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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 consists of an implantable metallic stent and a disposable, flexible introducer system for placement of 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.

The provided document is a 510(k) premarket notification for the Taewoong Medical Co., Ltd. Esophageal TTS Stent. It states that the device is "substantially equivalent" to previously cleared predicate devices (K211706, K123205, K113551) with the "exception of a modification to the Indications for Use statement."

As such, this document does not contain acceptance criteria for this specific submission with new performance data to prove the device meets these criteria. Instead, it relies on the previous clearances and argues that the change in indication does not affect safety and efficacy, therefore no additional performance data is required for this 510(k).

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from this document. The document explicitly states:

• No additional biocompatibility information is required.
• Not applicable for Electrical safety and electromagnetic compatibility (EMC) as it contains no electrical components.
• Not applicable for Software Verification and Validation Testing as it contains no software.
• No additional performance data is required for Bench Testing because no design modifications were made.
• Not applicable for Animal Testing.
• Not applicable for Clinical Data.

The 510(k) submission relies on the substantial equivalence principle, asserting that since the new device is identical in design and materials to previously cleared devices, and the change in indication does not introduce new risks, the prior performance data of the predicate devices is sufficient.

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The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Esophageal TTS Stent consists of the implantable metallic stent and introducer system. The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis that has 10 radiopaque markers; 4 in each end and 2 in the center. It has a body diameter of 18, 20 and 22mm, and a total length from 60 to 150mm. The surface of the body portion of the stent is covered with silicone. The Esophageal TTS Stent is provided in two configurations, either fully covered with silicone or with both heads not covered in silicone (bare). The introducer system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The stent introducer system is passed over the guidewire and through an endoscope into the esophagus. The stent may be positioned appropriately using the X-ray markers for guidance under fluoroscopy.

The provided text is a 510(k) summary for the Esophageal TTS Stent. It describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it explicitly states that no clinical data or animal testing were performed to establish substantial equivalence.

Therefore, the study that proves the device meets acceptance criteria is not a clinical study involving human or animal subjects, but rather bench testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "All samples met their acceptance criteria, demonstrating that when manufactured to specification, the device functions as intended and can be found substantially equivalent to the predicate device." However, the specific acceptance criteria for each test (e.g., a specific force range for the Deployment Force Test) are not detailed within this document. Only the types of tests conducted are listed.

2. Sample size used for the test set and the data provenance

• Sample size: The document states that bench testing was conducted on "both the 22mm diameter size and the 220cm length" of the device. It does not provide a specific number of units tested for each test.
• Data provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Taewoong Medical Co., Ltd., which is based in Korea. This is a retrospective evaluation of the device performance during its development and prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device's substantial equivalence was established through bench testing, not a clinical study requiring expert assessment of patient data.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human judgment. The outcome of the bench tests would have been objective measurements against predetermined (but not specified in this document) specifications.

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 medical device (stent) and not an AI/software product, so an MRMC study and AI assistance are not relevant to its performance evaluation as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the bench testing would be the engineering specifications and design requirements for the device. The tests validated that the manufactured device performed in accordance with these established technical criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or a "training set" in the context of AI.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

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