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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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