(210 days)
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.
§ 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).