Search Results

Ask a specific question about this device

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).

Ask a specific question about this device

IntraMarX 3D Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.

The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many Gl conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the Gl tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IntraMarX 3D Radiopaque Marker, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria for novel performance claims. The "acceptance criteria" here are therefore inferred from the comparison of characteristics and the non-clinical performance data, which aim to show the device meets existing standards and is as safe and effective as the predicate.

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The studies mentioned are primarily non-clinical (biocompatibility, radiopacity). The data provenance is generally not explicitly stated beyond implying these are results from tests conducted by the manufacturer, Ankon Medical Technologies (Shanghai) Co., Ltd., to support substantial equivalence. It does not refer to patient data or clinical studies.

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

This information is not provided in the document. The studies mentioned are non-clinical hardware/material tests rather than diagnostic performance studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a clinical study or a test set requiring adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The document focuses on showing substantial equivalence of a physical medical device (radiopaque markers) to a predicate device, based on material properties and non-clinical performance, not on the diagnostic accuracy of an AI algorithm or its impact on human reader performance.

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

This device, the "IntraMarX 3D Radiopaque Marker," is a physical diagnostic aid. It is not an AI algorithm and therefore, no standalone algorithm performance study was mentioned or would be applicable in this context. The "diagnosis" is made by a physician based on the visualization of the markers on an X-ray.

7. The Type of Ground Truth Used

For the non-clinical tests (biocompatibility, radiopacity), the "ground truth" implicitly comes from the established pass/fail criteria of the referenced international and national standards (ISO, ASTM). For example, a material either passes or fails the cytotoxicity test based on the standard's definition. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device, as it's not a diagnostic algorithm being evaluated for accuracy against such benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The IntraMarX 3D Radiopaque Marker is a physical device, not an AI algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as above.

Ask a specific question about this device

IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult only, IntraMarX Radiopaque Markers is dispensed by physicians to patients for oral intake.

The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

The provided text describes the submission for FDA clearance of the "IntraMarX Radiopaque Markers" device (K191087) and compares it to a predicate device, the "SITZMARKS Capsule" (K181750).

However, the document does not contain specific acceptance criteria for "device performance" in terms of clinical outcomes, nor does it present a detailed study that proves the device meets such criteria in a comparative effectiveness manner (e.g., against human readers or other diagnostic methods). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material safety, physical properties, etc.).

Here's an analysis based on the available information, noting what's present and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy in diagnosing colonic motility issues) and thus does not report device performance against such criteria. The reported "performance" falls under non-clinical testing for safety and basic functionality.

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy for colonic motility. All listed tests are non-clinical, focusing on material and physical properties of the device itself. Therefore, information on sample size and data provenance (country, retrospective/prospective) related to a clinical test set is not provided.

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

Not applicable. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No clinical test set needing adjudication is described.

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

Not applicable. This device is a passive radiopaque marker, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the cited ISO, ASTM, USP, and ICH standards/protocols. For example:

• Cytotoxicity: Ground truth is whether cell viability falls below a certain threshold when exposed to device materials.
• Radiopacity: Ground truth is whether the markers are visible on X-ray according to the specified standard.
• Heavy metal testing: Ground truth is whether heavy metal levels are within established safe limits.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

Summary of Device and Approval Context:

The "IntraMarX Radiopaque Markers" device is a diagnostic aid consisting of capsules containing radiopaque rings. Patients swallow the capsule, and after five days, an X-ray of the abdomen is taken to observe the remaining rings in the GI tract. Physicians interpret the location and number of rings to evaluate colonic motility in patients with severe constipation.

The FDA clearance (K191087) is based on demonstrating substantial equivalence to a previously cleared predicate device, the "SITZMARKS Capsule" (K181750). This means the applicant showed that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The core of this demonstration relies entirely on the non-clinical performance data listed above, proving the physical and biological safety of the marker material and its radiopacity. There is no mention of new clinical studies on diagnostic accuracy for this submission. The effectiveness is presumed to be equivalent to the predicate device, which itself would have had to demonstrate effectiveness.

Ask a specific question about this device