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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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