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The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing, and usually does not involve clinical studies with human patients or "AI" in the context of diagnostic algorithms. Therefore, many of the questions related to AI performance metrics (e.g., human reader improvement with AI assistance, MRMC studies, training set details, ground truth for training) are not applicable to this specific type of device and submission.

Acceptance Criteria and Device Performance Study (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System)

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative "acceptance criteria" in the typical sense of performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and material characterization tests. The primary acceptance criterion is that the new device performs comparably to the predicate and does not introduce new safety concerns.

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

• Sample Size: Not applicable in the context of a clinical "test set" for performance evaluation like diagnostic devices. The "test set" here would refer to the number of stents/delivery systems tested in various engineering studies. The document does not specify the exact number of units tested for each engineering study, but such tests typically involve a statistically relevant number of units to ensure reliability.
• Data Provenance: The studies were bench performance testing and engineering studies, not studies on human patients. The data is thus internally generated by the manufacturer (IDEV Technologies, Inc.) through laboratory experiments. No country of origin for patient data is relevant. The studies are by nature prospective in their design (i.e., experiments were designed and executed to test specific parameters).

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

Not applicable. "Ground truth" in this context would refer to the characteristics being measured (e.g., material composition, mechanical properties). These are established by standardized physical/chemical testing methods, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive "ground truth" requiring adjudication by experts. The results are quantitative measurements from engineering tests.

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 device is a physical medical implant (stent) and its delivery system, not a diagnostic imaging device, AI software, or a device that assists human readers. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is based on engineering and material standards and specifications. This includes:

• Chemical analysis standards (e.g., ASTM A967-05)
• Mechanical property test standards (e.g., ASTM F2516-07e2, ASTM E739-91, ASTM F2129-08, ASTM F2063-05, ASTM E1447-09, ASTM E1409-08)
• Nickel ion release testing standards.
• The established design and performance characteristics of the legally marketed predicate device (SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, K122546).

8. The Sample Size for the Training Set

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

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

Not applicable.

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The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen, a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the 6 Fr delivery catheter is 80cm and 120cm. The working length of the 7Fr delivery catheter is 120 cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

This document describes the marketing authorization for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546). This is a 510(k) submission, meaning the device demonstrated "substantial equivalence" to a legally marketed predicate device, rather than undergoing a de novo pathway requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device for performance metrics derived from clinical trials often doesn't directly apply.

Instead, for a 510(k), acceptance is based on demonstrating substantial equivalence through various means, primarily bench performance testing in this specific case, and comparison of design, materials, and intended use. The "acceptance criteria" are implicitly met by demonstrating that the modified device performs similarly or equivalently to the predicate devices across relevant engineering and performance tests.

Here's an analysis of the provided information, addressing your questions where applicable within the context of a 510(k) submission for a stent:

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

For this 510(k), the "acceptance criteria" are not explicitly defined as numerical thresholds in this summary. Instead, they are implied by demonstrating "substantial equivalence" to the predicate devices through bench performance testing. The reported performance is that this testing "demonstrated that the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is substantially equivalent to its predicate devices."

The specific tests performed were:

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: The document does not specify the sample sizes (e.g., number of stents or delivery systems) for the Deployment, Trackability Force Characterization, Catheter Tip Integrity, and Sterilization Validation tests. These would typically be detailed in the full test reports, which are not included in this summary.
• Data Provenance: The data is from "bench performance testing," which implies laboratory testing. No country of origin is specified for the data itself, but the submitter (IDEV Technologies, Inc.) is based in Webster, Texas, USA. This testing is inherently prospective with respect to the 510(k) submission, as it was conducted to support the submission for the modified device.

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 device received 510(k) clearance based on bench testing demonstrating substantial equivalence to predicate devices, not on a clinical trial requiring expert ground truth assessment of patient data.

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

Not applicable, as this was not a clinical study involving human assessment of outcomes or images. The "adjudication" for the bench tests would have been the objective measurements obtained during the tests themselves against predefined engineering specifications.

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 (stent and delivery system), not an AI/imaging diagnostic device, and thus MRMC studies are not relevant to its clearance.

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

Not applicable. This is a physical medical device, not an algorithm or software-only device.

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

The "ground truth" for this 510(k) submission is the performance of the predicate devices. The modified device's performance in bench tests (Deployment, Trackability, Catheter Tip Integrity, Sterilization) was compared against the expected performance and specifications derived from the predicate devices to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

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

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The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device: a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; and the System. Lock which eliminates the possibility. of premature deployment. The working length of the delivery catheter is 120cm.

The SUPERA® stent housed within the 120cm SUPERA VERITAS® stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

Here's a breakdown of the acceptance criteria and the study information for the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Verification Bench-top Testing" and that this testing ensured the device met product specifications. However, specific sample sizes for each test are not provided in the document. The data provenance is from bench-top testing, not clinical data, and is therefore neither retrospective nor prospective in the typical clinical sense.

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

This information is not provided in the document. The testing described is physical, bench-top testing of the device's mechanical properties, not an evaluation requiring expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as the testing is bench-top performance verification, not an evaluation that typically involves adjudication of results by multiple human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or is mentioned. This device is a medical stent, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

No standalone algorithm performance study was done. This device is a physical medical device (stent delivery system), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing ("Verification Bench-top Testing") was product specifications and requirements. Each test (e.g., Bond Tensile Strength, Dimensional Characterization) would have had a predefined acceptable range or threshold set by the manufacturer against which the device's performance was measured.

8. The Sample Size for the Training Set

Not applicable. This device is a physical stent and delivery system, not an AI model requiring a training set.

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

Not applicable. As the device is not an AI model, there is no training set or ground truth in that context.

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The SUPERA™ VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker and Distal Sheath Marker embedded in the Outer Sheath to aid in proper stent positioning; a Thumb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver (ratchet) which moves the stent distally relative to the Outer Sheath; and the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 80cm and 120cm. The SUPERA® Stent is housed within the SUPERA VERITAS® stent delivery catheter and is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends. The SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.

The device is the SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System, indicated for the palliative treatment of biliary strictures caused by malignant neoplasms.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical bench and biocompatibility testing, not a clinical study involving human patient data. Therefore, there is no "test set" in the context of clinical images or patient data.

• Test Set Sample Size: Not applicable (no human patient/image test set).
• Data Provenance: Not applicable. The testing was performed on the device itself and in animal models (Thrombogenicity Study in Dogs).

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

Not applicable. As this was non-clinical testing, there was no ground truth established by medical experts for a test set of images or clinical cases. The "ground truth" was determined by established scientific and engineering protocols and measurements.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical testing was not required in order to demonstrate safety and efficacy for the device modifications described in this 510(k)." The study focused on non-clinical performance and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (stent delivery system), not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was based on:

• Established Biocompatibility Standards: Results of biocompatibility tests were compared against predefined acceptance criteria for each specific test (e.g., cytotoxicity, pyrogenicity, hemolysis).
• Engineering Performance Specifications: Bench tests measured physical properties and performance characteristics (e.g., radial force, torque strength, deployment accuracy) against engineering specifications designed to ensure safe and effective device function, often benchmarking against predicate devices.

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this was not an AI or machine learning study, nor a clinical trial that had distinct training and test patient cohorts. The non-clinical tests were performed on a sufficient number of devices/samples to yield statistically sound results for each specific test.

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

Not applicable. There was no training set. The "ground truth" for the non-clinical tests was established by adhering to recognized standards, protocols, and methods for medical device testing (e.g., 21 CFR, Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies, ISO 10555, ISO 1093, USP , AAMI TIR42).

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SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System is a 7Fr, 0.014" or 0.018" guidewire compatible, multi-lumen sheath based delivery system comprised of a Handle and a SUPERA® Biliary Stent. The stent delivery catheter includes a radiopaque Stent Length Marker Band and Distal Sheath Marker Band embedded in the Outer Sheath to aid in proper stent positioning; a Thurnb Slide connected internally for advancing the Stent out of the Outer Sheath while the Outer Sheath moves proximally in a de-coupled fashion; a Sheath Flush Port for flushing the central lumen of the device; a Deployment Lock that when actuated enables the final deployment stroke of the stent; a Guidewire Lumen with a radiopaque Catheter Tip located on the distal end of the Catheter Shaft; a Guidewire Flush Port used for flushing the Guidewire Lumen; a Stent Driver which deploys the stent distally relative to the Outer Sheath; the System Lock which eliminates the possibility of premature deployment. The working length of the delivery catheter is 120cm.

The SUPERA® Stent housed within the SUPERA VERITAS" stent delivery catheter is a closed end interwoven self-expanding Nitinol stent. The SUPERA® stent is composed of 6 interwoven, closed loop Nitinol wires. The wire loops are closed via a proprietary welding process which utilizes small Nitinol tubes that act as a coupler to provide the mechanical means of joining the wire ends.

The provided text describes the 510(k) summary for the SUPERA VERITAS™ Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. It details the device, its intended use, comparison to predicate devices, and the performance testing conducted.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Engineering studies were performed per the FDA's 'Guidance of Premarket notification 510(k) Submissions for Short Term and Long Term Intravascular Catheters'; the Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; ISO 10555 - Sterile, Single-use Intravascular Catheters; and ISO 10993 - International Standard for 'Biological Evaluation of Medical Devices.'"

While specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a detailed table within this summary, the overall acceptance criterion was demonstrating substantial equivalence to predicate devices. The reported device performance, in this context, is that the device met this criterion.

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

• Sample size for the test set: Not explicitly stated. The document mentions "bench and animal performance testing" but does not provide details on the number of units tested or animals used.
• Data provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it is expected to be from studies conducted by the manufacturer (IDEV Technologies, Inc.) or contracted labs. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission. No country of origin for the data is specified, but the submitter is a US-based company.

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

Not applicable. This submission relies on engineering and animal testing, not human expert interpretation of data or images to establish ground truth.

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

Not applicable. This study does not involve human interpretation or adjudication of results to establish ground truth.

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 (stent and delivery system) submission, not an AI/software-as-a-medical-device (SaMD) submission. No MRMC study was conducted.

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

Not applicable. This is a physical medical device.

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

The ground truth for the performance testing was based on engineering measurements and observations from bench testing (e.g., mechanical properties, deployment characteristics, material integrity) and physiological and safety outcomes in animal models (e.g., biocompatibility, deployment success, patency).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is indicated for use with the 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in palliative treatment of biliary strictures produced by malignant neoplasms.

The SUPERATM Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter was designed and is manufactured by IDev Technologies, Inc. for use with the FDA 510(k) cleared SureSave™ Self-Expandable Biliary Nitinol Stent (K060557), a.k.a. SUPERA™ biliary nitinol stent, in the palliation of malignant strictures (neoplasms) in the biliary tree. It shares the same indication for use and design features as the Precision™ Stent Delivery Catheter (K060557) with the exception of modifications that do not significantly affect the function and/or safety of the device.

Please refer to Figure 1. The SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter is a 7 Fr, 0.018" guide wire compatible, multi-lumen sheath based delivery system comprised of an Outer Sheath (1) attached proximally to a Handle (2); a radiopaque Marker Band (3) located on the Outer Sheath that can be visualized under fluoroscopy to assist in system placement/SUPERA™ stent deployment; a Thumb Slide (4) connected internally to a means for advancing the SUPERA™ stent out of the Outer Sheath as the Outer Sheath moves proximally in a de-coupled fashion; a Stopcock (5) for flushing the central lumen of the device and for contrast injection; a Retention Cable (6) connected to the proximal end of a stent to assist in resheathing/repositioning the stent; a Resheath Collar (7) that can be actuated to allow for resheathing or deployment of a stent; a Torquer (8) connected to the Retention Cable for external visualization of the deployment process, a dedicated Guidewire Lumen (9) for traversing over an 0.018" guidewire with a radiopaque Flexible Tip (10) and Guidewire Luer Fitting (11), used for flushing the Guidewire Lumen, located on the distal and of the Guidewire Lumen, respectively; a Hemostasis Valve (12) that can be tightened to eliminate relative motion of the Flexible Tip with respect to the Outer Sheath; a Y-Port (13) housing the Retention Cable and serving as a point of reference for deployment; an introducer Valve Defeater (14); a Re-Sheathing Indicator (15); and a Packaging Mandrel (16).

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific acceptance criteria with numerical performance metrics for the device itself (SUPERA™ Interwoven Self-Expanding Nitinol Biliary Stent Delivery Catheter). Instead, it states that the device is "substantially equivalent" to a predicate device based on preclinical testing.

Therefore, a table of specific numerical acceptance criteria and reported device performance from the provided document cannot be generated.

However, based on the narrative, the implicit acceptance criterion is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557).

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

The document mentions "preclinical testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This often implies bench testing, animal studies, or a combination, but the details are not provided.

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

The document does not mention the use of experts to establish ground truth. Preclinical testing for a device like a stent delivery catheter often focuses on engineering specifications, mechanical properties, and functional performance in simulated environments or animal models. Expert adjudication is more common in diagnostic or image-interpretation devices.

4. Adjudication Method for the Test Set

As there's no mention of experts establishing ground truth, there is no adjudication method described.

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

No, an MRMC comparative effectiveness study was not done or is not mentioned in the provided text. The evaluation method focused on preclinical testing for substantial equivalence, not human reader performance.

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

N/A. This device is a medical instrument (stent delivery catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device itself performs its function.

7. The Type of Ground Truth Used

The text doesn't explicitly state the "type of ground truth" using terms like "pathology" or "outcomes data." However, given it's a medical device, the ground truth for preclinical testing would likely involve:

• Engineering specifications and measurements: Verifying dimensions, material properties, deployment forces, etc.
• Functional performance in simulated environments: Assessing the catheter's ability to navigate, deliver, and resheath a stent under controlled conditions.
• Animal study observations (if conducted): Direct observation of successful stent delivery and performance in an in-vivo model, potentially with histological evaluation or imaging to confirm proper placement and tissue response.

8. The Sample Size for the Training Set

Not Applicable (N/A). This device is not an AI/ML algorithm. Therefore, there is no "training set."

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

Not Applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of Acceptance Criteria and Study (Based on Substantial Equivalence):

The primary acceptance criterion described is substantial equivalence to the predicate device, the Precision™ Stent Delivery Catheter (K060557). This equivalence was confirmed through preclinical testing. While the details of this testing (specific tests, sample sizes, metrics) are not provided, the implication is that the tests demonstrated that the modified features of the new device "do not significantly affect the function and/or safety of the device" compared to the predicate. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.

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The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is indicated for palliative treatment of biliary strictures produced by malignant neoplasms.
The SureSave " Self-Expandable Biliary Nitinol Stent and Precision" Stent Delivery Catheter is intended for use in the palliation of malignant neoplasms in the biliary tree.

The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is comprised of two components; the implantable SureSave™ metallic stent and the Precision™ delivery system. The stent, provided pre-mounted on the delivery system, is a woven wire is constructed from a biomedical superalloy wire, braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, self-expanding and can withstand strong radial force. The delivery system consists of an inner and outer catheter. The exterior catheter serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. The inner catheter contains a central lumen which will accommodate a 0.018" guidewire.

The provided text describes a 510(k) submission for a medical device called the SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter. This document is a regulatory approval letter from the FDA, not a detailed study report. As such, it does not contain the acceptance criteria or the specifics of a study that proves the device meets those criteria, nor any of the detailed information about sample sizes, ground truth establishment, or expert involvement that you requested.

The information provided is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance, rather than a clinical trial demonstrating performance against specific, quantifiable acceptance criteria.

Therefore, I cannot fulfill most of your request from the given text.

However, I can extract the following limited information:

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

This information is not available in the provided document. The document states: "The SureSave™ Self-Expandable Biliary Nitinol Stent and Precision™ Stent Delivery Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through preclinical testing." It does not provide specific performance metrics or acceptance criteria for that preclinical testing.

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 available in the provided document. The document mentions "preclinical testing" but does not specify sample sizes or data provenance.

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 available in the provided document.

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

This information is not available in the provided document.

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:

This information is not applicable/available. The device is a physical stent and delivery system, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable/available. The device is a physical stent and delivery system, not an algorithm.

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

This information is not available in the provided document beyond the general statement of "preclinical testing" for substantial equivalence.

8. The sample size for the training set:

This information is not applicable/not available. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable/not available. The device is a physical medical device, not a machine learning model.

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The Texan LONGhorn™ Foreign Body Retrieval Device is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan LONGhorn™ is comprised of the following:

• A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a catheter. The "loop" portion of the wire has a platinum core for enhanced radiopacity.
• An inner member accepting an 0.018" guidewire. The proximal end of the inner carrier extends out the side port of a Y-connector allowing for the physician to manipulate the guidewire thru the device.
• An outer member. The proximal end is connected to a hemostasis Y-connector, having a side port and Tuohy-Borst connector on the central port for securing the hypotube.
• the Tuohy-Borst connector allows the physician to secure the loop size once it is deployed to the desired diameter
• the side port of the Y-connector allows access to the guidewire-dedicated lumen and the T-connector to allow for contrast injection and flushing
  The loop is activated by moving the red capped knob and handle axially. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by retracting the red capped knob proximally while the device is held stationary in position. Once the loop is tightened around the foreign body, the handle and shaft shall be locked by rotating the hemeostasis valve connected to the proximal end of the handle clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan LONGhorn™ TX30120060 and the foreign body as a unit into the sheath.

The provided document is a 510(k) summary for the Texan LONGhorn™ Foreign Body Retrieval Device, seeking substantial equivalence to a predicate device. It contains information about the device description, intended use, technological characteristics, and a non-clinical performance test. However, it does not provide the detailed acceptance criteria and study results in the format requested.

Specifically, the document states:
"The Texan LONGhorn™ Foreign Body Retrieval Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:

• Tensile to verify design meets minimum tensile strength requirements at all joints, as 프 defined in product specification.
• Animal Study to evaluate the safety and efficacy of a proposed device, and evaluate . operational characteristics of the device with respect to utilization of a predicate device."

This is a high-level summary and lacks the specific details required to populate the requested table and answer many of the questions.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated as unavailable based on the provided text:

1. Table of acceptance criteria and reported device performance:

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

• Test set sample size: Not specified. The document mentions an "Animal Study," but the number of animals or specific foreign body retrieval instances is not provided.
• Data provenance: Prospective (as it's an animal study conducted for regulatory submission). Country of origin is not specified, but the submission is to the US FDA.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified. Given it's an animal study for a medical device, it would likely involve veterinary professionals and/or device engineers, but no details are provided.

4. Adjudication method for the test set:

• Not specified.

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, a MRMC comparative effectiveness study was not done. This device is a mechanical foreign body retrieval device, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used:

• For the tensile test, the ground truth would be the pre-defined product specifications for tensile strength.
• For the animal study, the ground truth would be the observed safety outcomes (e.g., absence of perforation, embolization, or other adverse events) and successful retrieval/manipulation of foreign bodies in the animal model, observed directly by the investigators.

8. The sample size for the training set:

• Not applicable. This device is a mechanical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable as there is no training set for this type of device.

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The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.

The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is comprised of three discrete elements:

• . An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure.
• 트 An inner member, connected distally to the distal cnd of the thrombasket. Proximally, the inner member is connected to a handle.
• 트 A thrombasket, composed of woven or braided stainless steel wire.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The documents are FDA 510(k) clearance letters for the Akonya Eliminator Plus Mechanical Thrombectomy Device. They establish substantial equivalence to predicate devices and outline the indications for use. While they mention "pre-clinical animal data presented in the performance section of this 510(k) submission" as the basis for an expanded indication, the details of this data, including the specific criteria and results you've asked for, are not included in these documents.

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The Texan™ Foreign Body Retrieval Device is indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan™ is comprised of the following:

• A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a dedicated catheter lumen. The "loop" portion of the wire has a radiopaque feature, comprised of Nitinol wire with a platinum core and tungsten sheath
• A two-lumen catheter body. One lumen is dedicated for use by the loop wire, which is secured to the push-rod (shaft) at the proximal end of the loop wire. The second and larger lumen is dedicated for use of a guidewire and contrast. The proximal catheter end is to be attached to a hemostasis valve with a flush port.
• The hemostasis valve has 2 ports:
• side port having access to the guidewire-dedicated lumen for contrast injection; and
• primary port dedicated for a guidewire, and having a Tuohy-Borst connector.

The loop is activated by pushing the shaft distal to the Touhy-Borst connector while holding the Touhy-Borst stationary. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by pulling the shaft proximally while the device is held stationary in position. Once the loop is tightened around the foreign body the shaft shall be locked by rotating the homeostasis valve connected to the proximal end of the shaft clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan™ and the foreign body as a unit into the sheath.

The provided text is a 510(k) summary for the Texan™ Foreign Body Retrieval Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and details non-clinical performance testing. It does not contain information about acceptance criteria in the form of specific performance metrics or a study designed to prove the device meets these criteria in the context of clinical or comparative effectiveness.

Here’s a breakdown of the information that is and is not available:

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

This information is not present in the provided document in the format of specific, quantifiable acceptance criteria and corresponding reported device performance values. The document states that the device "successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device," but it does not list these requirements as specific acceptance criteria (e.g., success rate > X%, retrieval time

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