(27 days)
IntraMarX 3D Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.
The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many Gl conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the Gl tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IntraMarX 3D Radiopaque Marker, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria for novel performance claims. The "acceptance criteria" here are therefore inferred from the comparison of characteristics and the non-clinical performance data, which aim to show the device meets existing standards and is as safe and effective as the predicate.
| Acceptance Criterion (Inferred from Substantial Equivalence and Standards) | Reported Device Performance (IntraMarX 3D) |
|---|---|
| Biocompatibility: | |
| - Absence of Cytotoxicity | Pass (per ISO 10993-5) |
| - Acceptable Implantation Response | Pass (per ISO 10993-6) |
| - Absence of Intracutaneous Reactivity/Sensitization | Pass (per ISO 10993-10) |
| - Absence of Material-Mediated Pyrogenicity/Systemic/Subacute Toxicity | Pass (per ISO 10993-11) |
| Radiopacity: | Pass (per ASTM F640-12) |
| Functional Equivalence: | - Same Indications for Use as predicate. |
- Same Mechanism of Action (oral intake).
- Same Capsule Material (HPMC).
- Similar Radiopaque Marker Material (Thermoplastic Elastomer 50% for subject vs. Polyvinyl Chloride 45-46% for predicate, both with Barium Sulfate).
- Same Sterile status (No), Single-Use (Yes), Shelf Life (2 Years).
- Differences in capsule packaging and image area diameter are acknowledged but not stated to impact safety/effectiveness as they don't raise new questions. |
| Safety and Effectiveness: | Performance testing demonstrated the IntraMarX 3D is as safe and effective as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The studies mentioned are primarily non-clinical (biocompatibility, radiopacity). The data provenance is generally not explicitly stated beyond implying these are results from tests conducted by the manufacturer, Ankon Medical Technologies (Shanghai) Co., Ltd., to support substantial equivalence. It does not refer to patient data or clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies mentioned are non-clinical hardware/material tests rather than diagnostic performance studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided as the document does not describe a clinical study or a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The document focuses on showing substantial equivalence of a physical medical device (radiopaque markers) to a predicate device, based on material properties and non-clinical performance, not on the diagnostic accuracy of an AI algorithm or its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, the "IntraMarX 3D Radiopaque Marker," is a physical diagnostic aid. It is not an AI algorithm and therefore, no standalone algorithm performance study was mentioned or would be applicable in this context. The "diagnosis" is made by a physician based on the visualization of the markers on an X-ray.
7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, radiopacity), the "ground truth" implicitly comes from the established pass/fail criteria of the referenced international and national standards (ISO, ASTM). For example, a material either passes or fails the cytotoxicity test based on the standard's definition. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device, as it's not a diagnostic algorithm being evaluated for accuracy against such benchmarks.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The IntraMarX 3D Radiopaque Marker is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as above.
§ 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).