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The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

• Degenerative disc disease (Define as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• Degenerative spondylolisthesis with objective evidence of neurologic impairment,
• Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint,
• Fracture,
• Dislocation,
• Scoliosis,
• Kyphosis,
• Spinal tumor,
• Failed previous fusion (pseudarthrosis).

The Erisma® LP MIS device is intended to be used for the surgical treatment of spinal pathologies by percutaneous access. The treatment consists of the stabilization of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.
The Erisma® LP MIS consists of cannulated extended pedicle screws and straight or pre-bent rods that can be used via posterior percutaneous surgical approach to provide the immobilization and the stabilization of spinal segments in mature patients as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar and sacral spine.
The components are available in a variety of diameters and lengths to accommodate patient anatomy and are made from ISO 5832-3 or ASTM F136 medical grade Titanium alloy.
The Erisma® LP MIS also contains surgical instruments common for posterior percutaneous spinal fixation approach. The primary purpose of this submission is to extend the breakoff tabs of the pedicle screws to allow for minimally invasive surgery.

The provided document is a 510(k) premarket notification decision letter from the FDA for the Erisma® LP MIS device. This type of submission is for medical devices and their physical performance characteristics and safety, not for AI-powered diagnostic tools or software as a medical device (SaMD) that typically have acceptance criteria focused on diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score).

Instead, the "Performance Data" section mentions:

• Bench Testing: This refers to physical and mechanical testing of the device.
  • Dynamic ASTM F1717 testing: This is a standard for spinal implant constructs in a simulated in-vivo environment to assess their mechanical integrity and fatigue life. The acceptance criteria would be defined by the stress and cycle limits set in the standard for equivalence to the predicate device.
  • Sterilization validation: This ensures the device can be properly sterilized, meeting specific sterility assurance levels, which are critical for patient safety.
• Substantial Equivalence: The primary "proof" is that the device is substantially equivalent to legally marketed predicate devices in terms of material, design, and indications for use, and that the minor change (extended breakoff tabs for MIS insertion) does not raise new safety or effectiveness questions.

In summary, the document does not provide the type of information requested for an AI/diagnostic device, such as acceptance criteria for diagnostic performance, sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies. The "study" referenced is bench testing to demonstrate mechanical and sterilization equivalence to predicate devices, which is typical for physical medical implants.

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