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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 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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