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The MotiliCap GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.

Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.

Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.

The system measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.

Not for use in pediatric patients.

The MotiliCap GI Monitoring System is comprised of the following components:

• MotiliCap Capsule (Catalog Number: CP-US-7010)
• Data Recorder (Catalog Number: MO-US-8001)
• Computer Software (MotiliScan: V1. MO-US-8005)
• Smartphone App (MotiliCap: V1. MO-US-8006)

The single-use capsule consists of the pressure sensor, the pH sensor, and the temperature sensor, which separately measure the pressure, pH, and temperature in the GI tract to determine transit times of the stomach, small bowel, and colon. The system provides information that aids clinicians in the evaluation of motility-related disorders. The data recorder records biomedical data transmitted by the capsule. The MotiliScan software is installed on a general-purpose computer. Before the examination, the software can create a case to start a test. After the test is complete, the software can receive, and process downloaded test data from the data recorder and graphically display the data for easy analysis and review. The MotiliScan software analyzes data and calculates motility indices such as GET, SBTT, CTT, and WGTT. The MotiliCap App is installed on a smartphone. This App is connected to the data recorder via Bluetooth, displays the connection status, and shows information about the capsule connected to the data recorder.

The provided FDA 510(k) clearance letter and summary for the MotiliCap GI Monitoring System does not contain the specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The document states that substantial equivalence was based on "technological similarities of the devices and the results of the bench testing." It also briefly mentions "A small clinical evaluation of the device supported that the device could function as intended in the clinical environment and the patient is generally satisfied with the examination and software operation." However, it does not provide quantitative acceptance criteria for performance metrics (like accuracy, sensitivity, or specificity for transit times or other measurements), nor does it detail a study that demonstrates these criteria were met.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (SmartPill GI Monitoring System), largely based on similar indications for use and technological characteristics, and general bench testing results.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not list specific acceptance criteria (e.g., "GET accuracy must be within X minutes of reference method") or quantitative reported device performance for clinical metrics. It only generally states that "The MotiliCap GI Monitoring System demonstrates the ability to measure pressure, pH, and temperature per the developed specifications."

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

• Cannot be provided for performance metrics. The document mentions "A small clinical evaluation," but does not specify the sample size for this evaluation, its design (e.g., prospective/retrospective), or the country of origin of the data. The bench testing would have a "sample size" of capsles/components, but this is not typically what is sought when asking about a "test set" for clinical performance.

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

• Cannot be provided. Ground truth establishment methods, number of experts, and their qualifications are not mentioned in relation to the "small clinical evaluation."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Cannot be provided. The document does not describe any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No evidence of an MRMC study related to AI assistance. The document makes no mention of AI assistance or MRMC studies evaluating its impact on human readers. The device calculates motility indices, but the clearance is for its measurement capabilities, not necessarily for interpretative AI that assists human readers.

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

• Cannot be definitively answered with specific performance metrics. The device "calculates motility indices such as GET, SBTT, CTT, and WGTT." This implies a standalone algorithm for these calculations. However, the document does not present quantitative performance data for these calculations as a standalone algorithm against a reference standard in a dedicated study. It only states the system demonstrates the "ability to measure" these parameters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. The document does not specify the type of ground truth used for any clinical evaluation or for validating the calculated transit times. For bench testing, the ground truth would be known physical parameters (e.g., calibrated pH solutions).

8. The sample size for the training set:

• Cannot be provided. The document does not discuss a "training set," implying the product development and validation relied on existing knowledge and bench testing, rather than a machine learning model developed with a distinct training/test split that would require a separate training set.

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

• Cannot be provided. As no training set is discussed, its ground truth establishment is also not mentioned.

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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 Xpress Stomach Capsule is intended for visualization of the stomach of patients >= 6 years old with BMI =

NaviCam® Xpress Stomach Capsule Endoscope System enables the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any direction during examination. The direction and angulation of the capsule camera head can be adjusted in real-time, hence realizing complete control of capsule endoscope movement and attitude during examination in the X left and right, Y forward and backward, Z up and down directions as well as rotation clockwise and counterclockwise.

This document (K231960) describes a 510(k) premarket notification for the NaviCam Xpress Stomach Capsule Endoscope System. The filing is an expansion of the Indications for Use for an already cleared device, primarily expanding age and BMI limitations. As such, the performance study focuses on demonstrating that the device's performance is not adversely affected by these expanded patient characteristics.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of metrics like sensitivity, specificity, or accuracy for a specific diagnostic task from an AI component. This is because this 510(k) notification is for an expanded indication for use of an existing device, not for the clearance of a new AI-powered diagnostic algorithm.

The "performance data" section focuses on demonstrating that the existing device's performance is not affected by the expanded age and BMI patient populations. Therefore, the "acceptance criteria" are implicitly that the device continues to perform as intended and safely within the expanded patient population.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document mentions "clinical data" and "real-world evidence" but does not provide a specific sample size for a test set. This suggests that a formal, prospective, rigorously controlled "test set" in the context of an AI study was not conducted. Instead, they relied on existing clinical literature and internal reports.
• Data Provenance: The document does not specify the country of origin. The data is described as "published in the scientific literature along with unpublished clinical reports" and "real-world evidence." This implies a mix of retrospective and possibly ongoing observational data.

3. Number of Experts and Qualifications

The document does not mention the number or qualifications of experts used to establish ground truth. This is expected given that the filing is not for an AI diagnostic algorithm requiring this type of ground truth establishment for its performance evaluation. The "ground truth" seems to be the continued functionality and safety of the device itself in the expanded population.

4. Adjudication Method

No adjudication method is mentioned, as it's not applicable to this type of device modification submission.

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

No MRMC study was done, as this submission is not about the effectiveness of a diagnostic algorithm or how it improves human reader performance.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study was done. This device is a capsule endoscope system, and while it has software, the submission is not for a new AI-driven diagnostic or analytical algorithm.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is clinical experience and technical (bench) data demonstrating the continued functional performance and safety of the existing device when used in the expanded age and BMI populations. It is not about diagnostic accuracy against a specific disease state.

8. Sample Size for Training Set

No training set sample size is mentioned. This is not a submission for a new AI/ML algorithm that would undergo a training phase.

9. How Ground Truth for Training Set was Established

Not applicable, as no training set for an AI/ML algorithm is discussed.

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