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The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.

This document is a 510(k) premarket notification for a medical device, the Chocolate™ PTCA Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not describe an AI/ML-driven device or study results related to AI performance metrics. Therefore, I cannot provide information on acceptance criteria or study details regarding AI performance, as the provided text does not contain such information.

The document describes the device, its intended use, and lists various physical and mechanical tests performed to establish substantial equivalence. It confirms that the device is a physical medical device (a balloon catheter), not an AI/ML software device.

Key information from the provided text, but not directly related to AI/ML study parameters, includes:

• Device Name: Chocolate™ PTCA Balloon Catheter
• Intended Use: Balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
• Predicate Device: Glider PTCA Balloon Catheter (TriReme Medical) - (K111544 and K121681)
• Testing Basis: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).
• Types of Tests Performed (to demonstrate substantial equivalence to the predicate):
  • Dimensional Verification
  • Balloon Preparation, Deployment & Retraction
  • Flexibility & Kink
  • Balloon Rated Burst Pressure (RBP)
  • Balloon Fatigue
  • Balloon Compliance
  • Balloon Inflation and Deflation
  • Catheter Bond Strength
  • Tip Pull Test
  • Torque Strength
  • Radiopacity
  • Particulate Evaluation
  • Biocompatibility Testing
• Conclusion: The device was deemed "substantially equivalent" to its predicate, with no new questions of safety or effectiveness identified.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and results, as this document pertains to a physical medical device and its traditional engineering and performance testing.

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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and the hydrophilic coating of the braided shaft will become optional. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes a medical device named "Chocolate PTA Balloon Catheter" and its regulatory clearance (510(k)). However, it does not contain information related to software, artificial intelligence, or diagnostic performance metrics that would be relevant to acceptance criteria for such systems.

Specifically, the document focuses on the substantial equivalence of a physical medical device (a balloon catheter) to existing predicate devices. The performance data section refers to "Bench testing" and "in vitro tests" like "Peak friction force in an established peripheral model" to demonstrate reliable physical performance and safety for its intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to AI/software performance for this specific document. The questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable to the information presented.

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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided document describes the Chocolate PTA Balloon Catheter, a medical device. The 510(k) summary focuses on establishing substantial equivalence to predicate devices, primarily through bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Study that proves the device meets the acceptance criteria:

The study conducted was a series of bench tests (in vitro tests) designed to evaluate the physical and mechanical properties of the Chocolate PTA Balloon Catheter. The purpose of these tests was to demonstrate that the device performs reliably and safely for its intended use, and that its performance is substantially equivalent to predicate devices.

Specific Information not available in the text:

The document broadly states that "Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and "Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use." However, it does not provide specific quantitative acceptance criteria or detailed results for each individual test. For example, it doesn't state what the accepted range for balloon rated burst pressure was, or the actual burst pressures observed.

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

• Sample Size: The document does not specify the sample size (number of devices) used for each individual bench test.
• Data Provenance: The data is from bench testing (in vitro), meaning it was conducted in a laboratory setting, not on human subjects or patient data. The country of origin for the testing is not explicitly stated, but the submitter (TriReme Medical, Inc.) is located in Pleasanton, CA, USA, suggesting the testing likely occurred in the US or under US regulatory standards.

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 evaluation was based on bench testing of physical device properties, not on interpretation of medical images or clinical outcomes that would require expert consensus for ground truth.

4. Adjudication method for the test set

• This information is not applicable as the evaluation was based on bench testing, not on human interpretation or categorization of data 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

• This information is not applicable. The device is a PTA Balloon Catheter, a physical medical device used for dilatation. It is not an AI-powered diagnostic or assistive technology that would involve human readers or an MRMC study.

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 physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used

• The "ground truth" for this device's evaluation was based on engineering specifications and established performance standards for PTA balloon catheters, as determined by the design and intended use of the device. The bench tests measured objective physical properties against these predefined parameters.

8. The sample size for the training set

• This information is not applicable. This is a traditional medical device (PTA balloon catheter), not a machine learning or AI-based device, so there is no concept of a "training set" in the context of its development or evaluation mentioned here.

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

• This information is not applicable for the reasons stated above (no training set for this type of device).

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The Glider™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Glider™ PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. .

The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braid reinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use.

The currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.

The provided text describes a 510(k) submission for the Glider™ PTCA Balloon Catheter, focusing on its substantial equivalence to predicate devices and the performance testing conducted. It does not describe a study involving AI, human readers, or the establishment of ground truth by experts in the context of an AI device.

Therefore, I cannot provide information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details as they relate to an AI device.

The document details the following for the Glider™ PTCA Balloon Catheter:

1. Acceptance Criteria and Device Performance:

The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported numerical results for each test. Instead, it states that "No new questions of safety or effectiveness were identified during device testing." This implies that the device met the implied acceptance criteria for each test to demonstrate substantial equivalence to the predicate devices.

Biocompatibility Tests listed:

• Hemolysis Assay Direct Contact
• Hemolysis Assay Extract Method
• Platelet & Leucocyte Counts
• Partial Thromboplastin Time
• Thromboresistance
• Complement Activation C3a and SC5b-9 Assay
• MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
• Intracutaneous Reactivity Test
• Guinea Pig Maximization Sensitization Test
• Materials Mediated Rabbit Pyrogen Test
• Acute Systemic Injection Test

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

The document does not specify the exact sample size for each performance test. It only states that "all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544." The testing appears to be primarily bench testing conducted on physical devices, not clinical data. The data provenance is not explicitly stated as country of origin, but the submission is from TriReme Medical, Inc. based in California, USA, implying the testing was likely conducted in the USA or under US regulations for medical devices. The nature of these tests classifies them as prospective bench tests on manufactured devices, not retrospective analysis of clinical data.

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

Not applicable. This is a premarket notification for a medical device (PTCA Balloon Catheter), not an AI device that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the design specifications and established engineering/biocompatibility standards.

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

Not applicable. This is a submission for a physical medical device, not an AI device where human adjudication of results is relevant. The "adjudication" for these tests lies in comparing test results against predefined engineering and regulatory standards.

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 describes a physical medical device (PTCA Balloon Catheter), not an AI-assisted diagnostic or interpretation system.

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

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

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

For the performance testing mentioned, the "ground truth" is based on established engineering standards, device specifications (e.g., balloon diameters at specific pressures, bond strengths), and biocompatibility guidelines outlined in FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010). There is no "expert consensus" on clinical cases, pathology, or outcomes data used to establish ground truth for these bench tests.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes the 510(k) summary for the Chocolate PTA Balloon Catheter. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The document discusses performance data, but it is entirely focused on bench testing for a physical medical device (a catheter), not an AI or software-based medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth, experts, and sample sizes for training/test sets are not applicable to this submission.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Device Type: The device is a "Chocolate PTA Balloon Catheter," which is a physical angioplasty catheter. It's not an AI/ML-driven diagnostic or prognostic tool.
• Performance Data: The performance data described ("Balloon Rated Burst Pressure," "Balloon Inflation and Deflation," "Balloon Fatigue," "Trackability," etc.) are all physical properties and functions of the catheter, evaluated through laboratory bench tests.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, image analysis, diagnostic performance metrics (e.g., sensitivity, specificity, AUC), ground truth determination by experts, test/training sets of patient data, or any other elements relevant to AI/ML device evaluation.

Conclusion:

The provided document describes a traditional medical device (a balloon catheter) and its mechanical performance testing. It does not contain the information requested regarding acceptance criteria, study design, expert involvement, or data characteristics for an AI/ML device.

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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes the 510(k) summary for the Chocolate PTA Balloon Catheter, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metric acceptance criteria in the way typically discussed for AI/ML devices.

The document is a regulatory submission for a medical device (a balloon catheter), and the "performance data" section focuses on bench testing to establish substantial equivalence to predicate devices, rather than meeting quantitative performance metrics against a defined standard.

Therefore, many of the requested sections (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, training set ground truth) are not applicable to this type of traditional medical device submission and its associated testing.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in a quantitative format. Instead, it lists the types of in vitro tests performed to demonstrate product safety and effectiveness for substantial equivalence. The "reported device performance" is implicitly summarized by the statement:

"Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use."

The tests performed are:

• Balloon Rated Burst Pressure
• Balloon Inflation and Deflation
• Balloon Fatigue / CS Fatigue
• Catheter Diameter, Balloon Profile and Tip Configuration
• Balloon Compliance
• Trackability, Pushability
• Kink Resistance
• Device Interface Compatibility

There are no specified numerical acceptance thresholds or results provided for these tests in this summary. The goal was to show they "conformed to the requirements for its intended use" and were "substantially equivalent" to predicate devices.

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

Not applicable. The performance data section refers to "bench testing" (in vitro tests), not clinical studies involving patient data or a test set in the context of an AI/ML device.

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

Not applicable. No ground truth was established by experts for a test set in this context. The "ground truth" for these tests would be the established performance specifications for the physical properties of the device.

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

Not applicable. No adjudication method for a test set was mentioned.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm that assists human readers.

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

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

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

Not applicable in the AI/ML sense. The "ground truth" for the listed in vitro tests would be the predefined engineering specifications and industry standards for medical device performance.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of traditional medical device bench testing.

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

Not applicable. As above, no training set.

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The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Glider PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braidreinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use.

The provided text describes the 510(k) summary for the Glider™ PTCA Balloon Catheter. This device is a medical instrument and its evaluation focuses on physical performance and biocompatibility, not on AI/ML algorithm performance. Therefore, many of the requested categories related to AI/ML studies (such as sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this document.

Here's the information that can be extracted from the provided text, adapted for a medical device that doesn't involve AI/ML:

Acceptance Criteria and Device Performance

The device performance was evaluated against the "FDA Guidance Class II Special Controls for Certain Perculaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010)." This guidance document specifies the acceptance criteria for the various performance tests. The given document states that the device was subjected to these tests and no new questions of safety or effectiveness were identified, implying that the device met the established acceptance criteria.

Study Details (Non-AI/ML focused):

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

   • The document does not explicitly state the sample sizes (e.g., number of catheters tested) for each physical performance and biocompatibility test. It only lists the types of tests performed.
   • Data Provenance: The testing was presumably conducted by TriReme Medical, Inc. or a contracted lab, as part of their submission to the FDA. The country of origin for the data is not specified, but the submitter is based in Pleasanton, CA, U.S.A. The studies are by nature prospective, as the device was manufactured and then tested to demonstrate performance.

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

   • This concept is not applicable to a physical medical device like a PTCA catheter. "Ground truth" in this context would refer to the objective, measurable outcomes of the physical tests (e.g., actual burst pressure, measured dimensions). These are determined by laboratory equipment and standardized procedures, not by expert consensus in an observational or diagnostic context.

3. Adjudication method for the test set:

   • Not applicable for physical performance and biocompatibility testing. Results are typically quantitative and objective measurements against predefined specifications.

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 as this is a physical medical device, not an AI/ML diagnostic or assistive tool.

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

   • Not applicable as this is a physical medical device, not an AI/ML algorithm.

6. The type of ground truth used:

   • For physical performance tests, the "ground truth" is established by the objective measurement of physical properties (e.g., direct measurement of dimensions, pressures, forces) against engineering specifications and regulatory guidance.
   • For biocompatibility tests, the "ground truth" is established by laboratory assays and biological testing outcomes (e.g., observation of cell viability, measurement of hemolysis rates) against established biocompatibility standards and limits.

7. The sample size for the training set:

   • Not applicable as this is a physical medical device. The concept of a "training set" is relevant for AI/ML models. For a physical device, development typically involves iterative design, prototyping, and testing, but not a "training set" in the AI sense.

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

   • Not applicable as this is a physical medical device.

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The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm. All materials are identical to GliderXtreme product. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. The Chocolate Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes the 510(k) summary for the TriReme Medical, Inc. Chocolate PTA Balloon Catheter. This device is an angioplasty catheter primarily relying on substantial equivalence to predicate devices, rather than a novel AI/ML algorithm requiring extensive clinical trials for performance validation. Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (like human reader studies, ground truth establishment, training sets) are not applicable in this context.

However, I can extract the relevant performance data and aspects that were used for FDA clearance in this traditional medical device submission.

Here's a breakdown based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (angioplasty catheter), performance is typically demonstrated through bench testing against established standards and comparison to predicate devices, rather than accuracy metrics seen in AI/ML. The provided document lists the tests performed, which serve as the "acceptance criteria" for demonstrating safety and effectiveness.

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

The document does not specify exact sample sizes for each bench test. The "test set" refers to the physical devices undergoing the described in vitro (bench) testing. The data provenance is from bench testing conducted by the manufacturer, TriReme Medical, Inc. There is no mention of human subject data or its origin.

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

Not applicable. For a traditional medical device like a balloon catheter, "ground truth" is established through engineering specifications, material science, and established in vitro testing methodologies, not through expert consensus on medical images or clinical outcomes in the same way an AI device would.

4. Adjudication Method for the Test Set

Not applicable. Bench testing results are typically objectively measured against pre-defined engineering specifications, not subject to human adjudication methods like 2+1 or 3+1.

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

No, an MRMC study was not done. This type of study assesses how human performance improves with AI assistance and is not relevant for a standalone physical medical device like this balloon catheter.

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

Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent in its design and manufacturing.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for evaluating this device's performance would be:

• Engineering Specifications and Industry Standards: Performance metrics (e.g., burst pressure, inflation/deflation times, material strength, dimensional tolerances) are compared against pre-defined engineering specifications for the device and relevant industry standards for angioplasty catheters.
• Predicate Device Performance: A key aspect of this 510(k) submission is the demonstration of substantial equivalence to predicate devices, meaning its performance should be similar or better than those already cleared.

8. The Sample Size for the Training Set

Not applicable. There is no training set for a physical medical device. This term is used in the context of machine learning, where an algorithm learns from a dataset.

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

Not applicable, as there is no training set.

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The PTA Balloon Catheter family is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

All of the devices in the PTA Balloon Catheter family, including the GliderXtreme PTA Balloon Catheter and the GliderfleX PTA Balloon Catheter consist of a standard balloon dilatation catheter on a braided shaft with or without a hypotube and an atraumatic, tapered and beveled tip. The devices are compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F or 6F introducer sheath (or 6F or 7F guide catheter). Overall catheter lengths are approximately 100 cm to 150cm.

The distal end has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating.

The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

All PTA Balloon Catheters in the family are supplied sterile and intended for single use only.

The provided document focuses on the mechanical and physical performance of a medical device (PTA Balloon Catheter family) rather than an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size', and 'ground truth for training set') are not applicable to this document.

Here's the information that can be extracted relevant to the performance of the PTA Balloon Catheter:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." However, specific quantitative acceptance criteria and the exact reported performance values are not detailed in this summary. Instead, it lists the types of tests performed.

The document concludes that "Performance testing demonstrated that the devices reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing."

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

The document mentions "Bench testing was performed" but does not specify the sample sizes used for each test. The tests are in vitro (laboratory bench tests) to assess physical device properties, not clinical data provenance.

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

Not applicable. This is not an AI/ML device requiring human expert ground truth for interpretation of clinical data. The tests are physical performance tests.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device would be established by engineering specifications, standards, and established physical measurement techniques. The tests performed (e.g., burst pressure, fatigue, strength) are quantitative physical performance evaluations against predefined engineering targets, not against clinical expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no "training set."

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

Not applicable. This is not an AI/ML device.

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The GliderfleX™ PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.

The GliderfleX™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.

The GliderfleX™ PTA Balloon Catheters are supplied sterile and intended for single use only.

The provided text describes a medical device, the GliderfleX™ PTA Balloon Catheter, seeking 510(k) clearance from the FDA. The document outlines its intended use, device description, and performance data from bench testing to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

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

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it lists the types of in vitro bench tests performed and then concludes with a general statement about the results. The "reported device performance" is a high-level summary that the device "reliably achieved the desired effect and is safe for its intended use" and that "no new questions of safety or effectiveness were identified."

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

The document does not specify the sample sizes used for each of the bench tests. It also does not mention data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically not applicable to purely in vitro bench testing of a device.

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. The study described is an in vitro bench test of the device's physical and mechanical properties. There is no "ground truth" derived from expert interpretation of clinical data in this context. The "ground truth" is established by the specifications and engineering requirements of the device itself.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are relevant in studies involving human interpretation or clinical outcomes, which are not detailed in this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes in vitro bench testing of the physical properties of the device, not a study involving human readers or clinical cases.

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

This question is not applicable to the GliderfleX™ PTA Balloon Catheter. This is a physical medical device (catheter), not a software algorithm or AI system. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and industry standards for balloon catheters. The bench tests evaluated the device's ability to meet predefined physical and mechanical properties, not clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for a physical medical device undergoing in vitro bench testing. Training sets are typically used in machine learning or AI algorithm development.

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

This information is not applicable, as there is no "training set" mentioned or implied by the described studies.

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