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OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.

OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of.

OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.

The provided text describes a 510(k) premarket notification for the "TME Temporary Myocardial Electrode" device. This document outlines the device description, indications for use, comparison to predicate devices, and non-clinical performance testing.

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML-driven medical devices.

The document details the device's technical specifications and biocompatibility testing, but it does not present a table of acceptance criteria for a specific performance metric (like sensitivity, specificity, accuracy) and the device's reported performance against those criteria. It also lacks details on:

• Sample size for a test set: The document mentions non-clinical performance testing without specifying a test set for a comparative effectiveness or standalone performance study.
• Data provenance: Not applicable here as no clinical or image data is being evaluated.
• Number of experts used to establish ground truth: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm-only) performance: Not mentioned.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Oscor Inc. Model TME 64S Bipolar Temporary Heart Wire) through:

• Identical construction: "The construction of the subject device and predicate device are identical. Osypka AG manufactures the complete line of Unipolar, Bipolar & Quadripolar Temporary Myocardial Heartwires for Oscor. There are no material, construction, specification, manufacturing process, or sterilization process differences."
• Similar indications for use: "The Indications for Use are very similar to the predicate device."
• Identical environment of use and patient population: "The use environments are the same... The patient populations are the same as the predicate and reference devices."
• Non-clinical performance testing: This includes tests like Bending Strength, Dielectric Strength, Tensile Strength, Corrosion Resistance, etc., to verify product specifications and user requirements. These are engineering-focused tests rather than clinical performance metrics.
• Biocompatibility testing: According to ISO 10993-1.

In summary, the provided FDA 510(k) clearance document for the TME Temporary Myocardial Electrode does not include the type of information requested regarding acceptance criteria and performance studies for AI/ML devices. It is a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing.

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