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The LIBERTY" Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the LIBERTY™ Anterior Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis Spinal deformities: scoliosis, lordosis, kyphosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion Tumor resection All components of the LIBERTY™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only. WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The LIBERTY" Anterior Spinal System consists of the following implants components: Rods (LIBERTY™ Rods, TSRH® Rods, CD HORIZON™ Knurled Rod, CD HORIZON™ Rod), Screws (LIBERTY™ Closed Screws, LIBERTY™ Closed Screw w/10° Oblique Canal, LIBERTY™ Closed Screw w/15° Oblique Canal, LIBERTY™ Open Screw), Connectors and Cross Connectors (LIBERTY™ 12-32 Break-Off Set Screw, LIBERTY™ Open Implant Closure Saddle, TSRH® Single Hole Staples, TSRH® Two Hole Offset Staples, Left and Right, TSRH® Washer, TSRH® Low Profile CROSSLINK® Offset Plate, TSRH® Low Profile CROSSLINK® Plate, 0.625 in length, TSRH® Low Profile CROSSLINK® Plate Set). The implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel or from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, one of the CD HORIZON spinal rods which may be used with the LIBERTY™ Anterior Spinal System and the TSRH® Single Hole Anterior Staples are fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium implants are not to be used with stainless steel implant components in a spinal construct A LIBERTY anterior construct may involve either a single rod or two rods. The implant components may be sold sterile or non-sterile. Instrumentation is also available to facilitate implantation of the device components.

The provided text is a 510(k) summary for the LIBERTY™ Anterior Spinal System. It does not include information about acceptance criteria, detailed study designs, or actual performance metrics that would typically be found in a clinical study report. The document focuses on describing the device, its materials, intended use, and a claim of substantial equivalence based on mechanical test data.

Therefore, for almost all of your questions, the answer will be that the information is not provided in the given text.

Here is a breakdown based on the information provided:

Acceptance Criteria and Study Information for LIBERTY™ Anterior Spinal System

1. A table of acceptance criteria and the reported device performance

   • Not provided. The document does not describe specific acceptance criteria (e.g., minimum tensile strength, fatigue life) or quantifiable performance metrics of the device against such criteria. It states that "Mechanical test data were supplied or referenced in support of the V. LIBERTY™ Anterior Spinal System 510(k) notification." but does not elaborate on what those criteria or results were.

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

   • Not provided. The document refers to "mechanical test data" but does not specify sample sizes, type of data (e.g., in vitro, in vivo animal, human clinical), country of origin, or whether it was retrospective or prospective.

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)

   • Not applicable / Not provided. This question relates to studies with human expert interpretation (e.g., image analysis, clinical diagnosis). The 510(k) summary mentions "mechanical test data," which typically does not involve human expert ground truth establishment in this manner.

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

   • Not applicable / Not provided. Similar to point 3, this is relevant for studies involving human assessment or data interpretation. The document only references "mechanical test data."

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

   • No. This device is a physical spinal implant system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this product and was not performed.

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

   • No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

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

   • Not provided. For "mechanical test data," ground truth would typically refer to established engineering standards, material properties, and physical testing methodologies. The document does not specify these details.

8. The sample size for the training set

   • Not applicable / Not provided. This refers to machine learning algorithms. The device is a physical implant. The concept of a "training set" in the context of mechanical testing would relate to design iterations or material characterization, but such details are not provided.

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

   • Not applicable / Not provided. Similar to point 8, this is not relevant for this type of device and the information provided.

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