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The Streamline 1 Temporary Pacing Leads are indicated for temporary atrial, or atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The devices are supplied sterile and intended for single use only.

Model 6491 Unipolar Pediatric Temporary Pacing Lead: The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6492 Unipolar Temporary Atrial Pacing Lead: The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6494 Unipolar Temporary Myocardial Pacing Wire: The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6495 Bipolar Temporary Myocardial Pacing Lead: The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6500 Unipolar Temporary Myocardial Pacing Lead: The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.

Model 6491: The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 1). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6492: The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 2). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6494: The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi- filament wire (1) (see Figure 3). One end of this wire has been stripped to have an electrode surface (2). This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle (3). An atraumatic chest needle (4) at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.

Model 6495: The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi- filament lead (see Figure 4) which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Model 6500: The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 5). A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body, except the silicone rubber disc (6) in case of atrial application.

This document is a 510(k) summary for Medtronic's Streamline™ Temporary Pacing Leads. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document states that the modifications to the Streamline™ Temporary Pacing Leads "do not affect the intended use of the devices or alter the fundamental scientific technology of the devices." This suggests that the substantial equivalence claim is based on the known performance characteristics of the predicate devices and the minor nature of the changes (pin protector, sterile barrier, packaging, and shelf-life reduction).

Therefore, based on the provided text, I cannot provide the requested information about:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report with detailed performance metrics against acceptance criteria.

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