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The Niti-S Esophageal 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 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 and Niti-S Esophageal 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. A length of suture is attached to one end of the stent and can be used for stent repositioning during initial placement, in accordance with the instructions for use.

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Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system.

The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm.

The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for medical devices. It primarily focuses on the substantial equivalence determination for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent.

Crucially, this document does not describe studies involving AI or software-based medical devices with performance metrics like sensitivity, specificity, or AUC. It is for a physical medical device (stent and delivery system) and the performance testing mentioned are mechanical and material integrity tests.

Therefore, I cannot provide the information requested regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/software device. The questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all irrelevant to the content of this document.

The "Performance Testing" section (page 7) lists the following non-clinical tests:

• Packaging strength and dye penetration
• Sterility verification
• Deployment accuracy test
• Deployment force test
• Dimensional test
• Tensile strength test (SDS)
• Trackability and visualization test
• Repositioning force test

These are standard engineering and material science tests for physical medical devices to ensure they function as intended and are safe. The document states that the results "demonstrate that the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are as safe and effective as the predicate device and supports a determination of substantial equivalence."

In summary, the provided document does not contain the information requested about AI device performance studies.

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The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist 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 several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm.

The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.

This document is a 510(k) summary for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and performance data from bench testing. It does not describe a study involving human subjects or AI.

Here's an analysis of what is present and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "The results of the bench testing show that the subject devices meet their specifications" for various tests. However, it does not provide a specific table outlining the acceptance criteria and the numerical results for each test. Instead, it lists the types of bench tests conducted:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified. The document only refers to "bench testing."
• Data Provenance: Not specified. Bench testing is typically performed in a lab setting, so country of origin isn't directly relevant in the same way as clinical data. This is not a study on patient data.

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 document describes bench testing of a medical device (stent and introducer system), not an AI algorithm or a diagnostic tool requiring expert ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As this is bench testing, there is no expert adjudication of image interpretations or clinical diagnoses.

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:

No. This is a 510(k) submission for a physical medical device (stent), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported here.

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

No. This is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. The document states the tests "meet their specifications."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.

Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip.

The device is the Optimos™ Cystotome. The study described focuses on bench testing to demonstrate substantial equivalence to a predicate device, the Wilson-Cook Cystotome.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Thermal Effects Comparison:
  • Optimos™ Cystotome (Subject Device): 18 samples (Model number OCT1906)
  • Cystotome™ Cystoenterostomy Needle Knife (Predicate Device): 18 samples (Model number CST-10)
• Data Provenance: This was a bench test conducted in a laboratory setting using porcine stomach and duodenum tissue. The document does not specify the country of origin of the data beyond the manufacturer (Taewoong Medical Co., Ltd. from Korea) performing the tests. It is retrospective in the sense that the data has already been collected and analyzed.

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

• The document does not specify the use of experts to establish ground truth for the bench testing. The ground truth for thermal damage was established by quantitative measurements of thermal damage zones under a microscope, analyzed using histological strain and NADH.

4. Adjudication method for the test set

• An explicit adjudication method (e.g., 2+1, 3+1) is not mentioned or implied. The measurements and evaluations appear to be made against objective criteria.

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

• No MRMC comparative effectiveness study was done. This device is an electrosurgical accessory, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• N/A. This is a medical device (Cystotome), not an algorithm. The performance described is for the device itself (its ability to puncture tissue and the thermal effects it produces) in controlled bench testing.

7. The type of ground truth used

• For the thermal effects comparison, the ground truth was objective physical measurements derived from histological analysis of tissue samples (porcine stomach and duodenum). This involved measuring the length, width, and depth of the thermal damage zone under a microscope and analyzing it using histological strain and NADH.

8. The sample size for the training set

• N/A. This device does not involve machine learning or AI, so there is no concept of a training set.

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

• N/A. As there is no training set, this question is not applicable.

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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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