(123 days)
RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.
RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.
The acceptance criteria and study proving the device meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Device can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation. | Clinical evidence from a prospective trial of 60 adults "clearly supports product safety and performance and the indications for use in that RED can safely be used to evaluate neuromuscular function of the patient's ability to expel its contents from the rectum in adults with functional constipation (defined by Rome IV criteria)." The specific quantitative measure for "safely" is not explicitly defined here but is inferred to be the absence of reported adverse events or complications during the study. The ability to evaluate neuromuscular function is indirectly supported by the fact that the device is analogous to traditional balloon expulsion tests. |
| Device can be safely and effectively used as a qualitative test for rectal hypersensitivity. | The study "demonstrates that RED can be safely and effectively used as a device for qualitative testing for rectal hypersensitivity, whereas 31.0% of patients experienced rectal hypersensitivity with RED distended when queried on the patient perception to defecate." Safety is again inferred from the absence of reported adverse events. Effectiveness for qualitative testing for rectal hypersensitivity is demonstrated by the ability to identify a significant percentage of patients (31.0%) exhibiting this condition as per patient perception to defecate when the RED device is distended. |
| RED offers benefits with respect to assessing hypersensitivity compared to primary predicate. | "RED offers benefits... Firstly, the equipment and complexities required to use the primary predicate greatly limits the access to hypersensitivity testing. As such, the large subpopulation of individuals who are hypersensitive to lower volumes, but are never tested due to testing complexities of the predicate, are likely to benefit greatly through referral to physical therapy. Further, as the sensitivity evaluation simply requires asking a question about urge to defecate for individuals who are already undergoing rectal expulsion testing, it provides that added benefit at no additional risk than rectal expulsion testing alone with RED would provide." This criterion is met by detailing the advantages of RED in terms of accessibility and ease of use, leading to increased detection of hypersensitivity. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 60 adults
- Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.
4. Adjudication method for the test set:
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
- For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.
8. The sample size for the training set:
The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
As there is no machine learning model or training set, this question is not applicable.
§ 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).