The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Atlantis PV Imaging Catheter" and focuses on regulatory approval based on substantial equivalence to a predicate device. It does not include details on acceptance criteria, a specific study proving device performance, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device as outlined in your prompt.

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The PT2TM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature.

The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.

Guide Wire: The PT2TM Guide Wires with ICE® hydrophilic coating are steerable, polymer-tipped guide wires. The PT2TM is available in a nominal diameter of 0.014 inches, two rail support models, Light Support and Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The 185-centimeter version of the PT2TM is designed with a proximal extension section. This proximal extension section allows connection to the AddWireTM Extension Wire or the similarly designed TrooperTM/PatriotTM Extension Wire. The PT2TM corewire consists of a PTFE coated SS corewire segment coupled to a tapered Nitinol corewire segment. The PT2TM coupler is a stainless steel material. The distal most end of the PT2TM corewire is a SS ribbon. The distal tapered Nitinol corewire segment of the PT2TM is coated with an adhesive pre-coat. The pre-coated corewire is then jacketed with a Tungsten loaded polyurethane sleeve. The entire polymer sleeve of the PT2TM Guide Wire is coated with ICE® Hydrophilic coating.

Extension Wire: The AddWireTM Extension Wire is a PTFE coated SS wire with a connector at the distal end that connects to the proximal end of BSC extendable guide wires. The nominal length is 145 cm and the nominal diameter is 0.014 inches. The AddWireTM Extension Wire is similar in design and materials to the LRM Extension Wire that is currently marketed by BSC as the TrooperTM/PatriotTM Extension Wire.

The Boston Scientific Corporation (BSC) PT2™ Guide Wire and AddWire™ Extension Wire, covered by K030617, received 510(k) clearance based on substantial equivalence to existing predicate devices.

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

The submission does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that "Test results verified that the PT2TM Guide Wires met all of the minimum requirements and are adequate for their intended use" and similarly for the AddWire™ Extension Wire. The performance is summarized qualitatively by confirming that both devices met their respective minimum requirements and are adequate for their intended use.

However, based on the non-clinical tests conducted, the implicit acceptance criteria would have been successful completion of these tests without failure, demonstrating performance comparable to the predicate devices.

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 does not specify the sample sizes used for the non-clinical tests (tensile, fatigue, etc.) for either the PT2™ Guide Wire or the AddWire™ Extension Wire. The data provenance is not explicitly stated but is implicitly from in-vitro laboratory testing conducted by Boston Scientific Corporation. This would be considered prospective testing as it was performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This submission relies on non-clinical (bench) testing and comparison to predicate devices, not on clinical data involving human subjects or expert ground truth determination from images/patient data. Therefore, the concept of "experts establishing ground truth" as typically seen in AI/diagnostic studies is not applicable here. The "experts" would be the engineers and scientists at Boston Scientific Corporation who designed and performed the tests, verifying the device's physical and functional properties. Their qualifications are not provided.

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

As this is a non-clinical, bench testing submission, there was no adjudication method as typically applied to clinical data or subjective assessments by multiple experts. The tests performed are objective, measurable physical and mechanical 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 MRMC comparative effectiveness study was performed or is relevant for this type of medical device (guide wire and extension wire). This is a submission for a physical, interventional device, not an AI or diagnostic imaging device that involves human readers interpreting cases.

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 instrument, not an algorithm or AI.

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

For this type of device, the "ground truth" for non-clinical testing is established by objective engineering specifications, material standards, and benchmark performance of predicate devices. Biocompatibility testing relies on established and accepted biological and chemical assays. The performance is compared against these predetermined specifications and the known performance characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device and does not involve a "training set" in the context of an AI or machine learning model.

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

Not applicable. As stated above, there is no "training set" for this device.

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The Express™ Biliary LD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The 27 mm Express Biliary LD Premounted Stent System will be identical to the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Express Biliary LD Stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs. The Express Biliary LD Stent is made from 316L surgical grade stainless steel tubing. The seamless tubing is initially extruded to a cylindrical shape, and is then drawn down in a series of steps to the final tubing dimension. The stent is formed by laser cutting the pattern from the tube, after which it is cleaned and electropolished to obtain smooth rounded struts. The geometry is a continuous pattern consisting of large and small sinusoidal bands connected by axial struts. The deployed stent provides radial strength while conforming to the natural curvature of the anatomy. The stent provides a ghost like image using conventional radiographic imaging equipment. The currently marketed Express Biliary LD Premounted Stent System is offered with stent diameters of 6 - 10 mm, in one mm increments. The 6 - 8 mm diameter stents has lengths of 17 mm, 37 mm, and 57 mm. The 27 mm length is proposed for these stent diameters and is the subject of this submission. These are considered to be the Small Lumen (SL) models. The 9 mm and 10 mm diameter stents have lengths of 25 mm. 37 mm, and 57 mm. These are considered to be the Large Lumen (LL) models. The balloon delivery catheter for the 27 mm Express Biliary LD Premounted Stent System will be identical to the one utilized on the currently marketed Express Biliary LD Premounted Stent Systems (K021630). The Balloon Delivery Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guide wire. The proposed device is designed to be placed over guide wires which have outer diameters of 0.035" or smaller. This lumen can also be used for infusion of contrast medium. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the stenting procedure. The guide wire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings.

This document describes the regulatory submission (K024048) for the Boston Scientific Express Biliary LD Premounted Stent System (27 mm). The submission asserts substantial equivalence to a previously marketed device (K021630) and does not contain detailed primary study data or explicit acceptance criteria with numerical performance targets and reported device performance.

Therefore, many of the requested sections regarding specific study details, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, cannot be extracted from the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding device performance metrics. Instead, it describes general functional testing and states that "Test results verified that the Express Biliary LD Premounted Stent System is adequate for its intended use."

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document describes non-clinical (functional and biocompatibility) testing. It does not mention clinical data or human subject data.

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. The document describes non-clinical engineering and biological testing, not expert-derived ground truth from clinical cases.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This concept applies to expert review of clinical cases. The testing described is objective, functional 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 comparative effectiveness study was not done.
• Effect Size of AI Assistance: Not applicable, as this is not an AI-assisted device.

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

• Standalone Performance: Not applicable, as this is a medical device (stent system), not an algorithm.

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

• Ground Truth: For the non-clinical tests described, the "ground truth" would be established engineering specifications, material standards, and validated test methods (e.g., tensile strength, corrosion resistance, dimensional tolerances). There is no reference to expert consensus, pathology, or outcomes data for establishing ground truth in this non-clinical submission.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a medical device, not an AI model, so there is no concept of a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable.

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The Ultra-soft SV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.

The provided text describes a medical device submission (510(k)) for the Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI device or a clinical trial with primary endpoints.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the safety and performance aspects as described:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specifically stated. The document mentions "bench testing" and "biocompatibility testing," which are laboratory tests, not human subject studies with a "test set" in the context of AI or clinical trials.
• Data provenance: Not applicable in the context of clinical data provenance. The data comes from internal laboratory testing (bench and biocompatibility).

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. This document does not describe a study involving expert consensus for establishing ground truth.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. This document describes laboratory testing against design specifications and predicate device equivalence, not clinical test set adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC study: No. This is a medical device (PTA catheter) submission, not an AI diagnostic/imaging device.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Ground truth: For this type of device, "ground truth" would be established by engineering specifications, material standards, and performance characteristics of the predicate device. For example, balloon diameter, inflation pressure, burst pressure, and biocompatibility standards. The document states that the device was designed and tested "to assure conformance to the requirements for its intended use."

8. The sample size for the training set:

• Sample size for training set: Not applicable. This submission concerns a physical medical device, not a machine learning model.

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

• Ground truth establishment for training set: Not applicable.

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The WALLGRAFT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallgraft Endoprosthesis (stent graft) consists of a metallic stent comprised of biomedical superalloy monofilament wire with a radiopaque core, braided in a tubular mesh configuration. A platinum nickel micro-cable is incorporated into the stent to enhance radiopacity of the device. A graft material comprised of braided polyester varn (PET) is adhesively bonded to the outside of the metallic stent. This design configuration results in a stent graft that is flexible, compliant, and self-expanding with the barrier characteristics of a tubular graft.

The Unistep Plus Delivery System consists of a coaxial tube system. The exterior tube serves to constrain the stent graft over the interior tube until retracted during deployment. The coaxial tubes have the capability of re-constraining the stent graft after partial deployment. A holding sleeve and stent cup, attached to the interior tube, aid in the re-constraining process.

Radiopaque marker bands situated adjacent to the proximal and distal ends of the stent graft facilitate imaging during deployment. A radiopaque marker band located on the exterior tube and a limit marker band on the interior tube function as deployment limit markers. Re-constrainment is possible up to the point where the exterior tube marker band is proximally retracted to the location of the interior tube limit marker.

The interior tube of the coaxial system contains a central lumen which will accommodate a 0.035" guide wire. The delivery system will be available in a single working length of 90 cm.

The document provided is a 510(k) summary for the WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System. It describes the device, its intended use, and a summary of performance testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "All test results verified that the modified 9 F - 11 F delivery system is adequate for its intended use." This implies that the observed performance met internal company specifications or expected performance characteristics for such devices.

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

The document does not specify the sample sizes used for each test.
The data provenance is internal testing conducted by Boston Scientific Corporation. The country of origin of the data is not specified, but the submitter's address is in Maple Grove, Minnesota, USA. The testing appears to be prospective, performed specifically for this 510(k) submission to demonstrate the modified device's performance.

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

This section is not applicable. The study described involves performance testing of a medical device (mechanical, material, and biocompatibility testing), not a diagnostic or prognostic medical AI algorithm that requires expert-established ground truth.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical endpoints, not for engineering performance testing of a device.

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 section is not applicable. The submission is for a medical device (stent graft and delivery system), not an AI algorithm. Therefore, no MRMC study or assessment of AI assistance for human readers was performed or reported.

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

This section is not applicable. As stated above, this submission is for a medical device, not an AI algorithm.

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

This section is not applicable in the traditional sense of clinical ground truth. For the engineering performance tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., tensile strength required per standard, dimensional tolerances). The "truth" is whether the device meets these pre-defined performance metrics.

8. The sample size for the training set

This section is not applicable. The submission details performance testing of a physical medical device, not an AI algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

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The Biliary Wallstent® Endoprosthesis with Monorail Delivery System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System consists of the following components:

• Biliary Stent
• Monorail Delivery System

The Biliary Wallstent covered in this submission is a self-expanding endoprosthesis constructed of biomedical DFT (drawn filled tubing) monofilament wires, braided in a tubular mesh configuration. It is designed to self-expand to a specified diameter following deployment into the stricture. The Biliary Wallstent is provided pre-mounted on a monorail type delivery system.

The stent will be available in unconstrained diameters of 6.0, 8.0 and 10.0 mm. The three stent diameters will be available in the following lengths.

The monorail delivery instrument consists of two coaxially arranged shafts: an inner shaft made of stainless steel proximally and thermoplast distally, and an outer sheath made of thermoplast. The central lumen within the inner shaft continues to the tip and accepts a 0.014" guide wire through the distal tip that exits the inner through two guide wire holes (inner and outer exit holes).

The stent is pre-loaded on the stent carrier located on the distal segment of the inner shaft. Two radiopaque markers on the inner shaft and one radiopaque marker on the retractable outer shaft are used to facilitate stent placement. The proximal end of the stent is firmly held on the inner shaft with a stent holder, which enables a partially deployed stent to be recaptured and repositioned, if desired. A black release marker on the proximal stainless steel shaft identifies the maximum deployment allowable for recapture of the stent.

The distal end of the outer sheath covers the stent and is retracted to allow for stent deployment. The space between the coaxial inner shaft and the outer sheath is accessed through the T-connector. All catheter models have the same overall length.

The provided document describes a Special 510(k) Notification for the Boston Scientific Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with Monorail Delivery System. This is a premarket notification for a medical device seeking clearance to market, not a study proving device performance against specific acceptance criteria in a clinical setting. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (in-vitro) testing.

Therefore, many of the requested categories for a clinical study on device performance, such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.

Here’s an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for each test, nor does it provide detailed quantitative results. Instead, it lists the types of non-clinical tests performed and states that "All in-vitro test results verified that the Biliary Wallstent Endoprosthesis with Monorail Delivery System is adequate for its intended use."

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

• Sample Size: Not specified. The document refers to "testing" conducted, but does not provide the number of devices or components tested for each non-clinical evaluation.
• Data Provenance: Not applicable. These were in-vitro, non-clinical tests performed by the manufacturer, not data derived from patients or clinical settings.

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

• Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome, which is not part of this non-clinical testing. The "ground truth" for these engineering tests would be the established engineering specifications and measurement standards.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment. These were objective 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

• Not applicable. This document pertains to a physical medical device (biliary stent and delivery system), not an AI algorithm. Therefore, MRMC studies or AI assistance are not relevant.

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

• Not applicable. See point 5. This is not an algorithmic device.

7. The type of ground truth used

• Engineering Specifications / Test Standards: The "ground truth" for the non-clinical tests would be the established engineering specifications, performance standards, and test methods designed to evaluate device integrity, functionality, and safety. The report states "Testing was conducted in accordance with the FDA Guidance for Metal Expandable Biliary Stents."

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this type of medical device submission. Training sets are relevant for machine learning or AI models.

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

• Not applicable. See point 8.

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The NIROYAL® Biliary Premounted Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

The NIROYAL® Biliary Premounted Stent System (NIROYAL® Biliary System) is a stent system consisting of a 0.018" balloon delivery catheter and a gold plated stainless steel stent. The modified NIROYAL® Biliary System is the same as the NIROYAL® Biliary System cleared under K003929, with the exception of the delivery balloon size for the 7 mm x 14 mm stent. The 7 mm x 14 mm stent will be mounted on a 20 mm balloon, instead of a 15 mm balloon as described in K003929.

Acceptance Criteria and Device Performance for NIROYAL® Biliary Premounted Stent System

This document outlines the acceptance criteria and the summary of the study performed to demonstrate that the NIROYAL® Biliary Premounted Stent System (with a modified balloon size) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The following table details the functional testing performed on the modified NIROYAL® Biliary System and the corresponding acceptance criteria. The document states that "Functional testing was conducted to verify the integrity of the modified balloon length of 20 mm for the 7 mm x 14 mm NIROYAL® Biliary System." and implies that the device met these criteria, as substantial equivalence was determined.

2. Sample Size and Data Provenance

The document does not specify the exact sample size used for each functional test. The study appears to be a non-clinical bench test and therefore does not involve human subjects or data from a specific country of origin in the context of clinical trials. The data provenance is internal to Boston Scientific Scimed, Inc. and is generated during product development and modification. This is a retrospective analysis of the modified features against pre-defined engineering specifications.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study involves functional, non-clinical bench testing of a medical device, not a diagnostic or AI-driven system that requires expert consensus for ground truth.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies. This document describes non-clinical functional testing.

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

Not applicable. This is a submission for a modification to an existing medical device, involving non-clinical functional testing, not an MRMC comparative effectiveness study of a diagnostic AI system.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Non-Clinical Test Summary" section describes various functional tests performed on the device itself, independent of human interaction beyond the execution of the tests. This is a standalone (algorithm/device only) performance evaluation of the physical aspects of the stent system.

7. Type of Ground Truth Used

The "ground truth" for this study is based on engineering specifications and pre-defined performance limits established for the device's functional integrity and safety. These limits (e.g., maximum force, minimum pressure, maximum profile) serve as the objective standards against which the device's performance is measured.

8. Sample Size for the Training Set

Not applicable. This is a medical device modification submission based on non-clinical functional testing, not an AI/ML model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As noted above, this is not an AI/ML model; therefore, there is no training set or ground truth established for a training set in this context.

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