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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 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 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 GliderXtreme™ 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 GliderXtreme™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheaths (or 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 at specific pressures. The balloon is available in multiple sizes and contains one or two 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 design of a hypotube 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. A second lumen intended for guidewire use is contained within the catheter. The balloon catheters are available in Rapid Exchange or Over-The-Wire configuration.

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

The provided 510(k) summary for the GliderXtreme™ PTA Balloon Catheter (K101062) describes the performance data as "Bench testing was performed to support a determination of substantial equivalence." This means the device's performance was evaluated through a series of in vitro tests, not clinical studies involving human or animal subjects. As such, many of the requested categories (e.g., sample size for test set, experts, adjudication, MRMC studies, ground truth for training/test set) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of tests performed but does not explicitly state quantitative acceptance criteria or specific numerical results. It 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 GliderXtreme™ PTA Balloon Catheter reliably achieved the desired effect and is safe for its intended use."

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

• Sample Size: Not applicable. The studies were bench testing (in vitro/laboratory tests), not clinical studies with patient data.
• Data Provenance: Not applicable, as no human data was used. The tests were performed in a lab setting.

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

• Not applicable. No expert ground truth was established as this was bench testing.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method was used as this was bench testing.

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

• No. An MRMC study was not performed. This device is a physical medical device, not a diagnostic algorithm that would typically involve human readers interpreting images.

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

• Not applicable for a "ground truth" in the diagnostic sense. For each bench test, the "ground truth" or reference was likely defined by engineering specifications, validated test methods, and industry standards for medical device performance. For example, balloon burst pressure would be compared against a predefined burst pressure specification.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of bench testing for a physical device.

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

• Not applicable. There is no "training set" or associated ground truth for this type of submission.

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The Glider™ 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 Glider™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" guidewires and 5F introducer sheaths (or 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 at specific pressures. The balloon is available in multiple sizes and contains one or two 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 design of a hypotube 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. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip.

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

Here's an analysis of the provided text regarding the TriReme Medical Glider™ PTA Balloon Catheter:

The provided document is a 510(k) Summary and related FDA correspondence for a medical device. It does not contain information about acceptance criteria, device performance metrics, or a study that specifically "proves the device meets acceptance criteria" in the way one would describe an AI/software-as-a-medical-device (SaMD) study.

This document describes a physical medical device (a balloon catheter) and its clearance through the FDA's 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel clinical effectiveness through large-scale trials with predefined acceptance criteria.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission. I will address the points that can be inferred or explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

• Not applicable in the context of an AI/SaMD device. For physical devices like this catheter, "acceptance criteria" are typically related to engineering specifications (e.g., burst pressure, fatigue resistance, dimensional accuracy) and "performance" refers to how the device meets these specifications during bench testing. This document states "Bench testing was performed... 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 quantifiable acceptance criteria and their corresponding reported values are not disclosed in this summary. The FDA's 510(k) summary typically doesn't detail these engineering specifics.

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

• Not applicable for a clinical test set in the context of AI/SaMD. The "test set" here would refer to the physical devices subjected to bench testing. The sample size for these engineering tests is not provided in the summary. Data provenance is not relevant in this context.

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

• Not applicable for a physical device. "Ground truth" as it relates to expert consensus for image annotation or clinical diagnosis is not relevant for the bench testing of a physical catheter.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for AI/SaMD, to establish ground truth from expert opinions. This is not relevant for bench testing of a physical device.

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

• No. An MRMC study is a type of clinical trial often used for diagnostic devices (including AI/SaMD) to compare the performance of human readers with and without AI assistance. This document describes a physical interventional device, and no such study is mentioned or implied.

6. If a Standalone (Algorithm Only) Performance Study was done

• No. This question is exclusively applicable to AI/SaMD.

7. The Type of Ground Truth Used

• Not applicable for a clinical ground truth. For the bench testing of this physical device, the "ground truth" would be established by objective, measurable physical properties and engineering standards (e.g., pressure sensors for burst pressure, calipers for dimensions, flow meters for fluid dynamics). It's based on physical measurements against pre-defined engineering specifications, not expert consensus or pathology in a clinical sense.

8. The Sample Size for the Training Set

• Not applicable. This question exclusively applies to AI/SaMD.

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

• Not applicable. This question exclusively applies to AI/SaMD.

Summary of what can be extracted from the document:

• Device Name: Glider™ PTA Balloon Catheter
• Intended Use: Balloon dilatation of lesions in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries), not for coronary or cerebral vasculature.
• Regulatory Pathway: 510(k) Premarket Notification.
• Basis for Clearance: Substantial equivalence to predicate devices (NanoCross PTA Dilatation Catheter (K090849) and Sterling ES MR and OTW PTA Balloon Dilatation Catheters (K080982)).
• Evidence of Performance: "Bench testing was performed... 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."
• Conclusion: "Performance testing and biocompatibility testing demonstrated that the Glider™ PTA Balloon Catheter reliably achieved the desired effect and is safe for its intended use. No new questions of safety or effectiveness were identified during device testing."

Key Takeaway: This document is about the regulatory clearance process for a physical medical device. The types of "acceptance criteria" and "studies" you're asking about are more typical for AI/Software as a Medical Device (SaMD) or clinical trial reports, which differ significantly from a 510(k) summary for a physical product.

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