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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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