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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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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.

The proposed device Single Use Electrosurgical Knife is a sterile, single-use endoscopic device, intended to be used with endoscopes and electrosurgical units for dissection, elevation, irrigation and preparation of tissue layers in combination with monopolar cutting and coagulation within the digestive tract.

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. 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 Single Use Electrosurgical Knife is divided into I type, T type, O type and IT type according to the shape of the Cutting Knife. The main materials include ABS, Stainless Steel, PTFE, Zirconia, TPU and Gold. The physical and chemical performances of the device are stable. The proposed devices 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 3 years.

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.

The provided text describes a 510(k) premarket notification for a medical device, the "Single Use Electrosurgical Knife". This document establishes substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative study with a "reported device performance" in the way an AI/ML device would.

Therefore, the requested information elements such as "reported device performance," "sample sizes for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "effect size," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established" are not applicable to this submission, as they pertain to clinical or AI/ML performance evaluation, which is not the focus of this 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and performance data from bench testing.

Here's a breakdown of the information that is available in the document, formatted as requested where applicable, with explanations for missing sections:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for diagnostic devices, or specific outcomes for therapeutic devices) that would typically be associated with an AI/ML or comparative effectiveness study. Instead, it lists performance data from bench testing used to establish substantial equivalence to a predicate device. The acceptance criteria for these tests are implied to be that the proposed device performs comparably to the predicate device and works as intended.

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

• Sample size: Not explicitly stated in terms of a specific numerical count for each bench test. The document refers to "bench testings" but does not give a specific n-value for the items tested.
• Data provenance: The performance data comes from "bench testings" performed by the manufacturer, Micro-Tech (Nanjing) Co., Ltd., based in China. This is not clinical data, so country of origin of patient data or retrospective/prospective is not applicable.

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

• Not applicable. This is a 510(k) for a physical electrosurgical knife, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth for a test set. The "ground truth" for its performance is assessed via engineering and biocompatibility standards.

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

• Not applicable. As noted above, this is not a study requiring expert adjudication of results.

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. No MRMC study was conducted. This device is a physical electrosurgical knife, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable in the context of clinical ground truth. For the bench testing, "ground truth" is defined by established engineering standards (e.g., ISO, IEC, ASTM) and performance expectations for electrosurgical devices, and comparison to the predicate device's known performance.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling.

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

• Not applicable. This device does not involve a "training set."

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Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.

Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.

The Electrosurgical System comprises:

• ◆ Electrosurgical Generator;
• ◆ Bipolar polypectomy snare combination;
• Single use electrosurgical knife combination.

The Electrosurgical Generator is designed to deliver bipolar high-frequency current for the purpose of cutting and coagulating tissue. It consists of High frequency generator, footswitch, bipolar connecting cable and power cord. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activated the bipolar high-frequency current output for cut; the other pedal activates the bipolar high-frequency current output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by AGS for generating and controlling the two energies delivered. The Bipolar connecting cable connects electrosurgical instruments to the Electrosurgical Generator, it transfer electrical energy - without changing the energy - from devices to instruments. The Electrosurgical Generator, Footswitch, Bipolar connecting cable and Power cord are non-sterile and reusable.

Bipolar polypectomy snare combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Polypectomy snare (Bipolar) and Distal attachment. It is for endoscopic use. It is used for removal of polyps within the digestive tract using high-frequency current. EO sterilization and use for single use only.

Single use electrosurgical knife combination is an accessory to Electrosurgical Generator. It is a sterile device consists of Single use electrosurgical knife and Distal attachment. It is for endoscopic use. It is used for cutting tissues within the digestive tract using high-frequency current. EO sterilization and use for single use only.

The provided text is a 510(k) summary for an Electrosurgical System, comprising an Electrosurgical Generator, a Bipolar polypectomy snare combination, and a Single use electrosurgical knife combination. However, the document does not describe a study involving acceptance criteria and associated device performance for an AI/ML-based medical device.

Instead, it focuses on demonstrating substantial equivalence to predicate electrosurgical devices through:

• Comparison of Technology Characteristics: This section details differences in output parameters for the electrosurgical generator (e.g., frequency, voltage, power) and differences in the principles of operation, energy use, and structure for the accessories (bipolar vs. monopolar, materials).
• Performance Testing: This section lists the types of performance testing conducted to address the differences between the proposed device and predicate devices. These tests are primarily focused on electrical safety, thermal effects on tissue, biocompatibility, and bench testing.

Crucially, the document explicitly states "No Clinical test is included in this submission" (Page 12, Section 5.9). This strongly indicates that the device's clearance was based on demonstrating equivalence through non-clinical performance data and comparison to existing predicate devices, rather than a clinical study evaluating its acceptance criteria in human subjects, especially not a study involving human readers or AI assistance.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set with provenance, number/qualifications of experts, adjudication method, MRMC study details, standalone performance, ground truth type for test set, training set details) because the document does not describe an AI/ML device or a clinical study that would have generated such data in the context of human-in-the-loop performance or diagnostic accuracy.

The provided text pertains to a traditional electrosurgical device, not an AI/ML-driven solution that would involve complex data analysis or human reader performance studies.

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KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract.
This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use.

This document describes the premarket notification for the Olympus Single Use Electrosurgical Knives KD-625 and KD-645. It does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs related to an AI/ML device from this document.

However, I can extract the general performance data and acceptance criteria mentioned for these electrosurgical knives:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

Since this document is for a traditional electrosurgical knife and not an AI/ML device, the following points are not applicable or cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models typically involves expert annotation of data.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for an electrosurgical tool, not an interpretive diagnostic aid.
6. Standalone (algorithm only without human-in-the loop performance) performance: Not applicable.
7. Type of ground truth used: Not applicable for an AI/ML device; for this device, ground truth established by physical and functional testing.
8. Sample size for the training set: Not applicable (no AI/ML model for training).
9. How the ground truth for the training set was established: Not applicable.

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These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for Endoscopic Submucosal Dissection (ESD).

The provided document is limited to the summary of non-clinical testing for the Olympus Single Use Electrosurgical knife (K171158) in comparison to its predicate devices. It describes tests performed to establish substantial equivalence but does not provide detailed acceptance criteria or numerical reported device performance for these specific tests in a table format, nor does it detail a study that explicitly proves the device "meets" acceptance criteria with quantifiable metrics. Instead, it states that the results were "evaluated as substantially equivalent."

Therefore, I cannot fully complete the requested table or answer all questions with specific numerical data from the given text. However, I can extract the available information and indicate where details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical values or quantitative metrics for "equivalency" in cutting, lifting, and thermal damage.
• The exact acceptance criteria thresholds (e.g., "within X% of predicate," "no statistically significant difference at alpha=0.05").
• Futher details on "performance" for knife operation, dimensions, and general durability.

Study Details:

The document describes several non-clinical tests rather than a single unifying "study" with a single test set. The information below is a synthesis based on the provided text.

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

• Test Sets (Ex-vivo porcine digestive tract mucosa): Used for cutting, lifting, and thermal damage tests (Tests A, B, C).
  • Sample Size: Not explicitly stated (e.g., number of tissue samples or repetitions per test).
  • Data Provenance: Ex-vivo porcine (pig) digestive tract mucosa (esophagus, stomach, and colon). The specific country of origin for the porcine tissue is not mentioned. These are in-vitro or ex-vivo laboratory tests, not human data.
• Other Performance Testing: No specific sample sizes mentioned for knife operation, dimensions, general durability, risk analysis, shelf-life, sterilization, biocompatibility, or safety tests.

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

• Not applicable as these are non-clinical, ex-vivo tests comparing device performance metrics, not diagnostic or clinical accuracy involving human expert interpretation. For histological evaluation (Test C), a pathologist would typically establish ground truth, but the number or specific qualifications are not mentioned.

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

• Not applicable for these non-clinical, ex-vivo performance tests.

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, an MRMC comparative effectiveness study was not done. This device is an electrosurgical knife, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical electrosurgical knife, not an algorithm.

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

• For Cutting (Test A) and Lifting (Test B): The "ground truth" for comparison was the performance demonstrated by the predicate devices (KD-620LR for cutting, Hybridknife for lifting). The comparison aimed for "equivalency" in direct physical performance metrics.
• For Thermal Damage (Test C): Histological study was carried out to evaluate the degree of thermal damage. The ground truth here would be the pathological assessment of tissue changes attributed to thermal damage, again benchmarked against the predicate device's performance.
• For Other Tests: Engineering specifications, functional requirements, and adherence to recognized standards (e.g., ISO, ASTM, IEC).

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable (no training set for a physical device).

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Single Use Electrosurgical Knife KD-610L/KD-611L/KD-620LR/KD-630L/KD-640L This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract and using high-frequency current.

The following five models of Single Use Electrosurgical Knives are the subject of this 510(k) notification: KD-610L, KD-611L, KD-620LR, KD-630L and KD-640L.

The KD-610L and KD-611L knives have isolation tips on the distal tip to prevent inadvertent deep cauterization. The KD-611L knive also has an electrode at the bottom of the isolation tip, which can also cut tissue.

The KD-620LR knive is a L-shaped knife, which cutstissue by hooking the mucous membrane. This device is rotatable so that both longitudinal and lateral dissection is possible.

The KD-630L knife consists of flexible wire, which is adjustable by the user, preventing inadvertent deep cauterization.

The KD-640L knife has a triangle tip to the distal end of the knife, which hooks mucous membrane to cut. Both longitudinal and lateral dissection is possible without rotating the instrument due to the triangle tip design.

This document is a 510(k) summary for a "Single Use Electrosurgical Knife Series." It describes the device, its intended use, and compares it to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot fulfill your request for the specific points listed (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) because this information is not present in the provided text.

The document states:

• "The Single Use Electrosurgical knives are basically identical to the predicate device in intended use, and similar in specifications except for cutting knife shapes." (Section 6)
• "When compared to the predicate device, the Single Use Electrosurgical Knives do not incorporate any significant changes that could affect the safety or effectiveness of the device." (Section 7)

These statements indicate that the submission relies on the established safety and effectiveness of the predicate device (KD-1L-1, Preamendment Device) to support substantial equivalence for the new devices. No new performance studies with defined acceptance criteria are described.

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