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The Ultraflex Esophageal NG Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula.

The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for Boston Scientific's Ultraflex Esophageal NG Stent System and WallFlex Esophageal Stent System. This document explicitly states that the proposed devices are identical to their legally marketed predicate devices in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life, and manufacturing process.

Therefore, the submission does not describe a study involving acceptance criteria and device performance based on a test set, expert ground truth, or AI assistance. The clearance is based on the substantial equivalence of the new devices to existing, already cleared devices.

Here's why the requested information cannot be extracted from this document:

• No new performance data is presented. The core argument for clearance is "identity" to predicates, not "improved performance" or meeting specific performance thresholds through new testing against a defined ground truth.
• The document states, "The testing performed on the proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System demonstrates the devices are substantially equivalent." This testing would likely be engineering or bench performance tests (e.g., stent radial force, deployment accuracy, material compatibility) to demonstrate the identity and safety of the new devices, not clinical performance against a diagnostic task or a clinical outcome. These tests are not detailed in the provided summary.
• The context is a 510(k) premarket notification for a Class II device. For such devices, especially those claiming identity to predicates with established performance, a comparative effectiveness study involving human readers with and without AI assistance is generally not required or performed.
• AI/Machine Learning is not mentioned. The document describes physical medical devices (stents), not AI-powered diagnostic or therapeutic tools.

In summary, the provided text does not contain the information requested regarding acceptance criteria, study design (test set, ground truth, experts, adjudication, MRMC, standalone), or training set details because the basis for clearance is substantial equivalence (identity) to existing devices, not a new performance claim for an AI/ML-driven device or a device requiring new clinical performance validation in the way described in your prompt.

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Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant turnors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates an updated Magnetic Resonance (MR) Conditional statement in the Directions for Use.

The Ultraflex™ Esophageal NG Stent System (K130004) is substantially equivalent to its predicates because it has identical design and materials, and the only change is an updated MR Conditional statement in the Directions for Use (DFU). This updated statement ensures compatibility with 1.5 and 3.0 Tesla MRI use, aligning with ASTM standard F 2503-08.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Sample Size: Not explicitly stated as a "test set" in the context of human data. The performance data section refers to "Magnetic Resonance testing."
   • Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies laboratory testing rather than human clinical data.

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

   • Not applicable. The "ground truth" here is defined by the technical standard ASTM F 2503-08 for MR Conditional labeling, not by expert medical opinion on a patient dataset.

4. Adjudication Method for the Test Set:

   • Not applicable. The evaluation is based on adherence to a technical standard and laboratory testing, not on human adjudication of cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This study is focused on the MR safety labeling of a medical device, not on diagnostic performance or the effectiveness of human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • Not applicable. This device is a stent, not an AI algorithm. The performance evaluation relates to its physical properties and interaction with an MR environment.

7. The Type of Ground Truth Used:

   • Technical Standard Compliance: The "ground truth" for the device's MR compatibility is established by adherence to the ASTM F 2503-08 standard for MR Conditional labeling.

8. The Sample Size for the Training Set:

   • Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable. There is no training set for this device.

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Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered covered with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device incorporates a material formulation change for the stent covering and covering adhesive material.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, the document describes a 510(k) summary for a medical device called the "Ultraflex™ Esophageal NG Stent System."

This submission is a Special 510(k) Premarket Notification for a device that is substantially equivalent to a previously cleared device. The key difference in the proposed device is a material formulation change for the stent covering and covering adhesive material.

Therefore, the "performance data" section focuses on in-vitro testing to demonstrate that this material change does not negatively impact the device's performance. There is no mention of an AI/ML component, diagnostic performance metrics (like sensitivity, specificity, accuracy), or any studies involving human readers or ground truth establishment relevant to AI.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device is a physical medical implant (stent) and does not involve artificial intelligence or machine learning for diagnostic or assistive purposes.
• Performance Data Type: The "Performance Data" mentioned (dimensional, tensile strength, integrity, exposure resistance, chemical analysis, and biocompatibility) are typical for material changes in medical devices, not for evaluating AI algorithms.
• Comparison to Predicate: The entire submission is built on demonstrating substantial equivalence to a legally marketed predicate device, primarily through in-vitro testing for the material change.

Therefore, I cannot provide the requested table and details because the provided input document describes a traditional medical device submission (a stent with a material change), not an AI/ML device.

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Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device also incorporates two adhesive material changes and the addition of a visual marker on two models.

The provided text describes a 510(k) premarket notification for a medical device called the Ultraflex™ Esophageal NG Stent System. This submission is a "Special 510(k)," which typically means minor changes have been made to a previously cleared device. As such, the emphasis is on demonstrating substantial equivalence to the predicate device rather than presenting new clinical performance data for acceptance criteria and a detailed study proving performance.

Here's an analysis based on the provided text, addressing your points:

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

Rationale: The 510(k) summary (Section 7) states that "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This confirms that the device meets its internal design specifications and performance requirements for in-vitro tests, which are used to demonstrate substantial equivalence, especially for a Special 510(k). However, specific acceptance criteria for clinical outcomes (e.g., success rates, complication rates) are not provided, as this type of submission usually relies on the predicate device's established clinical profile. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate in all relevant aspects, supported by in-vitro testing for the changes made.

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

• Sample Size for Test Set: Not applicable / Not provided.
• Data Provenance: The performance data described is "In-vitro testing." This suggests laboratory-based testing rather than patient-derived data (e.g., retrospective or prospective clinical studies). Therefore, there is no country of origin for patient data.

Rationale: The submission explicitly states "In-vitro testing." This means the testing was likely conducted in a lab environment using physical devices or models, not on a patient population. Consequently, there's no patient data, sample size for test sets (in a clinical sense), or data provenance from a geographical perspective.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

Rationale: Since the performance data is derived from "in-vitro testing" and not clinical studies involving diagnostic accuracy or treatment efficacy evaluated by experts, there is no need for experts to establish ground truth in the context of this submission. The "ground truth" for in-vitro tests is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

• Adjudication Method: Not applicable.

Rationale: As there are no human-interpreted results or clinical outcomes requiring independent review or consensus, an adjudication method is not relevant to "in-vitro testing."

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable.

Rationale: This device is an esophageal stent system, which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not applicable.

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

• Standalone Performance Study: Not applicable.

Rationale: This device is a physical stent system and does not involve an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used

• Type of Ground Truth: Engineering specifications and objective measurements for in-vitro performance.

Rationale: For "in-vitro testing," the ground truth is typically established by predetermined performance specifications, material properties, and objective measurements (e.g., mechanical strength, deployment characteristics, fatigue resistance) that the device must meet.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable.

Rationale: There is no mention of "training" in the context of an algorithm or statistical model. The testing described is performance testing of a physical device.

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

• How Ground Truth for Training Set was Established: Not applicable.

Rationale: As there is no "training set" in the context of an algorithm, the concept of establishing ground truth for it does not apply.

In summary:

This 510(k) submission for the Ultraflex™ Esophageal NG Stent System is a "Special 510(k)," indicating minor changes to a previously cleared device. The primary method of demonstrating performance and substantial equivalence relies on in-vitro testing to show that the modified device's components and full systems meet all required specifications. The submission does not present clinical performance data (e.g., patient-based studies, expert evaluation, or AI algorithm performance) to establish acceptance criteria or prove effectiveness in the way one might expect for a novel device or an AI/diagnostic software product. The "acceptance criteria" are implicitly met by showing the new device performs identically to or within acceptable limits of the predicate device through laboratory testing.

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The Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and, for occlusion of concurrent esophageal fistula (for covered stents only).

The Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

The Covered Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex™ Esophageal NG Stent System consists of a self-expanding metal stent preloaded on a flexible delivery catheter. The stent is offered either bare or covered and with either a proximal release or distal release delivery system.

The stent may be placed flouroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. To deploy the stent, hold the handle hub in the palm of one hand, and grasp the finger ring with the other hand. As the finger ring is retracted, the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When the stent is completely released, the delivery catheter is removed.

This section describes the performance data and acceptance criteria for the Ultraflex™ Esophageal NG Stent System.

1. Acceptance Criteria and Reported Device Performance:

• A modified crochet suture pattern on the delivery catheter to create a 10mm "visual marker" (for proximal release product codes only).
• Modified suture material threaded around the circumference of each stent end. |
  | Impact on Device Performance | These modifications have not impacted the device performance as demonstrated by bench testing. |

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

• Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of clinical data. The performance was demonstrated through "bench testing."
• Data Provenance: The document implies that the "bench testing" was conducted internally by Boston Scientific Corporation. The data provenance is presumed to be internal laboratory testing rather than human subject data with country of origin.

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

• Not applicable. The "ground truth" for this submission was based on engineering bench testing, not expert clinical interpretation of data.

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

• Not applicable. No clinical adjudication method was used for this bench testing.

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 pertains to a medical device (stent system) and its mechanical performance, not an AI or imaging diagnostic tool that would involve human readers.

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

• Not applicable. This device is not an algorithm. Bench testing was performed on the device itself.

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

• The "ground truth" was established through bench testing to assess the mechanical and functional characteristics of the device, primarily focused on ensuring that the stated modifications did not negatively impact performance compared to the predicate device. This would likely involve measurements of physical properties, deployment mechanics, and other relevant engineering parameters.

8. The sample size for the training set:

• Not applicable. This submission describes bench testing for a physical device, not an AI model that requires a training set.

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

• Not applicable. No training set was used.

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