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The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex Tracheobronchial Stent System is a permanently implanted expandable metal stent designed to serve as an intralumenal support to keep open the inner lumen of the tracheobronchial tree. They consist of a flexible delivery catheter preloaded with an expandable metallic stent.

The stent is an open-ended cylindrical mesh constructed from a single strand of nitinol wire. The wire is configured into a series of circumferential interwoven loops, with the number of loops being dependent on the diameter of the stent. The stent is elongated and compressed onto a plastic delivery catheter. The stent is held onto the delivery catheter by a crocheted nylon suture wrapped around the stent. The delivery catheter has a flush taper tip at the distal end, and a round hub handle at the proximal end.

The partially covered stent has a single layer of silicone that covers the midsection of the stent. Partially covered stents are available with a distal release system only. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The uncovered stents are available with a distal or proximal release system.

The radiopaque (RO) markers on the delivery system and stent facilitate fluoroscopic placement.

The uncovered stent has one pair of RO markers indicated the approximate locations of the margins of the deployed stent. The partially covered stent has four (4) RO markers. The outer two (2) RO markers indicate the estimated final position of the ends of the deployed stent. The inner two (2) RO markers indicate the estimated final position of the margins of the deployed stent cover.

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire. The delivery system is passed over the guidewire into the tracheobronchial lumen. The stent is positioned appropriately using the RO markers for guidance under fluoroscopy and by bronchoscopic visualization of the stent.

The provided text does not describe acceptance criteria for a device performance study in the context of diagnostic accuracy, which is typically represented by metrics like sensitivity, specificity, or AUC. Instead, it describes acceptance criteria and testing for the safety of a medical device within a Magnetic Resonance (MR) environment.

Here's an analysis of the provided information based on your request, focusing on what is available:

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

The document does not explicitly state numerical acceptance criteria for each test in a table format, nor does it provide detailed quantitative results for the device performance beyond stating compliance. However, it implicitly states that the acceptance criteria are compliance with the FDA Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021.

List of Tests Performed (as part of demonstrating compliance):

• Magnetically Induced Displacement Force: Tested per ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
• Magnetically Induced Torque: Tested per ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
• Heating by Radio Frequency (RF) Fields: Tested per ASTM F2182, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
• Image Artifact: Tested per ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

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

This information is not provided in the document. The tests described are "bench performance testing," implying laboratory-based evaluations of the device itself, not a study involving patient data or human subjects. Therefore, concepts like sample size for a "test set" in the context of diagnostic accuracy or data provenance (country, retrospective/prospective) are not applicable here.

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)

This information is not provided and is not applicable. The study described is bench testing for MR safety, not a study evaluating diagnostic performance where expert ground truth would be established.

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

This information is not provided and is not applicable, as it's a bench test, not a study with human adjudication of results.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is bench testing for MR safety. AI assistance is not relevant to this type of testing.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The performance testing was for the physical device's safety in an MR environment.

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

The concept of "ground truth" (expert consensus, pathology, outcomes data) as it pertains to diagnostic accuracy studies is not applicable here. The ground truth for the safety testing is established by adherence to the specified ASTM standards and the FDA Guidance for MR safety, which define acceptable parameters for magnetic displacement, torque, heating, and artifact generation.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI/algorithm-based device requiring a training set.

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

This information is not provided and is not applicable, as there is no training set mentioned or implied for this device.

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The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Ultraflex™ Tracheobronchial Uncovered Stent System consists of a self-expanding nitinol stent preloaded onto a flexible delivery catheter. The stent is a permanent implant designed to provide intraluminal support to keep open the inner wall of the tracheobronchial tree. A suture is threaded through the stent loops at the proximal end of the stent, to aid in stent removal during the initial procedure in the event of incorrect placement. The stent is preloaded onto the delivery catheter via crocheting of the deployment suture around the stent onto the delivery catheter. The system is provided sterile.

The Ultraflex™ Tracheobronchial Stent is available with either a proximal or distal release system. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The proximal release system begins stent deployment from the upper (proximal) end of the delivery catheter.

The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire, and has two (2) radiopaque (RO) markers on the delivery system to facilitate fluoroscopic placement.

To deliver the stent, the stent delivery system is passed over the guidewire into the tracheobronchial lumen. The delivery catheter is advanced, so that the stent is in the appropriate implant position. This positioning step is conducted under fluoroscopy and/or by bronchoscopic visualization of the stent. The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring, that is attached to the deployment suture, with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. This deployment technique is identical to the predicate Ultraflex stent. The deployed stent expands and creates a scaffold support to assist in maintaining lumen patency of the airway at the implant position.

The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241).

The retention suture material is identical to that of the predicate Ultraflex™ Esophageal NG Stent System (K091816). The wire knot adhesive and the retention suture knot adhesives have been changed to Ultraviolet (UV) cured adhesives with enhanced strength and shorter manufacturing curing times.

The provided text describes a 510(k) premarket notification for the Ultraflex™ Tracheobronchial Uncovered Stent System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute performance against specific acceptance criteria through a clinical study with human readers and ground truth.

Therefore, many of the requested categories for AI/ML device studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.

However, based on the provided text, I can extract information related to the performance data and the conclusion of the study to demonstrate the device meets acceptance criteria by showing substantial equivalence to predicate devices.

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

The acceptance criteria here are implicitly based on demonstrating that the new device is as safe, as effective, and performs as well as the predicate devices. The performance data presented demonstrates that the device met required specifications which are aligned with these criteria.

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

The document mentions "In-vitro and In-vivo testing" and "simulated use bench models." It also states, "Testing was conducted on both the proposed sterile Ultraflex™ Tracheobronchial Stent and the non-sterile Aero™ Tracheobronchial Stent System." However, specific sample sizes (e.g., number of stents tested for each parameter) are not provided. The data provenance is internal testing performed by Boston Scientific Corporation. The nature of the tests (bench models, in-vitro/in-vivo) suggests a prospective, controlled testing environment rather than retrospective data from a specific country of origin.

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 is a medical device submission, not an AI/ML algorithm study requiring human experts to establish ground truth for image or data interpretation. The "ground truth" for this device's performance is established by meeting engineering specifications and scientific standards in a lab setting, rather than expert consensus on clinical cases.

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

Not applicable. This is not an AI/ML algorithm study that would involve adjudication of expert interpretations.

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 not an AI/ML algorithm that assists human readers. No MRMC study was conducted.

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

Not applicable. As this device is a physical medical implant, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently its function when implanted or used.

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

The "ground truth" for this device's performance is based on documented engineering specifications, international standards (e.g., ANSVAAMI, AAMI/ANSI/ISO, USP), and established scientific testing methodologies (e.g., cytotoxicity tests, fatigue tests, pyrogen testing). Performance is measured against these objective criteria rather than subjective expert consensus, pathology, or clinical outcome data in the context of an AI/ML study.

8. The sample size for the training set

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

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

Not applicable. No training set for an AI/ML algorithm was used.

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The Ultraflex Diamond Biliary Stent is indicated for palliative treatment of patients with malignant biliary strictures.

The Ultraflex Esophageal Stent System is indicated for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors.

The Ultraflex Tracheobronchial Stent System is indicated for treatment of tracheobronchial strictures produced by malignant neoplasms.

The proposed Esophageal, Biliary and Tracheobronchial Ultraflex stents are comprised of two components, a metallic expandable stent and a flexible delivery catheter. The stents are mounted on a delivery catheter. The delivery catheter is placed over a guidewire and through the working channel of an endoscope to deliver the stents are available in a variety of diameters and lengths.

This document is a 510(k) summary for the Boston Scientific Ultraflex™ Stent Systems, seeking a labeling claim for MRI safety and compatibility. It is a Special 510(k), which implies modifications to an already cleared device, primarily regarding labeling for performance characteristics rather than changes to the fundamental design or indications for use. As such, the information provided focuses on the MRI safety claim rather than a comprehensive assessment of the stent system's primary clinical performance.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the primary functions of the stents (e.g., esophageal, biliary, or tracheobronchial stricture treatment). The focus of this 510(k) is specifically on MRI safety and compatibility.

For the MRI safety and compatibility claim, the document states:

• Acceptance Criteria (Implied): The stent system must be demonstrated as "MRI safe and MRI compatible." While specific numerical thresholds for aspects like magnetic field interaction, heating, or image artifact are not quantified in this summary, the general acceptance criterion is that the device does not pose an unacceptable risk or degrade image quality significantly in an MRI environment.
• Reported Device Performance: "Bench testing was conducted to support the MRI safety and compatibility claim." No specific quantified results of this bench testing (e.g., deflection angles, temperature rises, artifact sizes) are provided in this summary.

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: Not specified for the bench testing. For MRI compatibility testing of medical devices, the "sample size" typically refers to the number of device units tested.
• Data Provenance: The bench testing would have been conducted in a laboratory setting, likely within Boston Scientific or a contract research organization. The document doesn't specify country of origin or whether it was retrospective/prospective, but bench testing is generally considered prospective in its execution for a regulatory 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):

This question is not applicable to the type of study described. Bench testing for MRI safety and compatibility typically involves engineers and physicists conducting standardized tests according to recognized standards (e.g., ASTM F2052, F2182, F2119). Expert clinical interpretation (like from a radiologist) would not be directly involved in establishing "ground truth" for the physical properties measured during MRI bench testing.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process for resolving discrepancies in expert opinions, typically in clinical studies or image interpretation. Bench testing results are usually objective measurements that do not require such adjudication.

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 concerns a physical medical device (stent) and its MRI compatibility, not an AI or imaging diagnostic product. Therefore, MRMC studies or AI assistance are not relevant to this document.

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

Not applicable, as this is not an algorithm or AI device.

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

For MRI safety and compatibility bench testing, the "ground truth" is established by the physical measurements and properties of the device under specific, controlled MRI conditions, following recognized industry standards (e.g., ASTM standards for MRI compatibility). The "truth" is the measured magnetic field interaction, temperature rise, or image artifact extent.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable, as there is no training set for this device.

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