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

The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam Capsule Endoscope System or the NaviCam Xpress Stomach Capsule Endoscope System.

The provided text does not describe an AI-powered device or a study proving its performance against specific acceptance criteria. Instead, it is a 510(k) summary for a NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether. This system is a medical device for visualizing the stomach and esophagus, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the information requested in the prompt, as it pertains to AI-specific performance criteria and studies, which are not present in the provided document.

Here's an analysis of why the requested information cannot be extracted from the given text:

• No mention of AI/ML: The document does not describe the device as having any artificial intelligence or machine learning components. It's a hardware device (capsule endoscope and tether) for aiding visualization.
• No acceptance criteria for AI performance: Since there's no AI, there are no acceptance criteria related to its performance (e.g., sensitivity, specificity, AUC).
• No study proving AI performance: Consequently, there's no study described that would prove the device meets AI-specific acceptance criteria. The performance data section focuses on non-clinical (biocompatibility, bench testing) and clinical experience (references to scientific literature demonstrating safety and value, and a meta-analysis on battery life), not AI performance.
• No data provenance for AI testing: Without AI, there's no test set, training set, or related data provenance for AI models.
• No experts for AI ground truth: The concept of experts establishing ground truth for AI model performance isn't applicable here.
• No MRMC study: The document does not describe a multi-reader multi-case study, which is typically done to assess the impact of AI assistance on human readers.
• No standalone algorithm performance: As it's not an algorithm, there's no standalone performance to report.
• No ground truth type for AI: The "ground truth" discussed in the context of AI (e.g., pathology, expert consensus for disease detection) is not relevant for this device's submission.

In summary, the provided FDA 510(k) summary is for a physical medical device (capsule endoscopy system) and does not involve AI. Therefore, the questions related to AI-specific performance criteria and studies cannot be answered from this text.

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The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI

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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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.

• Same Mechanism of Action (oral intake).
• Same Capsule Material (HPMC).
• Similar Radiopaque Marker Material (Thermoplastic Elastomer 50% for subject vs. Polyvinyl Chloride 45-46% for predicate, both with Barium Sulfate).
• Same Sterile status (No), Single-Use (Yes), Shelf Life (2 Years).
• Differences in capsule packaging and image area diameter are acknowledged but not stated to impact safety/effectiveness as they don't raise new questions. |
  | Safety and Effectiveness: | Performance testing demonstrated the IntraMarX 3D is as safe and effective as the predicate device. |

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.

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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.

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