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The device is indicated to provide a pathway through which diagnostic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.

The C304-HIS device is a radio opaque, braid-reinforced catheter with a deflectable distal tip. The catheter shaft is constructed from Polyether Block Amid (PEBA), with a medical stainless-steel braid and an inner Polytetrafluoroethylene (PTFE) liner. The shaft construction is manufactured by an external vendor Teleflex. The shape of the distal catheter deflectable segment is controlled by a pull wire connected to the handle which can be adjusted to accommodate individual anatomies and to allow access to the target sites. The pull wire is anchored to a distal gold marker band.

The device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle, and an out-of-plane curve on the distal tip. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.

This document is a 510(K) summary for the Medtronic SELECTSITE C304-HIS Deflectable Catheter System. It describes a medical device, its intended use, and its equivalence to previously cleared devices. It does not present acceptance criteria or detailed study results as typically found in a performance study for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document explicitly states: "Clinical data was not generated. This section is not applicable." This indicates that the device was cleared based on non-clinical data (device integrity, mechanical, functional, biocompatibility testing) and substantial equivalence to predicate devices, not on a clinical performance study with human subjects, which would typically involve the metrics and study design parameters you've requested.

The information provided only includes:

• Device Name: SELECTSITE C304-HIS Deflectable Catheter System
• Predicate Device: SelectSite™ C304-S5901 and C304-L6901 Deflectable Catheter Systems (K033989, K061416)
• Non-Clinical Data Summary: "Device integrity testing was performed to support the equivalency of the C304-HIS device to the predicate devices. Testing included mechanical, functional, and biocompatibility testing. The C304-HIS device met all specified design and performance requirements."
• Biocompatibility: Evaluated consistent with ISO 10993-1.
• Sterilization: Validated Ethylene Oxide (EtO) sterilization process.

Since the device is a physical medical catheter and not a software or AI/ML diagnostic tool, the typical framework for evaluating AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not applicable here.

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The Selectra lead introducer system is used to facilitate implantation of leads in the coronary sinus or to facilitate lead implantation into the heart chambers.

BIOTRONIK's Selectra lead introducer system is a combination of quiding catheters and implantation accessories used to facilitate access to the heart for suitable leads and catheters. The Selectra lead introducer system consists of several individually available guiding catheters with various different curve shapes and the Selectra accessory kit. The Selectra Accessory Kit includes the following components in a single sterile package: 1 Selectra Slitter Tool, 1 quide wire, 4 transvalvular insertion (TVI) tools, 1 syringe, 1 torque tool, 2 check valves, 2 stopcocks, 2 sealing caps. The catheters are available as inner (5F) and outer (7F) catheters which jointly form a telescopic system, and facilitate implantation of leads into the heart. The Selectra catheters are compatible with one another as well as the Selectra Accessory Kit.

This document is a 510(k) summary for the BIOTRONIK Selectra Lead Introducer System. The submission, K183265, seeks to demonstrate substantial equivalence to previously cleared predicate devices.

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

The document explicitly states: "Performance data was not required to support this submission because no design change has been made." Therefore, there are no specific acceptance criteria for performance or reported device performance in this 510(k) summary. The submission is based on the premise that the device's technological characteristics are identical to the predicate devices.

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

Not applicable. No performance data was required or provided in this submission because no design change was made.

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)

Not applicable. No performance data was required or provided.

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

Not applicable. No performance data was required or provided.

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 a medical instrument (lead introducer system), not an AI-assisted diagnostic or interpretative system.

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

Not applicable. This device is a medical instrument, not an algorithm.

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

Not applicable. No performance data was required or provided.

8. The sample size for the training set

Not applicable. No new performance data was generated or analyzed as part of this submission. The device is a physical medical instrument, not a learned algorithm.

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

Not applicable. No new performance data was generated or analyzed as part of this submission.

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