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The NaviCam Small Bowel (SB) Capsule Endoscopy System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 2 years of age.

The NaviCam Tether is an accessory of the NaviCam SB Capsule. It is intended to aid the capsule for visualizing the esophagus prior to the capsule's release into the gastrointestinal tract for a SB capsule endoscopy procedure in adults (≥ 22 years).

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:

• a. Capsule: 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.
• Data recorder: The Data Recorder is an external receiving/recording unit that receives b. and stores the acquired images from the capsule.
• ESView Software: The ESView is a software application for processing, analyzing, c. 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.
• Locator: The Locator is a handheld device that is used to turn the NaviCam Capsule d. 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.
• e. Tether: The NaviCam Tether is a disposable product, which serves as an accessory to the NaviCam SB Capsule to allow for examination of the esophagus prior to releasing the NaviCam SB Capsule into the small bowel.

Please note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed acceptance criteria and performance metrics. Therefore, some of the requested information, particularly quantitative acceptance criteria and specific performance metrics of the device itself from a dedicated new study, is not explicitly present in the provided document. The document primarily relies on existing clinical experience with similar devices and bench testing for the new components.

Here's an attempt to extract the information based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the NaviCam Small Bowel Capsule Endoscopy System in the context of a new efficacy study. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device (Given PillCam Platform with PillCam SB Capsules) and confirming safety and effectiveness for expanded indications through existing clinical data and bench testing.

The "reported device performance" is largely framed by demonstrating equivalence to the predicate and showing that the expanded indications are supported by existing clinical experience.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Missing from the document: Specific measurable acceptance criteria (e.g., minimum sensitivity, PPV for lesion detection) from a dedicated clinical study for this specific device.

Additional Information:

2. Sample size used for the test set and data provenance:

• Test Set for Pediatric Indication Expansion (2-21 years old): The submission relies on a summary of 1566 pediatric patients from 10 published clinical studies (a meta-analysis from 2001-2010 with 723 patients, and 9 additional studies from 2011-2022 with 843 patients).
• Data Provenance: The data is retrospective, drawn from published clinical trials and meta-analyses. The specific countries of origin for each study are not detailed in this summary, but these are generally international publications.
• Test Set for NaviCam Tether and Packaging: Not specified for a clinical test set. Bench testing was performed for these components.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• The document does not describe a new study where experts established ground truth for a test set specifically for this 510(k) submission. It relies on previously published clinical data. Therefore, the number and qualifications of experts involved in the original studies establishing ground truth for the 1566 pediatric patients are not detailed here.

4. Adjudication method for the test set:

• Not applicable, as a new clinical study with a prospectively adjudicated test set was not conducted for this submission. The information is derived from a compilation of past clinical trials.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done according to the provided text. The submission focuses on substantial equivalence based on technological characteristics and existing clinical data for similar devices, rather than a direct comparison of human readers with and without AI assistance for this specific device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The document does not describe a standalone performance study of an algorithm for lesion detection or diagnosis. The device is described as an "endoscopic capsule imaging system" that acquires images for processing, analyzing, storing, and viewing by a software application to create a video for "physician review." This implies an always human-in-the-loop design.

7. The type of ground truth used:

• For the pediatric population data, the ground truth would have been established within the original clinical studies from which the meta-analysis and publications were drawn. Typically for capsule endoscopy, this might involve:
  • Expert Consensus: Review of capsule endoscopy videos by experienced gastroenterologists.
  • Follow-up Endoscopy/Colonoscopy with Biopsy: If medically indicated and feasible, direct visualization and histological confirmation.
  • Clinical Outcomes/Diagnosis: Correlation with patient symptoms and other diagnostic test results.
    The specific method for each of the 10 included studies is not provided here.

8. The sample size for the training set:

• The document does not describe a training set for an AI algorithm, as the submission focuses on hardware and software for image acquisition, storage, and viewing, and relies on existing clinical experience for its indications. Therefore, the sample size for a training set is not applicable or provided.

9. How the ground truth for the training set was established:

• Not applicable, as no AI training set is described in this submission.

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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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