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The BIOTRONIK RETROX RX 53/60-BP and RETROX RX 45/53-JBP transvenous, active-fixation endocardial leads are indicated for permanent pacing and sensing. Active-fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators. The leads may be used with single- or dual-chamber pacing systems.

RETROX RX-BP and RX-JBP leads differ in the shape of the distal portion of the lead. The RX-BP models are intended for placement in the ventricle or atrium and have straight distal ends. The RX-IBP models have a pre-formed J-shaped distal end to facilitate lead placement in the right attial appendage.

BIOTRONIK's Retrox leads are transvenous, bipolar, active fixation, endocardial pacing leads. The Retrox lead being introduced in this 510(k) notification is identical to the Retrox lead already cleared for distribution with the exception that the material used to construct the fixation helix has changed to Elgiloy. Currently, the fixation helix in the Retrox is manufactured with an alloy containing 70% platinum/30% iridium.

The provided document is a 510(k) summary for a medical device (Retrox Active Fixation Endocardial Lead) seeking substantial equivalence to a predicate device. It confirms FDA clearance but does not contain a study description or acceptance criteria as requested in your prompt. The document focuses on device description, predicate device comparison, and regulatory approval.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information about this.
6. Standalone performance study: No information about this.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document indicates that the device introduced through this 510(k) is "identical to the Retrox lead already cleared for distribution with the exception that the material used to construct the fixation helix has changed to Elgiloy." This suggests that the substantial equivalence argument relies on the prior clearance (K981083) and the material change, rather than new, extensive performance studies detailed in this specific document.

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