Search Results

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.

Ask a specific question about this device

Endoscopic Instruments are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/ laparoscopic, general surgical procedures.

Endoscopic Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The device includes Disposable Endoscopic Surgical Instrument and Reusable Endoscopic Surgical Instrument. Both of the disposable and reusable endoscopic instruments are provided sterile when they're released. After used for the first time, Reusable Endoscopic Instrument needs to be sterilized by the end users. The instruments are 5mm in diameter as well as 340mm in length.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics that would typically be found in an Acceptance Criteria table. Instead, it refers to compliance with international standards and internal design control procedures.

However, based on the non-clinical testing performed, we can infer some performance aspects:

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

The document describes non-clinical laboratory testing (e.g., electrical safety, performance, biocompatibility). It does not involve a "test set" in the context of clinical data or AI model evaluation.

• Sample Size for performance tests: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specified standards and characteristics. For the thermal effects on tissue, it involved "fresh pig's liver, kidney, and muscle tissue," but the number of samples is not quantified.
• Data Provenance: The tests were conducted in a laboratory setting as part of the device's design control and regulatory submission. The document doesn't specify the country of origin for the non-clinical test data itself, beyond the manufacturer being based in China. The study is a prospective evaluation of the device against predefined performance standards and characteristics.

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

Not applicable. This device is an electrosurgical instrument for cutting, dissecting, manipulating, and cauterizing tissues. There is no AI component or image analysis that would require expert adjudication to establish "ground truth" for a test set. The evaluation is based on objective measurements and compliance with technical standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of expert review or clinical data.

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 a medical device (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

Not applicable. This device is a manual surgical instrument that requires human operation. It does not have an autonomous algorithm component.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective, measurable performance of the physical device against established engineering standards and specifications. Examples include:

• Compliance with International Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993 series.
• Physical and Functional Specifications: Appearance, basic dimension, corrosion resistance, various holding forces (transverse, longitudinal, ratchet), cutting efficacy.
• Biological Outcome: Thermal damage zone measured via histology on tissue samples, sterility assurance level (SAL).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As there is no AI model, there is no training set or associated ground truth establishment process.

Ask a specific question about this device