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When used as a pedicle screw fixation system of the non- cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal System is indicated 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 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 modified Erisma® Lp Spinal Fixation System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System device (K240872). The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

The cleared Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System is composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, Offset Connectors, screw sets and associated instruments. Further, the implants used in the cleared Erisma® Lp Spinal Fixation System device and modified Erisma® Lp Spinal Fixation System are both made of Ti6Al4V alloy per ASTM F136.

The modified Erisma® LP MIS is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® LP MIS device (K162367). The Erisma® LP MIS device is indicated 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 subject of this submission is the extend to the Erisma® Lp Spinal Fixation System and the Erisma® LP MIS, with the addition of new components: 'Uniplanar Screws'

The provided text describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered device. Therefore, it does not contain the specific information requested about acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices for a modified Erisma® Lp Spinal Fixation System and Erisma® LP MIS. The performance data presented are for mechanical tests, not clinical studies involving AI or human interpretation.

Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this submission is not for an AI/ML powered medical device.

The "Performance Data" section explicitly states: "Dynamic compression bending test and Static torsion mechanical verification test according to ASTM F1717 and static torsional grip test according to ASTM F1798 were performed to characterize the subject modification addressed in this notification." These are mechanical tests for a physical implant, not a study of an AI algorithm's diagnostic or predictive capabilities.

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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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