(23 days)
The Gastric Sizing Balloon Catheter is indicated for use in gastric surgical procedures to size the gastric pouch and drain and remove gastric fluid.
The Gastric Sizing Balloon Catheter is an invasive device that consists of a 55 cm flexible gastric tube designed to be used during gastric and bariatric surgical procedures in a healthcare facility/hospital environment by a clinician. The 18 Fr catheter is inserted into the mouth, down the esophageal passage and advanced into the stomach temporarily. The Gastric Sizing Balloon Catheter is supplied with a 20 cc syringe, provided sterile in peel-open packaging, and intended for single-use only.
The provided text describes a 510(k) premarket notification for a medical device called the "Gastric Sizing Balloon Catheter." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe a study involving an AI/Machine Learning device or a multi-reader, multi-case (MRMC) comparative effectiveness study, or the use of human experts to establish ground truth for a test set.
Therefore, many of the requested details about acceptance criteria, study methodologies, and AI-related aspects cannot be extracted from this document.
However, I can extract the acceptance criteria and performance related to the non-clinical tests mentioned.
Here's the information that can be extracted from the document, with an acknowledgement of what cannot be found:
1. A table of acceptance criteria and the reported device performance
The document states that acceptance criteria were met for several non-clinical tests, but it does not provide the specific quantitative thresholds for these criteria. It only reports that the device "met the acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance | Specific Criteria (not provided in text) |
|---|---|---|
| Biocompatibility Testing | Met acceptance criteria (nontoxic) | In accordance with BS EN ISO 10993-1:2003 |
| Dimensional and Compatibility Analysis (Zero-time & Accelerated Aged) | Met acceptance criteria | Outer diameter and length of the balloon catheter |
| Inflated Balloon Tensile (Zero-time & Accelerated Aged) | Met acceptance criteria | Peak load of the balloon portion, in accordance with Annex B of BS EN 1618 |
| Balloon Burst (Zero-time & Accelerated Aged) | Met acceptance criteria | Burst pressure of the catheter balloon |
| Sideport Tensile (Zero-time & Accelerated Aged) | Met acceptance criteria | Uniaxial testing, in accordance with Annex B of BS EN 1618 |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The tests are non-clinical, likely bench testing, and the number of units tested is not detailed.
- Data Provenance: Not applicable in the context of clinical data. These are non-clinical (bench) tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the document describes non-clinical engineering and biocompatibility testing, not studies involving human expert analysis of medical images or other data for diagnostic purposes. Ground truth here relates to engineering specifications and material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept typically applies to clinical studies where human readers provide interpretations that need to be reconciled for ground truth. For non-clinical bench testing, the results are typically quantitative measurements against predefined specifications.
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, an MRMC study was not done. This document pertains to a traditional medical device (catheter), not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" would be established by engineering specifications, material science standards (e.g., ISO, BS EN), and internal quality control criteria. For instance, for dimensional analysis, the ground truth is the specified dimensions of the catheter and balloon. For biocompatibility, it's compliance with established safety standards.
8. The sample size for the training set
- Not applicable. This document describes the testing of a physical medical device, not the training of an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. As above, no AI/ML model training is described.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.