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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 SmartPill 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 SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to aid in the evaluation of gastrointestinal motility diseases and conditions. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times: GET - Gastric emptying (transit) time SBTT - Small bowel transit time SLBTT - Combined small and large bowel transit time CTT - Colonic transit time WGTT - whole gut transit time

The provided text describes the SmartPill GI Monitoring System, Version 2.0, and its performance evaluation. However, it does not explicitly detail acceptance criteria in a quantitative table format or a study specifically designed to prove all acceptance criteria. Instead, it discusses clinical testing that "validated the device's indications for use" and "support the product's intended use, indications for use, performance and clinical claims."

Here's an attempt to extract and synthesize the information based on your request, with significant limitations due to the lack of explicit detail in the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The document does not present a formal table of acceptance criteria with corresponding performance metrics from a single, comprehensive study. Instead, it broadly states that "clinical testing was conducted to validate the device's indications for use." The performance summary refers to "multiple bench tests to verify the accuracy and precision of the device" and "clinical testing" that "support the product's intended use, indications for use, performance and clinical claims."

Inference: The "acceptance criteria" appear to be broadly defined by the "Indications for Use" and the ability of the device to measure specific GI transit times (Gastric Emptying Time, Small Bowel Transit Time, Combined Small and Large Bowel Transit Time, Colonic Transit Time, Whole Gut Transit Time) accurately enough to aid in evaluating motility disorders. The clinical studies likely aimed to establish and validate normal and abnormal ranges for these transit times, thereby demonstrating the device's utility in clinical decision-making.

Given the lack of specific quantitative acceptance criteria in the document, a hypothetical table based on the implied performance goals of the device would look like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions two prospective clinical studies:

• Study 1: "established cutoff values for colonic and combined small large bowel transit time."
• Study 2: "validated the cutoff values in symptomatic constipated patients."

Sample Size: The exact sample sizes for these clinical studies (test sets) are not provided in the excerpt.
Data Provenance: The studies were prospective clinical studies. The country of origin is not specified, but given the FDA submission, it's likely conducted in the US or under protocols recognized by the FDA.

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

This information is not provided in the document. The method for establishing ground truth for human interpretation of transit times or the involvement of experts in determining "cutoff values" is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not applicable as the device is a diagnostic capsule system that measures physiological parameters. It is not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed (or at least not mentioned as such). The device provides automated data analysis ("MotiliGIT™ Software performs data analyses automatically").

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

Yes, in a sense. The "MotiliGIT™ Software performs data analyses automatically and provides the physician with a printable report containing regional gut transit times." This implies a standalone algorithmic processing of the capsule's data to derive the transit times. The clinical studies would then assess the accuracy and clinical utility of these automatically derived transit times against clinical outcomes or other diagnostic standards. The "performance of the SmartPill GI Monitoring System" in bench tests and clinical trials implies an assessment of the device's (including its algorithms) ability to correctly measure and report the relevant physiological parameters.

7. The Type of Ground Truth Used

The document generally states that clinical testing validated "indications for use" and established "cutoff values." For a device measuring physiological transit times, the ground truth would likely involve:

• Clinical Outcomes Data: For example, in patients with suspected gastroparesis or chronic constipation, the transit times measured by the SmartPill would be correlated with definitive clinical diagnoses, patient symptoms, or responses to treatment.
• Comparison to Established Diagnostic Methods: Although not explicitly stated as "ground truth," the mention of "Konsyl Sitzmarks" as a predicate device for colonic transit time suggests that the SmartPill's CTT measurements might have been compared to this established method, which uses radiopaque markers to assess colonic transit.
• Expert Consensus: Likely involved in establishing the "cutoff values" based on clinical expertise and observed patient populations.

8. The Sample Size for the Training Set

The document explicitly mentions "two prospective clinical studies" that involved establishing and validating cutoff values. It does not specify separate "training" and "test" sets in the context of machine learning model development or explicit algorithm training. However, the first study "established cutoff values" which could functionally serve as a "training" or "calibration" phase, and the second study "validated the cutoff values," acting as a "test" phase.

Sample Size: The exact sample sizes for these studies are not provided.

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

As inferred above, if the "first study" that "established cutoff values" is considered the training phase:

• The ground truth would likely have been established through clinical observation and correlation with patient diagnoses and symptoms in a population of subjects relevant to the device's indications (e.g., healthy individuals to define normal ranges, and patient populations with known gastroparesis or constipation to define abnormal ranges).
• It's probable that medical experts (e.g., gastroenterologists) were involved in interpreting the results and setting these cutoff values based on clinical utility and statistical analysis of the study data. The document does not provide details on the specific methods used.

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The SmartPill GI Monitoring System is indicated for use in evaluating patients with suspected delayed gastric emptying (gastroparesis).

The SmartPill GI Monitoring System measures pH, pressure and temperature throughout the gastrointestinal tract. These physiological measurements are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). In addition, pressure contraction patterns from the antrum and duodenum are used to calculate motility indices.

Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.

Not for use in pediatric populations

The SmartPill GI Monitoring System senses and records pH and pressure measurements from the entire length of the gastrointestinal tract for use by physicians to evaluate patients with delayed gastric emptying. Sensors on board an ingestible capsule measure pH and pressure as the capsule travels the length of the GI tract. Measurements are transmitted from the capsule within the GI tract via ASK modulated RF signal at 434 MHz to a patient-worn Data Receiver and subsequently downloaded to PC for analysis and review. MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time.

The provided document is a 510(k) summary for the SmartPill GI Monitoring System (K053547). It outlines the device's intended use, comparison to predicate devices, and a high-level summary of performance testing. However, it does not provide specific acceptance criteria or detailed results of the study that proves the device meets those criteria.

Here's an analysis based on the available information, highlighting what is present and what is missing based on your request:

The SmartPill GI Monitoring System is indicated for evaluating patients with suspected delayed gastric emptying (gastroparesis). It measures pH, pressure, and temperature throughout the gastrointestinal tract to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT). It also uses pressure contraction patterns to calculate motility indices.

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The "PERFORMANCE SUMMARY SAFETY TESTING" section states: "The SmartPill GI Monitoring System was tested in multiple bench tests to verify the accuracy and precision of the device. In addition, clinical testing was conducted to validate the device's indications for use. Results of these tests support the product's intended use, indications for use, performance and clinical claims."

However, specific quantitative acceptance criteria (e.g., "GET measurement must be within X% of a reference standard") and the corresponding performance achieved (e.g., "achieved Y% accuracy for GET") are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "clinical testing was conducted to validate the device's indications for use" but does not specify the sample size for this clinical testing. It also does not mention the data provenance (e.g., country of origin) or whether the data was 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)

This information is not provided in the document. The method for establishing ground truth is not detailed, nor are the experts involved or their qualifications.

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

This information is not provided in the document.

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

The SmartPill GI Monitoring System is a diagnostic device that measures physiological parameters, not an AI-assisted diagnostic tool that humans interpret. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not applicable in this context and was not mentioned. The device's output (gastric emptying time, etc.) is reported to the physician, who then uses this information for evaluation.

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

The device itself is a "standalone" system in the sense that the capsule collects data and the "MotiliGI™ Software performs data analyses automatically and provides the physician with a printable report containing gastric emptying time, motility index, and total transit time." This implies an algorithm-only analysis of the collected data. The document states "clinical testing was conducted to validate the device's indications for use," which would assess the accuracy of these automated measurements against clinical reality, serving as a standalone performance evaluation. However, specific performance metrics are not reported.

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

The document states that the system's measurements "are used to determine gastric emptying time (GET), total transit time (TTT), and combined small-large bowel transit time (SLBTT)" and that "pressure contraction patterns from the antrum and duodenum are used to calculate motility indices." The clinical testing was done "to validate the device's indications for use" in evaluating "suspected delayed gastric emptying (gastroparesis)." This implies that the ground truth for validation would likely involve established diagnostic methods for delayed gastric emptying, potentially including gastric emptying scintigraphy (GES) or other recognized clinical assessments for gastroparesis. However, the specific type of ground truth used is not explicitly stated.

8. The sample size for the training set

The document does not provide any information about a "training set" or its sample size. This suggests that the device's algorithms were either developed based on established physiological principles and perhaps small internal validation, or this detail was not considered necessary for this 510(k) summary.

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

Since no training set is mentioned, this information is not provided.

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