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The Atmo® Gas Capsule System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal transit times are used for evaluating motility disorders.

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, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined, the system will report combined Small and Large Bowel Transit Time (SLBTT).

Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance.

Not for use in pediatric patients.

The Atmo Gas Capsule System is a prescription only ingestible telemetric medical device system used to measure transit times of the gastrointestinal (GI) tract. The system consists of a single-use Capsule, reusable Receiver, Mobile Device with Clinician App, and an online Clinician Portal.

Sensors onboard the Capsule provide measurements for temperature, hydrogen concentration, and carbon dioxide concentration, along with indicators of oxygen level, capsule tumble, and antenna reflectance that are used to identify regional gastrointestinal anatomical landmarks. The Capsule data is transmitted from within the GI tract via radiofrequency communication to a Receiver worn by the patient. The Mobile Device runs the Atmo Clinic App, a software application which guides the clinician through the pairing process, Capsule administration, and subsequent transfer of stored data from the Receiver to a cloud server. The Atmo Clinician Portal, accessible through a web browser, displays the resulting data and provides guidance for the physician to review, confirm and create a downloadable Motility Study Report containing whole and regional gut transit times.

The provided FDA 510(k) clearance letter and its associated 510(k) summary pertain to the Atmo Gas Capsule System. However, this document does not contain specific acceptance criteria or the detailed results of a study designed to prove the device met those criteria in the format requested.

The information provided largely describes the device, its intended use, comparison to a predicate device, and general details about the clinical study (e.g., multi-site, prospective, sample size, Bland-Altman analysis for agreement) and non-clinical testing. It states that "all pre-determined end points successfully met" for agreement with the predicate device, but it does not specify what those pre-determined endpoints/acceptance criteria were (e.g., a specific agreement percentage, limits of agreement, maximum allowable difference, or statistical p-value for non-inferiority).

Therefore, based on the provided text, I cannot complete most of the requested table and details about the study that proves the device meets the acceptance criteria. I can only extract what is present.

Here's what can be inferred and what information is missing:

Acceptance Criteria and Device Performance

Since the document does not explicitly state the acceptance criteria for GET and CTT agreement, I cannot fill this table as requested. It only says "all pre-determined end points successfully met."

Table of Acceptance Criteria and Reported Device Performance (Information Not Provided in Source):

Study Details Proving Device Meets Acceptance Criteria

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

   • Sample Size: 213 participants.
   • Data Provenance: Multi-site, prospective study across 12 US sites and 1 OUS (Outside US) site. Participants had "confirmed or suspected dysmotility issues of the gastric and/or colonic regions."

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

   • Not provided. The study assessed agreement between the Atmo Gas Capsule System and a predicate device (SmartPill GI Monitoring System, version 2.0). It doesn't explicitly mention external expert consensus for ground truth on transit times, but rather the comparative performance against an already cleared device. For a "gastrointestinal motility monitoring system," the ground truth for transit times is typically derived from the measurements themselves, not from expert interpretation of images or other subjective data.

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

   • Not provided. This type of adjudication (e.g., for image interpretation or diagnosis) is generally not applicable to the direct measurement of physiological parameters like transit times by a capsule system. The study focused on agreement between two devices.

4. 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:

   • No, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic tool that humans interpret. The study compared the device's measurements to those of a predicate device.

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

   • Yes, in the context of the device itself. The Atmo Gas Capsule System and the predicate device both automatically identify transit markers, with the user then manually confirming them. The study evaluated the agreement of the Atmo system's derived transit times against the predicate, implying the performance of the system's algorithm in calculating these times. The "human-in-the-loop" aspect (manual confirmation of markers) is part of the system's operation, but the core measurement and algorithm for transit time derivation is standalone.

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

   • The "ground truth" for the Atmo Gas Capsule System's performance was the measurements obtained by the legally marketed predicate device, the SmartPill GI Monitoring System, version 2.0. The study's primary objective was assessing agreement between the investigational device and the predicate device.

7. The sample size for the training set:

   • Not provided. The document describes a clinical validation study (test set) but does not mention details about the training data used for the device's algorithms.

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

   • Not provided, as training set details are absent.

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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 intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.

The G-Tech System is a non-invasive wireless gastrointestinal monitoring system for use by the physician or staff in the hospital setting, clinic, or physician's office. The device is intended for use while the patient is under direct supervision (e.g., in hospital or clinic) as well as after discharge to home or to intermediate setting. The device is for prescription use only. The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS application, a secure cloud storage server and computer-based data analysis algorithms. The G-Tech Patch is a single use, wearable electrode patch that reads the electrical signals of the gastrointestinal tract from the abdominal skin surface. The Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch Monitor. The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient interface to allow the patient to manual enter events such as meals, bowel movements, pain or the taking of medications. Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines. These measurements are made available to physicians for aid in clinical evaluation of their patient.

The provided document describes the G-Tech Wireless Patch System (WPS), a non-invasive device for measuring gastrointestinal myoelectrical activity. The information details the device's characteristics, intended use, and substantial equivalence to predicate devices, through various studies. However, the document does not explicitly state acceptance criteria in a quantitative, measurable format with corresponding reported device performance values in a table. It also does not present a traditional "study" in the sense of a clinical trial with a defined test set, ground truth experts, adjudication, or MRMC design for regulatory clearance.

Instead, the submission focuses on demonstrating substantial equivalence through a combination of:

• Bench Performance Study: Functional testing with known signals to assess the system's ability to extract rhythmic motor activity.
• Animal Study: Comparison of G-Tech Wireless Patches with internal electrodes in mini-pigs to show fidelity of surface-measured signals to internal ones.
• Clinical Studies (Primary Evidence): Simultaneous measurements with manometry and Smart Pill to demonstrate concordance in frequency and time of myoelectrical activity with internal measurements. These appear to be more akin to validation or correlation studies rather than a pass/fail performance study against pre-defined acceptance criteria for diagnostic accuracy.
• Supplemental Evidence: Four peer-reviewed publications demonstrating correlation with clinical markers and reproducibility.

Given the information provided, I will interpret "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of the available data, which focuses on demonstrating substantial equivalence through various aspects of performance and comparison to established methods, rather than a single, pre-defined algorithm performance study with specific cutoffs.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not provide a quantitative table of acceptance criteria with corresponding reported device performance values for the overall device's diagnostic capability (e.g., sensitivity, specificity for a specific disorder). The "acceptance criteria" for this 510(k) submission appear to be implicit and qualitative: demonstrating that the device performs as intended, is safe, and is substantially equivalent to predicate devices.

The "performance" is described broadly:

• G-Tech Patches are reliable and provide consistent electrical measurement devices.
• Data processing algorithms are efficient engines for extracting rhythmic motor activity signals. |
  | Fidelity to Internal Signals | Detectable slow wave signals at the skin surface (stomach, small intestine, colon) with fidelity to internally measured signals in frequency and spectral shape. | Animal Study demonstrated:
• Slow wave signals associated with the three major GI organs (as observed with internal electrodes) are detectable at the skin surface with the G-Tech Wireless Patches.
• Signals have fidelity to the internally measured signals in frequency and spectral shape. |
  | Clinical Concordance | Records signals identifiable as originating from Stomach, Duodenum/Jejunum, and Colon, with concordance to manometry and Smart Pill data. | Clinical Studies (Primary Evidence) demonstrated:
• Non-invasive patch system records signals identifiable as being from the Stomach, Duodenum/Jejunum, and Colon by concordance with frequency and time of spectral analysis of high-resolution manometry data.
• Concordance in frequency and time observed between G-Tech Wireless Patch measurements and Smart Pill measurements. |
  | Clinical Utility/Correlation | (Implicit) Utility in understanding measurement capabilities and potential clinical use; correlation with clinical markers of postoperative recovery; reproducibility; sensitivity to external stimulus. | Clinical Studies (Supplemental Evidence - Peer-Reviewed Publications) demonstrated:
• Correlation between G-Tech Wireless Patch Measurements and clinical markers of postoperative recovery in adult and pediatric populations.
• Reproducibility of the gastric and intestinal myoelectrical profile over multi-year periods.
• Sensitivity of measurements to an external stimulus in specific examples. |
  | Safety | Electrical safety, EMC, biocompatibility, mechanical strength. | Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-1-2, ANSI C63.27-2017.
  Biocompatibility assessed with ISO 10993-1:2009 (compliant for intact skin up to 30 days).
  Mechanical strength testing (wear adhesion, tensile, impact, drop, shock, vibration) demonstrates performance as intended and safety. |
  | Software Performance | Software acquires and processes myoelectrical signals, generates reports as intended. | Software documentation developed in consideration of "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices". (Implies verification and validation were done to meet these guidelines). |

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

The document does not explicitly define a "test set" in the context of an AI/ML model for a diagnostic study, but rather describes various validation/correlation studies.

• Bench Performance Study: Known signals were applied to the system, but the specific number/type of signals is not quantified as a "sample size."
• Animal Study: Data from "a study" undertaken to compare measurements in "adolescent Yucatan mini-pigs." The number of animals is not specified. Data provenance: likely laboratory/research setting (not specified country).
• Clinical Studies (Primary Evidence): Describes "simultaneous measurements between G-Tech Wireless Patches and antroduodenal and colonic manometry" and "concordance... between G-Tech Wireless Patch measurements and Smart Pill measurements." The number of human subjects/patients involved in these "primary evidence" studies is not specified. Data provenance: "IRB-approved studies and well-documented case histories," implying prospective or retrospective for specific cases. Country of origin is not specified, but the applicant is US-based.
• Clinical Studies (Supplemental Evidence - Peer-Reviewed Publications): These are external studies. The document only lists the publications without detailing their sample sizes or methodology beyond their titles. To get this info, one would need to refer to the publications themselves.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the device's performance appears to be established through:

• Known signals (bench testing).
• Internal electrodes (animal study).
• Established clinical methods like manometry and Smart Pill (clinical studies).

There is no mention of human expert consensus or adjudication being used as a "ground truth" reference for this device's output. The device provides "measurements" to be used at the "discretion of the Physician or Clinical User," suggesting the physician interprets the device's data rather than the device providing a definitive "diagnosis."

4. Adjudication Method for the Test Set

This information is not applicable/provided. No "test set" in the context of expert review with adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

This information is not provided and such a study design is not described for this device. The G-Tech WPS provides "measurements" for physicians to use in their diagnosis; it is not described as an AI-powered diagnostic aid that re-interprets medical images or provides a direct diagnostic output that a human then uses. Therefore, a study on human reader improvement with/without AI assistance isn't relevant to the information presented for this device.

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

The document states: "Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines." The "Bench Performance Study" and "Animal Study" would represent aspects of standalone algorithm performance, as they assess how well the system, through its algorithms, extracts and measures signals compared to known inputs or internal direct measurements.

• Bench Performance Study: Confirmed algorithms are "efficient engines for extracting rhythmic motor activity signals."
• Animal Study: Confirmed surface signals "have fidelity to the internally measured signals in frequency and spectral shape."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The types of "ground truth" or reference standards used are:

• For Bench Testing: Known, synthetic electrical signals with realistic background, artifact, and noise characteristics.
• For Animal Study (Fidelity): Simultaneous measurements using "multi-element electrodes sutured to serosal surfaces of stomach, small intestine, and colon." (i.e., direct internal physiological measurements).
• For Clinical Studies (Concordance):
  • High-resolution manometry data (for antroduodenal and colonic myoelectrical activity).
  • Smart Pill measurements (for gastrointestinal transit and related activity).
• For Clinical Utility/Correlation (Supplemental Evidence): Clinical markers of postoperative recovery.

8. The Sample Size for the Training Set

This information is not provided. The document describes the device as a measurement system, not a machine learning model developed with explicit training and test sets in the typical AI/ML sense (though data analysis algorithms are present). If the algorithms involved machine learning, the training set details would be critical, but they are not mentioned here.

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

This information is not provided, as details regarding a specific "training set" are absent.

Summary of Missing Information critical for a typical AI/ML Diagnostic Study:

• Quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for human clinical "test sets."
• Details on expert involvement, qualifications, and adjudication methods for any human interpretation studies.
• MRMC study results for human-AI collaboration.
• Explicit training set details, including size and ground truth establishment, for the data analysis algorithms (if they are AI/ML-based algorithms requiring such, which is not explicitly stated).

The provided text focuses on the device's technical performance (signal acquisition, processing, safety) and its correlation/concordance with existing physiological measurement techniques, supporting its claim of substantial equivalence as an electrogastrography system.

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