

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

• Not applicable. The device is a surgical instrument requiring human operation. There is no mention of a standalone algorithm component that performs autonomously.

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

• For the non-clinical bench tests, "ground truth" is typically defined by engineering specifications, regulatory standards (e.g., IEC, ISO), and performance targets for the device's physical functions (e.g., amplitude, frequency, temperature, cutting efficacy).
• For Usability and Cadaver Lab tests, the "ground truth" or validation came from "KOLs feedback and evaluations" and "evaluation process conducted by clinicians," implying expert assessment of performance, safety, benefits, and usability.

8. The sample size for the training set:

• Not applicable. The document does not describe an AI/ML device that requires a training set.

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

• Not applicable. The document does not describe an AI/ML device that requires a training set.

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The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.

This FDA 510(k) summary (K240340) for the Surgical Drive System (Model: ES70, ES90, E8) describes a device that is not an AI/ML-driven medical device. The document focuses on establishing substantial equivalence to a predicate device based on technical design, intended use, and conventional performance and safety testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, cannot be extracted from this document because it does not involve AI/ML.

However, I can provide a summary of the non-clinical performance testing that was conducted to support the substantial equivalence claim for this medical device, which addresses the "study that proves the device meets the acceptance criteria" in a general sense, but not for AI/ML specific criteria.

Non-AI/ML Related Acceptance Criteria and Study Summary (Based on Provided Document):

The acceptance criteria for this non-AI/ML device are primarily related to safety, electromagnetic compatibility, and reprocessing effectiveness, demonstrated through adherence to recognized international standards.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

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

• Test Set Sample Size: Not explicitly stated in terms of number of devices / units. Testing would typically involve a statistically relevant sample of devices or components to demonstrate compliance with standards.
• Data Provenance: Not explicitly stated, but testing is implied to be conducted by the manufacturer (Guangdong Jinme Medical Technology Co., Ltd.) or a contracted testing facility. The nature of these tests (safety, EMC, reprocessing validation) implies prospective testing on manufactured devices to meet specific engineering and regulatory requirements.

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

• This concept is not applicable as this is a non-AI/ML device. "Ground truth" established by expert consensus is typically relevant for evaluating the diagnostic or classification performance of AI/ML algorithms. For this device, compliance is measured against engineering specifications, industry standards, and regulatory requirements, which do not rely on expert "ground truth" in the same way.

4. Adjudication method for the test set:

• Not applicable for a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or performance evaluations for diagnostic devices to resolve discrepancies in expert interpretations, particularly for establishing ground truth for AI model training or testing.

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 as this is a surgical drive system, not an AI-driven diagnostic or assistive imaging device involving human readers.

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

• Not applicable as this is a hardware-based surgical drive system, not an AI algorithm.

7. The type of ground truth used:

• For this device, "ground truth" is established by:
  • Engineering Specifications: The device is designed to meet specific performance parameters (e.g., motor speed, power output, operating mode).
  • International Standards: Compliance with established safety (e.g., IEC 60601-1), EMC (e.g., IEC 60601-1-2), and reprocessing (e.g., ISO 17665-1) standards, where the standard itself defines the acceptable criteria and test methods.
  • Software Design Requirements: For the device's control software, compliance is against its own validated design requirements and IEC 62304.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of AI/ML.

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

• Not applicable.

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The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles:

(1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time.
(2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time.
· The kit is intended for sterilization of non-porous loads.
· Do not stack kits during sterilization.
· Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.

The Guided Surgery Kit is offered in 2 complete kit variations for 3 implant systems: Legacy, Simply lconic, and InterActive as a reusable perforated tray for purposes of transport, steam sterilization and storage of dental instruments, similar to the reference device Standard Sterilizable Tray (K202524). The kit is sold non-sterile and contains site preparation instruments, dental driving tools, prosthetic driving tools and ratchet tool which can be used for implant placement. The proposed Guided Surgical Drills are reusable surgical instruments designed to prepare an osteotomy for a dental implant procedure. The features remain unchanged from the predicate Surgical Drills (K200265) except for the addition of a Guide Body and Shoulder Stop. The addition of a Guide Body allows the proposed drills to function with guide sleeves which can be integrated into an existing surgical quide template to assist in the drilling sequence and placement of dental implants.

The provided document, an FDA 510(k) clearance letter for a "Guided Surgery Kit," does not describe a study involving an AI/Artificial Intelligence device that requires the detailed information requested in the prompt.

The device in question, a "Guided Surgery Kit," is a collection of dental surgical drills and instruments to organize, steam sterilize, and transport between uses, including drills intended to cut into maxilla or mandible for dental implant placement. The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily regarding biocompatibility, cleaning, and sterilization validation.

Therefore, many of the requested categories related to AI/ML device performance studies, such as "acceptance criteria for device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set," are not applicable to the content of this regulatory submission.

The document explicitly states: "Clinical performance data is not required to establish substantial equivalence for the subject device." This further indicates that no human-in-the-loop or AI-specific performance study was conducted or reported in this submission for this particular device.

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TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

This document is a 510(k) Summary for the TRAUS SUS20, a piezo surgery engine set. It details the device's characteristics and its substantial equivalence to a predicate device, TRAUS SUS10. Since this is a submission for a medical device (bone cutting instrument), the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than a quantifiable performance metric (like sensitivity or specificity) for a diagnostic AI. The study presented here is primarily a comparison of technical characteristics and compliance with recognized standards, and not a clinical study involving human subjects or AI-specific performance metrics.

Here is an analysis based on your request, as much as can be extracted from the provided text for a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device. "Device performance" is shown through bench testing of key operational parameters.

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

This document describes a premarket notification (510(k)) for a conventional medical device, not an AI device or a diagnostic test involving a "test set" of patient data in the typical sense.

• Sample Size: Not applicable. The "test set" refers to the physical device components and their performance in bench tests (e.g., electrical safety, EMC, performance parameters) and comparison with a predicate device. The performance tests would use a sample of the manufactured device.
• Data Provenance: Not applicable in the context of patient data. The provenance of the data for this submission would be internal testing reports, external testing laboratory reports (for standards compliance), and comparison data from the predicate device (TRAUS SUS10, K151171) and a reference device (Compact Piezo LED, K151023) from Saeshin Precision Co., Ltd. and Mectron Spa, respectively. Given the context of a 510(k) submission, this data is generally prospective in terms of the testing done for the new device, but relies on existing data for the predicate devices.

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

Not applicable for this type of device submission. "Ground truth" in the context of diagnostic AI refers to clinically validated diagnoses from expert readers, pathology reports, or robust outcome data. For the TRAUS SUS20, the "ground truth" for the performance tests would be the established scientific and engineering principles behind accurate measurement and functional operation, validated by qualified engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret images/data and then reconcile disagreements, which is not relevant for this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices, particularly in medical imaging, to assess reader performance with and without an AI aid across multiple cases and readers. The TRAUS SUS20 is a surgical instrument, not a diagnostic device.

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

Not applicable. This device is a physical surgical engine set, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable. The "truth" for this device rests on:

• Engineering Specifications and Standards: The device performs according to its design specifications (e.g., vibration frequency, output power) and meets recognized international standards for electrical safety, EMC, and biocompatibility.
• Predicate Device Equivalence: The functional and safety characteristics are demonstrated to be substantially equivalent to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the computational sense.

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

Not applicable, as no training set exists for this device.

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The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

The provided document is a 510(k) summary for a medical device called "Surgical Drills." It is a regulatory submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria, ground truth, experts, and training/test sets are not applicable here.

However, I can extract and present the acceptance criteria and the studies performed to demonstrate the device's conformance, as detailed in the document.

Acceptance Criteria and Device Performance for Surgical Drills (Non-AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each test in the way you would typically see for an AI/ML study. Instead, it refers to "worst-case drills" for corrosion and distribution testing, and "all three groups" for performance testing (referring to the subject device and predicate device, likely with multiple samples per group).

• Provenance: This is a regulatory submission for a medical device. The data provenance is from the manufacturing company, Implant Direct Sybron Manufacturing, LLC, specifically from their non-clinical testing performed to support the 510(k) submission. These are prospective tests conducted by the manufacturer.

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

Not applicable. This is a physical medical device (surgical drills), not an AI/ML system that requires expert-established ground truth for classification or prediction. The "ground truth" for these tests is based on objective measurements and established industry standards (e.g., ISO, ASTM, AAMI).

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML study requiring expert adjudication of results. The results are based on objective physical and chemical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization.
• Industry Standards: e.g., ASTM F1089 for corrosion testing, AAMI TIR30 and TIR12 for cleaning validation, ASTM D4169-16 for distribution testing.
• Objective Measurements: e.g., axial drilling force measurements, visual/SEM assessment for performance, TOC and protein levels for cleaning, absence of visible corrosion.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical surgical device.

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The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:

1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.

2. Soft tissue debridement and removal, particularly in intrabony lesions.

The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:

• CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
  45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.

• CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.

• CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.

During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.

The provided text describes the Contour P-Insert System (CPIS), an accessory for dental piezo-surgery systems, and its substantial equivalence to predicate devices based on non-clinical testing. Here's a breakdown of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative, focusing on functionality, safety, and effectiveness in performing specific dental procedures. The reported performance likewise describes the successful fulfillment of these criteria.

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

The document does not explicitly state the exact sample sizes for each specific test in the "CPIS Functionality and Efficacy Report" and "Tooth Surface Damage Study." It generally refers to "100% of the CPIS samples" for compatibility tests and "all samples in all groups" for efficacy tests. More precise numbers are not provided.

The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified. However, the tests are described as non-clinical tests, implying they were likely conducted in a laboratory or controlled setting (e.g., using models, cadavers, or animal tissue as proxies for human tissue, though the document does not specify). There is no mention of human clinical data.

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

The document does not mention the use of experts to establish a "ground truth" for these non-clinical tests in the way one might for diagnostic imaging or clinical studies. The "ground truth" for these tests appears to be based on direct observation of physical interactions (e.g., fit, loosening) and outcomes of mechanical actions (e.g., amount of bone removed, effectiveness of debridement, presence/absence of tooth surface damage) against predefined objective criteria. No independent expert review or adjudication of results against a gold standard established by experts is described.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the non-clinical tests described. The "outcomes" are direct, measurable results of the tests (e.g., 100% fit, specific range of bone removal, discernible damage).

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

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a surgical accessory, not an algorithm. Its performance is always in the context of human operation.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical efficacy and safety tests is based on:

• Direct observation of mechanical fit and interaction: For compatibility tests (torque wrench, handpiece connection).
• Quantitative and qualitative measures of physical outcomes: For efficacy tests (e.g., "effectively debrided," "more than 1mm but less than 3mm of bone removed") and safety tests (e.g., "no discernible tooth surface damage," "extensive tooth surface damage").
• Compliance with established biological safety standards: For biological evaluation (ISO10993 series).
• Compliance with established sterilization standards: For sterilization validation (ISO standards).

These are essentially experimental outcomes from carefully designed non-clinical tests rather than "expert consensus," "pathology," or "outcomes data" in a clinical sense.

8. Sample Size for the Training Set

Not applicable. The Contour P-Insert System is a physical medical device (an accessory for a piezosurgery system), not an AI algorithm that requires a training set.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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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 Bonart Oral Surgery System is intended for use in oral surgery and dental implantology,

ARTeotomy ORAL SURGERY SYSTEM and ACCESSORIES (Model No. BIS)

The provided FDA document, K152125 for the "ARTeotomy Oral Surgery System and Accessories (Model No. BIS)", is a 510(k) premarket notification and focuses on establishing substantial equivalence to a predicate device. This type of document does not contain details about acceptance criteria, specific device performance metrics, or study designs (including sample sizes, ground truth establishment, or expert involvement) typically found in clinical validation studies for AI/software-as-a-medical-device (SaMD) products.

The document primarily states that the device is intended for "oral surgery and dental implantology" and has been determined to be substantially equivalent to a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as an FDA clearance letter, not a detailed study report.

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