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510(k) Data Aggregation
(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.
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(148 days)
The Single-Use Introducer is used for patient esophageal intubation to guide the catheters and tubes via the nasal or oral cavity. It is to be used in conjunction with endoscopes to allow visualization of the placement process. The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment.
The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.
The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.
The PatCom Single-Use Introducers are made from single lumen, medical grade polyvinyl chloride plastics. The tubing length is 30cm, with an open tip at one end, and a polycarbonate cone made of 2 halves at the other end.
This device is designed to work in conjunction with endoscopes to make the placement of certain catheters and tubes more pleasant for the patient and easier for the end user. The endoscope is placed inside the introducer and both devices together are guided through the nasal or oral passage into the pharynx, via the visual aid provided by the endoscope. The purpose of the visual aid is to prevent unnecessary aggravation of the nasopharyngeal or oropharyngeal wall. Once the introducer is in its desired position, the endoscope is extracted.
The introducer then functions as an open channel from the mouth or the tip of the nose through to the distal opening end of the introducer, as a guide for the placement of catheters and tubes, especially ones that do not contain their own open lumen for use of guidewires that are standard in the gastrointestinal industry. By feeding the catheters or tubes through the introducer, it again minimizes any possible aggravation of the pharyngeal wall as the catheters and tubes would follow the tunnel created by the introducer.
After the catheter is inserted through the introducer and placed into its proper positioning, the introducer is then extracted out of the nasal or oral cavity along the length of the catheter. Once the entire introducer is exposed, the user grips the 2 halves of the cone and pulls apart the introducer to remove and discard.
This document is a 510(k) premarket notification for a medical device, specifically an "PatCom Single-Use Introducer." It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for a novel AI/software medical device.
Therefore, much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and comparative effectiveness (MRMC) cannot be found in this type of document.
The document primarily describes nonclinical bench testing to demonstrate the device's performance, safety, and effectiveness.
Here's an attempt to answer your questions based on the provided text, indicating where information is not applicable or not present:
1. Table of acceptance criteria and the reported device performance
The document mentions that "Individual verification testing was conducted to verify the performance requirements and specifications of the introducer..." and lists the types of tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for these tests. It only states that "All testing and results were successfully completed."
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Dimensional verification meets specifications | Successfully completed |
| Visual inspection meets quality standards | Successfully completed |
| Kink resistance within acceptable limits | Successfully completed |
| Tensile strength within acceptable limits | Successfully completed |
| Device is as safe and effective as predicate | Demonstrated through testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for nonclinical bench testing.
- Data Provenance: The testing was conducted by H&A Mui Enterprises Inc., o/a Mui Scientific, which is based in Mississauga, Ontario, Canada (manufacturer's address). This is a prospective set of nonclinical bench tests.
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)
- This device is not an AI/software device that relies on human expert interpretation for "ground truth" in the way clinical diagnostic AI products do. Therefore, information about experts for establishing ground truth is not applicable/not provided. The "ground truth" for nonclinical bench testing is typically defined by engineering specifications and objective measurements against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the "test set" refers to nonclinical bench testing, there is no human adjudication process involved as there would be for subjective clinical assessments. The results are objective measurements.
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
- No. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the nonclinical bench testing, the "ground truth" is based on engineering specifications and objective physical measurements (e.g., dimensions, force required for kinking, tensile strength). There is no "expert consensus" or "pathology" in this context.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/machine learning training set, this question is not relevant to the PatCom Single-Use Introducer.
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