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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.

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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.

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The Solar Perfusion Pump 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. Designated catheters and accessories are required for measurement in each specific area.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Solar Perfusion Pump." It does not contain information about acceptance criteria, study design, or device performance against specific metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This document only confirms that the device has received 510(k) clearance based on substantial equivalence to a predicate device.

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The Ohmega system is intended to record, store, view and analyse pH, impedance, pressure and various auxiliary input data in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders.

Designated catheters and accessories are required for measurement in each specific area.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the Ohmega device, indicating that it has been found substantially equivalent to legally marketed predicate devices.

The text does provide information about the device's intended use:

• Device Name: Ohmega
• Regulation Number: 21 CFR §876.1725 (Gastrointestinal motility monitoring system)
• Product Code: FFX
• Indications For Use: The Ohmega system is intended to record, store, view and analyze pH, impedance, pressure and various auxiliary input data in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

However, it does not contain the detailed study information you requested, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphincter of oddi, small bowel, colon and anorectal area including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Solar GI including CIM-AUX Module". It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot answer your request based on the provided input. The document is primarily a regulatory approval letter and not a performance study report.

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The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.

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I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a device called "MMS Video Option," indicating it has been deemed substantially equivalent to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Sample sizes for training or test sets.

The letter primarily focuses on the regulatory clearance of the device for marketing based on its substantial equivalence to a predicate, and its stated "Indications For Use" (acquiring, viewing, recording, processing, printing, archiving, and retrieving video images for gastroenterology and urology procedures). It does not delve into the specific performance metrics or studies used to validate new technological claims.

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The Solar GI system is intended to record, store, view and analyse pressure, EMG, swallow and respiration and various auxiliary input device data on-line anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, duodenum, sphirycter of oddi, small bowel, colon and anorectal area including rectum and pelvic flor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Solar GI". It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), or training set information.

Therefore, I cannot provide the requested information based on the input text. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

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The Solar Neuro Module is indicated for electro-physiological testing of the pelvic organs including motor nerve conduction, sacral reflex and free-run EMG tests.

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I am sorry, but the provided text is a regulatory clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input. The document primarily focuses on:

• Device Name: Solar Neuro Module
• Regulation Numbers and Names: Specifies its classification as an Evoked response electrical stimulator, Nerve conduction velocity measurement device, and Urodynamics measurement system.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.
• Indications For Use: Electro-physiological testing of pelvic organs including motor nerve conduction, sacral reflex, and free-run EMG tests.
• Prescription Use: Confirms it's a prescription-only device.

The letter advises the manufacturer on regulatory compliance but does not detail the technical performance studies.

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