Search Results

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."

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.

Ask a specific question about this device

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

The Cook Gastric Sizing Balloon Catheter is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the cardia of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch. The silicone catheter is 18 French and 55cm long with centimeter markings every centimeter from 10cm to 50cm.

The Cook Gastric Sizing Balloon Catheter is a medical device and thus does not involve AI or algorithms, human readers, or image-based diagnostics. The provided context is a 510(k) premarket notification for a medical device, which outlines its substantial equivalence to an existing predicate device rather than presenting a study to prove its performance against specific acceptance criteria in the way an AI/algorithm would.

Therefore, many of the requested points are not applicable. Below is an interpretation of the available information in the context of a medical device submission, focusing on the available "Test Data" rather than an "acceptance criteria and reported device performance" as might be found for an AI model.

Acceptance Criteria and Reported Device Performance

• Analysis of Cuff Diameter Over Time
• Analysis of Cuff Pressure and Diameter at Various Inflation Volumes |
  | Biocompatibility | - Biocompatibility |
  | Overall Assurance | The results of these tests provide reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon. |

Study Information (Based on Available Data)

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "tests" were conducted, but does not specify sample sizes for these tests or the data provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device, "ground truth" is typically established through direct physical measurements and standardized test procedures rather than expert consensus on interpretive data.
3. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting data (e.g., medical images) where there might be inter-reader variability. This is not relevant for the type of physical performance tests described for this device.
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 versus without AI assistance: Not applicable. This device is a physical catheter, not an AI or algorithm, and does not involve human readers for interpretation in the context of its primary function.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical medical instrument, not an algorithm.
6. The type of ground truth used: For the mechanical performance tests, the ground truth would be the objective measurements obtained from the physical testing (e.g., actual burst volume, measured diameter and pressure at various inflation volumes). For biocompatibility, the ground truth would be established by standard biological assays and tests confirming the material's safety for contact with human tissue.
7. The sample size for the training set: Not applicable. This is not an AI/algorithm and therefore does not have a "training set." Device development involves iterative design and testing, but not in the machine learning sense of a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device Evaluation:

The Cook Gastric Sizing Balloon Catheter's substantial equivalence was established by comparing it to a predicate device (Gastric Balloon Suction Catheter by BioEnterics, K002838) based on similar indications for use, materials of construction, and technological characteristics. The provided "Test Data" primarily focuses on physical performance characteristics and biocompatibility, as expected for a physical medical device. These tests were conducted to "assure reliable design and performance under the specified testing parameters" and to provide "reasonable assurance that the Cook Gastric Sizing Balloon Catheter has been designed and tested to assure conformance to the requirements for its use as a gastric sizing balloon."

Ask a specific question about this device