(87 days)
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
| Acceptance Criteria Category | Specific Acceptance Criterion (Inferred from Indications for Use) | Reported Device Performance (General Statement from Document) |
|---|---|---|
| Gastric Emptying Time (GET) | Device accurately measures GET for evaluation of suspected gastroparesis. | Clinical testing validated indications for use. |
| Colonic Transit Time (CTT) | Device accurately measures CTT for evaluation of chronic constipation and differentiation of slow/normal transit. | Clinical testing validated indications for use and established cutoff values. |
| Combined Small and Large Bowel Transit Time (SLBTT) | Device accurately measures SLBTT as a surrogate for CTT when CTT cannot be determined. | Clinical testing validated indications for use and established cutoff values. |
| Whole Gut Transit Time (WGTT) | Device accurately measures WGTT. | Clinical testing validated indications for use. |
| pH Measurement | Device accurately measures pH throughout the GI tract. | "Senses and records pH... from the entire length of the gastrointestinal tract." Performance verified in multiple bench tests. |
| Pressure Measurement | Device accurately measures pressure contraction data from antrum and duodenum for motility indices. | "Senses and records... pressure measurements from the entire length of the GI tract." Performance verified in multiple bench tests. |
| Biocompatibility | Patient-contacting materials are non-sensitizing, non-toxic, non-irritating. | Passed ISO-10993 Part I and USP tests. |
| Electrical Safety | Device meets electrical safety standards. | Met IEC 60601-1 requirements. |
| Electromagnetic Compatibility (EMC) | Device meets EMC standards. | Met IEC 60601-1-2 requirements. |
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.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).