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The Reform Pedicle Screw System is intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. The Reform Pedicle Screw System is to be used with autograft and/or allograft.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Reform Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. The pedicle screws are included with or without hydroxyapatite (HA) coating

The provided text is a 510(k) Summary for the "Reform Pedicle Screw System" and does not contain information about acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets those criteria.

Instead, this document is a regulatory submission for a physical medical device (pedicle screws) and details its substantial equivalence to previously cleared predicate devices. The evaluation focuses on materials, design, intended use, dimensions, and mechanical strength, primarily through non-clinical (bench) testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the given input. The requested categories of information (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are relevant to AI/ML device evaluations but are not present in this document about a traditional implantable medical device.

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