(30 days)
HALO360 + Sizing Balloon model 3441C is indicated for 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+ Sizing Balloon model 3441C is used in conjunction with either the HALO360 Energy Generator models 1100C-115B (or 1100C-230B), or HALORLEX Energy Generator model 1190A-115A (or 1190A-230A) for assessing the size of the esophageal lumen, and facilitate the selection of the disposable single-use HALO360+ Coagulation Catheter. The HALO360+ Sizing Balloon model 3441C, like the predicate device HALO360 Sizing Balloon model 3441B is comprised of a sizing balloon, a catheter shaft with markings, and an electrical connector.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sizing accuracy | Met the same specifications as predicate devices. |
| Structural strength | Met the same specifications as predicate devices. |
| Material compatibility | Met the same specifications as predicate devices. |
| Sterility | Met the same specifications as predicate devices. |
| Esophageal diameter measurement capability | Increased to measure diameters higher than 33.7 mm (allowing identification of migration into the stomach). |
Note: The document explicitly states the modified device "met the same specifications requirements as the HALO360 Sizing Balloon and HALO360+ Ablation Catheter" for the first four criteria. The fifth criterion is a noted improvement in capability.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The information provided focuses on the device's technical specifications and a comparison to predicate devices, rather than a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided text does not contain information about the number of experts used or their qualifications to establish ground truth. As this appears to be a submission based on engineering and performance criteria for substantial equivalence, clinical expert assessment for ground truth is not detailed.
4. Adjudication Method
The provided text does not contain information about any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on material and performance specifications, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The HALO360+ Sizing Balloon is a medical device, not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant. The device itself is designed to be used by a human operator (a physician) to size the esophagus and select a coagulation catheter.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance appears to be established through engineering specifications and testing based on the predicate devices. For example, "sizing accuracy" would be compared against a known, precise measurement standard in a laboratory or simulated environment, rather than a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
The provided text does not contain information about a training set since this is not an AI/machine learning device. The testing described appears to be for device validation against established specifications.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no mention of a training set for an AI algorithm.
§ 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.