(28 days)
The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.
The Esophageal TTS Stents that are the subject of this 510(k) are identical to the devices cleared in K221482, with the exception of the modification to its introducer system. The Esophageal TTS Stents consist of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.
This document is a 510(k) premarket notification for a medical device called the "Esophageal TTS Stent." It explains that the new device is substantially equivalent to a previously cleared device (K221482) manufactured by the same company, Taewoong Medical.
The core of the document focuses on demonstrating this substantial equivalence, noting that the stent itself is identical to the predicate device, with modifications only to the introducer system (the delivery mechanism). Therefore, much of the testing performed is related to the performance and biocompatibility of this modified introducer system.
Based on the provided document, here's a breakdown of the requested information:
This document is a marketing submission for a medical device (Esophageal Stent) that does not involve AI or software. Therefore, many of the requested criteria related to AI/software performance validation, such as "acceptance criteria for an AI model," "MRMC study," "standalone algorithm performance," "ground truth establishment for training set," are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the standard non-clinical performance and biocompatibility testing for a physical medical device, not an AI or software component.
Here's a detailed response to the applicable sections of your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with specific numerical acceptance criteria and reported numerical performance for each test. Instead, it lists the types of performance tests conducted and then states a general conclusion that the device "meets its design requirements and performs as intended" and is "as safe and effective as the predicate device."
However, we can infer the types of tests and the general outcome:
| Acceptance Criteria Category | Specific Test Conducted (Implied Criteria: Meet Design Req. & Perform as Intended) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Pass (Supports SE) |
| Sensitization (ISO 10993-10:2021) | Pass (Supports SE) | |
| Intracutaneous Reactivity (ISO 10993-23:2021) | Pass (Supports SE) | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass (Supports SE) | |
| Pyrogen Test (ISO 10993-11:2017, USP ) | Pass (Supports SE) | |
| Device Performance | Deployment Test | Meets design requirements |
| Deployment Force Test | Meets design requirements | |
| Dimensional Test | Meets design requirements | |
| Tensile Strength Test | Meets design requirements |
Notes on Acceptance Criteria:
- For biocompatibility tests, the acceptance criteria would be defined by the ISO standards, e.g., "non-cytotoxic," "not a sensitizer," etc.
- For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the acceptance criteria would be specific to the device's engineering specifications, such as "deployment within X seconds," "deployment force less than Y Newtons," "dimensions within Z tolerance," "tensile strength greater than W," etc. These specific numerical criteria and results are not provided in this summary document. The document only states that the testing was conducted and found to demonstrate substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- The document does not specify the sample sizes used for the non-clinical performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength).
- For biocompatibility, the sample sizes would be typical for the specific ISO test methods (e.g., a certain number of mice for acute systemic toxicity, guinea pigs for sensitization), but these are not explicitly detailed.
- Data Provenance:
- This is a submission for a medical device (stent and introducer), not data related to a clinical study or AI model.
- The testing pertains to the physical characteristics and interaction of the device components.
- The manufacturer is Taewoong Medical Co., Ltd., based in the Republic of Korea. It's highly probable the testing was conducted there or at subcontracted labs.
- The tests are prospective in nature, as they are performed on newly manufactured devices or materials to demonstrate compliance for premarket submission.
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)
- Not Applicable. This device is a physical medical device (stent and introducer system) and does not involve a diagnostic AI or imaging interpretation. Therefore, there is no "ground truth" derived from expert interpretation of images or clinical data in the context of an AI model.
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and standardized biological safety tests. The "experts" involved would be engineers, material scientists, and toxicologists/biologists conducting and interpreting the non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth in machine learning contexts (e.g., for radiology readings) where there might be disagreement among human readers. Since this is a submission for a physical device based on non-clinical performance and biocompatibility testing, such adjudication methods are not relevant.
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 submission is for a physical medical device (esophageal stent) and its introducer system. It does not involve AI or software, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not have an "algorithm" component. It is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on engineering specifications and established test methodologies.
- For performance tests (Deployment, Deployment Force, Dimensional, Tensile Strength), the ground truth is defined by the pre-defined design requirements and specifications (e.g., a stent must deploy within a certain time, or a certain force is required for deployment).
- For biocompatibility tests, the ground truth is defined by the results of standardized in vitro and in vivo biological tests as per ISO 10993 series, indicating the material's safety for contact with the body.
- It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-related devices.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device. Therefore, there is no "training set." The device's design is based on engineering principles and knowledge gained from previous device iterations (the predicate device).
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set (being a physical medical device, not an AI), there is no ground truth establishment for a 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.”