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Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.

The Solo Pace Fusion System consists of the following components:

• Fusion Guidewire
• Fusion Ground Pad
• Fusion Connection Cable
• Solo Pace Control System, consisting of the following:
  • Solo Pace Remote Control Module (RCM), packaged with the Fusion Guidewire, Fusion Ground Pad and Fusion Connection Cable
  • Solo Pace External Pulse Generator (EPG) (sold separately)

The Fusion Guidewire is intended to deliver interventional devices into the heart and serve as the pacing conduit when used with the Solo Pace Control system. The Fusion Guidewire is made of stainless steel and includes a pre-shaped pigtail distal tip. The Fusion Guidewire has a diameter of 0.035" (0.89 mm) and a length of 275 cm. The Fusion Guidewire is supplied with a tip insertion tube to help advance the guidewire into a catheter. A PTFE coating covers the shaft for lubricity. The proximal 8mm is uncoated to allow connection of the Fusion Guidewire to the Fusion Connection Cable. The pigtail is coated with silicone for lubricity. The Fusion Guidewire is supplied sterile, non-pyrogenic and is intended for single use only.

The Fusion Ground Pad is a transcutaneous pad placed on the patient to serve as the anode terminal for unipolar pacing via a unique connection to the Fusion Connection Cable. The Ground Pad acts as the return electrode for the pacing signal delivered to the patient's heart through the Fusion Guidewire. The Ground Pad cable is 60 inches (1.5 m) long and the skin contacting surface area is 350 cm².

The Fusion Connection Cable connects the Fusion Guidewire and the Fusion Ground Pad to the Solo Pace Control System (EPG component) in a manner that ensures proper polarity. The Fusion Connection Cable is approximately 60 inches (1.5 m) long.

The Solo Pace Control System RCM is a single use sterile device supplied with the Solo Pace Fusion System. The Solo Pace RCM connects wirelessly with the EPG to allow physician control of the EPG in the sterile field.

The Solo Pace Control System EPG is a reusable, external pulse generator described in detail in its Instructions for Use (IFU). The Solo Pace Control IFU should be reviewed, in its entirety, prior to the use of the Solo Pace Fusion System. Solo Pace Control was cleared for use under K241781.

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The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to:

• · Complete heart block
• · Sinus bradycardia
• Sick sinus syndrome
• · Bradycardia with congestive heart failure
• · Cardiac complications during invasive or surgical procedures
• · Support, management, and evaluation of a patient before permanent pacemaker implantation
• · Support during permanent pacemaker replacement
• · Interventional cardiology procedures where pacing is required

The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)

The provided document is a 510(k) premarket notification letter from the FDA to Solo Pace, Inc. regarding their device, Solo Pace Control. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

• Specific acceptance criteria and reported device performance in a table format. It mentions "performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents," and "The results of the above performance testing met the specified acceptance criteria." However, it does not detail what those criteria were or the specific performance results.
• Sample sizes used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on regulatory aspects, such as the device's classification, indications for use, comparison to a predicate device, and a high-level summary of performance testing categories (e.g., electrical safety, EMC, software verification, cybersecurity). It confirms that testing was done and met acceptance criteria, but it does not provide the granular detail required to answer your specific questions about the study design, ground truth establishment, or specific performance metrics.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested detail. The document confirms that such studies were performed and met criteria, but it does not include the specifics of those studies.

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