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The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture. dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

The KAPSS® Spinal System consists of longitudinal members (rods), anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

The KAPSS® Spinal System is a medical device designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. This response summarizes the acceptance criteria and the study proving the device meets these criteria as described in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes mechanical performance testing rather than a clinical study involving human subjects or medical image data. Therefore, the concept of a "test set" for data provenance in the traditional sense (e.g., country of origin of data, retrospective/prospective) is not applicable here.

For the mechanical tests conducted:

• Sample Size (Test Set): The document does not specify the exact number of constructs tested for each type of mechanical test (static compression bending, dynamic compression bending, static torsion). It refers to "KAPSS® Spinal System constructs" generally.
• Data Provenance: The tests were performed "according to ASTM F1717," which is an international standard from ASTM International (originally American Society for Testing and Materials). This implies a controlled laboratory setting, testing physical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The study involved mechanical performance testing of physical devices against engineering standards (ASTM F1717), not clinical data requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as this was mechanical testing against a standard and not a clinical study requiring adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study described is mechanical testing of medical device components.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical spinal system, not an algorithm or AI software, so the concept of "standalone performance" in that context does not apply. The performance evaluated was the standalone mechanical performance of the device constructs themselves.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by engineering standards and predicate device performance comparison through mechanical testing. Specifically:

• Adherence to ASTM F1717 standards for various mechanical tests.
• Performance "as well as or better than the predicate devices" in those mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.

The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.

The provided text {0} discusses substantial equivalence based on basic design, intended use, indications, anatomic sites, and "mechanical performance." However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy. The document is a 510(k) summary for a medical device (Magnum Nail) and focuses on demonstrating substantial equivalence to predicate devices, primarily through design, intended use, and mechanical properties, not through a study demonstrating acceptance criteria for an AI/algorithm-driven device.

Therefore, most of the requested information (items 1-9) cannot be extracted directly from this document as it pertains to a different type of device evaluation (mechanical fixation rather than AI/algorithm performance).

However, I can extract the following relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance
Not applicable. The document assesses "mechanical performance" for substantial equivalence of a fixative nail, not diagnostic or algorithmic performance. No specific acceptance criteria or quantitative performance metrics are provided in the context of an AI/algorithm evaluation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for an AI/algorithm is mentioned.

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. No ground truth establishment for an AI/algorithm is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for an AI/algorithm is mentioned.

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
Not applicable. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for an AI/algorithm is mentioned.

8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.

9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is mentioned.

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