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The Opta LP and Powerflex Plus PTA Balloon Catheters are intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumen design with distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 150 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon

This submission, K981407, pertains to the Cordis Opta LP and Powerflex Plus PTA Balloon Catheters. The provided documents focus on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these specific documents.

Here's an analysis of what information can be extracted based on the provided text:

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

The provided documents do not contain a table of acceptance criteria or reported device performance in relation to specific quantitative metrics. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the performance is expected to be similar to legally marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given documents. The submission is a 510(k) premarket notification that relies on demonstrating equivalence rather than presenting a de novo clinical study with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as no specific test set requiring expert ground truth is described in the context of this 510(k) submission.

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

This information is not provided as no specific test set requiring adjudication is described.

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

An MRMC comparative effectiveness study is not mentioned or implied in these documents. This submission is for medical devices (balloon catheters), not an AI-assisted diagnostic tool.

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

This is not applicable as the device in question is a physical medical device (balloon catheter), not an algorithm or AI.

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

This information is not provided as there is no mention of a specific study requiring ground truth establishment for a diagnostic or AI performance evaluation. The "ground truth" for a device like this would typically relate to its physical and mechanical properties, and its ability to perform its intended function (e.g., dilate stenoses), which would be assessed through bench testing and potentially pre-clinical or limited clinical use, not typically through ground truth similar to diagnostic imaging.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/algorithm-based device requiring a training set.

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

This information is not provided and is not applicable as this is not an AI/algorithm-based device.

Summary of Information from the Provided Documents:

The core of this submission (K981407) is to demonstrate substantial equivalence of the Cordis Opta LP and Powerflex Plus PTA Balloon Catheters to predicate devices that have already received 510(k) concurrence.

Predicate Devices Referenced:

• Cordis Opta LP PTA Balloon Catheter
• Cordis Powerflex Plus PTA Balloon Catheter
• Cordis Opta5 PTA Balloon Catheter
• Cordis Powerflex PTA Balloon Catheter

Basis of Substantial Equivalence:

The submission states that the new devices are similar in their:

• basic design
• construction
• indications for use
• performance characteristics

This indicates that the "study" demonstrating this is a comparison to the established performance and safety profiles of the predicate devices, rather than a de novo clinical trial with specific acceptance criteria and detailed performance metrics presented here. The FDA's review and concurrence mean that they have accepted this argument of substantial equivalence.

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