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The Ultrasonic System is intended to be used to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 3 mm in diameter.

Ultrasonic Surgical System is an ultrasonic dissection and coagulation system composed of four components: Ultrasonic Generator (HD-CSD01), Hand Piece (HD-CSH01), a disposable Ultrasonic Shears includes 4 shaft lengths (HD-CS-DJ45, HD-CS-DJ36, HD-CS-DJ22, HD-CS-DJ14) and foot switch (HRF-M52).

A disposable Ultrasonic Shears is a sterile component that has undergone EO sterilization, including an ultrasonic horn, jaws, main shaft, axis rotation, handle, operating handle, and control switch. The operating handle is used to open and close the jaws that grip the tissue. The Ultrasonic Surgical System can simultaneously cut and coagulate tissues by setting different output power levels. The high-power range allows for faster tissue cutting, while the low-power range allows for better tissue closure. The ultrasonic frequency current in the ultrasonic generator is transmitted to the hand piece, which converts electrical energy into mechanical energy for forward and backward vibration. Through the transmission and release of the blade, the end of the blade vibrates at a certain frequency. The heat generated by friction causes water vaporization in the tissue cells that come into contact with the blade, protein hydrogen bonds break, cells collapse and the tissue is cut open after solidification; When cutting blood vessels, the knife head contacts with Histone and generates heat through mechanical vibration, leading to the destruction of the collagen structure in the tissue, causing the protein to coagulate, and then sealing the blood vessels to stop bleeding. The disposable ultrasonic shears are EO sterilized, but the other parts are non-sterilized packaging, and the hand piece must be cleaned and sterilized by the user before being used for surgery.

This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The provided text is a 510(k) Summary for a medical device called "Ultrasonic Surgical System." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain details about specific acceptance criteria for performance tests or the detailed study results that would typically prove a device meets those criteria in a format directly applicable to the table requested.

The document mentions "Performance test and functional tests were conducted on the proposed device in accordance with product design specifications. Data generated from the test met the predetermined acceptance criteria." but does not list those criteria or the specific performance data against them.

It also includes results from animal testing (burst pressure, acute, and chronic animal studies) but these are comparative to a predicate device rather than against predefined, quantitative acceptance criteria for the subject device itself.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly detailed in the provided document. The document states that "Data generated from the test met the predetermined acceptance criteria" but does not list the specific criteria or the exact performance data against them for each test.

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

• The document specifies a "porcine model" for animal testing.
• It does not specify the sample size for the burst pressure, acute, or chronic animal studies (e.g., number of animals or number of vessels tested per animal/group).
• The data is prospective, generated from the animal study using the subject device and a predicate device.
• The country of origin of the data is not specified, but the applicant (Hunan Handlike Minimally Invasive Surgery Co., Ltd.) is from China.

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

• This information is not provided in the document. The animal studies would typically involve veterinarians and potentially pathologists, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No MRMC study was done, as this is a surgical device, not an imaging/diagnostic AI device that would typically involve human readers interpreting cases. The comparative effectiveness assessment was against a predicate device in animal models.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable, as this is a physical surgical device, not a standalone algorithm. The device itself is evaluated.

7. The Type of Ground Truth Used

• For the animal studies, the "ground truth" would be established through direct observation during the procedures, histological examination of tissue samples, and measurements (e.g., burst pressure). These are effectively pathology and direct physiological measurements/observations.

8. The Sample Size for the Training Set

• Not applicable, as this is a physical surgical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable, as this is a physical surgical device.

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The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.

Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.

The provided text describes a 510(k) submission for the K500 Ultrasonic Surgical System, asserting its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven device.

The study described is a non-clinical performance comparison test to ensure that the proposed device, an ultrasonic surgical system, meets its design specifications and is substantially equivalent to a predicate device. This is a traditional medical device submission, not specifically an AI/ML device submission that would involve human-in-the-loop performance or standalone algorithm performance testing.

Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment cannot be fulfilled from the provided document.

Here's a breakdown of the available information based on the provided text, acknowledging that it's for a traditional medical device and not an AI/ML device performance study:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for device performance in the way one would for an AI/ML model (e.g., sensitivity, specificity thresholds). Instead, it describes performance comparison tests to demonstrate substantial equivalence to a predicate device.

Table 1: Non-Clinical Performance Testing and Outcomes

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: Not specified for any of the non-clinical tests (e.g., number of vessels, number of animals).
• Data Provenance: Not specified. "Animal study" mentioned without country or specific details. The manufacturer is Miconvey Technologies Co., Ltd. from Chongqing, China.

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 is not applicable as the study described is a non-clinical performance and biocompatibility study for a surgical device, not a diagnostic or AI/ML study requiring expert ground truth for interpretation.

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

Not applicable for this type of non-clinical device performance study.

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 or a diagnostic device where human readers would be involved in interpreting data assisted by AI.

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

Not applicable. This is not an AI/ML device. The "device" is an ultrasonic surgical system, a physical tool.

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

For the non-clinical performance tests:

• Performance Metrics: Measured directly (e.g., burst pressure, thermal spread, physical dimensions) against established engineering specifications and comparison to the predicate device's known performance.
• Biocompatibility: Assessed against ISO standards (e.g., presence/absence of irritation, cytotoxicity).
• Animal Studies: Observed physiological effects and outcomes (e.g., vessel sealing success, survival).

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. This is not an AI/ML device.

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The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.

This is an electrosurgical generator, not an AI/ML powered device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable. This is not an AI/ML powered device that uses a "test set" in the context of data analysis. The testing involved hardware and software validation against established medical device standards.

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

Not applicable. Ground truth, in the context of data for AI/ML, is not relevant for this device. Compliance was assessed against engineering and performance standards by qualified testing personnel and regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" for adjudication as it's understood in AI/ML studies. Compliance was determined by meeting predefined standards and test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is typically conducted for diagnostic AI tools involving human interpretation of data. This device is an electrosurgical generator, and such a study is not relevant to its function.

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

Not applicable. This is a hardware device with embedded software. It does not operate as a standalone algorithm in the sense of AI/ML. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used:

Ground truth for this device is established by:

• Engineering and Performance Standards: International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) set the objective criteria for electrical safety, electromagnetic compatibility, and specific electrosurgical device performance.
• FDA Guidance: FDA guidance documents for electrosurgical devices provide criteria for aspects like thermal effects.
• Software Validation Principles: Ground truth for software validation involves adherence to established software engineering principles and documentation requirements outlined in FDA guidance.

8. The Sample Size for the Training Set:

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

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

Not applicable. As there is no training set of data, no ground truth needs to be established for it.

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The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological surgery
• · Plastic and Reconstructive surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Wound Care
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The Ultrasonic Surgical Aspirator System (Model: XD880B) is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissues, and can also be used for precise cutting and shaping of bone tissue, using with the liguid-flow sleeve and liquid-flow tube. The product can be applied to a number of departments according to the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue breakage and aspiration.
• Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
• . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
  The Ultrasonic Surgical Aspirator System consists of a console, application software, foot switch, and accessories. The accessories include handpieces, tips, wrenches, liquid-flow sleeves, liquid-flow tubes, sterilization tray, suction canister and mobile cart. The handpiece, tip, liquid-flow sleeve and liquid-flow tube assemble to ultrasonic tool part to complete the cutting and fragment of soft tissue and bone tissue.

This looks like a 510(k) summary for an Ultrasonic Surgical Aspirator System (Model: XD880B) seeking to demonstrate substantial equivalence to a predicate device (K202299).

Here's an analysis based on your request, focusing on acceptance criteria and supporting studies. It's important to note that for a Class II device like this, the focus is often on demonstrating equivalence to an existing device rather than establishing novel clinical efficacy against specific, quantitative acceptance criteria in the same way a new drug or high-risk device might. The "acceptance criteria" here are implicitly related to demonstrating that the new device performs at least as well as the predicate device, especially for any design changes.

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the entire device. Instead, it describes changes from the predicate and then cites testing to show these changes do not negatively impact safety or effectiveness.

However, based on the non-clinical performance data section, we can infer some "acceptance criteria" related to the modifications:

Note: The document states, "the test results confirm that the performance specifications meets the modification inputs." This is the general statement of "acceptance," indicating compliance with internal specifications derived from the predicate's performance.

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 mentions "non-clinical tests" and "bench testing." It does not specify sample sizes for these tests, nor does it provide details on data provenance like country of origin or whether a "retrospective" or "prospective" design applies to bench testing (these terms are more relevant for human data). These are laboratory-based tests.

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 typically not relevant or included for non-clinical, bench testing of an ultrasonic surgical aspirator system. The "ground truth" for such tests would be measurable physical parameters (e.g., thermal output, acoustic frequency, cutting depth/speed) against established engineering specifications or comparisons to the predicate device.

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

Adjudication methods (like 2+1 or 3+1 consensus) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading, clinical outcomes). Since the testing described is non-clinical bench testing, this concept and information are not applicable or provided.

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

An MRMC study is not mentioned as this device is not an AI-powered diagnostic imaging tool requiring human interpretation. It is a surgical tool.

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

This refers to the performance of an algorithm or AI without human involvement. The Ultrasonic Surgical Aspirator System is a physical surgical device, not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The device's performance is inherently linked to its physical operation properties.

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

For the non-clinical tests mentioned:

• Soft Tissue Protection in Bone Cutting Mode: The ground truth would likely be based on objective measurements of tissue damage or protection, adhering to predetermined safety thresholds.
• Acoustic Performance Testing for modified tips: The ground truth would be quantitative measurements of acoustic parameters (e.g., frequency spectrum, amplitude) compared to design specifications or predicate measurements.
• Cutting Efficiency and Thermal testing Report for Modified Tips: The ground truth would be objective measurements of cutting speed/volume and temperature generated during operation, compared against predicate performance or safety limits.

The "ground truth" is thus based on objective physical measurements and engineering specifications, rather than subjective human interpretation, pathology, or clinical outcomes data for these non-clinical tests.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical surgical tool and not an AI or machine learning system, there is no "training set."

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

As there is no training set for an AI/ML model, this question is not applicable.

Ask a specific question about this device

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic surgical system consisting of handpieces and associated tips. The product is intended for the fragmentation, emulsification of both soft and hard (i.e. bone and bone approximations) tissue, the intended use is as follows with different configurations:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological surgery
• · Plastic and Reconstructive surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecological Surgery
• · Thoracic Surgery
• · Wound Care
• · Laparoscopic Surgery
• · Thoracoscopic Surgery

The XD880B Ultrasonic Surgical Aspirator System is an ultrasonic powered surgical tool. It can be used for precise breakage, aspiration and debridement of soft tissue, and can also be used for precise cutting, crushing and shaping of bone tissue. The product can be applied to a number of departments by using the suitable parameters and accessories, including:

• . Department of Neurosurgery, general surgery and other departments for soft tissue cutting, breakage and aspiration.
• . Department of Orthopedic surgery, Plastic and Reconstructive surgery, Department of Neurosurgery (only for bone) for bone cutting.
• . As well as the Department of Dermatology, Department of Trauma Orthopedics and other departments used for debridement.
  The XD880B Ultrasonic Surgical Aspirator System consists of a console, foot switch, and accessories. The accessories include handpiece, tips, wrench, liquid-flow tube, sterilization tray, suction bag, suction canister and mobile cart. The handpiece, tips, liquid-flow tube are assembled into ultrasonic tool part to complete the cutting and fragment of bone tissue and soft tissues.

This document describes the FDA 510(k) clearance for the Ultrasonic Surgical Aspirator System (XD880B), focusing on its substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria.

Therefore, the specific information requested, such as a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance, is not present or applicable in the provided document.

The document details the device's technical specifications and non-clinical performance data to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information in the context of your request:

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

• Not applicable in the context of this document. This document focuses on demonstrating substantial equivalence based on technical characteristics and non-clinical testing, not on achieving specific clinical performance metrics against predefined acceptance criteria from a clinical trial.
• The "performance" described is in terms of passing various non-clinical standard tests (e.g., electrical safety, EMC, software verification, sterilization validation, shelf-life, lifetime validation, acoustic performance, efficiency and temperature characteristics).

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

• Not applicable. This submission relies on non-clinical testing and comparison to predicate devices, not on a clinical test set in the way a diagnostic AI would.
• The document implies that various units of the device and its components were tested to meet the specified non-clinical standards, but explicit "sample sizes" for a clinical test set are not mentioned as no clinical performance study was conducted.

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

• Not applicable. No clinical ground truth establishment involving human experts is described. The "truth" for this submission is based on engineering standards and technical specifications.

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

• Not applicable. No clinical test set requiring adjudication is described.

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

• No. A MRMC study was not conducted as this is an ultrasonic surgical aspirator system, not a diagnostic AI system designed to assist human readers.

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

• Not applicable. This device is a surgical tool, not a standalone diagnostic algorithm. Its function inherently involves human operation.

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

• Technical Specifications and Standard Compliance: The "ground truth" for this submission is adherence to engineering specifications and compliance with international and national standards for medical devices (e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 62304 for software, ISO 17665-1 and ISO 11135 for sterilization). The device's performance is measured against these established technical benchmarks.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not an AI/ML model that requires a "training set" in the computational sense.

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

• Not applicable. See point 8.

Summary of Device Acceptance (from the document's perspective):

The acceptance mechanism for this device's FDA clearance is "Substantial Equivalence" to legally marketed predicate devices. This is achieved by demonstrating that the new device:

• Has the same intended use.
• Has the same or similar indications for use.
• Has the same or similar technological characteristics.
• Does not raise new or different questions of safety or effectiveness.

Studies/Data that Proved Device Meets "Acceptance Criteria" (i.e., Substantial Equivalence):

The document states that the following non-clinical tests were conducted and passed to support substantial equivalence:

• Electrical safety testing per IEC 60601-1
• EMC testing per IEC 60601-1-2
• Software verification and validation per IEC 62304 / FDA Guidance
• Moist heat sterilization validation per ISO 17665-1
• EO sterilization validation per ISO 11135 (demonstrates SAL of 10^-6)
• Shelf-life Testing
• Lifetime validation test for handpieces
• Acoustic Performance Test per IEC 61847
• Efficiency and Temperature Characteristics Test

These tests confirm that the device's design inputs and performance specifications are met, allowing the FDA to determine that it is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance by way of substantial equivalence.

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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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Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.

Sonic Surgeon 300 is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics. The tips can easily be changed during the treatment and can also be cleaned and autoclaved. The Ultrasonic Surgical Unit transforms generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it to the tip. The generator of the Ultrasonic Surgical Unit performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece.

This document describes the safety and effectiveness information of the Sonic Surgeon 300 / Ultrasonic Surgical Unit.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance benchmarks like accuracy, precision, or sensitivity. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards.

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

The document does not specify a sample size or test set in the context of a formal clinical or performance study involving patients or a dataset for evaluating an AI model. The "performance tests" mentioned are likely technical evaluations against standards rather than a study on a specific number of cases/patients.

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

This information is not applicable or provided. The document describes a device for surgical use and its technical compliance, not an AI or diagnostic tool that requires ground truth established by experts.

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

This information is not applicable or provided. The "performance tests" likely refer to engineering and electrical safety testing, not clinical performance evaluation with 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:

This information is not applicable or provided. The device is an ultrasonic surgical unit, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case study evaluating human reader improvement with AI assistance would not be relevant.

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

This information is not applicable or provided. The device is a physical surgical instrument, not an algorithm.

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

This information is not applicable or explicitly stated as ground truth is typically associated with diagnostic or AI performance evaluation. The "ground truth" in this context would be the specifications and requirements of the safety standards (IEC 60601-1, IEC 60601-1-2) and the operational characteristics of the predicate device (Piezosurgery, K043408). The device's performance is measured against these established technical specifications and the functionality of the predicate.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device, not an AI model that requires a training set.

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

This information is not applicable or provided for the same reasons as above.

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The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.

The FS 1000 RF Ultrasonic Surgical Aspirator System is comprised of a generator, which feeds a 23 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. An aspirator system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.

The provided document is a 510(k) summary for a medical device (Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of design, materials, and operating parameters. It does not present a study with acceptance criteria and device performance in the way that would be expected for a diagnostic AI or machine learning device.

Therefore, I cannot provide the requested information for an "AI or machine learning device" as the document describes a traditional surgical aspirator system. The questions about AI, reader studies, ground truth establishment, training sets, and sample sizes for diagnostic performance are not applicable to the content provided.

However, I can extract the information related to the device's performance based on the provided document, interpreting "acceptance criteria" as the voluntary standards it was tested against and "reported device performance" as the assertion of substantial equivalence based on meeting those standards and direct comparison to predicate devices.

Non-AI/ML Device Acceptance Criteria and Performance (Based on K062471)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a filing for a traditional surgical device and not an AI/ML diagnostic, the following questions are not directly applicable to the content provided in the 510(k) summary. I will state why for each:

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 to this document. This document describes non-clinical engineering and performance testing against standards, and a comparison of physical device characteristics to predicate devices. There is no "test set" of patient data in the context of diagnostic performance.

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 to this document. There is no "test set" requiring expert ground truth in the context of diagnostic assessment. The "ground truth" for non-clinical engineering tests would be the established scientific and engineering principles and the specifications of the device/standards.

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

• Not applicable to this document. No diagnostic test set requiring adjudication is described.

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

• Not applicable to this document. This is a surgical device, not a diagnostic imaging AI. No MRMC study or AI assistance is mentioned.

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

• Not applicable to this document. This is not an algorithm-only device. It is a manually operated surgical tool.

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

• Not applicable to this document in the diagnostic sense. For the engineering tests, the ground truth would be the validated measurements, specifications, and performance against established engineering standards. For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices.

8. The sample size for the training set

• Not applicable to this document. There is no "training set" as this is not an AI/ML device.

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

• Not applicable to this document. There is no "training set" as this is not an AI/ML device.

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