(24 days)
The HALO360+ Coagulation Catheter model is intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract.
The HALO360+ Coagulation Catheter is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
The HALO360 Coagulation System consists of the HALO460 Energy Generator with a disposable single-use HALO360+ Coagulation Catheter, a HALO300 Sizing Balloon, an output cable, and an optional footswitch. The HALO360 Coagulation System comprising catheter model 32041-XX performance and mode of operation is substantially equivalent to the already cleared HALO300 Coagulation System comprising catheter models 31041-XX and/or 31041-XXBR.
This 510(k) submission (K071543) is for a medical device (HALO360+ Coagulation Catheter) and appears to be a substantial equivalence submission, rather than one providing detailed clinical study data with acceptance criteria and device performance metrics in the way that would typically be described for AI/CADe devices. This type of submission relies on demonstrating similarity to legally marketed predicate devices, and therefore, does not typically include the specific performance metrics, ground truth establishment, or reader studies requested in your prompt as these are more common for novel device performance claims.
Here's a breakdown based on the provided document, addressing what can be found and noting what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance for a clinical study in the context of diagnostic accuracy, sensitivity, specificity, etc., which would be typical for AI/CADe devices. This is a submission for a physical medical device (coagulation catheter) claiming substantial equivalence to existing devices. The evaluation focuses on changes in materials and manufacturing processes.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. The submission states that "All these differences were evaluated on the bench and in the animal model." No details on the sample size of the animal model or data provenance are provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable/Not provided. This type of evaluation for a physical device typically doesn't involve expert ground truth establishment for a test set in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
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
No. This is not an AI-assisted device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The document mentions "bench and ... animal model" evaluations. For a physical device, the "ground truth" would relate to the physical and functional characteristics of the device (e.g., coagulation efficacy, safety parameters in an animal model) rather than diagnostic truth in patient data. Specific details are not provided in this summary.
8. The Sample Size for the Training Set
No training set is applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of what is present:
- Acceptance Criteria (Implied): The implied acceptance criteria for this 510(k) submission are that the changes in materials and manufacturing processes do not raise new questions of safety and efficacy compared to the predicate devices. The study performed ("bench and in the animal model") aimed to demonstrate that these changes maintain substantial equivalence in performance and safety.
- Device Performance (Implied): The devices (new and predicate) are considered "equivalent," meaning the HALO360+ Coagulation Catheter performs similarly to the predicate devices in its intended use for coagulation.
- Study Type: This appears to be a design verification and validation study, including bench testing and animal model testing, to confirm that the changes made (materials and manufacturing) do not negatively impact the device's safety and effectiveness compared to its predicates.
Why this information is largely absent in the provided text:
This 510(k) summary is for a physical medical device (a catheter) seeking clearance based on substantial equivalence to already cleared predicate devices. The "study" referenced ("bench and in the animal model") is to demonstrate that minor changes in materials and manufacturing processes do not alter the fundamental safety and effectiveness of the device as established by the predicates. This is fundamentally different from the rigorous clinical trial and performance metrics often required for novel devices, especially diagnostic AI tools, which necessitate detailed information on acceptance criteria, ground truth, reader studies, and sample sizes for various datasets.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.