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The Amethyst HP PTA OTW 0.035" catheter is indicated for:

• Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
• Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature

The Amethyst HP PTA OTW 0.035 catheter is a balloon catheter consisting of an over the wire catheter with a non-compliant inflatable balloon fixed at the distal end of the tip. The balloons are designed to provide consistent balloon diameters and lengths at high pressures. A radiopaque tapered tip positioned at distal of the balloon facilitates the advancement of the catheter to and through the stenosis. A Luer lock fitting (Y hub) at the proximal end allows connection with an inflation device. The catheter is a co-axial catheter with a balloon at the distal tip. One lumen is used for the inflation of the balloon and is accessed via the lateral port of the Y hub. The second lumen, start at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The balloon has two radiopaque markers to aid in positioning the balloon relative to stenosis. The balloon is dilated using the lateral port, at which the balloon opens to a known diameter at a specific pressure. The maximum recommended guide wire diameter is 0.035". The catheter is supplied sterile and is intended for single use.

The provided text describes the Amethyst HP PTA OTW 0.035" Catheter, a medical device for Percutaneous Transluminal Angioplasty (PTA). This document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

However, the information provided does not contain details about acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an AI/ML model for medical image analysis, which your request implies. The document focuses on the physical and performance characteristics of a catheter, and the "performance data" listed are standard non-clinical tests for such a device.

Here's an analysis based on the information available in the document, with a clear statement that the requested AI/ML specific information is not present:

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

The document lists various performance tests carried out on the catheter, and states that the "subject device... met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, FDA guidance documents and test protocols." However, it does not provide a table specifying the quantitative acceptance criteria for each test or the reported numerical performance outcomes.

Instead, it lists the types of tests performed. To illustrate the concept of such a table based on the provided test types for a physical device, it would generally look like this (but the actual data is missing from the document):

Please note: The actual numerical acceptance criteria and reported performance values are not detailed in the provided text. The document only states that "all the predetermined acceptance criteria" were met.

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 relates to a physical medical device (catheter), not an AI/ML system. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective" for data, and "number of experts" are not applicable in the way they would be for an AI/ML study.

For the non-clinical performance tests described (e.g., Catheter Torque Strength, Balloon Rated Burst Pressure), the sample sizes are not explicitly stated. The testing would typically involve a specific number of devices or components to statistically ensure reliability, but these details are not in the summary.

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 question is not applicable to the type of device and study described. The document is about a physical catheter, not an AI/ML system requiring expert-established ground truth from a test set.

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

This question is not applicable to the type of device and study described.

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 question is not applicable to the type of device and study described. The document does not describe an AI-assisted diagnostic or interpretive system.

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

This question is not applicable to the type of device and study described.

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

This question is not applicable to the type of device described. The "truth" for this device's performance is determined by meeting physical and mechanical specifications through direct measurement and testing against established engineering standards and regulatory guidance, not by medical ground truth as in a diagnostic study.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

In summary: The provided FDA 510(k) summary pertains to a physical medical device (a catheter) and outlines non-clinical performance testing (e.g., mechanical, material, packaging tests) to demonstrate substantial equivalence. It does not describe an AI/ML-based device or a study involving data sets, ground truth establishment by experts, or metrics like sensitivity/specificity, which are associated with AI/ML performance evaluations. Therefore, most of the questions related to AI/ML study specifics cannot be answered from the provided text.

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The Ebony HP PTA OTW 0.035" Catheter is indicated for;

· Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

· Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.

This document describes the premarket notification (510(k)) for the Ebony HP PTA OTW 0.035" Catheter. The information provided outlines the device's characteristics, indications for use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain details regarding a study for an AI/ML powered medical device, particularly with the specific criteria asked for in your prompt (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment).

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study from the given text. The document focuses on the non-clinical performance testing of a physical medical device (a catheter) and its biocompatibility, mechanical properties, and compliance with standards.

To directly answer your request based on the provided text, the device in question is a physical medical device, not an AI/ML powered one. Thus, the concepts of acceptance criteria for AI performance, training/test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this document.

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The Tamarin Blue PTCA RX Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. A hydrophilic coating has been applied on the distal portion of catheter i.e., up to the RX port, to improve catheter pushability. The balloon material expands to a known diameter at a specific pressure as defined in the compliance table supplied with the catheter.

The device is supplied sterile and intended for one-time use.

This document is a 510(k) summary for the Tamarin Blue PTCA RX Dilatation Catheter (K210012). It details the device's comparison to predicate and reference devices and non-clinical testing performed to establish substantial equivalence.

Here's an analysis to extract the requested information, although it's important to note that this document pertains to a medical device (catheter) and not an AI/ML-driven diagnostic or image analysis device, which are typically the subject of the detailed acceptance criteria and study design questions you've posed. Therefore, many of the requested fields related to AI/ML performance, ground truth establishment by experts, MRMC studies, training sets, etc., will not be applicable or present in this type of submission.

The information consistently aligns with a submission for a physical medical device, not a software/AI device.

Here's the closest interpretation of your request based on the provided document:

Device Name: Tamarin Blue PTCA RX Dilatation Catheter

Device Type: Medical Device (PTCA Dilatation Catheter)

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for this device, as detailed in a 510(k) submission, revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through non-clinical bench testing to ensure the device performs as intended and meets established safety and performance standards for its class. The document explicitly states that the technological characteristics (components, design, sterilization method, shelf life, operating principle) are identical to the predicate device, with the only notable difference being the addition of a hydrophilic coating, which was tested and shown not to raise new questions of safety or effectiveness.

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

Since this is a physical medical device, "acceptance criteria" are not reported as classical sensitivity/specificity/AUC metrics for a diagnostic algorithm. Instead, they are engineering and performance benchmarks validated through bench testing. The document states that the device "met all acceptance criteria."

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

• Sample Size: Not explicitly stated as a "sample size" in the context of clinical studies for diagnostic accuracy. The non-clinical bench testing would involve a certain number of manufactured devices for each test (e.g., a specific batch size for burst pressure testing, a number of devices for fatigue testing). These numbers are not detailed in this summary.
• Data Provenance: The testing is non-clinical bench testing, meaning it's performed in a laboratory, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable.

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

This concept is not applicable here as the "ground truth" for a physical device is its adherence to engineering specifications and performance standards, validated through objective bench testing. There are no "experts" establishing ground truth in the sense of medical image interpretation for diagnosis.

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

Not applicable. This is for objective bench testing, not subjective human interpretations that require 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 is for an AI/ML-driven diagnostic/image analysis device. This product is a physical medical catheter.

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

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

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

The "ground truth" for this device is based on engineering specifications, established performance standards (e.g., burst pressure limits), and material properties. Compliance is demonstrated through objective bench testing.

8. The sample size for the training set:

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

Summary of the Study:

The study proving the device meets acceptance criteria is a non-clinical bench testing program. The purpose of this testing was to demonstrate that the Tamarin Blue PTCA RX Dilatation Catheter (K210012), with the addition of a hydrophilic coating, is substantially equivalent to its predicate device (Tamarin Blue PTCA RX Dilatation Catheter, K112735) and equivalent to a reference device (Filao NC RX PTCA Dilatation Catheter, K141933) for the coating aspects.

The testing evaluated various performance characteristics, including:

• Coating Inspection
• Coating Integrity (Performance and Durability)
• Balloon preparation, deployment and retraction
• Balloon Rated Burst
• Balloon Fatigue
• Balloon compliance
• Balloon inflation/deflation
• Particulate

The conclusion from these tests was that the hydrophilic coating performed as intended, did not impact the functionality of the device, and that the subject device "met all acceptance criteria" and is biocompatible. The technological characteristics, intended use, and indications for use were found to be identical or substantially similar, with any differences not raising new questions of safety or effectiveness.

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The Filao NC RX PTCA Dilatation Catheters are indicated for:

Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)

The Filao NC RX PTCA Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a non-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenosis. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating improves pushability of the catheter.

The Filao NC PTCA RX Catheter is available in balloon diameters ranging from 2.00 mm to 4.50 mm, and balloon lengths ranging from 8mm to 30 mm in step of 1 mm. The maximum recommended guide wire diameter is 0.014"

This document is a 510(k) summary for the Filao NC RX PTCA Dilatation Catheter (K141933). It describes the device, its intended use, and a comparison to predicate devices, along with performance data.

Here's an analysis of the provided text in relation to your questions:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical tests conducted, implying that the device met internal acceptance criteria for each test to demonstrate substantial equivalence. The performance data is summarized in a qualitative manner.

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 mentions "non-clinical testing" but does not specify the sample sizes for these tests. It also does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. Given it's non-clinical testing, it would typically be laboratory-based rather than patient data.

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

This information is not applicable and therefore not provided. The study detailed is non-clinical performance testing of a medical device (dilatation catheter), not a diagnostic study requiring expert ground truth for interpretation of medical images or patient conditions.

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

This information is not applicable and therefore not provided. The study involves non-clinical performance testing of a physical device, not a diagnostic study with human observers requiring 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

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI/software device that would involve human readers or AI assistance.

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

This concept is not applicable here. The device is a physical catheter, not an algorithm.

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

For a physical medical device like a PTCA catheter, "ground truth" for performance testing typically refers to:

• Engineering standards and specifications: The device's performance is compared against pre-defined engineering requirements and industry standards (e.g., ISO standards for medical devices).
• Reference measurements: Using calibrated equipment to measure physical properties like dimensions, burst pressure, inflation/deflation times, bond strengths, etc., and comparing these measurements to the specified design parameters.
• Predicate device comparison: Performance data is also often compared to that of a legally marketed predicate device to demonstrate substantial equivalence.

The document implicitly states that the non-clinical testing addressed various considerations to demonstrate substantial equivalence, meaning the device met its design specifications and performed comparably to predicate devices.

8. The sample size for the training set

This information is not applicable and therefore not provided. This is not an AI/machine learning study, so there is no "training set."

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

This information is not applicable and therefore not provided. This is not an AI/machine learning study.

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The Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature.

The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature.

The Ebony ® PTA 0.014" over the wire catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated. Maximum guide wire diameter is 0.014" (0.36 mm). The usable catheter length for OTW is 120 cm and 150 cm.

In order to correctly position the balloon under fluoroscopy, two radiopaque markers are placed on the shaft under the balloon itself, defining its cylindrical area. The catheter includes a smooth, soft and atraumatic tip to facilitate advancement of the catheter through the stenosis. In order to facilitate advancing through the vasculature, a hydrophilic coating is present on the distal shaft and the balloon.

The Ebony ® PTA 0.014" over the wire catheter is available in 2 usable lengths: 120 and 150 cm; and in the balloon sizes shown in Table 1. The Ebony ® PTA 0.014" over the wire catheter will be supplied sterile and is intended for one time use.

The Ebony® PTA 0.018" over the wire Catheter is a standard catheter with a balloon near the distal tip and a Y-connector at the proximal end. The guide wire lumen (inner tubing) permits the use of guide wires to facilitate advancement of the catheter to and through the stenosis to be dilated and it ends at the tip of the catheter. Maximum guide wire diameter is 0.018" (0.46 mm).

The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.

The Ebony® PTA 0.018" over the wire Catheter is available in two catheter lengths and the balloon sizes shown in Table 2 below. The Ebony® PTA 0.018" over the wire Catheter is supplied sterile and is intended for one time use.

This document describes the performance testing for the Ebony® PTA 0.014" over the wire catheter and Ebony® PTA 0.018" over the wire catheter.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary states that "all catheter test samples met the acceptance criteria for each of the performance tests." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific numerical results obtained. It only provides a list of the tests performed and a general statement of compliance.

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

• Sample Size: The document does not specify the exact sample size used for each performance test. It only states "all catheter test samples."
• Data Provenance: The tests are described as "in vitro bench tests and analyses." The country of origin for the data is implied to be Natec Medical Ltd. in Mauritius, where the applicant is located. The tests are prospective in nature, as they involve testing the manufactured devices against pre-defined criteria.

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

Not applicable. This device is a medical instrument (catheter), and its performance is evaluated through objective engineering and biological bench tests, not through expert interpretation of data or images where "ground truth" would be established by human experts.

4. Adjudication Method for the Test Set

Not applicable. As described above, the performance is assessed through objective bench testing against pre-determined acceptance criteria, not through expert adjudication.

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

Not applicable. This is a medical device (catheter), not a diagnostic AI system or an imaging modality that would involve human readers interpreting cases.

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

Not applicable. This is a physical medical device. The performance tests are for the device itself, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests is established by industry standards, engineering specifications, and regulatory requirements (e.g., ISO, ASTM, FDA guidelines) for medical device performance. For biocompatibility, it's defined by the passing criteria within the specified ISO and ASTM standards.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set. The performance tests evaluate the device's physical and biological characteristics.

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

Not applicable. As this is not an AI/machine learning algorithm, there is no "training set" or corresponding ground truth establishment in that context.

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The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA . 035'' OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.

The Ebony® PTA 0.035 Peripheral Dilatation Catheter is a standard Over The Wire (OTW) PTA catheter with a semi-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature. The modified Ebony® PTA 0.035 Peripheral Dilatation Catheter line extension adds 3.0 mm and 4.0 mm diameter balloon and additional balloon lengths to the currently available sizes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) premarket notification summary for a medical device. For such devices, the "study" demonstrating that the device meets acceptance criteria often refers to non-clinical bench testing to show substantial equivalence to a predicate device, rather than a clinical trial with human participants if the changes are minor. This is the case here.

Acceptance Criteria and Device Performance for Ebony® PTA 0.035 Peripheral Dilatation Catheter (K143036)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not specify the exact sample sizes for each non-clinical bench test. It generally states that the "new balloon sizes met all of the verification/validation acceptance criteria."
• Data Provenance: The data provenance is from non-clinical bench testing. It's not human data and therefore does not have a country of origin in the typical sense; these tests are performed in a laboratory setting. These were retrospective in relation to the original K103354 device, as the tests were performed on the modified device to show equivalence to the previously cleared predicate.

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

• N/A. For non-clinical bench testing (like mechanical and material properties of a catheter), "expert ground truth" in the way it's described for image analysis or clinical outcomes is not applicable. The "ground truth" for these tests is based on established engineering principles, material science, and regulatory standards for device performance, which are evaluated by qualified engineers and scientists.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical or image-based studies. For bench testing, the results are typically quantitative measurements against predefined specifications; there's no "adjudication" of expert opinions involved.

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 assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This device is a physical medical device (a catheter) and not an AI-powered diagnostic tool, so such a study would not be applicable.

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

• No. This question is typically relevant for AI algorithms. Since this is a physical medical device (catheter), the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is based on regulatory standards and established engineering specifications for the physical and functional performance of a PTA catheter. This includes parameters like balloon burst pressure, fatigue, material biocompatibility, and physical dimensions, all of which are defined and verified through objective measurements and tests. The predicate device (K103354) served as the benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

• N/A. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely refined through engineering development and quality control, but this isn't analogous to an AI training set.

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

• N/A. As there is no "training set" in the AI sense, this question is not applicable. The performance characteristics and specifications for the device are derived from engineering design, material properties, and regulatory requirements for safe and effective medical devices.

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The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.

The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature.

The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.

The provided document is a 510(k) premarket notification for a medical device, specifically a peripheral dilatation catheter. It details the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, this type of submission focuses on demonstrating equivalence rather than proving device performance against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details for proving the device meets those criteria, and specifics about AI algorithms, ground truth, experts, and multi-reader studies cannot be fully extracted from this document. This document describes a traditional medical device (a catheter) and its mechanical/physical performance, not an AI-powered diagnostic or therapeutic device.

Here's a breakdown of what can be extracted and why other parts cannot:

What can be extracted (and partially inferred):

• Acceptance Criteria (Implied): The document states that "The new balloon sizes met all of the verification/validation acceptance criteria." While explicit numerical acceptance criteria are not listed, the types of performance tests performed serve as the basis for these criteria.

  • Balloon compliance
  • Balloon burst pressure
  • Balloon fatigue
  • Shaft resistance (Torque Test)
  • Bond strength
  • Catheter dimensions
  • Deflation time
  • Guide wire and introducer compatibility

• Study Proving Acceptance Criteria: The document mentions "bench testing" was performed. This refers to in-vitro (laboratory) testing, not human clinical trials or observational studies for typical AI device evaluation.

Information that CANNOT be extracted from this document, as it pertains to a different type of device (AI/diagnostic) and study design:

1. A table of acceptance criteria and the reported device performance: While the types of tests are mentioned, the actual numerical acceptance criteria (e.g., "burst pressure > X atm") and the specific reported performance results are not included in this summary. It only states they "met all... criteria."

2. Sample size used for the test set and the data provenance: This refers to patient data for AI algorithms. The "sample" here refers to physical catheter units tested in a lab, not a patient test set. The document does not specify the number of catheters tested for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a physical device like a catheter. Ground truth in this context would be engineering specifications and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for bench testing of a physical 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. This document is not for an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the catheter, the "ground truth" for the bench tests would be established by validated test methods, engineering specifications, and industry standards, measured using calibrated equipment. This is not "expert consensus" in the diagnostic sense, nor is it pathology or outcomes data.

8. The sample size for the training set: Not applicable. This device does not use a "training set" in the machine learning sense.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

This document describes the 510(k) clearance for the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter, which is a physical medical device. The submission focuses on demonstrating substantial equivalence to predicate devices for a line extension (new balloon diameter and lengths).

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

(Note: Specific numerical criteria and performance values are not provided in this summary document, only the confirmation that the device "met all of the verification/validation acceptance criteria" for each listed test.)

2. Sample size used for the test set and the data provenance:
The document refers to "bench testing" performed on the modified catheter. The specific sample size (number of catheters tested) for each bench test is not provided. Data provenance is from in-vitro (laboratory) testing conducted by the manufacturer, Natec Medical Ltd. It is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of physical device bench testing, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by an expert consensus process involving human readers.

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:
No, this was not done. This study is for a physical medical device (catheter), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for the bench tests would be defined by the engineering specifications, design requirements, and relevant industry standards against which the physical performance (e.g., burst pressure, dimensions) of the catheter units were measured and compared.

8. The sample size for the training set:
Not applicable. This device does not have a "training set" as understood in machine learning.

9. How the ground truth for the training set was established:
Not applicable.

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The Tamarin Blue® RX PTCA Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

The Tamarin Blue® PTCA RX Dilatation Catheter is a standard Rapid Exchange (RX) PTCA catheter with a single lumen proximally, a dual lumen distally, a semi-compliant inflatable balloon and a soft, tapered distal tip to aid in crossing tight stenoses. One lumen of the catheter's dual lumen is used for inflation and deflation of the balloon, and the other lumen allows guide wire access through the distal part of the catheter. The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows connection with an inflation device. Two radiopaque markers on the guide wire lumen tubing provide visual reference points for balloon positioning across the stenosis. The balloon material expands to a known diameter at specific pressure as defined in the compliance table supplied with the catheter.

Here is an analysis of the provided 510(k) summary regarding the Tamarin Blue® PTCA RX Dilatation Catheter, focusing on acceptance criteria and the supporting study information:

Acceptance Criteria and Device Performance

The provided document describes a medical device, the Tamarin Blue® PTCA RX Dilatation Catheter, and its non-clinical testing. It asserts that the device met all the predetermined acceptance criteria of design verification and validation. However, the document does not explicitly list the acceptance criteria values or the specific reported device performance values for each test. It only states that the device successfully met these unlisted criteria.

Therefore, a table with specific acceptance criteria and reported performance cannot be created from the provided text. The document broadly states the types of tests performed.

Study Information

The provided document describes a non-clinical study involving various in vitro tests to demonstrate the safety and effectiveness of the device. It is not a clinical study involving human subjects or AI algorithms.

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

   • Sample Size: Not specified for any of the individual non-clinical tests. The document only lists the types of tests performed.
   • Data Provenance: The tests are non-clinical (laboratory-based) and conducted according to international standards (ISO, ASTM) and US federal regulations (21 CFR 58 GLP). The country of origin of the data is not explicitly stated, but the sponsor is Natec Medical Ltd. from Mauritius.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes non-clinical engineering and materials testing, not a study requiring expert consensus for diagnostic ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Non-clinical physical and chemical tests have predefined objective pass/fail criteria, not subjective interpretation requiring 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: Not applicable. No MRMC or AI-related study was performed or mentioned. This device is a physical medical device (catheter), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically defined by pre-established engineering specifications, material standards, and regulatory requirements. For example, a bond strength test would have a minimum force requirement (ground truth) that the device must meet. Biocompatibility has specific toxicological thresholds.

7. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/machine learning study.

8. How the ground truth for the training set was established: Not applicable. There is no training set.

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The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries. This catheter is not for use in coronary or neuro-vasculature.

The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses. The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm. It will be supplied sterile and is intended for one time use.

The provided text is a 510(k) Summary for a medical device (Ebony® PTA .014" RX Peripheral Dilatation Catheter). However, it does not contain any information about a study involving AI/ML directly related to clinical performance or human reader improvements. The "performance data" section exclusively refers to non-clinical tests and analyses of the physical device, not an AI model.

Therefore, I cannot fulfill the request as it pertains to a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement, or complex ground truth establishment. This document describes a traditional medical device submission, focusing on physical and biocompatibility properties.

The document covers:

• Acceptance Criteria for the physical device: These are defined by various non-clinical tests (e.g., balloon compliance, burst pressure, fatigue, bond strengths, dimensions, biocompatibility).
• Study Proving Device Meets Acceptance Criteria: This is broadly stated as "data collected from non-clinical tests and analyses."
• "Reported device performance": This is described in terms of a list of tests performed and is summarized as "The subject device...met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols."

Based on the provided text, here’s why I cannot answer the specific questions related to AI/ML studies:

• No AI/ML Component: The device described is a physical catheter, not an AI/ML algorithm or system.
• No Test Set/Ground Truth for AI: There's no mention of a test set of images or data that an AI would process, nor is there any discussion of establishing ground truth for such data (e.g., expert consensus, pathology).
• No Human Reader Study: There is no multi-reader multi-case (MRMC) study mentioned, no human performance metrics, and certainly no comparison of human readers with or without AI assistance.
• No Standalone AI Performance: Since there's no AI, there's no standalone AI performance to report.
• No Training Set: The concepts of training sets and how their ground truth is established are irrelevant to a physical device submission like this.

To directly address the prompt while acknowledging the content of the provided text:

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

Regarding the AI/ML specific questions (2-9):

The provided 510(k) summary does not contain any information related to an AI/ML component, a test set for AI, experts establishing ground truth for AI data, adjudication methods for AI performance, MRMC studies, standalone AI performance, type of ground truth for AI, training set size for AI, or how ground truth for an AI training set was established. The document explicitly focuses on the non-clinical, physical, and biological performance of a medical catheter.

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The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries.

The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

The Ebony® PTA .035 Peripheral Dilatation Catheter is a standard Over the Wire (OTW) PTA Catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing tight stenoses.

It is a double lumen catheter, one lumen for the guide wire used for inflation/deflation of the balloon and one lumen for the guide wire used to access to the distal tip of the catheter (max/0.035″). A luer lock fitting allows the connection with an inflation device (Y hub). The balloon has two radiopaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.

The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics.

The balloon material expands to a known diameter at specific pressure defined in a compliance chart supplied with the catheter. The device is available in balloon. diameters of 5, 6, 7, 8, 9, 10 or 12 mm, balloon lengths of 20, 40, 60, or 80 mm and catheter lengths of 80, 130, or 150 cm.

lt will be supplied sterile and is intended for one time use.

This is a 510(k) premarket notification for a medical device, the Ebony® PTA .035 Peripheral Dilatation Catheter, not a typical AI/ML device, therefore the information you requested like samples size for the test set, provenance of data, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set size and ground truth for training set are not available in the provided document. The study described focuses on nonclinical, bench-top testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies.

Here's the available information presented in the requested format:

Acceptance Criteria and Device Performance Study for Ebony® PTA .035 Peripheral Dilatation Catheter

This submission refers to non-clinical bench testing to demonstrate substantial equivalence, rather than a clinical study with human patients. As such, many of the typical acceptance criteria and study details relevant to AI/ML device performance or clinical trials are not applicable or not provided in this document.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally understood to be met if the device performs equivalently to the predicate device in a series of in vitro bench tests. The document states that the subject device met all predetermined acceptance criteria.

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

• Sample Size: Not specified in the provided document. The tests are "in vitro bench tests and analyses."
• Data Provenance: The data is generated from in vitro bench tests conducted by Natec Medical Ltd. or its contracted laboratories. No country of origin for the data is specified beyond the company's location in Mauritius. These are experimental, non-clinical tests rather than retrospective or prospective patient data.

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

• Not Applicable. For this type of submission involving physical device performance, "ground truth" is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance, rather than expert human interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data. This submission focuses on objective physical and chemical properties of a medical device.

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

• No. An MRMC study is not relevant for this type of device submission. This pertains to evaluating the effectiveness of a diagnostic tool or intervention with human readers, which is not the purpose of this submission.

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 or AI system.

7. The Type of Ground Truth Used

• Engineering specifications, validated test methods, and performance of a legally marketed predicate device (ADMIRAL XTREME™ PTA Catheter). The "ground truth" for the tests is adherence to predefined engineering specifications and demonstrating performance comparable to the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This submission does not involve 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, this question is not relevant.

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