(28 days)
The InSIGHT Model S980000 Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons and medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used for esophageal motility and anorectal motility studies. The system includes analysis software, but requires skilled interpretation by a physician to make a diagnosis.
The InSIGHT Model S980000 Gastrointestinal Motility system consists of three basic subsystems. These are: Signal conditioning and recording hardware, Analysis software, and Probes and transducers.
The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. Instead, it describes a 510(k) Premarket Notification for the InSIGHT Model S980000 Gastrointestinal Motility System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's an analysis based on the information provided, highlighting why many requested points cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Safety | "designed to either completely eliminate or mitigate all known health hazards" | |
| "performs as well as or better than the legally marketed predicate devices." | The document states the device meets UL 2601-1 for safety through internal and external lab testing. It doesn't provide specific quantitative safety metrics or criteria. | |
| Effectiveness | "performs as well as or better than the legally marketed predicate devices." | Effectiveness is primarily claimed through substantial equivalence to predicate devices, implying similar diagnostic aid capabilities. No specific quantitative effectiveness criteria (e.g., sensitivity, specificity, accuracy for specific digestive motility disorders) are defined or reported. |
| Key Technological Characteristics are Equivalent to Predicate Devices | "The technological characteristics of the InSIGHT Model S980000 are the same as, or perform equivalently to, the predicate devices." | This is the core "acceptance criterion" for a 510(k) submission: demonstrating equivalence in design and performance to a legally marketed device. The document states this equivalency is met. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / No information provided. The document explicitly states: "No formal clinical testing has been performed, nor is any believed to be necessary." Therefore, there is no test set or related data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / No information provided. As no formal clinical testing was performed, there was no test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / No information provided. No test set, so no adjudication method.
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
- Not applicable / No information provided. The device is a "Gastrointestinal Motility System" with analysis software, not explicitly an "AI" device as typically understood in the context of MRMC studies comparing human readers with and without AI. No such study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No information provided. While the system includes "analysis software," it explicitly states it "requires skilled interpretation by a physician to make a diagnosis." There is no indication of standalone performance testing of just the algorithm without a human in the loop. The "non-clinical testing" mentioned focuses on safety standards (UL 2601-1) and internal design specifications, not diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / No information provided. Since no formal clinical testing was performed to establish device performance against a diagnostic gold standard, no ground truth type is specified. The device's "effectiveness" is based on its functional equivalence to predicate devices which are already accepted diagnostic aids.
8. The sample size for the training set
- Not applicable / No information provided. There's no mention of an "AI" or machine learning component that would involve a training set as often discussed in the context of acceptance criteria for diagnostic algorithms.
9. How the ground truth for the training set was established
- Not applicable / No information provided. As there's no mention of a training set, the method for establishing its ground truth is not applicable.
Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:
The document describes a bench testing and design verification approach, not a clinical study. The primary "study" that supports the device meets its "acceptance criteria" (which are fundamentally about safety and substantial equivalence to predicate devices) involves:
- Design Controls Procedures: Internal processes to ensure the device meets predefined specifications.
- Compliance with UL 2601-1: Meeting a recognized standard for medical electrical equipment safety. This was achieved through a "planned combination of internal design testing to written protocols and outside laboratories."
- Comparison to Predicate Devices: Demonstrating that the "technological characteristics... are the same as, or perform equivalently to, the predicate devices" (BioVIEW Model S960000 and Sandhill DMS). This comparison forms the basis of the "effectiveness" claim in the absence of clinical data.
In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices and adherence to safety standards through non-clinical testing, rather than presenting results from a clinical study with defined performance acceptance criteria, test sets, or ground truth.
§ 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).