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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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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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