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The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI < 38. The system can be used in clinics and hospitals, including ER settings.

The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach capsule endoscopy (MCCE) procedure.

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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The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

The NaviCam Small Bowel Capsule Endoscopy System is an endoscopic capsule imaging system intended to obtain images of the small bowel. It is comprised of the following components:

1. Capsule (AKES-11SW, AKES-11SI): The disposable, ingestible NaviCam Small Bowel Capsule is designed to acquire video images during the natural propulsion through the GI tract. The capsule transmits the acquired images via an RF communication channel to the NaviCam Data Recorder located outside the body.
2. Data recorder (AKR-1, AKRI-1): The Data Recorder is an external receiving and recording unit that receives and stores the acquired images from the capsule.
3. ESView Software: The ESView is a software application for processing, analyzing, storing, and viewing the acquired images collected from the NaviCam Data Recorder to create a video of the images. The software also includes a reporting function to create detailed clinical reports and a capsule endoscopy atlas.
4. Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule on. It is also used for determining if the capsule is still in the body when the patient is not sure whether he/she expelled it.

The NaviCam Small Bowel Capsule Endoscopy System was assessed for its performance primarily through a comparative clinical study against a predicate device, the PillCam SB3 Capsule Endoscopy System, and also through various bench/in-vitro tests.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions that the clinical study was a prospective study (NCT05086471).
However, the specific sample size (number of patients or cases) used for the test set is not provided in the given text.
The data provenance (e.g., country of origin) for the clinical study is also not stated.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text. The text only states that the NaviCam system was compared to the PillCam SB3 in terms of diagnostic performance, but it doesn't detail how discrepancies or consensus was handled for establishing ground truth or comparing diagnostic findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

A comparative clinical study was performed, but it was to compare the device's performance (NaviCam Small Bowel Capsule Endoscopy System) to a predicate device (PillCam SB3 Capsule Endoscopy System), not specifically an MRMC study assessing human reader improvement with or without AI assistance. The study evaluates the diagnostic agreement between the two capsule endoscopy systems. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable/not reported in this context.

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

The NaviCam Small Bowel Capsule Endoscopy System includes "ESView Software...for processing, analyzing, storing, and viewing the acquired images... The software also includes a reporting function". While the software performs analysis, the clinical study appears to evaluate its overall diagnostic performance in detecting abnormalities, which would typically involve human review of the generated images/reports. The text does not explicitly state if a standalone algorithm-only performance study was conducted separate from human interpretation. The reported "diagnostic Overall Percent Agreement" is for the system, which implies the combined interpretation of the images.

7. The Type of Ground Truth Used

The ground truth for the clinical study is based on the detection of abnormalities of the small bowel by both the NaviCam system and the predicate PillCam SB3 system. The phrase "diagnostic Overall Percent Agreement" implies that the agreement was measured against the findings of another diagnostic tool (the predicate device), which often serves as a form of "ground truth" in equivalence studies when a gold standard (like pathology) is not universally available for every finding. The document does not explicitly state that pathology or outcomes data were used as the definitive ground truth for every finding. It strongly suggests the predicate device's findings were used as the reference point for comparison.

8. The Sample Size for the Training Set

This information is not provided in the given text. The document focuses on the performance study data, not the training dataset for any underlying AI/software components.

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

This information is not provided in the given text, as details about a training set are absent.

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The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

The NaviCam Xpress Stomach System is a 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: Ingestible capsule (AKEM-11SW) for obtaining images, Data recorder (AKR-1) for logging image data, Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body, Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach, ESView software for review of the images obtained by the capsule and generating reports.

The provided text is a 510(k) summary for the NaviCam Xpress Stomach Capsule Endoscope System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical accuracy. The "Performance Data" section solely discusses bench/in-vitro testing related to the controller's functionality and compliance with electrical safety standards, not the diagnostic performance of the capsule endoscope system itself.

Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, expert involvement, and ground truth for a diagnostic study cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, alongside what is missing:

1. A table of acceptance criteria and the reported device performance

The following information cannot be extracted from the provided text:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

Reasoning for Missing Information:

This 510(k) summary focuses on demonstrating substantial equivalence for a modification to an already cleared device (the NaviCam Stomach System). The "Performance Data" section details bench/in-vitro testing and compliance with electrical safety and EMC standards. It explicitly states, "The NaviCam Xpress Stomach System successfully passed the following test," and then lists functional and safety-related tests for the controller. It does not discuss any clinical diagnostic performance studies comparing the NaviCam Xpress Stomach System's ability to detect stomach abnormalities against a ground truth, which would involve patient data, expert review, and metrics like sensitivity or specificity.

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