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The ISOBAR Closed Pedicle Screw is to be used in conjunction with the ISOBAR Spinal System, a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. The U-line pedicle screws, rods, nuts and crosslink members were cleared on Single of manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is a pedicle screw with a closed set-screw. It has a U shaped head to accept a rod in the same manner as the U-line screw. The difference is the set-screw used to secure the rod into place. As the set-screw is tightened the rod is secured in the U slot of the screw and is fixed in position.

The provided 510(k) summary for the ISOBAR Closed Pedicle Screw does not contain information typically found in acceptance criteria and study reports for software-driven medical devices or AI algorithms. This submission is for a physical medical device (a pedicle screw spinal system), not a software or AI product.

Therefore, many of the requested categories are not applicable to this submission. I will address the applicable points based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The "test set" in this context would refer to the physical screws or components tested according to ASTM F1717-96. The document does not specify the number of screws tested or the origin of the data beyond the standards applied.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. For a physical device like a pedicle screw, "ground truth" is established through physical and mechanical testing against recognized engineering standards (like ASTM F1717-96), not by expert consensus or interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading), not for objective mechanical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. MRMC studies are used for evaluating diagnostic software (often AI-driven) where human readers interpret medical images. This submission is for a physical orthopedic implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as this is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance would be the objective measurements obtained from mechanical testing (static and fatigue compression) against the specified ASTM F1717-96 standard. The standard itself defines the acceptable parameters for these measurements.

8. The sample size for the training set

This is not applicable as there is no "training set" for a physical medical device in the context of an algorithm.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set mentioned or implied for this physical device.

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