(80 days)
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.
| Acceptance Criteria (Inferred for Expanded Use) | Reported Device Performance (as presented in the summary) |
|---|---|
| Safety: Device modifications and expanded use must not introduce new, unacceptable risks or increase existing risks. | "The modified structural and dimensional features of the added applicators do not adversely affect the safety or effectiveness of the Helix Hydro-Jet." (Conclusion statement) |
| Effectiveness: Device must continue to perform its intended cutting and dissection function effectively in the expanded use cases (Total Mesorectal Excision and laparoscopic surgery). | "The clinical documentation provided demonstrates that the Helix Hydro-Jet may be used safely and effectively to cut/dissect soft tissue that is in close proximity of the abdomen [Note: Shown by use in Total Mesorectal Excision (TME)]. The evaluations also show that system can be used in laparoscopic procedures for the target tissues with regards to safety and efficacy." (Conclusion statement) |
| Substantial Equivalence: The modified device must be substantially equivalent to a predicate device, particularly regarding its safety and effectiveness for the expanded indications. | "The modified device is the same as the predicate except for a slight expansion of the intended use and the addition of supporting applicators." (Similarities and Differences) "All available/known studies involving the Helix Hydro-Jet and like water jet equipment in conjunction with the expanded intended use have been provided..." "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." (Conclusion statement) |
| Applicator Performance: New applicators must function as intended and safely support the expanded indications. | "The applicators have been verified/validated in design control. Risk analysis also has been performed with regards to the features." (Similarities and Differences) |
Detailed Information on Studies (Based on Provided Text):
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.