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The Advocate PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 15-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.

This document describes the Advocate PTA Catheter and its 510(k) premarket notification (K192907). It addresses a change in manufacturing location and an expansion of the Indications for Use. The relevant information provided focuses on the safety and performance testing related to these changes.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics for the expanded indications for use. Instead, it states that "extra Validation testing was done on the device to qualify the expanded indications for use" and lists the types of tests successfully completed. This implies that the tests performed met internal acceptance criteria for demonstrating safety and performance.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set (i.e., the number of catheters or tests performed for Deliverability AVF Trackability and Pushability).

The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective testing conducted by Merit Medical Systems, Inc. to qualify the expanded indications for use and the manufacturing location change.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the document describes physical performance testing of a medical device, not a diagnostic or AI-based study requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes physical performance testing of a medical device, not a study requiring adjudication of expert opinions.

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

This information is not applicable. The document describes the testing of a medical device (PTA Catheter), not an AI algorithm. Therefore, no MRMC study or comparison of human readers with/without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The document describes the testing of a medical device (PTA Catheter), not an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of expert consensus, pathology, or outcomes data. For the physical performance tests, the "ground truth" would be the engineering specifications and expected performance characteristics of the device, assessed through laboratory testing.

8. Sample Size for the Training Set

This information is not applicable as the document describes the testing of a medical device, not an AI algorithm that requires a training set.

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

This information is not applicable as the document describes the testing of a medical device, not an AI algorithm that requires a training set and ground truth establishment.

Summary of Key Information from the Document:

• Device: Advocate PTA Catheter
• Purpose of Submission (K192907): Change in Indications for Use and manufacturing location.
• Expanded Indications for Use: Balloon dilation of iliac, femoral, popliteal, infra-popliteal, renal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
• Testing Performed to Qualify Expanded Indications: Deliverability (AVF Trackability) and Deliverability (Pushability).
• Outcome of Testing: Successfully completed.
• Manufacturing Change: Moved from a subcontractor (Arravasc) to Merit Medical in Galway, using the same qualified processes.
• The document implies that the successful completion of the listed safety and performance tests demonstrates that the device meets the necessary acceptance criteria for the expanded indications. However, it does not provide detailed quantitative acceptance criteria or specific numerical results.

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The Merit S-MAK XL™ is intended for percutaneous placement of up to a 0.038" (.097mm) guide wire or catheter into the vascular system.

The S-MAK XL TM utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred. The S-MAK XL TM consists of the following components: One (1) 4F Coaxial Introducer/Dilator Pair (30 cm length) One (1) 21 gauge Introducer Needle One (1) 0.018" (0.46mm) 80cm Nitinol/Palladium Guide Wire

The provided text describes the 510(k) summary for the S-MAK XL™ device. Based on the information available, a study was conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on performance and biocompatibility.

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

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

The document does not explicitly state "acceptance criteria" in a quantified table format for each test. Instead, it lists the types of performance and biocompatibility tests conducted and states that "Passing results were demonstrated on all tests above." We can infer the acceptance criterion for each test was a "passing result" according to the specified international standards and guidance documents.

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

The document does not explicitly state the sample sizes used for each performance and biocompatibility test set. The provenance of the data is implied to be from laboratory testing conducted according to the listed international standards (e.g., ISO, ASTM, USP). There is no information about the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable to the type of testing performed for the S-MAK XL™. The tests are primarily physical, chemical, and biological evaluations, not requiring expert human interpretation to establish a ground truth in the way medical imaging or diagnostic studies might. The "ground truth" is inherently defined by the technical specifications and standards (e.g., a device either passes a tensile strength test or it doesn't).

4. Adjudication method for the test set

Not applicable. The tests are objective and based on established international standards, not requiring adjudication by multiple experts.

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. The S-MAK XL™ is a medical device (vessel dilator/introducer sheath), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant.

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

Not applicable. The S-MAK XL™ is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant.

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

The ground truth for the performance tests and biocompatibility tests is based on adherence to the specified international standards and guidance documents (e.g., ISO, ASTM, USP). For instance, for cytotoxicity, the ground truth is whether the device extract causes a cytotoxic effect within defined parameters. For physical performance, the ground truth is whether the device meets its design specifications (e.g., correct length, ability to insert guide wire).

8. The sample size for the training set

Not applicable. As a physical medical device, the S-MAK XL™ does not involve machine learning algorithms that require 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 Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, and renal arteries.

The Advocate PTA Catheter consists of two lumens, a compatible guidewire lumen (0.014", 0.018" or 0.035") extending from guide wire port in the manifold to the catheter distal tip, and an inflation lumen extending from the proximal inflation port in the manifold to the balloon interior. There are various size balloons in the product matrix, ranging from 2.0-12.0mm in diameter and 20-300mm in length. The catheter has two radiopaque marker bands that facilitate visibility and location during the placement and inflation of the balloon. The catheter is inserted through a 4Fr, 5Fr, 6Fr or 7Fr haemostatic or non haemostatic introducer, depending on the model selected.

The provided document is a 510(k) premarket notification decision letter from the FDA to Merit Medical Systems, Inc. regarding the Advocate PTA Catheter. It outlines the regulatory classification, intended use, and substantial equivalence to predicate devices.

Crucially, this document is for a physical medical device (a catheter for angioplasty), not a software or AI-based medical device. Therefore, the specific questions related to AI/software performance, such as acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, are not applicable to the information contained within this document.

The document explicitly states: "No Safety or Performance testing is required to establish the safety and efficacy of the subject device." This is because the device is being marketed as substantially equivalent to existing predicate devices (Pirouette 014, 018, and 035) with "no technological differences" and manufactured by the "same Manufacturer who makes the identical device under the Pirouette name." The only difference noted is the naming and labeling of the product.

Therefore, I cannot provide the requested information based on this document. The questions you posed are relevant for AI/software medical devices, which typically require extensive validation studies to demonstrate performance.

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Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Merit InQwire® Amplatz Super Stiff Guide Wires are intended to facilitate the placement of devices during diagnostic and interventional procedures. The guide wires consist of a Blue PTFE (Polytetrafluoroethylene) coated flat wire coil, with an inside core wire. The core wire enhances the "Super Stiff" characteristic of the guide wire. The core wire extends the full length of the coil and is welded to the coil at three (3) points; a) the distal end, b) the proximal end and c) a spot weld approx. 22cm from the distal end. These welds are designed to provide integrity and ensure that the guide wire components remain together The outside coil is PTFE coated and this Blue PTFE coating extends from the distal tip of the wire to within 7cm of the proximal tip, which remains uncoated. The Merit InQwire® Amplatz Super Stiff Guide Wires are offered in 0.035-inch and 0.038-inch outer diameter with a 1cm, 3cm, 3.5cm ,4cm, 6cm and 7cm straight and J tip configuration and are available in lengths from 75cm to 260cm. The wires will be provided in a spiral hoop dispenser sized appropriately for the wires diameter and length. The dispenser has a standard flush port luer adapter that accepts any standard luer lock or slip tip syringe to facilitate flushing of the guide wire prior to use. A J-straightener is provided on the dispenser to facilitate the advancement of the wire tip into other devices.

The provided text describes testing conducted for the InQwire Amplatz Super Stiff Guide Wire (K170700) to demonstrate its substantial equivalence to predicate devices, not specifically for a software algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable.

However, I can extract the information that is present regarding the acceptance criteria and the study performed for this medical device.

1. Table of acceptance criteria and the reported device performance

2. Sample sized 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 exact sample sizes used for each performance test. It states that "A battery of testing was conducted" and implies these were laboratory-based tests comparing the subject device to existing predicate devices.

• Sample Size: Not specified.
• Data Provenance: The tests are implied to be conducted by the manufacturer, Merit Medical Systems, Inc., which has locations in South Jordan, UT, USA, and Galway, Ireland. The data is from laboratory testing of the physical device, not patient data (retrospective or prospective).

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 is a physical medical device, not an AI/software device requiring expert interpretation of results for ground truth. Therefore, this information is not applicable. Ground truth was established through validated engineering and scientific testing methods against established standards.

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

This is not applicable as it refers to expert consensus for interpreting results, which is not relevant for the performance testing of a physical guide wire.

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 is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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

The ground truth for the reported tests was established by:

• Reference to predicate devices (Merit InQwire® Amplatz Super Stiff Guide Wire [K163575] and Amplatz Super Stiff Guidewire [K843012]).
• Adherence to industry standards and guidance documents (e.g., FDA guidance Coronary and Cerebrovascular Guide Wire Guidance, ISO 11070:2014, ISO 11135:2014, ASTM F1980-07, ISO 10993-1:2009, ISO 11607-1:2006).
• Risk analysis.

The "ground truth" for a physical device is its measurable physical and chemical properties and performance characteristics against established benchmarks.

8. The sample size for the training set

This is not applicable as this is not an AI/software device.

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

This is not applicable as this is not an AI/software device.

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The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.

The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "EN Snare Endovascular Snare System." It focuses on demonstrating substantial equivalence to a predicate device through various performance and safety tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list specific numerical acceptance criteria for each test. Instead, it lists the types of tests performed and concludes that the device "met the acceptance criteria applicable to the safety and effectiveness of the device."

Therefore, a table cannot be constructed with specific numerical acceptance criteria. The performance is reported as meeting these (unspecified in detail) criteria.

Note: For medical devices, acceptance criteria are typically well-defined in the test protocols, but these are often considered proprietary and not included in publicly available 510(k) summaries beyond broad statements of compliance.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for kink resistance). It reports a "battery of testing" was conducted.

Moreso, this is a premarket notification for a medical device (EN Snare Endovascular Snare System), and the studies described are engineering and bench testing rather than clinical trials with human subject data. Therefore, concepts like "country of origin of the data" (for human subjects) or "retrospective or prospective" do not directly apply in the typical sense. The data provenance would be from laboratory and bench testing environments, likely performed at the manufacturer's (Merit Medical Systems, Inc.) facilities or certified testing labs.

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

This question is not applicable to the type of studies described. The "ground truth" for these engineering and biocompatibility tests is established by objective measurements against predefined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidance documents, not by expert human consensus (like in diagnostic AI studies). The "experts" involved would be engineers, material scientists, and microbiologists who design and execute the tests and interpret the results against those standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective diagnoses or assessments which then need to be reconciled. For device performance testing, the results are objective measurements from instruments or standardized observations which either meet or fail the specified acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often in comparison to human readers, and involves multiple human readers assessing medical cases.

The document describes pre-market testing for a physical medical device (an endovascular snare system), focusing on its mechanical, material, and biological safety characteristics, not its diagnostic or interpretative capabilities.

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

This is not applicable. The device described, the "EN Snare Endovascular Snare System," is a physical medical instrument used for retrieving foreign objects and manipulating catheters. It is not an algorithm, software, or AI system requiring standalone performance evaluation in that context.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the EN Snare Endovascular Snare System is constituted by:

• Engineering Specifications: Explicit design requirements and performance parameters set by the manufacturer.
• International Standards: Compliance with relevant ISO (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135, ISO 10993-1, ISO 2233) and ASTM (e.g., ASTM F1980-07) standards.
• FDA Guidance: Adherence to FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance, FDA Modified ISO 10993 Test Profile FDA Memo G95-1).

The tests confirm that the device physically functions as intended, is safe in terms of materials and interactions with the body, and meets required structural integrity, rather than confirming a medical diagnosis.

8. The Sample Size for the Training Set

This question is not applicable. The studies described are physical performance, material, and biocompatibility tests for a medical device. There is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

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

This question is not applicable, as there is no "training set" for physical device testing in the context of AI. The "ground truth" for the device's design and manufacturing relies on established scientific and engineering principles, verified material properties, and adherence to quality control standards, rather than a labeled dataset.

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The Merit plastic jacketed introducer guide wire is intended to facilitate the placement of devices during diagnostic and interventional procedures, specifically sheath introducers. The wire is indicated for the peripheral vasculature only.

The Merit Prelude Plastic jacketed introducer guide wire consists of a high quality metallic core wire with a radiopaque polymer jacket. The wire will be offered in straight and angled versions, in various lengths.

The provided document is a 510(k) Summary for a medical device (Prelude Plastic Jacketed Guide Wire). It describes the device, its intended use, comparison to a predicate device, and a summary of safety and performance tests. However, it does not contain a detailed table of acceptance criteria and reported device performance with specific values. Instead, it broadly states that tests were conducted according to standards and met acceptance criteria.

Therefore, many of the requested elements cannot be fully extracted or are explicitly stated as not applicable to this type of submission.

Here's an analysis based on the information available:

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

The document does not provide a specific table with quantitative acceptance criteria and corresponding reported device performance values. It generally states that "A battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."

It lists the types of tests performed in the "Safety & Performance Tests" section, but without specific criteria or results.

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 test set or the data provenance. This level of detail is typically found in the full test reports, not usually in the 510(k) summary.

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

Not applicable to this type of device (guide wire). The "tests" are primarily physical, chemical, and biological evaluations, not diagnostic assessments requiring expert interpretation of images or patient data.

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

Not applicable. See point 3.

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 device is a medical instrument (guide wire), not an AI/software device that assists human readers.

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

Not applicable. This is not an algorithm or AI device.

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

For the performance tests listed (e.g., tensile strength, flexibility, biocompatibility), the "ground truth" would be established by the defined test methodologies and expected physical/chemical properties as outlined in the referenced standards (e.g., ISO, ASTM, USP). For example, a "fracture test" would have an acceptance criterion that the wire should not fracture under certain conditions, and the "ground truth" would be the observation of fracture or no fracture.

8. The sample size for the training set

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

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

Not applicable. See point 8.

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