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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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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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UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

The UltraFlex IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) regulates the inflation and deflation of the balloon.

The UltraFlex IAB catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.

The provided text is a 510(k) summary for the UltraFlex™ IAB, an intra-aortic balloon catheter. This document describes the device, its indications for use, and a comparison to a predicate device. It also mentions various bench tests conducted to demonstrate substantial equivalence, but it does not contain information about a study proving the device meets acceptance criteria using a test set with expert adjudicated ground truth, multi-reader multi-case studies, or information about training sets and their ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria by extracting information from the given text.

The closest relevant information extracted is:

Acceptance Criteria Mentioned (but specific values are not provided):

• The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device.

Study Type (Bench Tests, not clinical or image-based AI performance studies):
The document states that technological differences have been evaluated through bench tests. The following tests were performed:

• Catheter Insertion Test
• Aneurysm Test
• Durability Test
• Catheter Tip to Balloon Bond Tensile per ISO 10555-1
• Outer Lumen to Balloon Bond Tensile per ISO 10555-1
• Sheath and Dilator Surface Visual Inspection per ISO 11070
• Sheath and Dilator Tensile Testing per ISO 11070
• Balloon Volume Test
• Catheter Rate Limit Test
• Kink Resistance
• Sheath and Dilator Dimensional Analysis

Data Provenance/Sample Size (Not Applicable in the provided text for a clinical test set):
The document does not describe a clinical test set, nor does it specify sample sizes for the bench tests.

Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Details (Not Applicable/Not Present in the provided text):
The 510(k) summary focuses on demonstrating substantial equivalence based on bench testing of physical and functional characteristics of the device compared to a predicate device, not on diagnostic performance or AI algorithm validation using image data, which would typically involve expert readers, ground truth establishment, and MRMC studies. Therefore, the requested details about expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment methods for training sets are not present in this document.

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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 Systems are permanently implanted expandable metal stents designed to serve as an intralumenal support to keep open the inner 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 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 covered stent has a single layer of translucent polyurethane that covers the midsection of the stent.

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

The covered stent has four 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 (Figure 1B).

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 stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring 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. When using the proximal release system, stent deployment begins from the upper (proximal) end of the delivery system, and continues to release toward the tip of the delivery system (distally) as the entire suture unravels. When using the distal release system, stent deployment begins from the lower (distal) end of delivery system, and continues to release towards the operator (proximally) as the entire suture unravels.

After the stent is completely released, and the nylon suture has been completely removed, the delivery system catheter can be removed.

The provided document is a 510(k) premarket notification for a medical device (Ultraflex™ Tracheobronchial Partially Covered Stent System). It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, this document does not contain information about a study based on statistical performance metrics (like accuracy, sensitivity, specificity, or AUC) or human reader performance. The "Performance Data" section (Section 7) on page 5 details in-vitro testing and compliance with various standards for aspects like dimensions, fatigue, compression, deployment accuracy, magnetic resonance, corrosion, sterility, pyrogenicity, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to a statistical study, nor can I answer questions 2 through 9, as these pertain to information that is not present in the provided text.

The information provided only demonstrates that the device ("Ultraflex™ Tracheobronchial Partially Covered Stent System") met required specifications for a series of in-vitro tests and complies with various safety and material standards. This is the basis for its substantial equivalence determination by the FDA for market clearance.

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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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The ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

The ACCU-CHEK Ultraflex is an ethylene oxide sterilized, single-use, disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The infusion set includes a stainless steel introducer needle to facilitate insertion of the soft cannula into the dermis. The unit is designed to interface with commercially available insulin infusion pumps with suitable luer connections. The insulin infusion pump systems are designed to control the delivery of U100 insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

The provided text describes the ACCU-CHEK® Ultraflex Infusion Set and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria for device performance or the details of a study proving the device meets specific performance criteria.

The document states that "Non-clinical testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use" and "Non-clinical testing included: soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification testing."

It also explicitly states: "Clinical testing was not required to validate the device modification or support substantial equivalence."

Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through material and design similarities and non-clinical testing, rather than a clinical performance study with detailed acceptance criteria and expert-adjudicated ground truth.

Here's what I can extract based on the provided text, along with what is explicitly missing:

Acceptance Criteria and Device Performance

Detailed Study Information (Based on what is NOT in the document)

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

   • Not provided. The document refers to "non-clinical testing" without detailing sample sizes for specific tests. No clinical test set.

2. 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. No clinical test set with expert-established ground truth was reported.

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

   • Not applicable. No clinical test set with expert adjudication was reported.

4. 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 device is an infusion set, not an AI or imaging device that would involve human readers or AI assistance.

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

   • Not applicable. This device is an infusion set; it does not involve algorithms or AI.

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

   • Not applicable. No clinical ground truth was established as clinical testing was not required. Non-clinical testing would rely on engineering specifications and measurement standards.

7. The sample size for the training set

   • Not applicable. No "training set" in the context of machine learning or AI is relevant here. If referring to design verification or validation, it's not specified.

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

   • Not applicable.

In summary, the provided K122686 510(k) summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical engineering tests (soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification). It explicitly states that clinical testing was not required for this submission.

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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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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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ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

This document is a 510(k) summary for the ACCU-CHEK Ultraflex Infusion Set. It states that the device meets the requirements for its intended use and is substantially equivalent to a predicate device. However, it does not contain any data, acceptance criteria, or study details about device performance.

Therefore, I cannot provide the requested information. The document explicitly states:

"Testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the ACCU-CHEK Ultraflex Infusion Set is substantially equivalent to the predicate device."

This is a summary statement, not a presentation of the actual data or the study design. To answer your questions, I would need access to the full test report or detailed data provided within the 510(k) submission, which is not present in the provided text.

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