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The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI

The NaviCam Xpress Stomach System is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator.

The NaviCam Xpress Stomach System includes the following key components:

• 1. Ingestible capsule (CP-US-7005) for obtaining images.
• 2. Data recorder (MC-US-1006) for logging image data.
• 3. Locator (SB-US-2006) for turning on the capsule and for determining if the capsule is still in the body.
• 4. Controller, NaviEC-2000 (MC-US-1002) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
• 5. ESView software for review of the images obtained by the capsule and generating reports.
• Optional Accessory: NaviCam Tether (ES-US-7005) for aiding the capsule in visualizing 6. the esophagus.

This document is a 510(k) summary for a software addition, not a comprehensive clinical study report. Therefore, much of the requested information about clinical performance, ground truth, and expert involvement is not present in this document.

Here's a breakdown of what can be extracted based on the provided text:

Device: NaviCam Xpress Stomach System (addition of GastroScan feature to NaviCtrl software)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic capabilities. Instead, it focuses on demonstrating that the software addition does not negatively impact the existing cleared device's performance or introduce new risks. The reported "performance" is that the device "performs as intended based on the non-clinical bench testing."

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

• Test Set Sample Size: Not specified for any performance testing related to diagnostic accuracy. The non-clinical performance and bench testing would have used specific test cases, but the number of such cases is not provided.
• Data Provenance: The new software features were evaluated through non-clinical performance and bench testing. This is typically internal testing. No information about country of origin for this testing or whether it was retrospective or prospective is provided. The document states that "No additional Animal and clinical performance testing were conducted."

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

Not applicable for this submission, as no new clinical performance testing was conducted. Ground truth for previous clinical evidence (mentioned in point 9) would have been established, but details are not provided here.

4. Adjudication Method for the Test Set

Not applicable for this submission, as no new clinical performance testing was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done for this submission. The document explicitly states "No additional clinical literature has been provided in this submission." It refers to previous clinical evidence from predicate devices but does not provide details of those studies in this document.

6. Standalone Performance Study

A standalone study of the algorithm's core diagnostic performance (e.g., sensitivity/specificity for detecting stomach abnormalities) was not performed as part of this specific submission. The submission focuses on the safety and efficacy of a software addition to an already cleared device. The "performance bench testing" mentioned would assess the functionality of the new software feature (GastroScan) rather than clinical diagnostic accuracy.

7. Type of Ground Truth Used

For this specific submission, the "ground truth" for the non-clinical performance and bench testing would be defined by the expected outcomes of the software functions and hardware interactions as specified in design documents and testing protocols. No clinical ground truth (e.g., pathology, expert consensus on patient cases) was used for this particular submission's evaluation.

8. Sample Size for the Training Set

No training set information is provided, as this submission is for a software feature addition to a previously cleared device. It's unlikely that machine learning model training was a primary component of this specific update.

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

Not applicable for this submission (see point 8).

Summary of this Submission's Focus:

This 510(k) submission (K230694) is for a software update (GastroScan feature) to an already cleared device (NaviCam Xpress Stomach System, K203192). The primary goal of this submission is to demonstrate that this software addition does not change the indications for use, does not introduce new risks, and does not negatively impact the performance of the existing device. Therefore, the evidence focuses on non-clinical software verification, human factors, and risk analysis, rather than new clinical trials or diagnostic performance metrics. The clinical evidence for the overall system's diagnostic capabilities would have been established in previous submissions (DEN190037 and K203192).

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