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The HC Biologics Osteopoint Spinal Fixation System is intended to provide immobilization 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 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),

-Spondylolisthesis.

• -Trauma (i.e., fracture or dislocation),
  -Spinal stenosis,

• -Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
  -Tumor,

• -Pseudoarthrosis, and/or
  -Failed previous fusion

HC Biologics Osteopoint Spinal Fixation System is top-loading, multiple components, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated and spondylolisthesis screws, rods (straight and curved), connectors, hooks, and setscrews. It allows surgeons and functions to build a spinal implant construction to stabilize and promote spinal fusion. The System components are supplied non-sterile, for single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.Various sizes of these components are available to be used by a professional in a healthcare facility/ hospital.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to HC Biologics LLC for the "HC Biologics Osteopoint Spinal Fixation System." This type of document is part of the regulatory process for medical devices in the United States, where a manufacturer demonstrates that their new device is "substantially equivalent" to an already legally marketed device (a predicate device).

The document mainly covers:

• The FDA's determination of substantial equivalence.
• Regulatory requirements and guidelines for the device.
• The indicated uses of the device.
• A comparison of the new device to a predicate device (MSFX Mikron Spinal Fixation System) in terms of indications for use and technological characteristics.
• Mention of biomechanical tests performed according to ASTM standards for the Mikron System (which is stated to be identical to the HC Biologics Osteopoint Spinal Fixation System), but it does not provide the results of these tests or specific acceptance criteria met by those results.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, or other study-specific information because it is not present in the provided text.

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