(200 days)
HANAROSTENT® Esophagus (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
HANAROSTENT® Esophagus (CCC) is a self-expanding polygon mesh surface, tubular prosthesis designed to maintain patency of esophageal strictures caused by malionant tumors. The stent is made of Nitinol wire (hook and cross wire structure) and a silicon membrane designed in such a way as to prevent migration and tumor in-growth. The stent is symmetrical in shape, with the diameter of both ends of the stent extending beyond the diameter of the stent body (larger banded flanges). This band design has become standard practice and aids in preventing stent migration.
Based on the provided text, the device in question, HANAROSTENT® Esophagus (CCC), is a medical device, specifically an esophageal stent, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "device performance" in the context of AI models (e.g., accuracy, sensitivity, specificity) and human reader studies (MRMC) does not directly apply here.
The document describes a 510(k) submission for substantial equivalence to predicate devices, focusing on physical and mechanical properties, as well as intended use.
However, I can extract information related to the device's technical specifications and compare them to predicate devices, which serves as the basis for its "acceptance" by the FDA as substantially equivalent.
Here's an interpretation based on the provided text, framed to align as closely as possible with your request, even though it's a medical device rather than an AI system:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are generally demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing intended use, technological characteristics, and performance data to ensure no new safety or effectiveness concerns are raised.
In this case, the reported "device performance" is a comparison of key physical and mechanical properties to predicate devices. The "acceptance criteria" are implied to be that these characteristics are similar enough to not introduce new risks.
| Characteristic | Acceptance Criterion (Predicate Device: Choostent™ covered Esophageal Stent / Ultraflex™ Esophageal NG Stent System) | Reported HANAROSTENT® Esophagus (CCC) Performance |
|---|---|---|
| Intended Use | Maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula. | Matches Predicate (stated as "substantial equivalent intended use") |
| Prostheses configuration | Fully coated | Fully coated |
| Coating material | Silicone | Silicon |
| Stent diameter (mm) | 18mm / 23mm | 18 / 22mm (Within acceptable range or minor difference not raising new concerns) |
| Stent length (mm) | 80-170mm / 100 / 120mm | 80 / 170mm (Within acceptable range) |
| Delivery diameter | 6mm | 6mm |
| Expansion Force (lbs) | 0.83 lbs | 0.94/0.79 lbs (Comparable) |
| Compression force (lbs) | 2 lbs | 1.88 lbs (Comparable) |
| Corrosion (in simulated gastric fluid) | >18 days | > 18 days (Matches Predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "The results of bench and test laboratory testing indicate that the new device is as safe and effective as the predicate devices." and mentions "analyzing both bench as well as laboratory testing to applicable standards".
- Sample size for test set: Not explicitly stated. The testing appears to be on the physical device itself (material, mechanical properties, etc.), not a clinical "test set" of patients.
- Data provenance: Not explicitly stated. It's bench and laboratory testing, likely conducted by the manufacturer, M. I. Tech Co., Ltd. (Korea), given their address is provided.
- Retrospective or prospective: Not applicable as it's bench/lab testing, not a clinical study.
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 is not applicable as the study involves bench and laboratory testing of a physical medical device's properties, not the evaluation of a diagnostic or predictive algorithm. There isn't a "ground truth" to be established by medical experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no adjudication method in the context of physical property testing for substantial equivalence.
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 is a physical medical device (esophageal stent), not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench and laboratory testing, the "ground truth" would be established by validated scientific methods and accepted engineering standards for measuring physical and mechanical properties (e.g., using calibrated instruments to measure force, diameter, corrosion resistance). It's not a clinical "ground truth."
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for a traditional medical device like this.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”