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The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block.

In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.

The Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for ventricular applications for long term cardiac pacing. The nominal lead length for the model 436-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal lead length for the model 437-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors.

The models 436-07 and 437-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 367-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-81(tapered stylet, limber), and model 365-82 (tapered stylet, firm).

The model 437-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter, VS-1 unipolar lead to 6 mm unipolar pacer).

The minimum introducer size recommended for both lead models is 10 French.

The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719).

The provided text is a 510(k) summary for pacing leads, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies typically associated with AI/ML device submissions.

The document focuses on demonstrating substantial equivalence to predicate devices for traditional medical devices (pacing leads) through:

• Device Description: Highlighting similarities in design and materials.
• Biocompatibility Studies: Testing the materials to ensure safety.
• Qualification Testing: Relying on previous testing of predicate leads.
• Clinical Summary: Referencing the low incidence of complications and effective performance of existing, similar devices.

Therefore, I cannot fulfill the request as the necessary information for Acceptance Criteria and Study details for an AI/ML device is not present in the provided text.

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