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As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

The Cirq Arm System serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw trajectory with surgical instruments. It consists of a passive, semi-rigid mechatronic arm system with structural components, several modules, instrument holding and clamping mechanisms and software to guide the user.

The Cirq Arm System 2.0 is a passive mechatronic device for holding and positioning surgical instruments; it is evolved from its predecessor, the Surgical Base System 1.4 (K202320).

The Cirq Arm System 2.0 is attached to the side rail of an operating table and is intended to be used in a hospital environment, specifically in rooms which are appropriate for surgical interventions (e.g. operating rooms). The base provides external power and communication with the IGS platforms and Alignment Software Spine (if applicable, ie. if used within the active configuration).

The Cirq Arm System 2.0 can be manually positioned by releasing the brakes in the joints, using the integrated buttons. The brakes in the joints open when powered (a voltage is supplied), and close without current. Therefore, the brakes close in case of a power failure. The brake state is visualized to the user by LED rings showing different colors for the two different brake states (open/closed) separately for each joint. The electronics and firmware are designed to be ready to operate meaning that the arm can be booted and used quickly after connecting it to the power supply.

The sterility of the device during the surgical intervention is ensured with a sterile drape, which is compatible to the Cirq Arm System 2.0 and the attached application module. The specific workflow and operating principles differ based on the attached module.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for the Brainlab Cirq Arm System (2.0), focusing on demonstrating substantial equivalence to a predicate device.

The document discusses:

• Device Description and Indications for Use: What the device is and what it's intended for (spinal screw placement procedures).
• Substantial Equivalence Comparison: A table comparing the subject device (Cirq Arm System 2.0) with its predicate device (Cirq Robotic Alignment Module - Spine, K202320) in terms of hardware, software, weight, dimensions, maximum payload, and brake/joint design. The intent of this comparison is to show that the new device has similar functionality, intended use, and technological characteristics.
• Performance Data (Verification): This section details the types of verification performed (software and hardware verification), but does not provide acceptance criteria or specific results in terms of device performance against those criteria. It mentions:
  • Software Verification: Performed through integration tests and unit tests. It also states that incremental test strategies were used for changes with limited scope, and that software verification covers all specifications, including SOUP items and cybersecurity.
  • Hardware Verification: Verified mechanical and electronic requirements, compliance to standards, and biological safety.
    • Mechanical verification: Conducted through CAD review, calculations, document review, and bench testing for holding force/payload, stiffness, mechanical safety factor, and lifecycle testing.
    • Electrical verification: Included documentation and schematics review, and physical testing.
    • Biological safety: Verified according to ISO 10993-1:2018.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample size, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth type, training set size, or training set ground truth establishment) because it is not present in the provided text.

The document states that the performance testing conducted supports the conclusion that the device is substantially equivalent to the predicate, but it does not detail the specific performance metrics or the study results themselves.

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