(423 days)
The CHOOSTENT™ covered esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula.
This stent is a self-expanding tubular prosthesis designed to maintain patency of esophageal stricture caused by malignant tumors. The unique structure of the membrane connects the several segments to increase the flexibility of the stent and to prevent migration and tumor in-growth. Since the both ends of stent have larger bands, the stent can be fixed firmly within the esophagus. There are totally 12 excellent radiopaque markers made of gold wires; 4 each on both ends of the stents and another 4 at the center. Two retrieval lassos attached to the both ends play a role in removing the stent when necessary or pulling the stent up to the right position in case the stent has been deployed deeply down the stricture. The fully expanded diameter is 18mm for the body and 24mm for both larger bands. There are four standard lengths: 80mm, 110mm, 140mm, 170mm.
This is a 510(k) premarket notification for a medical device, the CHOOSTENT™ covered Esophageal Stent. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a standalone AI or human-in-the-loop system.
Therefore, many of the requested fields are not applicable (N/A) because the provided information is for a physical medical device (esophageal stent) and not an AI/software as a medical device.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance (Ultraflex™ Esophageal Stent System) | CHOOSTENT™ Esophageal Stent Performance |
|---|---|---|---|
| Functional Performance | Deployment time | 21 Sec | 11-17 Sec |
| Functional Performance | Expansion force | 0.81 lb. | 0.83 lb. |
| Functional Performance | Compression force | 2 lb | 2 lb |
| Physical Dimension | Diameter | 18 mm | 18 mm |
| Biocompatibility | Corrosion (in simulated gastric fluid) | No corrosion after 90 days | SAME (No corrosion after 90 days) |
| Mechanical Strength | Tensile strength | >90 lb (more than adequate for safe removal) | >15 lb. (more than adequate for safe removal) |
| Materials | Construction materials | Nitinol wire and Polyurethane | Nitinol wire, gold, and Nusil silicone |
| Indication for Use | Esophageal strictures due to malignant tumors | Yes | Yes |
| Indication for Use | Occlusion of concurrent esophageal fistula | No (implied, not explicitly stated as an indication for predicate) | Yes |
Note: The acceptance criteria for the CHOOSTENT™ are implicitly defined by showing comparable or superior performance to the predicate device across these metrics. The conclusion explicitly states that "the CHOOSTENT™ covered Esophageal Stent is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
Study Details (Applicable to AI/Software as a Medical Device - N/A for this Stent)
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Sample size used for the test set and the data provenance: N/A (This is a physical medical device, not an AI/software requiring a test dataset of patient data. The "tests" mentioned are bench and laboratory tests on the device itself.)
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as understood for AI is not applicable here.)
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
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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: N/A (This is not an AI-assisted diagnostic or therapeutic device.)
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This device is implanted by a human physician, not an autonomous algorithm.)
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device, the "ground truth" is defined by established engineering and material science standards for device performance, biocompatibility, and safety. This is demonstrated through bench and laboratory testing. The regulatory standard is substantial equivalence to a legally marketed predicate device.
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The sample size for the training set: N/A (No AI training set.)
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How the ground truth for the training set was established: N/A (No AI training set.)
§ 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.”