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The NAJA Gastrointestinal Balloon Catheter is intended to administer contrast medium to the small intestine.

The NAJA Gastrointestinal Balloon Catheter ("NAJA device") is a single-use, single-operator, over the-wire, double balloon catheter that is compatible with 0.035" guidewires. The device is introduced orally and designed for temporary occlusion of the gastrointestinal (GI) lumen (small intestine), allowing infusion of fluids for enteroclysis studies (i.e., imaging tests of the small intestine). The device is designed to fit inside the working channel of a gastroscope and reaches its intended location by tracking over a 0.035" guidewire.

The NAJA device features a separate hub connector that is attachable and detachable from the catheter. This feature allows removal of the gastroscope from the catheter once the balloons are in the correct location and before the hub connector is attached for balloon inflation and infusion of fluids into the GI lumen. The hub connector is supplied with 1-way stopcocks on the inflation and infusion ports. The NAJA device is also provided with a 30cc syringe for balloon inflation and infusion of fluids. The balloons are inflated independently using air.

Here's a breakdown of the acceptance criteria and study information for the NAJA Gastrointestinal Balloon Catheter, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary details various design verification tests. The "Specification" column represents the acceptance criteria, and the "Test Result" column indicates if the device met that criterion (mostly "Pass" or a specific measurement).

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes bench and performance testing (also referred to as design verification testing), and biocompatibility testing. These are typical for medical device submissions and do not involve human subjects or clinical data in the form of a "test set" from patients.

• Sample Size: Not explicitly stated for each individual bench or biocompatibility test, but device verification testing typically uses a statistically relevant number of samples to ensure robust performance across manufacturing batches.
• Data Provenance: The tests are conducted in a laboratory setting using manufactured devices. There is no information regarding country of origin of data in terms of patient demographics, nor is it retrospective or prospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the type of studies presented here.

• The studies are engineering and laboratory tests (bench, performance, and biocompatibility). They do not involve interpretation of medical images or patient data that would require "experts" to establish "ground truth" in a clinical context. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., ISO, internal design specifications).

4. Adjudication Method for the Test Set

This question is not applicable. As explained above, there is no "test set" in a clinical or diagnostic sense requiring human adjudication. The results are based on objective measurements against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for a physical medical device (catheter), not a diagnostic algorithm or AI-powered device. The studies focus on the physical and functional aspects of the catheter itself, not its impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is defined by:

• Engineering Specifications: Numerical ranges, physical properties, and functional requirements established during device design and development (e.g., "Pouch seal width is ≥ 0.19"").
• International Standards: Specifically, ISO standards for biocompatibility (e.g., ISO 10993-5, ISO 10993-23, ISO 10993-10).
• Observed Performance: Direct observation of device functionality and integrity (e.g., "Device components are free of damages").

These are objective, measurable criteria, not subjective interpretations requiring clinical ground truth like pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. The NAJA Gastrointestinal Balloon Catheter is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, there is no "training set" for this type of device.

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