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The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-thewire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, coaxial dual lumen shaft, and a distal dilatation balloon. Hydrophilic coating covers the distal 240 mm of the catheter and radiopaque markers indicate the proximal and distal dilating surface of the balloon and facilitate placement across the stenosis. The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is compatible with 4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.

The provided text describes a 510(k) premarket notification for a medical device, the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance data often found in AI/Reader studies.

Therefore, many of the requested categories (2, 3, 4, 5, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided primarily pertains to the general performance data and conclusion.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a 510(k) submission based on bench testing and comparison to predicate devices, not a clinical study on a test set of data.

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

Not applicable. No expert ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No test set adjudication is mentioned.

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 physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool.

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. The device (catheter) performance was evaluated via bench testing.

7. The type of ground truth used

For bench testing, the "ground truth" would be established engineering specifications, performance standards, and the performance characteristics of the predicate devices. The study compares the new device's physical and mechanical properties against these established benchmarks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and fundamental technology are stated to be "same or similar" to previously cleared devices.

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

Not applicable. There is no "ground truth for a training set" as it's not an AI/machine learning device.

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The ADMIRAL XTREME™ (PTA) Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ADMIRAL XTREME™ PTA Catheter is an OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It is a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft and balloon cones are hydrophilic coated (balloon excluded). The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 80 and 130cm.

The provided text describes a 510(k) summary for the ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty (PTA) Catheter. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a novel device's performance.

Therefore, many of the requested details about acceptance criteria, clinical studies, sample sizes, and expert validation are not applicable as this submission is for a medical device cleared via the 510(k) pathway, which relies on demonstrating equivalence to an already approved device rather than proving clinical efficacy or diagnostic accuracy through a standalone study.

However, I can extract the relevant information regarding the performance data provided to establish equivalence.

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

Since this is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are related to in vitro engineering performance equivalence rather than clinical outcomes or diagnostic metrics. The document states that the testing "met the specified requirements" and were "comparable with the predicate device." Specific numerical acceptance values are not provided in this summary.

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

• Sample Size: Not specified for any of the in vitro tests.
• Data Provenance: The testing was "in vitro," implying laboratory testing rather than human subject data. Country of origin not specified, but the manufacturer is Invatec Innovative Technologies in Roncadelle (BS) Italy, and the submitter is ev3 Inc. in Plymouth, MN, USA.
• Retrospective or Prospective: Not applicable for in vitro laboratory testing.

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's performance was evaluated through engineering in vitro testing; it does not involve expert-established ground truth like in a diagnostic AI study.

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

Not applicable. There was no human expert adjudication of test results in the context of diagnostic accuracy.

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 physical medical device (catheter), not an AI diagnostic tool. 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 (catheter), not an algorithm.

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

Not applicable. The "ground truth" for the performance evaluation of this catheter was based on established engineering specifications and benchmarks to demonstrate equivalence to the predicate device. For example, balloon burst pressure would have a specified engineering tolerance rather than an expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. As there is no training set.

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The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.

This document is a 510(k) premarket notification for a medical device called the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. It's a submission to the FDA to demonstrate that the modified device is "substantially equivalent" to an already marketed device, meaning it's equally safe and effective.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Study Details:

The provided document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving these criteria were met using those metrics. Instead, the document focuses on demonstrating "substantial equivalence" to a predicate device through performance testing (bench testing) and similarity in intended use, materials, and technological characteristics.

Therefore, a table of acceptance criteria and reported device performance, and most of the detailed questions about studies, cannot be directly answered from the provided text as they relate to clinical effectiveness studies with human subjects or AI algorithm performance.

However, based on the available information, we can infer the acceptance criteria for a 510(k) submission of this type:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document focuses on demonstrating substantial equivalence, not on providing efficacy and safety data from clinical trials in the way an AI algorithm or a novel drug might. The "acceptance criteria" here are primarily satisfied by demonstrating that the device is fundamentally the same as a previously approved device.

The following questions relate to performance studies, often associated with AI/ML devices or clinical trials. Since this document is a 510(k) for a physical medical device (a balloon catheter) demonstrating substantial equivalence, these specific types of studies are not described or relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 physical medical device, not an AI diagnostic tool.
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.): Not applicable to a clinical test set from patient data. The "ground truth" for the bench testing would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from data.
9. How the ground truth for the training set was established: Not applicable.

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The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The DIVER C.E. Catheter is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheter features an aspiration lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of the catheter to the extension line (High Pressure Tubing), stopcock, and syringe that are included in the catheter package. The DIVER C.E. Catheter has a central aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheter is available in two configurations - with and without sideholes. The catheter is a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheter is compatible with guide wires with a maximum diameter of 0.014". Additionally, a 40u filter basket is also included to allow the physician to perform a post-procedure examination of the aspirated thrombi/emboli material removed during the procedure.

The provided document is a 510(k) summary for the DIVER C.E. Catheter, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics against pre-defined clinical acceptance criteria.

Therefore, the document does not contain the requested information regarding acceptance criteria, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC).

The section "Summary of Testing" states: "Performance Data: The results of verification testing demonstrated that the DIVER C.E. Catheter and its accessories met the established acceptance criteria and performs in a manner equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing program."

However, the specific acceptance criteria and the detailed results of the study that "prove" the device meets them are not provided in this document. The document primarily focuses on demonstrating substantial equivalence through comparison of technological characteristics and intended use, and confirming sterilization validation and general performance testing.

Here's a breakdown of what can be extracted and what is missing:

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

• Missing. The document states that "established acceptance criteria" were met, but does not list them or the specific performance values.

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

• Missing. The document mentions "verification testing" but does not provide details on sample sizes, country of origin, or whether the study was retrospective or prospective.

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

• Missing. No information on experts or ground truth establishment for a test set is provided. This type of detail is typically not part of a 510(k) summary focused on substantial equivalence.

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

• Missing. Not applicable given the document's content.

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:

• Missing. This device is a catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable.

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

• Missing. Not applicable as this is a physical medical device (catheter), not an algorithm.

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

• Missing. The document refers to "verification testing" and equivalence to predicate devices, not clinical ground truth establishment in the context of diagnostic accuracy.

8. The sample size for the training set:

• Missing. Not applicable to this type of device and submission.

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

• Missing. Not applicable to this type of device and submission.

In summary, the provided 510(k) summary for the DIVER C.E. Catheter confirms that verification testing was conducted and met "established acceptance criteria," but it does not disclose the details of those criteria or the study methodology (sample sizes, ground truth, expert involvement, etc.) as these are not typically required for a 510(k) demonstrating substantial equivalence for a device of this nature.

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The SKIPPER and SKIPPER RACE guidewires are intended for use in the peripheral and coronary vasculature.

The SKIPPER and SKIPPER RACE are 0.014" diameter stainless steel guidewires in usable lengths of 175, 195, and 300cm. The guidewires are designed for use in interventional surgical iongallo or 170, 1999, it is introduced percutaneously into the blood vasculature and advanced to a diseased area. The SKIPPER and SKIPPER RACE guidewires contain a silicone or a hydrophilic coating.

The provided text is a 510(k) summary for the SKIPPER™ and SKIPPER™ RACE guidewires. This type of document is for medical device clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria, study sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

Summary of available information related to your prompt:

1. Acceptance Criteria and Reported Device Performance: Not applicable/not explicitly stated in the context of specific quantitative criteria for device performance. The "performance data" section states that "Bench testing pertaining to performance characteristics was conducted on the SKIPPER and SKIPPER RACE guidewires and compared to the predicate device testing to demonstrate equivalency." This implies the acceptance criterion was "demonstration of equivalency" to the predicate device through bench tests, but no specific numerical criteria or results are provided.

2. Sample Size Used for the Test Set and Data Provenance: Not applicable. Performance was assessed through "bench testing," not a clinical study with a test set of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not applicable, as this was bench testing.

4. Adjudication Method for the Test Set: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical medical device, not an AI/software device, and no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device.

7. Type of Ground Truth Used: Not applicable. Performance was assessed via bench testing, likely against established engineering standards or the predicate device's performance, not against "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set: Not applicable. This is a physical medical device, and there is no mention of a "training set" in the context of an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established: Not applicable.

Additional Information from the Document:

• Device Type: Guidewires (physical medical device).
• Intended Use: For use in peripheral and coronary vasculature.
• Predicate Device: ev3 Nitrex™ Nitinol Guidewire (K024021, K031864, K040345).
• Testing Done: Biocompatibility testing (in accordance with ISO 10993 Part 1 and FDA Memorandum #G95-1) and performance bench testing.
• Conclusion: The guidewires are substantially equivalent to the predicate device in intended use, materials, technological characteristics, and performance.

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The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The DIVER C.E. Catheters are aspiration catheters indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheters fresh, son emoved an lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of a stopcock and a syringe for blood aspiration and clot removal (not provided). The DIVER C.E. Syringe for blood aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheters are available in two configurations, with and with ut sideholes. The catheters are a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheters are compatible with guide wires with a maximum diameter of 0.014".

This document is a 510(k) summary for the DIVER™ C.E. Catheter, a medical device. It does not contain the detailed information typically found in a clinical study report or a validation study. As such, I cannot extract specific quantitative acceptance criteria or detailed study results that would allow me to fill in all the requested sections of your query.

However, I can extract the information provided regarding the testing and equivalence.

Here's what I can provide based on the given document:

1. Table of acceptance criteria and the reported device performance:

The document mentions "Comparison bench tests regarding performance characteristics were performed on the DIVER C.E. Catheter (with sideholes), DIVER C.E. Catheter (without sideholes), and the predicate devices to demonstrate equivalency."

However, it does not explicitly state the acceptance criteria (e.g., specific thresholds for performance metrics) nor does it provide quantitative reported device performance values from these bench tests. It only states that the tests demonstrated equivalency.

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

• Sample size: Not specified. The document only mentions "Comparison bench tests" without detailing the number of catheters or test scenarios used.
• Data provenance: Not specified. It's bench test data, so it's not patient-derived from a specific country, and it's not explicitly stated as retrospective or prospective in this context.

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

• Not applicable. The document describes bench testing for "performance characteristics" and "biocompatibility," not a clinical study involving human expert assessment of a test set to establish ground truth.

4. Adjudication method for the test set:

• Not applicable. (See #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:

• No, an MRMC comparative effectiveness study was not done. The document describes bench testing for device performance and biocompatibility for a catheter, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (catheter), not an algorithm.

7. The type of ground truth used:

• For Biocompatibility: In vitro and/or in vivo tests were likely conducted according to ISO 10993 and FDA Memorandum #G95-1. The "ground truth" here would be established by the biological responses observed in these standardized tests (e.g., no cytotoxicity, no irritation).
• For Performance Data: The "ground truth" would be the measured physical and mechanical properties of the catheters and their ability to perform their intended function (e.g., aspiration efficacy, catheter navigability, flow rates) in a controlled bench test environment. These would be compared against the predicate devices.

8. The sample size for the training set:

• Not applicable. This 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:

• Not applicable. (See #8)

Summary of available information:

The document concerns the regulatory submission for a physical medical device (catheter). The "study" referenced is a summary of bench testing to demonstrate performance characteristics and biocompatibility testing to show material safety. The purpose of these tests was to demonstrate substantial equivalence to predicate devices, not to establish specific performance against a defined numerical acceptance criterion in a clinical setting or to evaluate an AI algorithm. Therefore, many of the requested fields are not applicable or the information is simply not present in this regulatory summary.

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The AMPHIRION™ DEEP 0.014'' OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.

The provided text describes a Premarket Notification (510(k)) Summary for the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria in the traditional sense.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this context. The "study" mentioned is primarily bench testing to support substantial equivalence for newly added balloon sizes, not a clinical trial evaluating diagnostic or treatment efficacy against specific performance metrics.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not relevant:

Acceptance Criteria and Device Performance for AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter

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

In the context of a 510(k) for a device like a PTA balloon catheter, "acceptance criteria" are not typically expressed as performance metrics like sensitivity/specificity for a diagnostic device or success rates for a novel therapeutic device against predefined thresholds. Instead, the acceptance criteria revolve around demonstrating substantial equivalence to a predicate device, meaning it has the same intended use, similar technological characteristics, and performs as safely and effectively.

For this specific submission, the "performance" referenced primarily pertains to bench testing to support the substantial equivalence claim for the newly added balloon sizes. The document explicitly states: "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use."

The document does not provide specific numerical acceptance criteria (e.g., burst pressure tolerance, deflation time) or reported performance values from these bench tests. It simply states that the tests were performed and support the claim.

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

The document refers to "Performance testing (bench)."

• Sample Size for Test Set: Not specified. Bench tests often involve a certain number of units per size/configuration to ensure statistical validity, but the exact count is not disclosed in this summary.
• Data Provenance: The tests are "bench" tests, meaning in-vitro laboratory testing, not human or animal studies. Therefore, concepts like country of origin for patient data are not applicable.

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

Not applicable. For bench testing of a device like a balloon catheter, "ground truth" is typically defined by engineering specifications, material properties, and physical measurements, not by expert clinical consensus. The evaluation is against engineering standards and requirements, not expert interpretations of clinical data.

4. Adjudication method for the test set

Not applicable. As described above, the "test set" involves bench testing against engineering specifications, not clinical cases requiring expert 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

Not applicable. This device is a medical instrument (PTA balloon catheter), not a diagnostic imaging system or an AI-powered tool. Therefore, MRMC studies involving human readers or AI assistance are entirely irrelevant.

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

For the bench testing, the "ground truth" would be the engineering specifications and validated testing methodologies against which the device's physical properties and performance characteristics (e.g., burst pressure, inflation/deflation times, guidewire compatibility, shaft flexibility) are measured. These are objective measurements compared to predefined limits and the predicate device's performance.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model that requires a "training set."

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

Not applicable. See point 8.

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The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm.

The provided document is a 510(k) summary for the AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER, a medical device. This type of document is for a medical device that does not use AI/ML technology, and therefore, many of the requested categories are not applicable. The document describes the device, its intended use, and how its safety and effectiveness were demonstrated through in-vitro testing and comparison to predicate devices, rather than a study with acceptance criteria and device performance as typically understood for AI/ML devices.

Here's an attempt to answer the questions based on the provided text, noting where information is not applicable or unavailable:

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device (a catheter) and not an AI/ML device, the "acceptance criteria" and "reported device performance" are based on a series of in-vitro physical tests designed to ensure the device meets engineering specifications and safety standards, rather than diagnostic accuracy metrics.

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

For physical medical devices, "test set" typically refers to the number of individual devices or components subjected to specific physical bench tests. The document does not specify the exact sample sizes (e.g., number of catheters tested for burst pressure), nor does it describe data provenance in terms of country of origin or retrospective/prospective, as these concepts are not applicable to the in-vitro mechanical and material tests described.

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

Not applicable. Ground truth for physical device testing is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical data interpretation or labeling decisions, typically involving multiple human readers to establish a consensus ground truth. This is not relevant for the in-vitro physical testing of a catheter.

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 physical medical device, not an AI/ML diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant.

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.

7. The type of ground truth used

For this device, the "ground truth" for demonstrating safety and effectiveness was based on:

• Engineering Specifications: Performance metrics (e.g., burst pressure, dimensions) were compared against predefined engineering and design specifications.
• Material Standards: Biocompatibility testing followed established material science standards.
• Predicate Device Equivalence: Performance was deemed "substantially equivalent" to legally marketed predicate devices through comparison of physical characteristics and mechanical testing data.

8. The sample size for the training set

Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary regarding AI/ML relevance:

The provided document describes a traditional 510(k) submission for a physical medical device (PTA balloon catheter). It focuses on demonstrating substantial equivalence to predicate devices through physical characteristics (design, materials, dimensions) and in-vitro performance testing (e.g., burst pressure, biocompatibility). None of the information suggests the involvement of AI/ML technology, hence many of the questions regarding AI/ML study design and performance metrics are not applicable.

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The SUBMARINE™ PLUS Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SUBMARINE PLUS Balloon Dilatation Catheter is a catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 inch (0.45 mm). The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated (balloon excluded). The SUBMARINE PLUS Balloon Dilatation Catheter is available in different balloon sizes (balloon diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.018" and the usable catheter length is 130 or 90 cm.

The SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter demonstrated its safety and effectiveness through in vitro testing.

Here's a breakdown 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 in vitro testing. Therefore, there is no "test set" in the context of human patient data. The sample sizes for each specific in vitro test (e.g., number of catheters tested for burst pressure) are not explicitly stated in this summary. The data provenance is from laboratory testing performed by Invatec Innovative Technologies, based in Roncadelle (BS) Italy. This testing is prospective in nature, as it was conducted specifically to demonstrate the device's characteristics.

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

Not applicable. As the study involved in vitro testing, there was no human test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for each test was determined by established engineering and material science standards and measurements.

4. Adjudication Method:

Not applicable. There was no clinical data or expert review requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done for this device. This is an in vitro performance study for a medical device (catheter), not an AI algorithm requiring human reader performance evaluation.

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

Not applicable. This device is a physical medical instrument (catheter), not a software algorithm.

7. Type of Ground Truth Used:

The ground truth used for this study was based on engineering specifications, material science standards, and direct physical measurements obtained during the in vitro testing. For example, balloon burst pressure would be compared against a defined maximum pressure, and dimensions against designed specifications.

8. Sample Size for the Training Set:

Not applicable. As this is an in vitro performance study of a physical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable, for the reasons stated above.

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The SAILOR™ PLUS PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SAILOR PLUS Balloon Dilatation Catheter is OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It has a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. Two radiopaque markers indicate the dilating portion of the balloon and help in correctly positioning the balloon within the vessel. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 130. 80 and 40cm

Here's an analysis of the acceptance criteria and study information for the SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA) Catheter, based on the provided text:

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on novel clinical trials with predefined acceptance criteria for AI/ML performance. For a medical device like a PTA catheter, the "acceptance criteria" primarily relate to engineering and biocompatibility performance data, ensuring it functions safely and effectively as intended, similar to existing devices.

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

Based on the provided 510(k) Summary, the acceptance criteria and reported device performance are related to in-vitro testing and biocompatibility, demonstrating the device's functional integrity and safety. Specific numerical acceptance criteria are not explicitly stated in this summary, but the general performance categories are listed.

It is important to note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device. For such devices, the "acceptance criteria" are generally met by showing that the new device performs similarly and safely in the specified in-vitro tests and materials are biocompatible, aligning with the predicate device and established standards. Specific numerical acceptance criteria would typically be found in detailed test reports, not usually in a high-level 510(k) summary.

Here's the additional information requested, based on the provided text, recognizing that this is for a physical medical device (a catheter), not an AI/ML algorithm. Therefore, many questions related to AI/ML studies (like test sets, ground truth experts, MRMC studies) are not applicable.

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

• Not applicable for this type of device and submission. The "test set" for this device refers to physical prototypes undergoing in-vitro testing, not a dataset for an AI/ML algorithm. The summary does not specify the number of devices tested in vitro, nor does it provide details on the provenance of test data beyond stating it was "in vitro testing."

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 is a physical catheter, not an AI/ML diagnostic or predictive tool. "Ground truth" in the context of AI/ML algorithms, established by expert consensus or pathology, is not relevant for the in-vitro performance testing of a PTA catheter.

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

• Not applicable. This question relates to the adjudication of expert labels for AI/ML ground truth, which is not relevant for the in-vitro performance testing of a physical medical 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

• Not applicable. An MRMC study is designed for evaluating diagnostic accuracy, particularly with AI assistance, which is outside the scope of this device (a physical interventional catheter).

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

• Not applicable. This device is a physical catheter, not an algorithm.

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

• Not applicable. For this physical device, "ground truth" concerning in-vitro performance would be defined by engineering specifications, material properties, and physical measurements/observations during testing, not clinical expert consensus, pathology, or outcomes data in the way these terms are used for AI/ML diagnostics.

8. The sample size for the training set

• Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.

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

• Not applicable. There is no "training set" for this physical device as it does not involve AI/ML.

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