(238 days)
The Mediplus Single Use Anorectal GI Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract.
The Mediplus Single Use Anorectal GI Manometry catheter is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.
Mediplus Single Use Anorectal GI Manometry Catheters are designed for the monitoring of anorectal canal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Anorectal GJ Manometry Catheter is a multilumen PVC tube.
The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the anorectal gastrointestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.
The provided text describes a 510(k) premarket notification for the "Mediplus Single Use Anorectal Manometry Catheter." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.
While the document states that the device has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K951 for the intended use, it does not provide a table of acceptance criteria for specific performance metrics (e.g., pressure accuracy, flow rates, durability) or a study report detailing how those criteria were met.
Therefore, many of the requested details about performance studies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993 | Device has been tested for biocompatibility and meets the requirements of ISO 10993. |
| 510(k) Memorandum: Meet requirements of USFDA 510(k) Memorandum - # K951 for intended use | Device has been tested and meets the requirements of USFDA 510(k) Memorandum - # K951 for the intended use. |
| Technological Characteristics: Technologically equivalent to predicate device in design and physical characteristics. | The Mediplus Single Use Anorectal GI Manometry is technologically equivalent to the predicate device in design and physical characteristics. It is made of PVC, like the predicate device. |
| Functional Performance (e.g., pressure measurement accuracy): | Not explicitly stated or quantified in this document. The document describes the device's function to "facilitates the measurement of pressure." However, no performance metrics (e.g., accuracy, precision, range) or their acceptance criteria are provided. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document states testing was done for biocompatibility and 510(k) memorandum requirements, but does not specify sample sizes or data provenance for these tests. This is a 510(k) submission, which primarily focuses on substantial equivalence rather than detailed clinical performance studies often submitted for PMAs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The type of testing mentioned (biocompatibility, technological equivalence) does not typically involve expert review for ground truth in the same way clinical diagnostic device studies would.
4. Adjudication method for the test set:
- Not applicable/Not 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. This device is an anorectal manometry catheter, not an AI-powered diagnostic imaging device. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not a standalone AI algorithm. It is used by a "trained physician."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility, the ground truth would be established by validated test methods and standards (e.g., ISO 10993).
- For technological characteristics, the ground truth is the specifications and materials of the predicate device.
- No other ground truth relevant to clinical performance is discussed.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/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).