(120 days)
The MPP Plus is an accessory device to be used with the MMS Solar GI system for intraluminal studies of the gastro-intestinal tract (Pharynx, esophagus, stomach, duodenum, Sphincter of Oddi, small bowel, colon, and anorectal area including rectum) to perfuse demineralized or distilled water through the lumen of a multi-lumen catheter to measure pressures.
The perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.
Designated catheters and accessories are required for measurement in each specific area.
Not Found
The provided FDA 510(k) document is a clearance letter for the MPP Plus device, which is an accessory for gastrointestinal motility monitoring. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
It does NOT contain the detailed information required to describe acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies. The 510(k) clearance process focuses on substantial equivalence to existing devices, not necessarily on novel performance claims requiring extensive new clinical proof.
Therefore, for almost all of the requested information, the answer will be that it is not available in this document.
Here's an attempt to answer based on the provided text, and explicitly stating where information is missing:
1. A table of acceptance criteria and the reported device performance
- Not available in this document. The 510(k) clearance letter does not include a table of acceptance criteria or detailed performance data from a study. It confirms substantial equivalence based on information submitted by the manufacturer, which would have included performance data, but that data is not part of this public letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in this document. The document does not describe a particular test set, its sample size, or its provenance.
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)
- Not available in this document. No information on ground truth establishment or expert involvement for a test set is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in this document. No information on an adjudication method is provided.
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 / Not available in this document. The MPP Plus is a physical accessory (perfusion pump) for a gastrointestinal motility monitoring system. It is not an AI-driven diagnostic device that would typically involve human "readers" or an MRMC study comparing AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not available in this document. As noted above, the device is a physical accessory, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in this document. Information on ground truth, if any was collected for performance verification, is not included. However, given it's a measurement device, the "ground truth" would likely relate to the accuracy and precision of the pressure measurements and pump functionality compared to calibrated standards, rather than clinical endpoints like pathology or outcomes data.
8. The sample size for the training set
- Not applicable / Not available in this document. This device is hardware for physiological measurement, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not available in this document. As above, no training set is relevant for this type of device.
§ 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).