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The Electrode Semi-Flotation Catheter is furnished in five, six and seven French sizes. The device has an electrode mounted at the distal tip. There are one to five electrodes mounted on the shaft proximal to the tip. The shaft has bands every ten centimeters. The electrode wires are connected to wire extensions with pin connectors. These are coded with numbers for identification.

AI/ML Overview

The provided text describes a 510(k) submission for the J-LLoyd Medical, Inc. Electrode Semi-Flotation Catheter. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with specific acceptance criteria as might be seen for novel technologies.

Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in the provided documentation. The "study" here is essentially a comparison to the predicate device and the existing knowledge about such devices.

Here's an analysis based on the provided text, addressing your points where possible:

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

The submission does not define specific, quantifiable acceptance criteria in the format of a typical clinical trial (e.g., sensitivity, specificity thresholds). Instead, the primary "acceptance criterion" is substantial equivalence to the predicate device, the J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter (K930069), regarding materials, basic design, assembly methods, and performance data.

Acceptance Criterion (Implied)	Reported Device Performance (Claimed)
Material Equivalence	"The Electrode Semi-Flotation Catheter and the Predicate Catheter are basically the same, using the same materials..."
Basic Design Equivalence	"...the same basic design..."
Assembly Method Equivalence	"...the same methods of assembly."
Performance Data Equivalence (Mechanical, Electrical)	"The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device."
Biological, Chemical, Sterilization Equivalence	"The Biological, Chemical and Sterilization specifications remain the same as the Predicate Device, in that only physical difference is the addition of materials (electrodes) presently used on the Predicate Device, and the elimination of the latex balloon." This implies that existing data/knowledge from the predicate device (which has already been approved) is considered applicable to the new device due to the equivalence of these specifications and the minor physical changes.
Safety	"Based on engineering testing, the J-LLoyd Medical, Inc. devices and the fact that the asic design has been in use since before May 28, 1976, by thousands of physicians, in hundreds of hospitals world wide, it is our judgement that this device presents an acceptable level of safety then properly used by a trained physician." This is a qualitative claim based on historical use and engineering testing, not a specific quantifiable safety metric from a new study.
Intended Use	The new device's intended uses (Temporary use in electrophysiology studies; Intracardiac ECG recording; Electrical Stimulation) are presented as an increase in function compared to the predicate's electrical stimulation and intracardiac ECG recording, but the predicate itself provides the basis for these functionalities. The document states that the addition of electrodes "increases the functions from electrical stimulation, and intracardiac ECG recording, but will also include electrophysiology studies." This indicates the device supports these new uses.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described for the new device itself. The evidence relies on:

Engineering testing on the device (not quantified in terms of sample size).
The established performance and safety of the predicate device.
The long history of similar basic designs in use since before May 28, 1976.

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

Not applicable. This was a 510(k) submission based on substantial equivalence, not a study requiring expert readers to establish ground truth for a new diagnostic or prognostic device's performance. The "judgement" of safety is provided by the submitter (James L. Skaggs, Sr., General Manager), referencing widespread physician use over a long period.

4. Adjudication method for the test set

Not applicable, as there was no test set requiring multi-expert adjudication.

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 device is an electrode catheter, not an AI-powered diagnostic tool.

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

Not applicable. This device is an electrode catheter.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic performance studies is not relevant here. The "truth" in this context is the demonstrated safety and performance of the predicate device and the manufacturing/design equivalence of the new device to that predicate. This relies on:

Engineering Test Data: Mentioned for mechanical strengths and electrical tests, and for safety, though specifics are not provided.
Historical Data/Clinical Experience: The widespread use of the basic design by "thousands of physicians, in hundreds of hospitals world wide" since before May 28, 1976, forms the basis for the safety judgment.
Predicate Device Approval (K930069): The predicate device's prior FDA approval provides the basis for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

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