(81 days)
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.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Safety: Minimal damage to surrounding tissues. | In neurosurgery, less tissue necrosis and edema can reduce post-operative neurological symptoms. |
| Safety: Preservation of critical structures. | The water jet is a non-thermal, selective instrument which preserves structures with higher fibrin content such as vessels, nerves, and ducts (including arachnoid membranes). Spared vessels as small as 0.3 mm (at 3-7 bars). Dissection of tissue without damage to the arachnoid membranes. |
| Safety: Reduced blood loss. | Sparing of vessels can result in less blood loss. |
| Safety: Absence of thermal damage. | Non-thermal modality. No thermal damage to surrounding tissue. |
| Safety: No increased risk of infection or tumor spreading. | Current results do not support the complications of a higher risk of infection, an increase of tumor recurrence, or tumor spreading. |
| Effectiveness: Accurate and successful dissection. | Applicable to malleable soft tissues (brain parenchyma or tumors). Cuts were extremely sharp and precise. Linear relationship between pressure and penetration depths established. Easy to handle. |
| Effectiveness: Precision in vital areas. | Efficacious in soft tissue dissection near vital structures where precision and less tissue trauma is paramount. |
| Effectiveness: Selective dissection. | Selective instrument that preserves structures with higher fibrin content due to its selectivity based on solidity/density. Optimal nozzle size (120 um) and technique virtually eliminated clogging/foaming. |
| Comparative Effectiveness (vs. CUSA): Reduced trauma. | Less edema formation and less intense microglial and astroglial reaction in rabbits. Less traumatic than ultrasonic aspirator. |
| Comparative Effectiveness (vs. CUSA): Specific advantages. | Enabled brain parenchyma tissue dissection and vessel coagulation without thermal damage. Dissection of tissue without damage to arachnoid membranes, where CUSA could not achieve these benefits. |
Study Details
The submission consolidates findings from various scientific and clinical investigations, rather than presenting a single, dedicated pivotal study.
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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.
- Animal Studies:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.