(259 days)
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
The mcompass Biofeedback Anorectal Manometry System is a manometry system for the measurement of anorectal pressures. It provides visual feedback (biofeedback) of the muscle action allowing the patient to modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), a previously cleared reusable RMD FOB (and related battery charger), and software that resides on a tablet PC and that collects, records and displays the pressure data. Air-charged balloons are used to measure contractile pressures of the anorectal canal and simulate a range of bowel fullness levels, in addition to measuring locational pressure at the distal tip of the catheter. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC
The provided text describes a 510(k) premarket notification for the mcompass Biofeedback Anorectal Manometry System (K143031). It focuses on demonstrating substantial equivalence to a predicate device (mcompass Anorectal Manometry System, K120088) rather than detailing specific acceptance criteria and a study to prove they are met in the same way one might for a novel AI device.
Therefore, the requested information, particularly regarding AI-specific criteria, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this document. This document pertains to the regulatory clearance of a physical medical device.
However, I can extract the information that is present regarding performance data and validation:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for substantial equivalence to an existing device, a direct "acceptance criteria" table with numerical performance targets similar to a novel AI algorithm's sensitivity/specificity is not explicitly stated. Instead, the "performance data" section focuses on demonstrating that the new device meets various safety and functional standards, and that its technological differences do not raise new questions of safety or effectiveness compared to the predicate.
| Category | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Intracutaneous Injection Test, Sensitivity) for surface-contacting devices ( |
§ 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).