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The Tracheal Stent System (Y -Shaped) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (Y-Shaped) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire by weaving in a Y shaped. This structure design can make the stent more flexible, compliant and self-expanding. The stent is integrated Y-shaped stent, which include 1 main stent, 2 branch stents, the integrated Y-shaped stent can replace three straight shape stents, and the overall design of Y-shaped stent can also be used for the expansion of the carina if there are strictures at the carina. The stent is woven from Nitinol wire. The branch stent is formed with a flange at either end. The stent is partially covered with silicone to restrict tumor in-growth through the wire mesh. To aid in visibility under fluoroscopy there are radiopaque markers at the stent. There are 3 retrieval loops at the end of stent which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

This document describes the Tracheal Stent System (Y-Shaped) and its substantial equivalence to a predicate device. However, the provided text does not describe acceptance criteria for a study proving device performance in the context of AI/ML or diagnostic accuracy, nor does it detail a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data related to an AI/ML component.

Instead, the document focuses on the substantial equivalence of a physical medical device (a tracheal stent system) to a predicate device, as required for a 510(k) premarket notification. The "performance data" sections list various engineering and biocompatibility tests conducted on the stent and its delivery system, ensuring its safety and functionality, not its diagnostic or interpretative accuracy in an AI context.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample size used for the test set or data provenance in an AI/ML context.
• Number of experts or their qualifications for establishing ground truth in an AI/ML context.
• Adjudication method for a test set in an AI/ML context.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data) in an AI/ML context.
• Sample size for the training set for an AI/ML model.
• How ground truth for the training set was established for an AI/ML model.

The document states:

• No animal study is included in this submission.
• No clinical study is included in this submission.

This indicates that the evaluation primarily relies on bench testing, biocompatibility testing, and comparison of technological characteristics to already approved devices, rather than a clinical trial or a study assessing human or AI diagnostic performance.

Summary of what the document does provide regarding device acceptance and performance (not AI/ML related):

The device is a Tracheal Stent System (Y-Shaped) indicated for treating tracheobronchial strictures caused by malignant neoplasms.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The results of all the performance testing demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device TRACHEOBRONXANE™ DUMON Tracheo-bronchial Silicone Stent and reference device AERO™ Tracheobronchial Stent Technology System."

While specific numerical acceptance criteria for each test (e.g., "Deployment Force shall be X to Y N") are not listed in this summary, the document broadly indicates that the device met these criteria. The "Performance Data" section lists the types of tests conducted:

2. Sample size used for the test set and the data provenance: Not applicable. These tests are primarily bench/lab tests, not studies on patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the defined specifications and physical properties of the device, assessed through engineering and biocompatibility standards, not expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:
The "ground truth" for the performance evaluation of this physical medical device is based on engineering specifications and established international standards (e.g., ISO, ASTM standards for biocompatibility, sterility, MR compatibility, and mechanical properties). The device's performance is measured against these predetermined specifications.

8. The sample size for the training set: Not applicable (no AI/ML training involved).

9. How the ground truth for the training set was established: Not applicable (no AI/ML training involved).

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The Tracheal Stent System (OTW) is indicated for use in the treatment of tracheobronchial strictures caused by malignant neoplasms.

The Tracheal Stent System (OTW) consists of a flexible delivery system preloaded with a self-expanding implantable metallic stent. The stent is made of Nitinol wire weaved in a tubular mesh shape. This structure may make the stent more flexible, compliant and self-expanding. The stent is partially or fully covered with silicone membrane and a polymer coating to restrict tumor in-growth through the wire mesh. A retrieval loop made of PE&PP is threaded through the proximal and distal ends of the stent and is intended to aid in removal during the stent placement procedure. To aid in visibility under fluoroscopy, there are Tantalum radiopaque markers at the body of the stent. The stent has flanges at the ends to aid in minimizing migration after

The provided text outlines the acceptance criteria and a study that demonstrates the Micro-Tech (Nanjing) Co., Ltd. Tracheal Stent System (OTW) meets these criteria for substantial equivalence to a predicate device. However, this is not a study that proves the device meets an acceptance criterion, but rather that it meets the acceptance criteria set by the predicate device.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of explicit acceptance criteria with numerical targets alongside performance results for each criterion. Instead, it states that "The results of all the performance testing demonstrated that the proposed device met the acceptance criteria and support substantial equivalence to the predicate device AERO™ Tracheobronchial Stent Technology System." The "acceptance criteria" are implied by the successful completion of the listed tests in accordance with relevant standards and guidelines, demonstrating functional equivalence to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for the various bench tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, which are not included in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for a device, not an AI/software product that relies on expert interpretation for ground truth. The "ground truth" for the performance tests would be established by the defined parameters and methodologies of the referenced international standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader performance.

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 submission, not an AI/software submission. No MRMC study was conducted or mentioned.

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

Not applicable. This is a medical device submission, not an AI/software submission. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

For the various performance tests (biocompatibility, mechanical performance, sterility, shelf-life, MR compatibility), the "ground truth" is defined by the acceptance limits and methodologies specified in the cited international standards (e.g., ISO 10993-1, ASTM F1980-16, ISO 11607, ISO 11135, ASTM F2052, etc.) and FDA guidance documents. These standards provide objective, measurable criteria for evaluating device properties.

8. The Sample Size for the Training Set

Not applicable. This is a medical device submission, not an AI/software submission. There is no mention of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no training set for an AI algorithm.

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