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The Monopolar Attachment combines the use of the Helix Hydro-Jet™ Applicator with suction (Part Number 20139-074) with the use of monopolar coagulation and cutting (optional drip irrigation is also available) when used in conjunction with an ERBE ESU (ICC or VIO Models).

The Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie Note: receptacle. The use of ERBE ESU ICC and VIO Models are recommended. Compatibility and settings should be demonstrated/established prior to using a different Generator in the clinical environment.

The ERBE Monopolar Attachment [P/N 20139-094] is used with the Helix Hydro-Jet™ and the ERBE Electrosurgical Generator (ESU) Systems (ICC or VIO Mc rels), The Helix Hydro-Jet™ is a hydraulic pressure delivery system that uses physiological same to cut and dissect soft tissue. The ERBE Electrosurgical Generator (ESU) Systems (IC or VIO Models) deliver High Frequency (HF) energy through the electrode tip of the ERBE Monopolar Attachment for coagulation and cutting of tissue. The ERBE Monopolar Attachment for Helix Hydro-Jet™ is made of stainless steel with plastic insulation except at the electrode to ribers isolates the HF energy to only the tip surface). The ERBE Monopolar Attachment has a channel and ring where the Helix Hydro-Jet™ Applicator slides into the Monopolar Attachment and is held in place for the Physician. The Monopolar Attachment is provided non-sterile and is reusable. (Note: The cleaning and sterilization processes are provided in the proposed draft labeling, "Notes on Use" - ERBE Monopolar Attachment, )

This 510(k) summary (K062712) for the ERBE Monopolar Attachment for Helix Hydro-Jet™ does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically expected for AI/ML medical devices.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.

Here's a breakdown based on your request, highlighting what is (and isn't) present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific performance metrics or acceptance criteria are presented in a table format. The core of this submission is a "comparison of similarities and differences" to predicate devices, asserting that the new device's intended use, principles of operation, and technological characteristics are the same.

2. Sample Sizes and Data Provenance:

No information regarding sample sizes for test sets or data provenance (country of origin, retrospective/prospective) is provided. This type of detail is not typically included in a 510(k) submission focused on substantial equivalence for a design change that combines existing functionalities.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is not a study assessing diagnostic accuracy or similar performance.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned as there's no diagnostic performance study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This submission does not include any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a surgical accessory, not an AI diagnostic tool.

6. Standalone Algorithm Performance:

No. This device is a physical attachment for existing surgical equipment, not a standalone algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no "ground truth" as it pertains to diagnostic accuracy or similar performance. The "proof" is based on the claim that the device's design changes have been "verified or validated in design control by ERBE Elektromedizin GmbH," implying internal engineering and testing to ensure the combined functionality works as intended and safely.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable.

Summary of Device and Evidence Presented:

The ERBE Monopolar Attachment for Helix Hydro-Jet™ is essentially an accessory that combines two existing functionalities into one handheld piece:

1. Water jet dissection: via the Helix Hydro-Jet™ Applicator.
2. Monopolar coagulation and cutting: via an ERBE Electrosurgical Generator (ESU).

The "study" or evidence presented for this 510(k) is a claim of substantial equivalence based on:

• Identical Intended Use: The combined use of the two predicate devices, now integrated into one instrument.
• Identical Principles of Operation: The device still uses the same water jet mechanism and the same electrosurgical energy, but in a combined form.
• Identical Technological Characteristics: The materials (stainless steel with plastic insulation, electrode tip) and basic function remain consistent with predicate devices.
• Design Control Validation: The manufacturer states that "All the instrument design changes have been verified or validated in design control by ERBE Elektromedizin GmbH." This refers to internal quality system processes to ensure the new design meets specifications and safety requirements.

The FDA's decision to clear the device (K062712) indicates they agreed that the device is substantially equivalent to the predicate devices and does not raise new safety or efficacy concerns. This type of submission relies on the established safety and effectiveness of the individual components that are being integrated, rather than requiring extensive new clinical performance trials.

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The Helix Hydro-Jet is intended for 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.

The Helix Hydro-Jet is a hydraulic pressure delivery system that uses physiological saline to cut and dissect soft tissue.

The provided 510(k) summary for the ERBE Helix Hydro-Jet describes the device's intended use and provides supporting documentation for an expansion of its indications to include neurosurgery. However, it does not present a formal table of acceptance criteria or a structured study designed to demonstrate performance against those criteria in a quantitative, statistical manner as would typically be seen for a new device or a more strictly defined performance claim.

Instead, the document relies on scientific and clinical literature to support the safety and effectiveness of the device for the expanded neurosurgical use. The "acceptance criteria" can be inferred from the reported findings about the device's performance in these studies.

Here's an attempt to structure the information based on your request, understanding that some aspects will be inferred or noted as "not applicable" given the nature of the submission (an expansion of intended use for an already cleared device, supported by existing literature rather than a de novo clinical trial with pre-defined statistical endpoints).

Acceptance Criteria and Device Performance

A formal table of acceptance criteria with specific quantitative thresholds is not explicitly provided in the submission. The "acceptance" of the device for expanded use in neurosurgery is based on qualitative findings from animal and human studies demonstrating its safety and efficacy.

Study Details

The submission consolidates findings from various scientific and clinical investigations, rather than presenting a single, dedicated pivotal study.

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

   • Animal Studies:
     • Porcine brain cadaveric tissue: Unspecified number of cadavers.
     • Rabbit Studies: 55 rabbits.
     • Provenance: Not explicitly stated, but likely from European research given the context of German industry (ERBE) and some phrasing. Retrospective (literature review findings).
   • Human Studies:
     • Helix Hydro-Jet in general: Largest patient population reported was 75 patients (with various brain tumors and epilepsy).
     • Helix Hydro-Jet vs. CUSA: 102 humans.
     • Provenance: These appear to be findings from published literature, so retrospective. Country of origin not specified for all studies, but potentially European data given the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is based on observed surgical outcomes, pathological examination of tissues, and clinical assessments reported in published studies, rather than a separate expert consensus process for a new test set. The authors of the referenced studies and the practicing surgeons are the implicit experts.

3. Adjudication method for the test set: Not applicable. This was a review of existing scientific literature and clinical experience, not a de novo study with adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The comparative effectiveness assessment was against the Cavitational Ultrasonic Surgical Aspirator (CUSA) based on reported clinical outcomes and pathological findings from existing studies, not a reader-based MRMC study comparing human performance with and without AI.

   • Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/imaging device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a surgical tool, not an algorithm. Performance is inherently tied to human use.

6. The type of ground truth used:

   • Animal Studies: Pathological examination of tissue (e.g., for necrosis, edema, microglial/astroglial reaction, vessel sparing, cut precision). Direct observation of dissection attributes (e.g., clogging, foaming, penetration depth).
   • Human Studies: Clinical outcomes (e.g., post-operative neurological symptoms, blood loss, efficacy of dissection, ease of handling, absence of thermal damage, incidence of infection/recurrence). Pathological assessment from resected tissues or biopsies.

7. The sample size for the training set: Not applicable. This is a medical device, and the "training" refers to the development and refinement of the device attributes based on historical experience and testing, not a machine learning training set. The various animal and early human studies would have informally contributed to understanding the device's characteristics to refine its design and use.

8. How the ground truth for the training set was established: Not applicable in the machine learning sense. The "ground truth" for device development and refinement (the informal "training set") would have been established through iterative experimental results, surgeon feedback, and pathological analysis during the device's initial development and subsequent iterations, leading to features like the 120 µm nozzle and recommended pressure ranges.

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The Helix Hydro-Jet is intended for the cutting and dissection of soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as laparoscopic surgery.

The Helix Hydro-Jet is a hydraulic pressure delivery system that uses physiological saline to cut and dissect soft tissue.

The provided text describes a 510(k) submission for a medical device called the Helix Hydro-Jet™, a water jet dissector. This submission focuses on expanding the intended use of the device and adding supporting applicators, rather than introducing a completely new device. As such, the information typically found in studies proving device performance against acceptance criteria for novel devices is not present. Instead, the submission relies on demonstrating substantial equivalence to a predicate device and providing scientific documentation to support the expanded indications for use.

Therefore, many of the requested categories (acceptance criteria, reported device performance, sample sizes used for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) cannot be directly extracted from the provided text for a de novo device performance study.

However, I can extract information related to the device and its intended use, and discuss how the justification for the expanded use is presented.

Here's a breakdown of what can be inferred and what is explicitly stated:

Acceptance Criteria and Device Performance (as inferred from the context of a 510(k) submission for expanded use):

For a 510(k) submission seeking an expanded indication for an already cleared device, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating that the modifications (expanded use, new applicators) do not adversely affect the safety or effectiveness, and that the device remains substantially equivalent to the predicate. The performance is assessed relative to its established safety and efficacy for the original indications, with specific attention to the new use cases.

Detailed Information on Studies (Based on Provided Text):

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

   • Sample Size: Not specified. The document states "All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use have been provided in this submission." This suggests a reliance on existing literature and clinical evaluations rather than a newly conducted, specific clinical trial with a defined sample size for this 510(k).
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be "clinical evaluations" and references to "scientific documentation" provided in Section 111-9 (which is not included in the provided text). The mention of "Total Mesorectal Excision (TME)" suggests clinical application in surgical settings. It is likely a combination of retrospective analyses of existing clinical data and literature.

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

   • Not specified. The clinical evaluations mentioned likely involved expert surgeons or medical professionals, but their number and specific qualifications are not detailed in this summary.

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

   • Not specified. Given the nature of a 510(k) for expanded use, it's unlikely a formal adjudication process akin to image-based diagnostic studies was performed. The "clinical evaluations" and "scientific documentation" would have been reviewed by the submitter and then by the FDA.

4. 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. This is not an AI-assisted diagnostic device. The device is a surgical tool. The text mentions: "The use of the Helix Hydro-Jet in TME was found to be better in comparison to other approved equipment. Greater visibility and tissue selectivity with the water jet system." This indicates a comparative assessment, but not an MRMC study in the context of diagnostic performance or AI assistance. The "effect size" is qualitative (better visibility, tissue selectivity) rather than a quantitative measure of improved human performance with AI.

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

   • Not applicable as this is a surgical device, not an algorithm.

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

   • For surgical devices, "ground truth" for effectiveness often relates to surgical outcomes, successful tissue dissection, minimal collateral damage, and patient recovery. For safety, it would involve complication rates. The text refers to "clinical documentation" and "evaluations" demonstrating safety and efficacy, implying clinical observations and potentially pathology reports on excised tissue, as well as patient outcomes. Specific details are not provided.

7. The sample size for the training set:

   • Not applicable in the context of device performance studies presented here. "Training set" typically refers to machine learning algorithms. The device's design and engineering would have gone through verification and validation activities (mentioned in the "Device Description" as being in the previous 510(k) K012464, Section 6-1), but this isn't a "training set" in the AI sense.

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

   • Not applicable.

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The Helix Hydro-Jet is intended for cutting and dissection of soft tissue such as liver and kidney in open abdominal surgery.

Not Found

This 510(k) submission for the Helix Hydro-Jet did not include any clinical studies or performance data in relation to acceptance criteria. The submission focused on establishing substantial equivalence through non-clinical testing and comparison to predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

Instead, the submission relied on the following non-clinical testing to establish substantial equivalence:

• Biocompatibility Testing: Successfully completed for patient contact materials, according to ISO 10993-1.
• Safety Testing: Successfully completed according to EN 60601-1 / IEC 601-1.
• EMC Testing: Successfully completed according to EN 60601-1-2.

The conclusion drawn by Andreas Pein Medizintechnik, GmbH was that the device is "safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices for the purposes intended." This conclusion was based on the non-clinical testing and comparison to predicate devices, not on a study proving the device meets specific performance acceptance criteria from clinical data.

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