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The Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Gladiator Elite is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y- connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gladiator Elite PTA Balloon Dilatation Catheter:

The document (K132810) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, the information you're requesting regarding acceptance criteria, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this type of submission.

Instead, the submission states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence." This means the testing aims to show the new device performs similarly to the predicate device, or meets established industry standards for such devices, rather than meeting specific performance metrics against a clinical ground truth.

Here's what can be extracted based on the provided text, and where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" for each test in the way you might expect for a novel device's clinical performance. Instead, it lists types of tests performed to demonstrate that the device performs equivalently to the predicate and is safe for its intended use. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.

Missing Information Details:

Due to the nature of a 510(k) submission for a substantially equivalent device, many of the requested details for a performance study are not applicable or not provided.

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

• Sample Size: Not specified for any of the in-vitro or biocompatibility tests. These typically involve a number of units sufficient to meet statistical confidence for engineering and biological testing standards, but a specific "test set" in the context of clinical images or patient data is not relevant here.
• Data Provenance: Not applicable. The data is from laboratory (bench) and in-vitro biocompatibility testing, not human subjects or clinical data.

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

• Not Applicable: This device is a PTA Balloon Dilatation Catheter. The "tests" relate to its physical and biological properties. Ground truth in the sense of expert consensus on an imaging finding or clinical outcome is not relevant to this type of device submission. Experts involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests according to established protocols.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "adjudication method" in the sense of multiple readers reviewing clinical data. The tests performed are objective laboratory measurements and standardized biological assays.

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 (a catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.

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

• No: This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: Established biological safety standards and validated laboratory test methodologies (e.g., ISO 10993 series for biological evaluation of medical devices).
• For In-vitro Performance: Engineering specifications, device design parameters, industry standards for balloon catheters, and performance characteristics of the predicate device (K113681).

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/algorithm-based device.

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

• Not Applicable: There is no "training set" for this physical device.

In summary: The provided document is a 510(k) summary for a physical medical device (catheter) seeking substantial equivalence to a predicate. The "study" described consists of bench testing and biocompatibility testing designed to show the new device performs similarly and safely compared to the predicate, and meets general regulatory and industry standards. It does not involve clinical trials, AI, or human reader performance evaluations in the way one might see for diagnostic software or novel therapeutic devices.

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