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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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