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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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ERBEJET® 2 System - The ERBEJET 2 is intended for lifting mucosal lesions by injection into the submucosa as well as the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME) in open as well as endoscopic surgery.

HybridAPC Probe - The HybridAPC probe is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope and for HF ablation of the mucosal lesions by Argon Plasma Coagulation (APC).

The HybridAPC Probe is used with the ERBE Water Jet Model ERBEJET 2 and an ERBE Argon Plasma Coagulator (APC) Model APC 2/ElectroSurgical Unit (ESU) VIO Model System. The Water Jet delivers pressurized sterile normal saline through the Probe to provide a saline cushion beneath mucosal lesions. The induction of the saline into the submucosa is a routine practice and acts as a cushion which can reduce/limit unwanted tissue damage (penetration depth) when applying argon plasma coagulation. The APC/ESU System with the Probe supplies ionized (electrically charged) argon gas to create the HF argon plasma for the ablation of the lifted lesions. The HybridAPC Probe consists of tubing to the Water Jet, a cable with a filter integrated connector for the APC, and dual lumen tubing. The inside lumen delivers the pressurized sterile normal saline and the outer lumen delivers the electrically charged argon gas for the HF argon plasma. Clinicians would attach the Probe to the Water Jet and APC/ESU System. Then the Probe is positioned at the operative site under direct visualization endoscopically. If an operative endoscope is utilized, the working channel must be greater than 2.5 mm. Upon the setup of the Water Jet and APC/ESU System, the Probe is ready for use. The pedal of the ERBEJET 2 footswitch activates its water-jet capabilities. The tip of the Probe is placed against a lesion and the saline accumulates within the submucosal layer which cushions the lesion. Then the tip of the Probe is placed in close proximity of the raised lesion (not touching/non-contact modality). Finally, the footswitch for the APC/ESU System is depressed which delivers the ionized argon gas to create the HF argon plasma for the ablation of the lesion. The HybridAPC Probe's dimensional working parameters (tubing/tip interfacing with scope as applicable/tissue) are 2.3 mm Outer Diameter, 1.9 m Length. The device is manufactured with typical materials or agents used in the medical device industry such as tungsten, stainless steel, plastics, silicone, etc. The HybridAPC Probe is provided sterile and is single use.

The document describes a 510(k) premarket notification for the ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe. The focus is on demonstrating substantial equivalence to predicate devices, particularly regarding the new HybridAPC Probe and the added functionality of lifting mucosal lesions to the ERBEJET 2 System.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The study used three (3) different ex-vivo tissue types (esophagus, stomach, and rectum) from pigs.
  • For coagulation/ablation testing, each tissue type was tested with and without submucosa lifting, and then with coagulation. Testing was done with minimum, default, and maximum intensity settings in triplicate (3X) for both the proposed and predicate devices.
  • For submucosa lift testing, the ERBE WaterJet System settings were Effect 40, 70, and 80 to deliver 2 ml, 3 ml, and 5 ml of 0.9% NaCl at an application angle of 90° into each specified tissue type in triplicate (3X) for both the proposed and predicate devices.
• Data Provenance: The data was generated from ex-vivo animal (pig) tissue. This indicates a lab-based, pre-clinical study. The data is prospective in the sense that the experiments were conducted specifically for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is ERBE USA, Inc. with the parent company ERBE Elektromedizin GmbH, suggesting European or US-based research.

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

This information is not provided in the document. The study involves macroscopic and histological examination, which implies expert assessment, but the number and qualifications of the individuals performing these assessments are not specified.

4. Adjudication method for the test set:

This information is not provided. Given the nature of macroscopic and histological examination, an adjudication method (such as independent expert review or consensus) would typically be employed, but it is not described.

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 was not an MRMC comparative effectiveness study, nor does it involve AI. The study is a bench and ex-vivo animal study comparing a new medical device to predicate devices for its physical and functional performance, not human diagnostic performance.

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

This is not applicable. The device is an electrosurgical cutting and coagulation device with a waterjet and APC probe, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The type of ground truth used:

• For the coagulation/ablation and thermal damage assessment: Macroscopic and histological examination of the ex-vivo pig tissues. This is a form of expert assessment of tissue damage and morphology.
• For the lifting/cushioning assessment: Macroscopic measurements for height and area of the created lift/cushion. This is an objective measurement based on the observed physical effect on the tissue.
• For the non-perforation test: Observation of the absence of detrimental damage (perforation) to the tissue.

8. The sample size for the training set:

This is not applicable/not provided. This study describes a pre-market submission for a physical medical device, not an AI/ML algorithm that would typically have a training set. The term "training set" is generally used in the context of machine learning model development.

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

This is not applicable/not provided for the same reasons as #8.

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