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The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.

Khelix Diagnostic Electrophysiology Catheters are a range of electrophysiology diagnostic cardiac catheters designed to facilitate electrophysiological mapping of the heart. The devices are intended for the electrical recording and/or stimulation of endocardial structures. The device consists of a catheter handle and catheter shaft containing an array of platinum-iridium electrodes for stimulation and recording. The subject device comes in a variety of models based on the distal catheter configuration including Steerable and Loop models. The device interfaces with standard electrophysiological recording equipment, such as ECG monitoring equipment, impedance based navigational equipment and cardiac stimulation equipment, via the Khelix Diagnostic Extension Cable (supplied separately). The device is available in different device models with several variants according to electrode configurations, curve types and loop diameters, as applicable. The subject catheters use 4 to 20 electrodes with variable spacing to provide for variation in physician preference. The catheter is intended to be used with the Khelix Diagnostic Extension Cable. The extension cable connects distally to the catheter (sterile field) and proximally to standard electrophysiology (EP) laboratory equipment such as heart signal monitors/records and stimulators (non-sterile field) via shielded tip pins. The Khelix Diagnostic Electrophysiology Catheter range is supplied sterile. The devices are sterilized using an ethylene oxide (EtO) sterilization process.

This K211327 510(k) summary is for a diagnostic electrophysiology catheter. As such, the acceptance criteria and study that proves the device meets the criteria are typically bench and laboratory tests rather than clinical studies requiring human-in-the-loop performance, expert consensus, or complex ground truth establishment like pathology or outcomes data. The document confirms this expectation.

Here's a breakdown of the information requested, based on the provided text:

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

The provided document doesn't detail specific quantitative acceptance criteria values beyond "Pass" for each test. It lists the tests performed and their methodologies.

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 and laboratory tests. It states that "Bench and laboratory testing was conducted." The data provenance is derived from the manufacturer's own internal testing. The manufacturer is CathRx Ltd, located in Rydalmere NSW 2116, Australia, implying the testing was conducted in Australia. The testing is retrospective as it was done to support the 510(k) submission.

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

This type of testing (bench and laboratory) does not typically involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for these tests is established by adherence to recognized international and industry standards (e.g., ISO, ASTM, IEC). The expertise lies in the engineers, technicians, and quality professionals who conduct these tests and interpret the results against the defined standards. The document does not specify the number or qualifications of these individuals.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or data by multiple readers. Since this device's performance was evaluated through bench and laboratory testing against established engineering and safety standards, no such adjudication method was employed.

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 conducted. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable to the scope of this 510(k) submission.

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

This refers to the performance of an algorithm without human intervention, usually in the context of AI/ML devices. Since the Khelix Diagnostic Electrophysiology Catheters are physical medical devices for electrical recording and stimulation, and not a software algorithm, this concept is not applicable. The device's "standalone" performance is assessed through its physical, electrical, and functional characteristics validated by the bench and laboratory tests.

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

The ground truth for these bench and laboratory tests is based on engineering specifications and established international/industry standards. For example:

• Sterilization: Defined by ISO 11135 (SAL of 10^-6).
• Biocompatibility: Defined by ISO 10993 and ASTM 756.
• Electrical Safety: Defined by IEC 60601 series.
• Functional Performance: Defined by ISO 10555-1 and internal workmanship standards.

There is no "expert consensus" on individual cases, pathology, or outcomes data used as ground truth for this type of device submission.

8. The sample size for the training set

This device does not involve a "training set" as it is not an AI/ML device that requires machine learning model training. Its design and manufacturing are based on established engineering principles.

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

As there is no training set for this device, the concept of establishing ground truth for it is not applicable.

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