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The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion.

The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen.

The dilatation catheter has a hydrophobic silicone coating on the outer surface of the proximal shaft and a hydrophilic polymeric based coating on the outer surface of the distal shaft, coated over 150 mm length (valid for 1.5 and 2 mm balloon diameter and 20 to 100 mm balloon length) or coated over 75 mm length (valid for 2 mm balloon diameter and 140 to 220 mm balloon length, and 2.5 to 4 mm balloon diameter and 20 to 220 mm balloon lenqth). The balloon has a hydrophilic patchwork coating.

The dilatation catheter is compatible with quide wire and introducer sheath sizes according to the recommendations on the label.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It generally refers to "all sizes," "all tested samples," or implies replicate testing (e.g., "90% of the balloons will survive the 20 inflation cycles"). The data provenance for these non-clinical tests is internal to the manufacturer (BIOTRONIK) and is retrospective, as the tests were conducted to secure prior market clearance.

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

Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance and safety is established through engineering and biological testing against predefined specifications and regulatory standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method

Not applicable, as this is a physical medical device. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., medical imaging AI).

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 MRMC comparative effectiveness study was done. This is a medical device clearance for a physical non-diagnostic product, not an AI-assisted diagnostic tool. No clinical data was submitted, and the determination of substantial equivalence did not rely on clinical data.

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

Not applicable. This is a physical medical device. There is no algorithm or AI component mentioned.

7. The type of ground truth used

The "ground truth" for the non-clinical tests detailed in the document is based on pre-defined engineering specifications, international standards (ISO-10993), and FDA guidance documents (e.g., Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters). For biocompatibility, it relies on established biological endpoints and observable reactions in in-vitro and in-vivo models.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. See point 8.

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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 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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The PowerCross .018" OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The PowerCrossTM .018" OTW PTA Dilatation Catheter is an over the wire (OTW) 0.018" coaxial catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. The distal portion of the catheter has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.018". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 and 200 mm devices, two additional marker bands denote the middle of the balloon body. The PowerCross .018" OTW PTA Dilatation Catheter is available in multiple balloon sizes. Nominal balloon diameter and length are printed on the strain relief.

The provided document, K093286, is a 510(k) Summary for the PowerCross™ .018" OTW PTA Dilatation Catheter. This type of submission is for medical device clearance, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested criteria related to AI studies, like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.

The document primarily focuses on bench testing to support the claim of substantial equivalence.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a PTA Dilatation Catheter), the "acceptance criteria" are typically the successful completion of various bench tests demonstrating physical and performance characteristics, and the "reported device performance" is the successful outcome of those tests, showing the device meets its design specifications and is comparable to predicate devices. Specific quantitative criteria and results are generally not detailed in the 510(k) summary but would be found in the full 510(k) submission.

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

• Sample Size: Not specified in the 510(k) summary, as this refers to bench testing of the device itself, not a clinical study involving a test set of data. The "test set" in this context would be the physical devices manufactured and subjected to various engineering tests.
• Data Provenance: Not applicable in the context of data used for an AI algorithm. The performance data is from bench testing of the manufactured medical device.

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

• Not applicable. Ground truth as typically defined for AI algorithms (e.g., expert labels on images) is not relevant to a 510(k) summary for a physical medical device based on bench testing. The "ground truth" for device performance is typically engineering specifications and established test methodologies.

4. Adjudication method for the test set

• Not applicable. "Adjudication method" usually refers to reconciling differences among expert annotators in an AI study. This submission is about a physical device and its engineering performance.

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

• No. An MRMC study is specific to AI-assisted interpretation tasks. This submission is for a physical medical device.

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

• No. This applies to AI algorithms, not a PTA dilatation catheter.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by engineering specifications and validated bench test methods. For example, a balloon must inflate to a certain diameter at a certain pressure without bursting, and this is verified through specific tests.

8. The sample size for the training set

• Not applicable. There is no AI training set involved in this submission.

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

• Not applicable. There is no AI training set involved in this submission.

Summary of the Study (Bench Testing):

The study was not a clinical trial or an AI performance study. It was a series of bench tests conducted to evaluate the physical and functional performance of the PowerCross™ .018" OTW PTA Dilatation Catheter. The purpose of these tests was to demonstrate that the proposed device performs as intended and is "substantially equivalent" to already legally marketed predicate devices (NanoCrossTM .014" OTW PTA Dilatation Catheter (K090849) and EverCrossTM .035" OTW PTA Dilatation Catheter (K082579)). The 510(k) summary 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." The specific details of these bench tests (e.g., number of devices tested for each parameter, the exact test protocols) are not included in the provided summary but would be part of the full 510(k) submission.

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