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The EBI® PI48 Spinal Fixation System is a single use spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

The EBI® P148 Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, couplers and hooks. The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and unalloyed titanium per ASTM F 67-00.

This document is a 510(k) summary for the EBI® P148 Spinal Fixation System. It establishes substantial equivalence to predicate devices and describes the intended use and materials. However, this document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The provided text focuses on:

• Device Identification: Proprietary name, common name, classification names.
• Predicate Devices: Lists EBI® Omega 21™ Spinal Fixation System and Webb-Morley Spine System as predicates.
• Device Description: Single-use spinal fixation device utilizing rods, screws, couplers, and hooks.
• Intended Use/Indications for Use: Detailed descriptions for pedicle screw fixation, posterior hook and sacral/iliac screw fixation, and anterior fixation, specifying spinal segments and conditions treated.
• Materials: Titanium alloy (Ti-6A1-4V ELI) and unalloyed titanium.
• Comparison to Predicate Devices: States "no significant differences" in intended use, materials, and function for substantial equivalence.
• FDA Communication: A letter from the FDA confirming the finding of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them because this data is not present in the provided text.

To answer your request, I would need a different document that details the performance studies conducted for the EBI® P148 Spinal Fixation System, including:

1. Acceptance Criteria: Specific performance thresholds (e.g., in terms of strength, fatigue life, biocompatibility) the device must meet.
2. Study Design: Details of mechanical testing (e.g., static, fatigue), animal studies, or clinical trials.
3. Reported Device Performance: The actual results obtained from these studies.
4. Sample Sizes and Data Provenance: For any test sets used.
5. Ground Truth Establishment: If applicable for human-in-the-loop or standalone AI studies (which is not relevant for a mechanical fixation device).
6. Adjudication Method: If applicable.
7. MRMC or Standalone Studies: If applicable.
8. Training Set Information: If applicable.

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