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Single Use Electrosurgical Knife:
These instruments have been designed to be used with endoscopes and electrosurgical for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

Fluid Pump System:
The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

The proposed device Single Use Electrosurgical Knife with Fluid Pump System includes Single Use Electrosurgical Knife and Fluid Pump System.

The Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract. The Fluid Pump System is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa. The Fluid Pump System is included as an accessory to the Single Use Electrosurgical Knife.

The Single Use Electrosurgical Knife is used with the Electrosurgical Unit (ESU), the ESU supplies high frequency (HF) energy through a retractable electrode of the Single Use Electrosurgical Knife for the cutting and coagulation of tissue. The Single Use Electrosurgical Knife consists of Cutting Knife, outer tube assembly, Middle Tube assembly and handle assembly. The Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the Cutting Knife. The Single Use Electrosurgical Knife has twenty-two (22) specifications; the main differences of these specifications are Cutting Knife Shape, Cutting Knife Length, and Effective Working Length and with injection function or without injection function.

Physicians would attach it to the ESU. For endoscopic procedures, the Single Use Electrosurgical Knife is placed down the channel of an endoscope that has a working channel equal to or greater than 2.8mm. Upon the setup of the ESU, the Single Use Electrosurgical Knife is ready for use. To activate cautery, the Cutting Knife is extended out and the ESU's footswitch is depressed. The subject devices with injection models can supply fluid into the submucosa to supply liquid, use a syringe or pump to connect with luer tap on the hand components.

The Fluid Pump System included in the proposed device is a fluid delivery device that can inject fluid with adjustable flow rate and can be used with the Single Use Electrosurgical Knife for elevation of tissue layers by injection into the submucosa.

The Fluid Pump System consists of a Foot Pedal, a Fluid Pump Console (with a Power Cord and a Control Button Cord), a Disposable Pump Cartridge, a Disposable Tubing Set, and a Disposable Control Button. The Disposable Pump Cartridge adopts the structure of a reciprocating pump, and the purpose of conveying sterile fluid is achieved through the piston's reciprocating movement. The Disposable Tubing Set is used to connect the Disposable Pump Cartridge's fluid outlet and Single Use Electrosurgical Knife's fluid injection port. The Fluid Pump Console provides a drive the Disposable Pump Cartridge to achieve reciprocating motion. The user can set the Effect value via the touch button on the touch screen or the physical knob. The Effect setting value range is 10 to 40, where Effect 10 corresponds to the minimum flow rate of 25mL/min, and Effect 40 corresponds to the maximum flow rate of 100mL/min. When Fluid Pump System used with Single Use Electrosurgical Knife, the recommended Effect is 10-30. The user can control the fluid delivery through the Foot Pedal or the Disposable Control Button, stepping on the Foot Pedal or pressing the Disposable Control Button to start fluid delivery, releasing the Foot Pedal or the Disposable Control Button, and immediately stop the fluid delivery.

The Single Use Electrosurgical Knife are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year.

The Disposable Pump Cartridge, Disposable Tubing Set and Disposable Control Button of Fluid Pump System are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of one year. The Foot Pedal and Fluid Pump Console of Fluid Pump System are non-sterile and reusable, the service life of the Foot Pedal and Fluid Pump Console are 8 years.

The acceptance criteria and the study proving the device meets them are not detailed in the provided text in the way the request specifies (e.g., a table with reported device performance, sample sizes for test sets, expert qualifications, etc.). The document is a 510(k) summary, which provides an overview of the device and its substantial equivalence to a predicate device, rather than a detailed report of individual study methodologies and results.

However, based on the Performance Data section (page 9-10), I can infer the types of acceptance criteria indirectly from the performed tests and provide a general overview of the supporting studies.

Here's a breakdown of what can be extracted and what information is missing:

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

The document states: "The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device Single Use Electrosurgical Knife (K193601)."

While the specific numerical acceptance criteria and reported device performance values are not provided, the types of tests conducted imply the categories of criteria the device had to meet.

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

• Sample Size: Not specified for any of the tests.
• Data Provenance (country of origin, retrospective/prospective): Not specified. These appear to be laboratory/bench tests, not clinical data sets.

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 as the described performance data pertains to bench testing against established standards and internal criteria for physical, mechanical, and safety aspects, not interpretation of medical images or clinical outcomes requiring clinical expert ground truth.

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

• This information is not applicable as the described performance data pertains to bench testing against established standards and internal criteria, not interpretation of medical images or clinical outcomes.

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 as no clinical or MRMC study using AI assistance is mentioned. The device is a physical electrosurgical knife and fluid pump system.

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

• This information is not applicable as the device is not an algorithm or AI system. Its performance evaluation is based on bench testing.

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

• The "ground truth" for the performance data appears to be established industry standards and predetermined internal specifications/criteria for device function, safety, and performance (e.g., ISO, IEC, ASTM standards, and internal material/design specifications). No clinical ground truth (like pathology or outcomes data) is mentioned as part of the performance data for this 510(k) submission.

8. The sample size for the training set

• This information is not applicable as the device is not an AI/ML system requiring a training set.

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

• This information is not applicable as the device is not an AI/ML system requiring a training set.

In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a physical medical device (electrosurgical knife and fluid pump system) through bench testing against recognized standards and internal specifications. It does not involve AI/ML components, clinical studies for human reader interpretation, or advanced ground truth establishment methods typically seen in AI device submissions. The "acceptance criteria" are implied by the types of tests performed (e.g., dimensional accuracy, functional performance, safety compliance), and the "study" consists of these various bench tests, shelf-life studies, sterilization validation, biocompatibility testing, and electrical/software safety assessments.

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