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The 0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an 0.018" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows iniection of fluids through the inflation lumen without removal of the quidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers identify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a quidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

This document is a 510(k) summary for the Hotspur Technologies, Inc. 0.018" Arrow GPSCath™ Balloon Dilatation Catheter (150 cm). It describes the device, its intended use, and substantial equivalence to a predicate device based on performance data.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria in a table format. Instead, it describes categories of in vitro preclinical tests performed and states that the product passed these tests. The reported device performance is qualitative, indicating compliance with established procedures and attributes.

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

The document does not specify the exact sample sizes (number of units tested) for each type of in vitro preclinical test. It generally states that "tests were performed" or "testing was conducted" without providing quantitative details on the number of samples.

The data provenance is in vitro preclinical tests. There is no mention of human subject data, animal studies, or specific geographic origin of the testing. The tests are described as being "in accordance with the FDA's Guidance for PTCA Catheters."

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 as the studies described are in vitro preclinical tests and do not involve human diagnostic or clinical evaluation where expert interpretation of ground truth would be required. The "ground truth" for these tests would be the established engineering specifications, material properties, and functional performance requirements of the device.

4. Adjudication Method for the Test Set

This information is not applicable for the in vitro preclinical tests described. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving expert disagreement on a diagnosis or outcome.

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

There is no MRMC comparative effectiveness study mentioned. The device is a physical medical device (balloon dilatation catheter), not an AI/software-as-a-medical-device (SaMD) that assists human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in vitro preclinical tests, the "ground truth" implicitly used would be:

• Engineering specifications and design requirements: For dimensional testing, visual inspection, and functional performance.
• Established standards: Such as ISO 10993-1 for biocompatibility and validation protocols for sterilization (ensuring SAL).
• Functional performance criteria: For simulated use testing, ensuring the device operates as intended in a model.

There is no mention of expert consensus, pathology, or outcomes data as type of ground truth for these specific tests.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device submission based on in vitro testing and substantial equivalence to a predicate, not an AI or machine learning model.

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

This information is not applicable as there is no training set for this device submission.

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The Arrow GPSCath Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

This document is a 510(k) summary for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). It is a "Special 510(k)", which means it refers to a previously cleared predicate device (K140351 from Hotspur Technologies). The submission focuses on minor changes and an update to performance data rather than a complete re-evaluation of the device's safety and effectiveness from scratch.

Therefore, the study details you are asking for, particularly related to clinical performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance, are not directly applicable or available within this specific 510(k) submission because it relies heavily on the predicate device's existing clearance.

However, I can extract the information that is present concerning the changes and the performance data provided for those changes.

Here's a breakdown based on the provided text, heavily emphasizing that clinical effectiveness studies for a new device are not detailed here because this is a Special 510(k) relying on a predicate:

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

The document mentions "additional testing of key performance data" for an update. It doesn't present a formal table of acceptance criteria and performance results in this summary. Instead, it states that the testing "result[ed] in an update to the Arrow GPSCath Balloon Dilatation Catheter (150cm) Compliance Chart and introducer sheath compatibility."

The "key performance data" tested includes:

• Balloon compliance: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
• Balloon rated burst pressure: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
• Crossing profile: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).

Note: For a Class II peripheral transluminal angioplasty catheter, the FDA typically references a set of recognized standards and guidance documents (e.g., ISO, ASTM, FDA guidance for PTA balloon catheters) that would define acceptance criteria for these physical/mechanical properties. This summary implies these tests were done to those standards, but the specific details are not published here.

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

• Test Set Sample Size: Not specified in this summary. The testing was for "key performance data, including balloon compliance, balloon rated burst pressure, and crossing profile." These are bench/mechanical tests, not clinical studies with human subjects.
• Data Provenance: The testing was conducted by Hotspur Technologies, Inc. (a subsidiary of Teleflex Medical, Inc.) in the USA. These are laboratory/engineering tests not related to patient data.
• Retrospective or Prospective: These are laboratory tests, not clinical studies.

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)

• Number of Experts: Not applicable. The "ground truth" for mechanical properties like compliance, burst pressure, and crossing profile is established through validated test methods and engineering calculations, not through expert consensus in the medical sense.
• Qualifications of Experts: Not applicable for this type of testing.

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

• Adjudication Method: Not applicable. This is not a clinical study involving human assessment or interpretation for which adjudication would be required.

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: Not applicable. This device is a balloon dilatation catheter, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

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

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

• Type of Ground Truth: For the mechanical tests (balloon compliance, burst pressure, crossing profile), the "ground truth" would be the scientifically measured and validated physical properties of the device, determined by standardized engineering testing methods and equipment. This is not medical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a physical medical 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

• Training Set Ground Truth Establishment: Not applicable.

Summary Explanation:

This 510(k) submission (K142300) is a "Special 510(k)" for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). These submissions are used when a modification to an already cleared device does not raise new questions of safety and effectiveness and the modified device remains substantially equivalent to the predicate.

The "study" cited here refers to additional engineering and bench testing conducted to update the device's "Compliance Chart and introducer sheath compatibility" due to a change in the product (presumably a minor manufacturing update or material change that impacted these specific physical properties).

The document explicitly states: "All other performance data applicable to the subject device is the same as for the predicate device (K140351) since there has been no change to the device design, materials, manufacturing processes, or sterilization cycle." This means the original predicate device (K140351) would have had the comprehensive performance data and potentially other studies (e.g., biocompatibility, sterilization validation, aging) to demonstrate its safety and effectiveness. This current submission only addresses the specific changes mentioned.

Therefore, questions related to clinical trials, expert adjudication, AI performance, or large clinical data sets are outside the scope of this specific Special 510(k) summary.

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The Arrow GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" quidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

The provided text describes the 510(k) premarket notification for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria in a clinical setting. Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, ground truth methodology, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of regulatory submission.

However, based on the provided text, I can infer and extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly from a clinical study for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). Instead, it states that the device underwent in vitro preclinical tests to verify safety and effectiveness and assure substantial equivalence to a predicate device.

The "acceptance criteria" for this device, as described, are passing various functional and safety tests, demonstrating biocompatibility, and achieving a certain sterility assurance level. The "reported device performance" is the successful completion of these tests.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the in vitro preclinical tests. It mentions "devices" being tested, implying a quantity greater than one, but no specific number.
• Data Provenance: The data provenance is "in vitro preclinical tests" conducted by Hotspur Technologies, Inc., a subsidiary of Teleflex Medical, Inc. The location (country of origin) is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are prospective in the sense that they were designed and executed to evaluate the new device.

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

• Number of Experts & Qualifications: Not applicable. The "ground truth" for the in vitro tests would be the established engineering and biological standards (e.g., ISO 10993-1, FDA Guidance for PTCA Catheters) and the objective measurements demonstrating compliance. There were no human experts establishing a "ground truth" in the diagnostic sense for these device performance tests.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. As these were in vitro engineering and biological tests, the data would have been analyzed against pre-defined quantitative and qualitative specifications. There's no mention of an adjudication process by human reviewers for these types of 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:

• MRMC Study: No. This document is for a medical device (a catheter), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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. Its performance is inherent in its design and manufacturing, tested through in vitro methods.

7. The type of ground truth used:

• Type of Ground Truth: The ground truth for these in vitro tests were established engineering specifications, regulatory standards (e.g., ISO 10993-1), and documented procedures based on FDA guidance for PTCA Catheters. For example, for biocompatibility, the ground truth is compliance with ISO 10993-1. For sterility, reaching an SAL of 1 x 10^-6.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no "training set" in this context. The device's design is based on engineering principles and knowledge, not data training.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned or relevant for this type of device submission.

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The Arrow GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The proposed Arrow GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The Arrow GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.

The provided text describes the Arrow GPSCath™ Balloon Dilatation Catheter and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of a diagnostic or AI-driven system.

The document is a traditional 510(k) notification for a physical medical device (a balloon catheter) and focuses on engineering and performance criteria for the device itself, rather than diagnostic accuracy or AI performance. The "performance data" section refers to bench testing, biocompatibility, and physical characteristics of the catheter.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria for an AI/diagnostic device, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The closest relevant section is:

I. Performance Data:

• Bench top tests: balloon compliance, catheter body burst strength, catheter torque strength, catheter balloon bond strength, catheter tip-pull strength, simulated use, balloon rated burst pressure, balloon fatigue, and balloon inflation/deflation time, contrast media flow rate, and catheter visual inspections.
• Other tests: biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, systemic toxicity, hemolysis, complement activation, thromboresistence, partial thromboplastin time, and MEM elution), package and simulated use test data.

J. Conclusions:

• "The Arrow GPSCath Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. All test results demonstrate that the Arrow GPSCath Balloon Dilatation Catheter met the established specifications necessary for consistent performance during its intended use."

This indicates that acceptance criteria were established and met for the physical device's engineering performance. However, these are not the type of acceptance criteria you would typically find for an AI diagnostic device.

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The GPSCath Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The GPSCath Balloon Dilatation Catheter is designed for dilation of peripheral vessels in the arterial svstem and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The GPSCath Balloon Dilatation Catheter is a 0.035" guide-wire compatible, PTA balloon catheter with a proprietary proximal valve system which allows injection of fluids. By providing an angioplasty balloon with fluid delivery capability, the user is able to treat obstructive lesions within the arterial system and arteriovenous dialysis fistulae without having to lose guidewire position.

Here's a breakdown of the acceptance criteria and study information for the GPSCath™ Balloon Dilatation Catheter, based on the provided document:

Acceptance Criteria and Device Performance

The document states that the purpose of the Special 510(k) is to revise the Instructions for Use (IFU) to illustrate a new balloon rated burst pressure and compliance table. This implies that the acceptance criteria are related to these physical properties and that the device performance met the new, higher specifications. While the exact numerical values for the original and new rated burst pressures, compliance, and other performance criteria are not explicitly detailed in a table, the document confirms that the device met them.

Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

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

   • Sample Size: Not explicitly stated in the document. The document mentions "bench top testing" but does not give specific numbers of devices or balloons tested for each criterion.
   • Data Provenance: The studies were "in vitro test data" and "bench top tests." This means the data was generated in a lab setting, not from human or animal subjects. The country of origin of the data is implied to be within the US, as Hotspur Technologies, Inc. is located in Mountain View, CA, and submitted the notification to the FDA.

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

   • This section is not applicable to this type of device and study. The testing for the GPSCath™ Balloon Dilatation Catheter involved physical bench-top performance metrics (e.g., burst pressure, compliance) rather than diagnostic interpretations requiring expert ground truth. The "ground truth" for these tests would be the measured physical properties of the device itself.

3. Adjudication method for the test set:

   • This section is not applicable as the study involved objective physical measurements, not subjective evaluations that would require adjudication.

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

   • This section is not applicable. The GPSCath™ Balloon Dilatation Catheter is a medical device (a balloon catheter) and not an AI-powered diagnostic system. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

   • This section is not applicable. This is a physical medical device, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant.

6. The type of ground truth used:

   • The "ground truth" for this device's performance assessment was physical measurement against predetermined specifications and applicable standards. For example, a burst pressure test would involve applying pressure until the balloon bursts, and that measured pressure would be compared to the specified rated burst pressure.

7. The sample size for the training set:

   • This section is not applicable. There is no "training set" in the context of this device. The phrase "training set" typically refers to data used to train machine learning models. This product underwent traditional engineering and quality assurance testing.

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

   • This section is not applicable for the same reason as point 7.

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The PTA-Duo PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The PTA-Duo PTA Balloon Catheter is designed for dilation of peripheral vessels in the arterial system and native or synthetic arteriovenous dialysis fistulae in the treatment of obstructive lesions. The PTA-Duo PTA Balloon Catheter is a 0.035" guide-wire compatible, non-compliant, high pressure balloon catheter with a proprietary valve system which allows distal injection of contrast media without the need to remove the guidewire. By providing an angioplasty balloon with distal contrast injection capability. the user is able to treat obstructive lesions within the arteriovenous dialysis fistulae without having to lose guidewire position to visualize the result.

This document describes the design verification and validation of the PTA-Duo PTA Balloon Catheter through various tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text details various tests performed and concludes that the device "met all predetermined acceptance criteria" and "all test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the PTA-Duo PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." However, specific quantitative acceptance criteria or detailed numerical results for each test are not explicitly provided in the given text.

Below is a table summarizing the types of tests mentioned. Without specific acceptance values from the document, we can only state that the device met those unstated criteria.

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

• Test Set Sample Size:
  • Biocompatibility: Not specified for each test, but standard models like guinea pigs and rabbits are mentioned.
  • In-Vitro Performance: Not specified, but generally involves multiple samples of the manufactured device.
  • In-Vivo Testing: "ovine specimens" (sheep) with synthetic arteriovenous access grafts. The exact number of specimens is not provided, but it states "test and control comparator groups," implying more than one animal.
• Data Provenance: The studies were internal company studies ("Hotspur Technologies, Inc.") and conducted in accordance with "21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'." The country of origin is not explicitly stated, but the company address is in Mountain View, CA, USA, and the submission is to the US FDA. This indicates US-based studies. The studies are prospective in nature for device verification.

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

Not applicable. The tests performed are primarily bench (in-vitro) and animal (in-vivo) studies focused on the physical and biological performance of the device itself, rather than diagnostic interpretation requiring human experts to establish ground truth. Physical measurements, chemical analyses, and histological examinations establish the "ground truth" for device performance.

4. Adjudication Method for the Test Set:

Not applicable for this type of device performance testing. Ground truth is established by objective measurements and scientific analysis, not by expert consensus adjudication.

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 diagnostic devices that rely on human interpretation of outputs (e.g., medical images) and AI assistance. This document describes the validation of a physical medical device (balloon catheter) where performance is measured objectively.

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

Not applicable. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth was established by laboratory assays measuring cellular response, immune response, and material interactions with biological systems according to ISO and ASTM standards.
• In-Vitro Performance: Ground truth was established by direct physical measurements (e.g., diameter, length, pressure, time) and engineering tests (e.g., fatigue, burst strength, torque).
• In-Vivo Testing: Ground truth was established by surgical observation, post-survival observation, and histological examination of vessel and organ response in ovine specimens, comparing the test device to controls.

8. The Sample Size for the Training Set:

Not applicable. This document pertains to the verification and validation of a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The EMBO-Plus Embolectomy Catheter is indicated for use within vessels in the arterial system and synthetic arteriovenous dialysis fistulae for the removal of fresh, soft emboli and thrombi.

The proposed EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. The EMBO-Plus Embolectomy Catheter is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system which allows injection of physician specified agents without the need to remove the guidewire. By providing two functions within the catheter the operator is able to remove fresh, soft emboli and thrombi from within the arterial system and synthetic arteriovenous dialysis fistulae without having to lose guidewire position.

The provided text describes a 510(k) premarket notification for the EMBO-Plus Embolectomy Catheter, a medical device. This document focuses on the device itself and its comparison to a predicate device, not on an AI system or software with acceptance criteria in the typical sense of a diagnostic or predictive model.

Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment cannot be provided from the given text.

The text details the following for the physical device:

• Device Description: The EMBO-Plus Embolectomy Catheter is designed for the removal of fresh, soft emboli and thrombi from within vessels in the arterial system and synthetic arteriovenous dialysis fistulae. It is an .035" guide-wire compatible, compliant embolectomy balloon system with a proprietary valve system allowing injection of agents without guidewire removal.
• Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and synthetic arteriovenous dialysis fistulae.
• Performance Data (for the device):
  • Biocompatibility testing: Conducted according to ISO/ASTM standards (e.g., ISO MEM Elution Assay, ASTM Hemolysis Assay, Complement Activation C3a and SC5b-9 Assay, Partial Thromboplastin Time, Thromboresistance Evaluation, Rabbit Pyrogen, Guinea Pig Maximization Sensitization, Acute Systemic Injection Test, Intracutaneous Reactivity Test, Pyrogen (LAL) Chromogenic).
  • In-vitro performance bench tests: Included Balloon Crossing Profile, Catheter Shaft Diameter, Guidewire Lumen Diameter, Catheter Shaft Markings, Balloon Working Diameter, Balloon Inflation/Deflation Time, Balloon Fatigue, Catheter Body Burst Strength, Catheter Bond and Tip Pull Strength, Catheter Torque Strength, Contrast Media Flow Rate, Adherent Clot Removal, Simulated Use/Flexibility/Kink, Radiopacity.
  • In-vivo animal model testing: Performed in accordance with 21 CFR Part 58 "Good Laboratory Practices for Nonclinical Laboratory Studies." Synthetic arteriovenous access grafts were surgically placed in ovine specimens, allowed to mature, and then a simulated procedure was performed on test and control comparator groups. Post-procedure animals were observed, and vessel and organ histology was completed to compare responses.

Acceptance Criteria and Device Performance (Based on Device Testing, Not AI Algorithm):

Information Not Applicable or Not Provided in the Text (Related to AI/Software):

1. Sample size for the test set and data provenance: Not applicable as this is a physical medical device, not an AI algorithm.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Device ground truth is established through physical and biological testing.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Standalone (algorithm only) performance: Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the device, ground truth is established through validated physical (bench) and biological (biocompatibility, in-vivo animal model) test methods, comparing performance against established specifications and a predicate device.
7. Sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions.

The proposed PTA-Plus PTA Balloon Catheter is designed for de-clotting and treating stenosis in synthetic dialysis grafts. It is an .035" guide-wire compatible, PTA balloon catheter with a proprietary valve system which allows injection of contrast and an embolectomy coil for mechanical removal of thrombus.

Here's a breakdown of the acceptance criteria and study information for the Hotspur Technologies, Inc. PTA-Plus PTA Balloon Catheter, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that the PTA-Plus PTA Balloon Catheter met "all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance documents, test protocols, and/or customer inputs." However, it does not provide a specific table or list of quantitative acceptance criteria values alongside the device's reported performance for each criterion. Instead, it broadly lists the types of tests performed and concludes that the device successfully met the established specifications.

Therefore, the table below reflects the categories of tests conducted and the general performance outcome as stated in the submission. Specific numerical values for acceptance criteria or performance are not detailed in the provided text.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro or in-vivo tests. For the in-vivo testing, it mentions "ovine specimens" and "test and control comparator groups" but no specific number of animals.
• Data Provenance:
  • In-vitro testing: Performed internally ("in-vitro").
  • In-vivo testing: Conducted using an animal model (ovine specimens). The study was performed "in accordance with 21 CFR Part 58 'Good Laboratory Practices for Nonclinical Laboratory Studies'," which suggests a controlled, prospective study design. There's no mention of the country of origin, but given the submission to the FDA, it's likely U.S.-based or conducted under U.S. regulatory standards.

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

This information is not provided in the document. The device's performance was evaluated through physical, chemical, and animal testing rather than human interpretation or expert-established ground truth in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved physical/chemical bench testing and animal studies, not human adjudication of results.

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

This information is not applicable. The device is a medical instrument (balloon catheter), not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a medical instrument, not an algorithm. The "standalone" performance here would refer to its physical and functional attributes, which were tested in-vitro and in-vivo.

7. The type of ground truth used

• Biocompatibility: Established by adherence to ISO and ASTM standards and specific assay results (e.g., non-toxic, non-sensitizing, non-pyrogenic).
• In-vitro Performance: Established by engineering specifications, comparative performance to predicate devices (which themselves met established safety and efficacy profiles), and adherence to predefined test protocols (e.g., balloon burst pressure, inflation/deflation times).
• In-vivo Performance: Established by surgical implantation outcomes, observation of animal specimens, and post-survival vessel and organ histology, comparing responses to test and control devices. The ground truth here is the physiological response and histological findings in the ovine model.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this physical medical device. The "training" for this device would refer to its design and manufacturing processes, which are not detailed in terms of a data set.

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

This information is not applicable for the same reasons as point 8.

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