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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, and infra-popliteal arteries.

The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The product family consists of 0.014" and 0.018" systems that are compatible with 0.014" and 0.018" guidewires, respectively. Overall catheter lengths range from 120-150 cm.

The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is constrained by a nitinol constraining structure (CS) which provides fast deflation and uniform re-wrap. Upon deflation, the CS is removed from the vessel along with the balloon catheter. The balloon is available in multiple sizes and contains two radiopaque markers to assist with positioning. The proximal end of the device is a common balloon catheter design of a braided shaft connected to a plastic hub and strain relief. The hub has two ports; the balloon port is used to inflate the balloon and the guidewire port connects to the guidewire lumen.

The Chocolate PTA balloon catheter is intended for single-use only and is provided sterile and non-pyrogenic.

The provided text describes a 510(k) premarket notification for the Medtronic Chocolate PTA Balloon Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a comprehensive de novo clinical trial with defined acceptance criteria and extensive performance studies.

Therefore, the document does not contain the information typically found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance: The submission focuses on comparing the new device's characteristics to a predicate, not on setting and meeting specific quantitative performance metrics like sensitivity, specificity, or accuracy.
• Sample sizes used for the test set and data provenance: No clinical test set involving patients or human data is described for performance evaluation.
• Number of experts used to establish ground truth or their qualifications: Ground truth establishment is not relevant in this type of submission, as it's about equivalence, not novel performance claims.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-assisted diagnostic device, nor is it a study comparing human performance with and without the device.
• Standalone (algorithm only) performance: Not applicable as this is a medical device (balloon catheter), not an algorithm or AI.
• Type of ground truth used: Not applicable.
• Sample size for the training set and how ground truth for training set was established: Not applicable, as this is a physical medical device, not an AI/ML algorithm.

What the document does describe in terms of "proving acceptance criteria":

The "acceptance criteria" in the context of this 510(k) submission are not performance metrics for clinical efficacy, but rather the demonstration of substantial equivalence to an existing predicate device. The "study that proves the device meets the acceptance criteria" refers to the various tests and analyses performed to support this equivalence.

Here's an interpretation based on the provided text:

Implicit Acceptance Criteria (for 510(k) Substantial Equivalence):

The implied acceptance criteria for this 510(k) submission are that the modified Chocolate PTA Balloon Catheter is as safe and effective as the predicate device (Chocolate PTA Balloon Catheter K130414) and does not raise new questions of safety or effectiveness. This is demonstrated by showing:

• Identical/Similar Intended Use: The intended use is largely the same, with a minor change in the exclusion of renal arteries.
• Equivalent Technological Characteristics: Key design principles, balloon specifications, and catheter technical specifications remain identical or acceptably similar.
• Biocompatibility: The device is biocompatible and safe for patient contact.
• Sterilization: The sterilization method is unchanged and validated.
• Packaging: Packaging changes do not compromise sterility or device integrity.

The "Study" (Evidence) Proving the Device Meets These Implicit Acceptance Criteria:

The "study" in this context is a compilation of various non-clinical testing and comparisons.

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

   • Acceptance Criteria (Implicit for 510(k)): Demonstration of substantial equivalence to the predicate device (K130414) for the Chocolate PTA Balloon Catheter. This is assessed by comparing intended use, technological characteristics, and performance data to ensure safety and effectiveness are maintained.
   • Reported Device Performance (as described in the document):
     • Intended Use: "The Chocolate PTA balloon catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries." (Note: this is a slight modification from the predicate, which also included renal arteries). The change does not introduce new safety concerns.
     • Technological Characteristics:
       • Identical: Intended Use (largely), Principle of Operation, Balloon technical specifications (diameters, lengths, materials, markers, burst pressure, nominal pressure, constraining structure material), Catheter technical specifications (lengths, guidewire/introducer compatibility, most materials), Packaging materials, Testing and Compliance to ISO 10993 and ISO 11135-1, Sterilization Method.
       • Similar (with justification for equivalence): Inner Member components (resin changes in outer and inner layers, tie-layer unchanged), IFU specifications (size, stitching), Compliance Card size/artwork, Pouch Label dimensions, Carton Label dimensions.
     • Biocompatibility: Passed required tests per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility). No new or increased biocompatibility concerns.
     • Packaging Validation: Passed packaging validation, packaging aging, and sterilization testing with a worst-case 72-page IFU and eIFU leaflet. No additional risks identified.
     • Sterilization: Successfully completed testing indicated no sterilization process changes required. Sterilization assurance level 10-6 maintained.
     • Performance Equivalence Conclusion: "The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market."

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

   • This document describes non-clinical testing (e.g., biocompatibility testing on material samples, packaging validation on multiple units). It does not specify "sample sizes" in terms of clinical patient populations.
   • Data Provenance: Not explicitly stated, but typical for medical device testing to be conducted at manufacturer facilities or contracted laboratories. No mention of country of origin for any human data (as none was used). The testing is retrospective in the sense that it supports the premarket notification.

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

   • Not applicable. "Ground truth" in the diagnostic sense is not established for this device's performance given the 510(k) pathway. Expert knowledge would be involved in designing and interpreting the engineering and material safety tests, but not in diagnosing conditions.

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

   • Not applicable, as this is not a diagnostic imaging study requiring multi-reader 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. This is a physical medical device (balloon catheter), not an AI diagnostic tool.

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

   • No. This is a physical medical device (balloon catheter), not an algorithm.

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

   • Not applicable in the clinical diagnostic sense. The "ground truth" for this submission is based on established engineering principles, material science, validated test methods (e.g., ISO standards), and a comparison to the known performance and safety profile of the legally marketed predicate device.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

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

   • Not applicable.

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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 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 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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