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The HYBRIDknife flex is intended for:
· monopolar cutting and coagulation.
· needle-free injection and tissue-selective hydrodissection including lifting mucosal lesions by injection into the submucosa (soft tissue).
The HYBRIDknife flex is used in endoscopic interventions.

The HYBRIDknife flex is a flexible monopolar probe that combines the technologies of hydrosurgery and electrosurgery in one instrument.
Each function can be activated without the need to change instruments. The HYBRIDknife flex is a sterile, single use device which is used with endoscopes with a minimal working channel diameter of 2.8mm. The hydrosurgical function is intended to deliver a pressurized fluid for tissue-selective hydrodissection and needle-free injection whereas the electrosurgical function is intended for cutting and coagulation of tissue. By means of needle-free injection a fluid cushion is formed in the submucosa, which provides a mechanical and thermal protection layer during cutting and coagulation of the target tissue. The elevation thus reduces the risk of perforation. All HYBRIDknife flex probes have a length of 2.3 meters and an outer diameter (OD) of 2.6mm. The only difference between the variants is the electrode type and length. The HYBRIDknife flex is available with a "T-type" electrode and an "I-type" electrode whereas both electrode types are available as a long (i.e. 2mm length) and short (i.e. 1.5mm) version. The protrusion of the T-type electrode gives the user the possibility to hook and move tissue. The instruments are designed for operation with the hydrosurgical unit ERBEJET 2 (K072404; K143306 & K231023) in combination with an Erbe Electrosurgical unit of the "VIO" series (e.g. VIO 3 K190823). HYBRIDknife flex is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done by using a footswitch.

The provided text is a 510(k) summary for a medical device called HYBRIDknife® flex. This document is a regulatory submission to the FDA, demonstrating that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is NOT a study report for an AI/ML medical device. It describes a physical electrosurgical cutting and coagulation device. Therefore, the questions about AI/ML specific acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document. The term "device" in the context of this document refers to the physical surgical instrument, not an AI model.

The document discusses non-clinical performance testing of the device, which aims to verify its safety and performance based on engineering principles and established standards for electrosurgical equipment. This is distinct from the type of performance study conducted for AI/ML devices, which involves evaluating the performance of an algorithm against a ground truth.

Here's how to address the request based on the provided text, while clarifying the limitations:

Acceptance Criteria and Device Performance (Based on the document for a physical medical device)

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit "acceptance criteria" in the way one might for an AI/ML model's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating that the new device does not raise new questions of safety or effectiveness and performs comparably to the predicate devices for its intended use.

The "performance" is verified through various non-clinical tests to ensure the device meets design specifications and relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, a table of acceptance criteria for algorithm performance metrics (like sensitivity, specificity, AUC) is not provided in the document. Instead, the document discusses conformity to standards and comparability to predicate devices. The "performance" here refers to the device's functional integrity and safety.

2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/ML test set. The testing referenced are non-clinical (e.g., tissue testing, electrical testing, biocompatibility testing, sterilization validation) of a physical device. There isn't a "test set" of patient data in the AI/ML sense. Data provenance would refer to the characteristics of the materials or test conditions used in the lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to AI/ML model validation using expert labels, which is not described here.

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 pertains to AI/ML model validation. The device is a physical surgical instrument, not an AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI/ML model validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI/ML context. For this physical device, "ground truth" would be established by physical measurements, chemical analyses, biological assays (e.g., for biocompatibility), and direct observation of electrosurgical and hydrodissection effects on tissue models, as per standard engineering and medical device testing protocols. The "truth" is adherence to specifications and standards.

8. The sample size for the training set
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.

9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model and does not have a "training set" in that sense.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Non-Clinical Performance Testing)

The "study" in this context refers to a series of non-clinical performance tests designed to demonstrate the safety and effectiveness of the HYBRIDknife® flex and its substantial equivalence to predicate devices. These tests were performed rather than a clinical trial or AI/ML validation study.

The primary goal was to show that despite some technological differences (e.g., higher dielectric strength, slightly different dimensions, fixed electrode states vs. adjustable), the device performs its intended functions comparably to existing, legally marketed devices and adheres to relevant safety and performance standards.

The non-clinical performance testing included:

• Functional Testing and Design Controls: To verify overall safety and performance, ensuring the device performs as intended and meets design specifications (in compliance with 21 CFR 820.30).
• Tissue Testing: To validate the cutting and coagulation performance and the waterjet function. This was done by comparing the HYBRIDknife® flex to the predicate device, specifically looking at the creation of equivalent fluid cushions. This would involve in-vitro or ex-vivo tissue models.
• EMC and Electrical Safety Testing: To ensure compliance with international standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, IEC 60601-1-2). This verifies that the device operates safely electrically and doesn't interfere with other medical equipment.
• Biocompatibility Testing: To ensure the new materials used in the device are safe for contact with the body (in compliance with ISO 10993-1).
• Sterilization Validation: To confirm the device can be consistently sterilized to a specific sterility assurance level (SAL of 10-6) and that ethylene oxide residuals are within safe limits (in compliance with ISO 11135 and ISO 10993-7).
• Packaging and Shelf-life Validation: To ensure the device remains sterile and functional over its intended shelf-life, including accelerated aging tests (in compliance with ISO 11607-1 and ASTM F 1980).

Data Provenance and "Test Set" Details (for a physical device):

The data would originate from laboratory and bench testing conditions. This is typically controlled and prospective, conducted specifically to gather data for regulatory submission. There isn't a "country of origin of the data" in the sense of patient data, but rather the location where the testing labs are.

In conclusion, the provided document is a regulatory submission for a physical medical device, not an AI/ML model. Therefore, many of the specific questions about AI/ML acceptance criteria and study design are not applicable. The "acceptance criteria" for this device are demonstrated through adherence to design specifications, relevant industry standards, and demonstrated substantial equivalence to predicate devices via rigorous non-clinical testing.

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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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The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.

The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.

Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.

The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

This document describes the Erbe Argon Plasma Coagulation Unit APC 3 with Accessories, and its substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics and safety standards rather than clinical performance or AI-driven improvements in human reading. Therefore, much of the requested information regarding AI acceptance criteria, clinical study specifics (sample size, expert involvement, MRMC studies, ground truth), and training set details for AI cannot be extracted from this document because it is about an electrosurgical device, not an AI/ML-driven diagnostic device.

Here's a breakdown of what can be extracted, and where limitations exist based on the provided text:

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

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics in a table format for clinical efficacy. Instead, it focuses on general safety, performance, and substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards.

Acceptance Criteria (Implied from the document):

• Safety: Adherence to electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Performance: Ability to deliver argon gas for argon plasma coagulation, ablation, and argon-assisted cutting as intended. This is assessed through "Output/Mode Comparison," "Tissue Testing," and "Capacitive Coupling" as listed in the "Performance Evaluations/Testing" section.
• Usability: Conformance to usability engineering standards (e.g., IEC 62366, IEC 60601-1-6).
• Compatibility: Operation with compatible Erbe VIO Electrosurgical Generators (ESU) and specific applicators/probes.
• Substantial Equivalence: Demonstrating that the new device has "essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit."

Reported Device Performance:
The document states that "Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate." However, specific numerical performance data (e.g., coagulation efficacy rates, ablation depth measurements, cutting speeds) are not provided. The "Output/Mode Comparison" and "Tissue Testing" are mentioned as performance evaluations, but their results are summarized qualitatively as proving substantial equivalence.

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

This document describes a medical device (an electrosurgical unit), not an AI/ML diagnostic algorithm tested on a dataset of patient data. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical/imaging data are not applicable here. The testing involves engineering and performance validation of the device itself, rather than testing on a retrospective or prospective clinical dataset.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert annotation of medical images or data to establish ground truth for a test set. The validation is technical and engineering-focused.

4. Adjudication method for the test set

Not applicable. As this is not a diagnostic device involving human interpretation of data, there is no need for adjudication of readings.

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 device is not an AI-assisted diagnostic tool, so an MRMC study and
assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is not an algorithm. It is a hardware medical device.

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

The "ground truth" for this device's performance evaluation is based on engineering standards, physical measurements, and comparison to the predicate device's established performance characteristics. It relies on:

• Compliance with recognized consensus standards: e.g., electrical safety, electromagnetic compatibility, usability (IEC, ISO standards listed).
• Physical (in-vitro/bench) testing: "Output/Mode Comparison," "Tissue Testing," "Capacitive Coupling." These tests would compare the device's output and tissue effects to specifications and the predicate.
• Functional verification: Ensuring the device operates as intended when connected to compatible components.

It does not involve "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

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

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

Not applicable. See point 8.

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