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The piezoelectric surgical system is indicated for: osteotomies, osteoplasties, drilling and shaping of hard tissue. Including:

• Otolaryngology,
• Maxillofacial surgery,
• hand- & foot-surgery and
• plastic & reconstructive surgery.

The new device, the "Piezomed Pro", is an ultrasonic surgical modular system which has to be connected to W&H's AMADEO device (K213221). The new device is an ultrasonic surgical system whose basic function is the conversion of electrical energy into mechanical vibration.

In addition, a physiological saline solution is pumped to the treatment site with a displacement pump, depending on the treatment.

Using a control unit with electronics, the user can change several operating parameters within predefined limits:

• oscillation amplitude, 5 to 100% in steps of 5 (100 % corresponds to max. power)
• coolant flow rate via pump speed control; 5 to 100% in steps of 5 (100% corresponds to max. water quantity)

The device is activated or deactivated via a foot control.

The provided FDA 510(k) clearance letter for the Piezomed Pro describes a surgical device (an ultrasonic surgical modular system), not a diagnostic AI device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML-enabled diagnostic device (such as accuracy, sensitivity, specificity, sample sizes, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

This document focuses on proving substantial equivalence for a physical medical device based on:

• Intended Use/Indications for Use: The Piezomed Pro is indicated for osteotomies, osteoplasties, drilling, and shaping of hard tissue in various surgical specialties. This is shown to be identical to the predicate device.
• Technological Characteristics: The device's operating principle (conversion of electrical energy into mechanical vibration), frequency, operating mode, electrical classification, and components are compared to predicate and reference devices, demonstrating similarity.
• Performance Data: This section details non-clinical testing for biocompatibility, electromagnetic compatibility, electrical safety, reprocessing validation, and general performance/functional testing (e.g., life-time, falling, vibration tests).
• Software and Cybersecurity: Compliance with relevant standards and guidance documents for software development and cybersecurity is stated.

Therefore, based on the provided text, it's not possible to extract the information required for an AI/ML diagnostic device performance study. The questions provided in the prompt are geared towards evaluating the performance of an AI algorithm against a ground truth, which is not the subject of this 510(k) submission for the Piezomed Pro.

If this were an AI/ML diagnostic device, the "Performance Data" section would describe clinical study results, including metrics like sensitivity, specificity, AUC, and details about the test set, ground truth, and reader studies. Since it's a surgical tool, the performance data relates to its physical and functional safety and effectiveness, rather than diagnostic accuracy.

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Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, 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.

Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude.

Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve).

The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition.

The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

The provided text describes an Ultrasonic Osteotomy Surgical System and its 510(k) summary for FDA clearance. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically understood for AI/ML performance (e.g., accuracy, sensitivity, specificity, or human reader improvement) does not apply directly in this context.

Instead, for this type of device (an ultrasonic surgical system), "acceptance criteria" relates to demonstrating that the new device is as safe and effective as its predicate device. This is primarily done through non-clinical performance data (bench testing) and demonstrating substantial equivalence in design, materials, and intended use. Clinical studies for performance improvements relative to human readers or AI algorithms are not relevant to this device type or regulatory pathway.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the AI/ML sense, nor information on sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the information provided in the document for this specific medical device.

However, I can extract what the document presents as evidence for "meeting acceptance criteria" in the context of a medical device 510(k) submission, focusing on Non-Clinical Performance Data and Substantial Equivalence.

1. "Acceptance Criteria" (in the context of a 510(k) for this device) and Reported Device "Performance":

For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and showing that differences do not raise new questions of safety and effectiveness, supported by non-clinical testing. The "reported device performance" is the successful outcome of these non-clinical tests, showing the device operates within expected parameters and safely.

• Same manufacturer, composition, indications for use, user interface, ultrasonic vibration activation, tip material, frequency, maximum flow, ultrasound output mode, electrical safety classification, power supply, power cord length, and operating/shipping/storage conditions.
• Minor differences (irrigation system pump placement, wrench type, sterilization method) are discussed and deemed to not impact safety or effectiveness. |
  | Sterilization Efficacy and Shelf Life | Single Use Disposable Components: EO sterilization validation tests for sterile package, sterile barrier testing, device performance testing on sterilized components, simulated shipment testing, accelerated and natural aged testing to support claimed shelf life.
  Reusable Components: Cleaning and sterilization testing performed for each reusable component (moist heat). |
  | Functional / Bench Performance | Successful completion of:
• Ultrasound Performance Testing
• Irrigation Performance Testing
• Cutting Efficiency and Thermal Testing
• Mechanical Testing for Torque Wrench |
  | Safety and Effectiveness | "Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device." |

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

• Sample Size for Test Set: Not specified in terms of patient data. The testing is primarily bench testing and validation studies for sterilization, shelf-life, and functional performance. It would involve specific numbers of device units or components tested to statistical significance, but these specifics are not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data. For non-clinical validation, the testing was performed by SMTP Technology Co., Ltd. in China. The data would be prospective in the sense that the tests were specifically conducted for this submission.

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

• Not applicable. This is not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device revolves around objective engineering and performance specifications (e.g., frequency output, flow rate, sterilization efficacy, cutting efficiency) which are measured against established physical standards and predicate device performance characteristics, not expert consensus on medical images.

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

• Not applicable. This is not a study involving human reader interpretation or clinical adjudication.

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 MRMC comparative effectiveness study was not done. This device is an ultrasonic surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, this device is not an algorithm. It is a physical surgical system. "Standalone performance" in this context refers to the device's functional performance metrics (e.g., frequency output, flow rate, cutting ability) which are detailed as "Non-Clinical Performance Data."

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

• The "ground truth" for this device's performance validation is based on engineering specifications, international standards (e.g., for sterilization), and direct comparison to the physical and functional characteristics of the predicate device. It relies on objective quantitative measurements (e.g., 39 kHz±4kHz frequency, 120ml/min±20% flow rate) and validated processes (e.g., EO sterilization efficacy). It does not involve medical "ground truth" in the diagnostic sense.

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. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. 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.

Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device.
The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.
Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.
The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage.
Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling.
The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.

The provided text is a 510(k) summary for the MediSonic Technology Co's "Ultrasonic Surgical System." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria for device performance in a clinical or AI-assisted context.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in the context of device performance as understood in questions 1-9 (e.g., accuracy, effect size with human readers, standalone performance, ground truth establishment). The document describes non-clinical bench testing for aspects like electrical safety, biocompatibility, sterilization, and software validation, which are about assuring the device itself is safe and functions as designed, not about its clinical efficacy or how it assists human users.

Here's what can be extracted based on the provided text, addressing the points where information is available or noting its absence:

Acceptance Criteria and Device Performance (Based on "Performance Testing" section):

The document lists various non-clinical bench tests performed according to FDA-recognized standards. The description states that "the device passed each test." This implies that the acceptance criterion for each of these tests was simply compliance with the respective FDA-recognized standard. The "reported device performance" is implicitly that it met these standards.

Here's a breakdown of the specific questions based only on the provided text:

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

   • Acceptance Criteria: As detailed in the table above, the acceptance criteria were compliance with the specified FDA-recognized standards for non-clinical bench testing.
   • Reported Device Performance: The document states that "the device passed each test" and that "all necessary testing has been performed and the results support the conclusion that Ultrasonic Surgical System is substantially equivalent."

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

   • This document describes non-clinical bench testing (e.g., electrical, biocompatibility, sterilization, software validation). It does not involve a "test set" in the sense of patient data or clinical images.
   • Sample size: Not applicable for this type of testing (no human or patient data samples).
   • Data provenance: Not applicable. The tests are laboratory-based demonstrations against engineering and safety standards.

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

   • Not applicable. Ground truth, in the context of clinical device performance, usually refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or long-term follow-up. This document focuses on demonstrating the safety and fundamental functionality of the surgical system itself through non-clinical testing, not diagnostic or clinical accuracy.

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

   • Not applicable. There is no mention of human adjudication for a test set.

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. This device is an "Ultrasonic Surgical System" for cutting bone, osteotomy, osteoplasty, and drilling. It is a surgical tool, not an AI-powered diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance.

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

   • Not applicable. This is a hardware surgical device, not a standalone algorithm. Its "performance" refers to its physical and functional capabilities, not an algorithmic output.

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

   • The "ground truth" for the tests performed relates to compliance with engineering and safety standards rather than clinical outcomes. For example, for biocompatibility, the ground truth is whether the materials elicit specific biological responses as defined by ISO standards. For electrical safety, it's whether the device meets insulation and leakage current limits. This is established by specific test methodologies outlined in the referenced standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML product developed with a training set.

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

   • Not applicable.

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XD880A Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, 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.

XD880A Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch and an irrigation set (liquid-flow tube and liquid-flow sleeve). The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module and the micro-processor electronic board that controls and supervises the functional parameters of the device. The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece. XD880A Ultrasonic Osteotomy Surgery System uses ultrasonic technology to generate mechanical micro-vibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude (less than 0.12mm), while keeping the soft tissues with elastic properties and free of damage.

The provided document does not describe a study involving an AI/Machine Learning device or an imaging device. Instead, it is a 510(k) premarket notification for a physical medical device: the XD880A Ultrasonic Osteotomy Surgical System. This system is an ultrasonic surgical tool used for cutting and shaping bone.

Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/ML or imaging device is not applicable to this document.

The document focuses on demonstrating the substantial equivalence of the XD880A Ultrasonic Osteotomy Surgical System to existing legally marketed predicate devices. The performance testing described is related to the physical and functional aspects of the surgical tool, not an AI or imaging algorithm.

Here's a breakdown of the performance testing that was conducted, as described in the document:

• Electrical Safety and Electromagnetic Compatibility (EMC): The system complies with IEC 60601-1:2006 for safety and IEC 60601-1-2:2007/2010 for EMC.
• Biocompatibility: Components in contact with patients (handpiece, tips, liquid-flow sleeve/tube) were tested. Materials (Titanium Alloy TC4, Medical Silicone Rubber) met ISO and JISK requirements, and studies showed them to be biocompatible.
• Software Verification and Validation: Conducted in line with FDA guidance for "moderate level of concern" software.
• Mechanical and Acoustic Testing: Bench testing and acoustic testing performed; results "demonstrated that the subject device performs within its specifications." (Specific acceptance criteria and reported performance values are not detailed in this summary).
• Animal Study (GLP):
  • Objective: Evaluate efficiency, convenience, and safety of 15 tips during spine surgery.
  • Subjects: 10 beagles, split into two groups of 5.
  • Procedure: Spinal surgery (cutting vertebral plate) using the device at maximum power settings.
  • Evaluation Metrics:
    • Efficiency: Cutting time of bone, bleeding volume.
    • Safety: Neurophysiological parameters (SEP latent period and fluctuation, MEP) before, during, and after surgery; clinical observation (mental state, behavior) on days 1, 3, 7 post-op; CT scan on day 7; histopathology on day 8.
  • Results: All tips were efficient and safe.
    • Average cutting time: 12min 2sec (Group 1), 10min 24sec (Group 2).
    • Average bleeding volume: 31.4mL (Group 1), 28.6mL (Group 2).
    • No accidental damage to nerves, vessels, or soft tissues.
    • Normal SEP/MEP values (with explanation for minor anomalies attributed to anesthesia).
    • Normal clinical evaluation scores (with minor, resolved anomalies).
    • CT scan showed normal spine, expected absence of vertebral plate, and minor post-op edema.
    • Histopathology showed no spinal cord tissue damage, and inflammatory cells considered normal tissue reaction.

In summary, the provided text describes a submission for a physical surgical device, not an AI/ML or imaging diagnostic device. Therefore, the questions about AI/ML performance metrics, data sets, and expert evaluations are not applicable to this document.

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Piezotome® M+ is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone, bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

Piezotome® M+ is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, scaling, prosthesis and oral surgery.

PIEZOTOME M+ is an Electromedical Device that uses micro-vibrations of associated Tips, to perform the clinical procedures defined in Intended Use.

PIEZOTOME M+ consists of a Console, a Multifunction footswitch, two reusable Handpieces, a range of Dental Tips, a range of Bone Surgery Tips, two Irrigation tubings and Flat Wrenches for Tips.

The Console is the heart of the PIEZOTOME M+. The Console contains the display board and the motherboard. Ultrasonic Handpieces and Footswitch are connected to the LCD Color Touch screen present on the front panel is used to define the settings of the PIEZOTOME M+ (modes, ultrasonic power, irrigation flow values).

The Multifunction footswitch has different functions. The access to a number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment, avoiding the risk of crosscontamination. The Footswitch is classified IP X8 (Protective Index) for operating theater applications.

The Ultrasonic Handpieces are held in the Surgeron's hand. The Ultrasonic Handpieces are connected to the Console via a Handpiece Cord. A Handpiece is dedicated to Conventional dental procedures (NEWTRON LED Handpiece) and a Handpiece is dedicated to Bone Surgery procedures (PIEZOTOME M+ Handpiece). The Ultrasonic Handpieces are equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical microvibrations. The Ultrasonic Handpieces are reusable and Sterilizable by autoclaving.

The Pump housings are designed to accommodate Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation Solution is intended to cool the clinical site and eliminate by rinsing the fragments such as bone or teeth.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpieces. Tips are in direct contact to the patient. The ultrasonic mechanical vibrations transmitted to the Tip permits the realization of the clinical procedures defined in Intended Use. Bone Surgery Tips are Single Use and delivered under Sterile State. Dental Tips are reusable.

The provided document is a 510(k) Premarket Notification for a medical device called PIEZOTOME M+, issued by the FDA. It declares the device to be "substantially equivalent" to legally marketed predicate devices.

This document describes a medical device (PIEZOTOME M+, an ultrasonic surgical system) and its performance data to demonstrate substantial equivalence to existing devices. Therefore, the questions related to acceptance criteria and study design for an AI/algorithm-based device (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance) are not applicable to this document.

The "performance data" discussed in the document refers to typical engineering and safety tests for a physical medical device, not an AI/algorithmic system. The information provided is about electrical safety, electromagnetic compatibility, software verification (specifically stating the software is identical to a predicate device, not a new algorithm), and performance testing bench (meaning physical tests to confirm the device functions as intended, not AI model performance).

Here's how the provided information relates to the request, focusing on what can be extracted and what is not applicable:

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

The document does not present "acceptance criteria" in the typical format for an AI/algorithm where specific metrics (e.g., accuracy, sensitivity, specificity) and thresholds are defined. Instead, it demonstrates equivalency through a comparison of technological characteristics and verification against established electrical and safety standards.

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

• Not Applicable. This document pertains to a physical medical device. The "performance data" refers to engineering and safety tests of the device itself and its components (e.g., electrical safety, EMC, sterilization, biocompatibility), not an AI/algorithm dataset. There is no mention of a "test set" in the context of data used for an algorithm.

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

• Not Applicable. This document does not describe an AI/algorithm that requires expert-established ground truth from medical images or clinical data.

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

• Not Applicable. See point 3.

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-assisted diagnostic or clinical decision support device. It's an ultrasonic surgical instrument.

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

• Not Applicable. There is no standalone algorithm. The "software" mentioned is identical to a predicate device's software, suggesting a control system for the physical device, not an analytical algorithm.

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

• Not Applicable. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., IEC, ISO) and benchmarks against predicate devices' physical characteristics and function.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. See point 8.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This device is an ultrasonic surgical system, not an AI-based diagnostic or assistive technology that would involve human "readers" or an MRMC study.

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord, a foot pedal, a wrench and a handpiece. The PIEZOELECTRIC SYSTEM device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue. A variety of attachments will be available for the Piezoelectric System for cutting bone, bone substitutes, osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of bones and teeth in a variety of surgical procedures. These attachments will be available "Sterile" -Single Use only (do not re-use).

This document is a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The information provided is primarily for classifying the device and establishing substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.

The provided 510(k) summary for the OSCAR 3 ultrasonic surgical instrument does not describe acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Orthosonics OSCAR OE3000DB and OSCAR Bone Resector).

Here's an analysis based on the provided text, highlighting what is present and what is absent:

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

• Not present in the document. The 510(k) summary states that "performance testing was carried out for some characteristics" but does not provide a table of acceptance criteria or the specific performance results in terms of metrics. It only generally concludes that "The data do in fact demonstrate equivalence."

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

• Not present in the document. There is no mention of sample sizes for any test sets, nor the provenance of any data (country, retrospective/prospective).

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/Not present. Since a specific performance study with a "test set" and "ground truth" to evaluate diagnostic or therapeutic accuracy is not described, there's no information on experts or their qualifications for establishing ground truth. The device is a surgical instrument for cutting bone and cement, not a diagnostic tool requiring expert interpretation as ground truth.

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

• Not applicable/Not present. As there's no diagnostic or interpretative "test set" described, adjudication methods are not relevant or discussed.

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. The device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

• Not applicable. This device is a physical surgical instrument, not a software algorithm.

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

• Not applicable/Not present. Given the nature of a surgical instrument for cutting, the concept of "ground truth" in the diagnostic sense is not directly applicable. The "testing" mentioned is likely related to engineering performance (e.g., cutting efficiency, material compatibility, electrical safety), not diagnostic accuracy. The document states "performance testing was carried out for some characteristics," but does not elaborate on the specific nature of these characteristics or how "ground truth" would be established for them.

8. The sample size for the training set

• Not applicable/Not present. This device is not an AI/ML algorithm that would have a "training set."

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

• Not applicable/Not present. Same as above, not relevant for an ultrasonic surgical instrument.

Summary of what is present regarding "testing":

The document mentions two types of testing that will be carried out or have been carried out:

• G. TESTING:
  • FCC Part 18: "Testing to FCC Part 18 will be carried out prior to marketing the device in the USA." (Electrical emissions/interference)
  • UL 60601-1: "Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA." (Medical electrical equipment safety)
  • Performance Testing for Substantial Equivalence: "performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence." However, the details of this performance testing, including specific acceptance criteria and results, are not included in this summary. The purpose of this testing was to confirm substantial equivalence to predicate devices, implying that the OSCAR 3 performs comparably to the devices it is replacing or integrating.

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

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

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

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

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

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

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

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

1. Table of acceptance criteria and the reported device performance

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

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

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

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

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

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

• Not applicable. No test set requiring adjudication is mentioned.

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

• Not applicable. This device is a surgical instrument (Piezosurgery Medical), not an AI/ML diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

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

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

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

8. The sample size for the training set

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

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

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

Summary of what is provided regarding performance and regulatory rationale:

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

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

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