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The Erbe Electrosurgical Unit (ESU/Generator) model VIO 3n with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3n is an electrosurgical unit (ESU) that delivers high-frequency (HF) electrical current for cutting and/or coagulation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different footswitches are available for activating the ESU. The ESU VIO® 3n has several clearly defined monopolar and bipolar cutting and coagulation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. In combination with the compatible argon plasma coagulation unit APC 3 (K191234), it offers monopolar modes for argon plasma coagulation and argon-supported modes. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle. Connections for the central power supply, for footswitches, for potential equalization of the operating theatre and Erbe Communication Bus (ECB) connections to other Erbe modules are located at the rear. The ESU emits sounds when instruments are activated, and messages are signaled. The actual application is carried out using compatible electrosurgical instruments that are connected to the generator. The VIO® 3n can be combined with matching Erbe devices and modules, instruments, and accessories.

To address various clinical needs, the ESU is available in 5 different configurations which are called "Fire", "Metal", "Stone", "Water" and "Timber". Whereas the configuration "Fire" includes all available modes and functionalities, the other configurations only offer a reduced number of modes and functionalities.

The provided FDA 510(k) clearance letter and summary for the Erbe ESU Model VIO® 3n with Accessories do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria, particularly for an AI/software as a medical device (SaMD).

This document pertains to an electrosurgical unit, which is a hardware device for cutting and coagulating tissue using high-frequency electrical current. The "software" mentioned in the document refers to the operating software of the ESU itself, not an AI or diagnostic algorithm, and thus the type of performance metrics, ground truth, and study designs you're asking about (e.g., MRMC, standalone performance, expert consensus on diagnostic images) are not applicable to this type of device submission.

Therefore, I cannot provide a table of acceptance criteria and device performance in the context of an AI/SaMD, nor detailed information on test set sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or specific training set details, because this document describes a hardware device.

However, I can extract the information that is present about the non-clinical performance testing and what it aims to demonstrate:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a hardware electrosurgical unit, the "acceptance criteria" are generally related to compliance with electrical safety, EMC, and functional performance standards for tissue cutting/coagulation. The document does not provide specific quantitative acceptance criteria values or detailed performance metrics in a table. It states that the device "performs as intended per the product specifications and requirements."

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified, but the tests were performed "non-clinical," implying laboratory or bench testing rather than clinical patient data. The manufacturer is Erbe Elektromedizin GmbH (Germany).

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

• This question is not applicable to the non-clinical testing of an electrosurgical hardware device. Ground truth, in the context of AI/SaMD, usually refers to labeled diagnostic data. For this device, "ground truth" would be the measurable physical parameters and effects on tissue.

4. Adjudication method for the test set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on ambiguous diagnostic cases in AI/SaMD studies. For an ESU, performance is measured against engineering specifications and observed physical effects.

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 study was not done. This type of study is relevant for diagnostic AI tools that assist human readers (e.g., radiologists interpreting images). The Erbe ESU Model VIO® 3n is an interventional hardware device, not a diagnostic AI.

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

• The term "standalone performance" for an AI algorithm is not directly applicable here. However, the non-clinical performance testing (functional, EMC, electrical safety) can be considered "standalone" in the sense that the device's technical capabilities were tested independently against specifications without a human operator's diagnostic interpretation loop. The device directly performs an action (cutting/coagulation) rather than providing information for human interpretation.

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

• For the functional testing, the "ground truth" would be the observable physical effects on tissue (e.g., degree of cutting, coagulation depth, eschar formation) and measured electrical parameters (power output, voltage, current) compared to established engineering specifications and the performance of predicate devices.
• For safety and EMC, the "ground truth" is compliance with international standards (e.g., IEC 60601 series).

8. The sample size for the training set

• This question is not applicable. The Erbe ESU Model VIO® 3n is an electrosurgical hardware device. It does not use a "training set" in the machine learning sense to learn and develop an algorithm. Its operating software is developed through traditional software engineering processes, not machine learning model training.

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

• This question is not applicable as there is no machine learning training set for this device.

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The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC).

Indications include but are not limited to:

• Barrett's esophagus
• Ulcers
• Arteriovenous Malformations
• Angioma
• Angiodysplasia
• Gastric Antral Vascular Ectasia (GAVE)
• Radiation Proctitis
• Gastroesophageal reflux disease (GERD)
• Post-polypectomy ablation/Post-EMR ablation

The HybridAPC probe is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments. It is used with the hydrosurgical unit Model ERBEJET® 2 and an Erbe APC unit in combination with an electrosurgical unit (ESU) VIO Model. The probe is used with endoscopes with a working channel diameter larger than 2.5mm.

The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the mucosa/mucosal lesion to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue and to reduce the risk of perforations. The electrosurgical (i.e. APC) function is intended for ablation of the lifted mucosa/mucosal lesion. The Hybrid APC probe has a length of 1.9 meters and an outer diameter (OD) of 2.3mm.

The HybridAPC probe 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 using a footswitch.

The provided FDA 510(k) clearance letter and summary for the HybridAPC probe primarily focus on demonstrating substantial equivalence to predicate devices, particularly regarding indications for use and technological characteristics. It does not present a detailed study with specific acceptance criteria and performance metrics for an AI/algorithm-driven device, nor does it mention a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The document highlights the device's mechanism (hydrosurgery and argon plasma coagulation) and its expanded indications based on real-world evidence from peer-reviewed literature. It details non-clinical bench performance testing for safety and functional aspects (tissue lifting and thermal effect), but these are not presented as acceptance criteria for an AI model's performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance of an AI model from this document. The document describes a medical device, not an AI/algorithm.

However, I can extract information relevant to the device's overall performance validation, which is different from an AI's performance.

Based on the provided document, here's what can be extracted about the device's validation:

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

The document describes various non-clinical bench tests to demonstrate safety and performance, but it does not list quantitative acceptance criteria or specific reported device performance metrics in a table format for an AI/algorithm. Instead, it states that:

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

• Test Set (for clinical evidence, specifically for expanded indications): "Data from various studies, involving more than 1,900 patients for safety and more than 1,200 patients/lesions for performance outcomes..."
• Data Provenance: "Real-world evidence in form of clinical data (peer-reviewed literature)." The country of origin is not specified but it's peer-reviewed literature, implying a broad range. The data is retrospective, as it's from existing literature.

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

• Not applicable/mentioned. The clinical evidence for expanded indications relies on peer-reviewed literature and a systematic literature review/meta-analysis, not an expert panel establishing ground truth for a specific test set.

4. Adjudication method for the test set:

• Not applicable/mentioned. The document does not describe an adjudication process for a test set. The clinical evidence is based on published literature.

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. The document does not describe a MRMC study, as it is reviewing a physical medical device, not an AI system.

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

• No. Not applicable, as this is a medical device, not an AI/algorithm.

7. The type of ground truth used:

• For the expanded indications, the "ground truth" or substantiation for safety and effectiveness is derived from real-world evidence in the form of peer-reviewed clinical literature (outcomes data, safety analysis reported in studies).
• For the device's functional performance, it relies on bench testing and validated engineering specifications.

8. The sample size for the training set:

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

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

• Not applicable. This is a physical medical device.

Summary of AI-related information:
The provided document is a 510(k) clearance for a physical medical device (HybridAPC probe), not an AI/algorithm product. Therefore, it does not contain the specific information requested regarding acceptance criteria, study design, and performance metrics for an AI-driven device, MRMC studies, or training/test sets for AI models. The "study" mentioned is a systematic literature review and meta-analysis to support expanded indications for the device based on existing clinical evidence.

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The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.

This FDA 510(k) summary describes a device (FiAPC plus probes) that is an electrosurgical accessory, not an AI/ML powered device. As such, it does not involve acceptance criteria related to algorithmic performance, ground truth, expert opinions, sample sizes for training/test sets, or MRMC studies that are typically associated with AI/ML devices.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. The evaluation is centered on the physical and functional characteristics of the probes, particularly a new variant with a modified tip design.

Here's an analysis of the provided information within the context of hardware/electrosurgical accessory evaluation:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to its physical and functional performance, safety, and equivalence to predicate devices. These criteria are established through adherence to various international and FDA-specific guidance documents and standards.

• Equivalent ignition distances: Confirmed through side-by-side tissue testing.
  Compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020. |
  | Design Controls | - Verification of design change: Performed in compliance with 21 CFR 820.30 to ensure safety and effectiveness of the device. |
  | Sterilization | - Sterilization validation: Complied with ISO 11135.
• Sterility Assurance Level (SAL): Documented at 10^-6, aligning with FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
• EO residual testing: Complied with ISO 10993-7. |
  | Packaging and Shelf-life | - Packaging and shelf-life validation: Complied with ISO 11607-1.
• Accelerated aging: Performed using ASTM F 1980, demonstrating safety and effectiveness for the defined shelf-life. |
  | Biocompatibility | - Biocompatibility testing: Complied with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
• No toxicologically relevant released substances: Chemical characterization showed no such substances.
• No cytotoxic, sensitizing, irritating, or acute systemic toxic properties: Demonstrated by testing.
• Absence of pyrogens: Fulfilled criteria.
• Biocompatible over entire life cycle: Conclusion based on tests. |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | - Successful testing: Complied with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2, as applicable. |
  | Software Impact (of parent device) | - Software documentation: Complied with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions".
• Probe recognition and mode limitation: Software updates in the parent device allow for this.
• No impact on safety/performance: User interface updates do not affect safety or performance.
• No changes to mode parameters, gas flow, or performance-relevant specifications: Confirmed. |

Given that this is a hardware device (electrosurgical probes) and not an AI/ML software device, the following points are not applicable or interpreted differently:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical testing (e.g., tissue testing, sterilization), sample sizes would be determined by relevant engineering standards for statistical significance and regulatory compliance, but are not specified in this summary. The data provenance would be from internal lab studies and external testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Tissue effects are assessed by objective measurements (e.g., coagulation depth, area) rather than expert consensus on a 'truth' dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image review), which is not the case 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, as this is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device does not involve an algorithm. The probes are medical instruments used by human operators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical performance aspects like tissue effects, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., histological analysis of tissue for coagulation depth) and instrumental measurements for ignition distance.
8. The sample size for the training set: Not applicable, as there is no training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

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The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening, i.e. axial opening (straight fire) or lateral opening (side fire).

This document describes the Erbe Elektromedizin GmbH FiAPC plus probes, an electrosurgical device accessory. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining novel acceptance criteria for a new type of device or an AI/software-based system.

Therefore, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets those criteria, particularly for AI/software, is not fully applicable or present in this document. This document describes a medical device accessory and its comparison to an already marketed predicate device, primarily focusing on physical and functional characteristics, and safety and effectiveness relative to that predicate.

However, I can extract the information that is relevant to your prompt based on the provided text, and explicitly state where information is not available or not applicable.

Here's a breakdown of the available information:

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

The document doesn't explicitly list "acceptance criteria" in the way a software/AI device might, with specific metrics to hit. Instead, it focuses on demonstrating comparable performance and meeting design specifications through various tests.

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

• Test Set Description: The "test set" for this device primarily refers to the physical units of the FiAPC plus probes and the predicate device used in bench and tissue testing.
• Sample Size:
  • For tissue testing: Not explicitly stated beyond "side-by-side tissue testing."
  • For other bench tests (EMC, electrical safety, sterilization, packaging): Not explicitly stated for each test, but it is implied that sufficient samples were tested to demonstrate compliance and validate performance.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests were conducted internally or by contracted labs as part of the manufacturer's (Erbe Elektromedizin GmbH, Germany) verification and validation activities.

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 and not provided in the document. The "ground truth" for this type of medical device (argon plasma coagulation probes) is established through biophysical principles, engineering standards, and medical consensus on desired tissue effects, rather than expert annotation of data like in an AI/software context. Tissue effects are measured directly.

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

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert opinions in studies involving subjective assessment (e.g., image interpretation for AI). For physical device performance, direct measurements and compliance with objective standards are used.

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 and not provided. MRMC studies are specific to evaluating diagnostic accuracy, particularly for imaging devices or AI tools where human interpretation is involved. This device is an electrosurgical accessory, not a diagnostic or AI-assisted system for human readers.

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

• This information is not applicable and not provided. This device is a physical electrosurgical probe, not an algorithm or a software-only device.

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

• The "ground truth" for this device's performance, as demonstrated in the document, is based on:
  • Direct Physical Measurements/Bench Testing: E.g., electrical load capacity, gas flow rate, probe dimensions.
  • Compliance with Industry Standards: E.g., ISO 10993-1 for biocompatibility, IEC 60601 series for electrical safety, ISO 11135 for sterilization.
  • Observed Tissue Effects: "Comparable tissue effects and comparable ignition distances" to the predicate device. This is a direct physical result rather than an expert consensus or pathology report in the typical sense, though assessment of these effects would involve trained personnel.
  • Comparison to Predicate Device: The overarching "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set:

• This information is not applicable and not provided. This device is not an AI/machine learning system, so there is no "training set" in the context of AI.

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

• This information is not applicable and not provided for the reasons stated in point 8.

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Indications for Use - VIO 3

The Erbe electrosurgical unit (ESU/Generator) model VIO 3 with instruments and accessories is intended to deliver high frequency (HF) electrical current for the cutting and/or coagulation of tissue, including ablation.

Indications for use - ERBECRYO 2

The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion (destruction) of tissue by the application of extreme cold, and cooling of tissue during radiofrequency ablation.

Indications for use - HybridTherm ablation probes
The HybridTherm probes are intended for ablation and coagulation of soft tissue. The following probes can also be used for cutting tissue: HybridTherm monopolar, eTip and HybridTherm bipolar, eTip.

The HybridTherm system consists of the electrosurgical unit (ESU) Model VIO 3, the cryosurgical unit Model ERBECRYO 2, the HybridTherm ablation probes and accessories.

HybridTherm ablation probes
The HybridTherm probes are a product family consisting of 8 probes to offer the user a range of instruments based upon the physician's preference. There are 4 monopolar and 4 bipolar ablation probes, which differ in the function of the distal end: with and without a monopolar cutting tip (eTip), as well as in their shape (i.e. straight or angulated/curved).

The HybridTherm probes combine high-frequency (HF) technology with cryotechnology. The HF technology is used for cutting (only variants with eTip), coagulation, and ablation of tissue. To reduce tissue desiccation and to increase the ablation zone, the probes are cooled. Cooling also minimizes tissue adhesion to the electrode. The primary function of the cooling is to support the ablation process.

VIO 3
The ESU Model VIO 3 delivers high frequency (HF) electrical current for cutting, coagulation and ablation of tissue. The unit can be mounted/secured to a cart/system carrier or on a ceiling mount. Different Footswitches are available for activating the ESU and as applicable to change modes of the ESU (Remode feature). The ESU Model VIO 3 has several clearly defined cutting, coagulation and ablation modes with different electrical waveforms and electrical parameters that are programmed with defined effect levels. Each effect level corresponds to a defined maximum power output and a voltage limitation. The ESU has a touchscreen monitor that provides the user with an onscreen tutorial as well as settings and operational information. It also provides a small number of physical controls, such as the power switch, instrument sockets and a neutral electrode receptacle.

ERBECRYO 2
The cryosurgical unit Model ERBECRYO 2 is connected to an electrical power source and a carbon dioxide (CO2) source. Upon activation, the Unit delivers a regulated CO2flow to the end of the connected instrument for cooling. The CO2 returning from the probe to the ERBECRYO 2 exists via the exhaust gas hose. Appropriate gas cylinder adapters are available for the various international gas cylinder connections.

HybridTherm System
The HybridTherm probes are connected to the units (VIO 3 and ERBECRYO 2) via respective plugs. The units are connected to each other via an Erbe Communication Bus (ECB) cable, whereby the user only interacts with the ESU Model VIO 3 (master-slave technology: the cryosurgical unit is controlled via the VIO 3). The ERBECRYO 2 additionally requires a CO2 gas cylinder. A footswitch is connected to the ESU, with which the activation of the available modes is started. The ESU supplies the HF current which is needed for cutting (only HybridTherm probe variants with eTip), coagulation and ablation of tissue. The ERBECRYO 2 supplies CO2 gas which is needed for cooling via the Joule-Thomson-effect to support the ablation.

The provided text is a 510(k) summary for the HybridTherm System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technical characteristics and non-clinical performance testing. It does not include information about AI/ML models, human reader studies, or the establishment of ground truth for such studies.

Therefore, many of the requested details about acceptance criteria, human performance, and ground truth are not present in this document. The information provided heavily emphasizes hardware and traditional medical device testing rather than algorithmic performance.

Here's what can be extracted and what cannot:

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

The document mentions "Side-by-side tissue testing against the respective predicate device(s) shows that the performance (i.e. cutting, coagulation and ablation) is as good as the performance of the predicate device(s)." This indicates a comparative performance acceptance criterion, but specific numerical thresholds or a formal table are not provided in this summary. The acceptance criterion is qualitative: performance is "as good as" the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This was "side-by-side tissue testing," likely in a lab setting, not a clinical study with patients or image-based data. No information on sample size (e.g., number of tissue samples), country of origin, or retrospective/prospective nature is given.

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)

Not applicable. Ground truth for the "tissue testing" was likely established through objective measurements of ablation zone size or tissue characteristics, not expert consensus (as there are no images or clinical interpretations involved).

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

Not applicable. There's no indication of adjudication for "tissue testing."

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. The document explicitly states "Side-by-side tissue testing" and discusses engineering safety and performance standards (e.g., electrical safety, EMC, biocompatibility, sterilization). There is no mention of a human reader study or AI assistance.

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

No. This device is a physical electrosurgical system, not an AI algorithm.

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

For the "side-by-side tissue testing," the ground truth would be physical measurements of the effect on tissue (e.g., ablation zone size, tissue integrity) rather than expert consensus or pathology from human subjects. The document does not specify the exact methods but implies objective performance metrics.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be defined.

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

Not applicable, as there is no AI/ML model or training set.

Summary of available and missing information based on the provided text:

Available Information:

• Acceptance Criteria (Qualitative): Device performance (cutting, coagulation, ablation) is "as good as" the predicate device(s) based on side-by-side tissue testing.
• Study Type: Non-clinical (bench) testing, including:
  • Side-by-side tissue testing
  • Functional testing and design controls (21 CFR 820.30)
  • Electromagnetic compatibility (IEC 60601-1-2)
  • Electrical safety (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18)
  • Software verification and cybersecurity (IEC 62304, FDA Guidance) - Note: This relates to the software controlling the electrosurgical unit, not an AI/ML component.
  • Biocompatibility (ISO 10993-1)
  • Sterilization validation (ISO 11135)
  • Packaging and shelf-life validation (ISO 11607-1, ISO 11607-2, ASTM F 1980)
• Ground Truth Type: Physical/objective measurements of tissue effects for performance testing.

Missing Information (Not contained in the provided 510(k) summary, as it pertains to AI/ML or human reader studies):

• Specific numerical acceptance criteria for tissue testing.
• Sample size for tissue testing (e.g., number of tissue samples).
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone (algorithm-only) performance.
• Sample size or ground truth establishment for a training set (as no AI/ML component is discussed).

This document is a standard 510(k) for a physical electrosurgical device, not a submission for an AI/ML-driven device. Therefore, the detailed questions about AI model validation and human performance studies are not addressed within this text.

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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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Indications for Use - Hydrosurgical unit:

The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is intended to pressurize a medium to perform needle-free injection and tissue-selective hydrodissection of soft tissue. The Erbe hydrosurgical unit ERBEJET 2 with instruments and accessories is used in endoscopic and surgical procedures.

Indications for Use - Applicators and ERBEJET probe:

20150-220: The ERBEJET probe is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in endoscopic interventions. The ERBEJET probe can be used free injection including lifting of mucosal lesions by injection into the submucosa.

20150-225: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery.

20150-226: The applicator is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator can be used for needle-free injection including lifting of mucosal lesions by injection into the submucosa.

20150-230, 20150-231, 20150-239: The applicators with suction are intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in open surgery. The applicators with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

20150-238: The applicator with suction is intended for dissection (tissue-selective hydrodissection) including separation of soft tissue in minimal invasive surgery. The applicator with suction can be used as well for suction when connected to an external suction module e.g. Erbe ESM 2.

The ERBEJET® 2 System includes the Hydrosurgical unit model ERBEJET® 2, the pump cartridge plus, instruments (applicators and ERBEJET probe), an optional suction model ESM 2 with accessories and a one- or two-pedal footswitch. Together these components form the ERBEJET® 2 System. The system provides an adjustable high-pressure water jet (pressurized normal saline solution) intended for tissue-selective hydrodissection and needle-free injection in endoscopic and/or surgical interventions. The ERBEJET® 2 unit together with its accessories is an active invasive surgical system. The sterile normal saline solution is the "medium" which is projected under pressure through a nozzle of the connected instrument to achieve the desired tissue effect.

This document is an FDA 510(k) summary for the ERBEJET® 2 System, which is a hydrosurgical unit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is largely not applicable or not provided in this type of submission.

The 510(k) summary outlines the device's indications for use, describes its components, compares its technological characteristics to predicate devices, and details non-clinical performance testing. The purpose of these tests is to show that the new device does not raise new questions of safety or effectiveness, not to establish new performance metrics against clinical acceptance criteria.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present clinical acceptance criteria with corresponding device performance metrics in a table format. The "performance" discussed is related to maintaining functional equivalence with the predicate device through non-clinical testing.

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

• Sample Size: Not applicable. The document describes non-clinical testing (bench testing, verification, validation) on the device components, not a clinical test set with patient data.
• Data Provenance: Not applicable. The testing is described as internal verification and validation activities. No country of origin for clinical data or retrospective/prospective study design is mentioned because it's not a clinical study.

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 a clinical study involving expert interpretation or ground truth establishment in a diagnostic context. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication process is detailed as there's no clinical diagnostic 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

• Not applicable. The ERBEJET® 2 System is a medical device (hydrosurgical unit), not an AI-powered diagnostic system or an assistive technology that would involve "human readers" or AI assistance in interpretation.

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

• Not applicable. This device does not involve an algorithm with standalone performance in a diagnostic or interpretive capacity. Its function is to deliver a pressurized water jet.

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

• Not applicable in the context of clinical ground truth. The "ground truth" for the non-clinical tests is adherence to established engineering standards, regulatory requirements (e.g., ISO, IEC, FDA guidances), and design specifications.

8. The sample size for the training set

• Not applicable. This information pertains to machine learning models, which are not relevant to the described ERBEJET® 2 System.

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

• Not applicable, as no training set for a machine learning model is mentioned or relevant to this device submission.

Summary of the FDA 510(k) Submission Perspective:

The FDA 510(k) process for the ERBEJET® 2 System is about demonstrating substantial equivalence to legally marketed predicate devices, not about proving novel clinical performance or algorithmic efficacy. The non-clinical tests mentioned (electrical safety, EMC, functional, biocompatibility, sterilization, packaging, software) are standard engineering and regulatory verification/validation activities to ensure the device is safe and effective when compared to its predicates, despite minor modifications. The document successfully argues that the subject device "does not raise new or different questions of safety and effectiveness" compared to the predicate devices.

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Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."

Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."

The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.

The provided text describes a 510(k) premarket notification for the ERBECRYO 2 Cryosurgical Unit and Accessories (K190651), comparing it to a legally marketed predicate device (K151041). The document primarily focuses on demonstrating substantial equivalence rather than a clinical study establishing acceptance criteria for a new AI/software device. There is no mention of an AI/software component in this submission.

Therefore, many of the requested categories are not applicable to the information provided. The document describes a medical device (cryosurgical unit and cryoprobes) and its physical and performance characteristics, along with various standard tests to ensure its safety and effectiveness relative to a predicate device.

However, I can extract the relevant information where applicable and indicate "Not applicable" for items that are not present or relevant to this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/software device and the submission focuses on substantial equivalence to a predicate, the "acceptance criteria" are generally compliance with recognized standards and demonstration that new features (like different cryoprobe dimensions or sterile single-use probes) do not raise new safety or effectiveness concerns. The performance reported relates to the cryosurgical function and material properties.

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 for Test Set: Not specified in terms of clinical trial patient numbers or image counts, as this is primarily a device safety and performance submission based on bench testing, ex-vivo, and in-vivo (animal) studies, and literature review.
  • Biocompatibility: "Erbe Flexible cryoprobes" tested. Specific number of probes or samples not given.
  • Sterilization Validation: "Mixed load sterilization cycle" validated. Specific number of samples not given.
  • Shelf Life Validation: "Sterilized samples" tested. Specific number of samples not given.
  • Performance Testing (Freezing, Biopsy Weight, In-vivo): "Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung)" and "animal testing in an in vivo porcine lung model" were conducted. Specific numbers of tissue samples or animals not given.
• Data Provenance:
  • Biocompatibility, Sterilization, Shelf Life, and Performance Testing were conducted by Erbe Elektromedizin GmbH, based in Germany. The specific testing facilities are not mentioned.
  • For the "removal of blood clots" indication, "peer-reviewed real world evidence (literature and published case reports)" were provided. This implies a retrospective review of existing published data globally.

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

• This is not applicable as there is no "ground truth" established by experts in the context of an AI/software device. The data is physical measurements, biological evaluations, and performance characteristics compared to a predicate device and existing literature.

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

• Not applicable, as there is no expert review or adjudication method described for establishing ground truth for an AI/software output. The testing methodologies are based on laboratory measurements and comparisons.

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 submission for a physical cryosurgical unit and cryoprobes, not an AI or software device. No human reader studies with or without AI assistance were performed.

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

• Not applicable. This device does not involve an algorithm or AI.

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

• The "ground truth" in this context refers to the established scientific and engineering principles for device performance, safety standards, and comparative data against a legally marketed predicate device.
  • Benchmarking/Comparative Data: Performance as measured against the predicate device (e.g., freezing performance, biopsy weight).
  • Standard Compliance: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for shelf life, IEC 60601 series for electrical safety).
  • Animal Model Data: In-vivo performance (porcine lung model).
  • Literature Review: Real-world evidence from peer-reviewed literature and published case reports for specific indications (e.g., removal of blood clots).
  • Laboratory Procedures: Sterility, shelf-life, and biocompatibility testing results.

8. The sample size for the training set

• Not applicable. This is not an AI/software device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/software device.

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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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The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).

The provided document pertains to a 510(k) premarket notification for a medical device, the Erbe ESU Model VIO® 3 with Accessories. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance acceptance criteria through clinical studies in the same way a PMA or a de novo submission might.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or how ground truth for training sets was established. These details would typically be found in clinical study reports or more extensive technical documentation, which are not part of this 510(k) summary.

Instead, the document highlights:

• Intended Use: "The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue."
• Substantial Equivalence: The submission claims the device is substantially equivalent to the predicate device, Erbe ESU Model VIO® 300 D with Accessories (K083452).
• Verification/Validation Activities: These activities focused on meeting recognized standards, including electrical safety (e.g., IEC 60601 series), software lifecycle (IEC 62304), usability (IEC 62366, IEC 60601-1-6), sterilization information (IEC 17664, AAMI ST81), and biological evaluation (ISO 10993-1).
• Performance Evaluations/Testing:
  • Output/Mode Comparison
  • Tissue Testing
  • Contact Quality Monitoring (CQM)
  • Capacitive Coupling (per Standard Number 60601-2-2)
  • Accessory Testing

These performance evaluations were likely bench or pre-clinical tests designed to show that the device performs as intended and similarly to the predicate device, but the specifics of acceptance criteria for these tests and their results in a tabular format are not provided in this summary.

In summary, the document does not provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as such detailed performance data is generally not part of a 510(k) summary that focuses on substantial equivalence.

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