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The Spinal Concepts, Inc. BacFix™ Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T)-SI).

When intended for pedicle screw fixation, implants are 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 the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.

In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation of the noncervical spine, the indications are:

1. Idiopathic scoliosis.
2. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Spinal fractures (acute reduction or late deformity).
5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
6. Neoplastic disease.
7. Spondylolisthesis.
8. Spinal stenosis.
9. Failed previous fusion.

The BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in a variety of diameters (1/4" and 3/16") and lengths; spinal anchor components, hooks and screws, of various sizes (6.0-7.5mm diameter screws) and types; locking connectors (wedge and nut) sized to fit the spinal rods; and a transverse connector assembly (link), also in various lengths. Hooks and screws may be placed at any position along the spinal rods and are secured with a three point shear clamp (wedge and nut). The open face of the wedge may be snapped over the spinal rod. Thus the component and wedge may be preassembled outside the wound, eliminating the need to attach the nut within the surgical opening and the need to pre-plan the position of each eyebolt on the spinal rod. Furthermore, an anchor component may be added to (or removed from) the construct at any time during the procedure.

The provided document describes the BacFix™ Spinal Fixation System (K983258), a medical device. The "study" that proves the device meets acceptance criteria is a mechanical testing comparison study rather than a clinical trial involving human subjects. This is a common approach for Class II medical devices seeking 510(k) clearance, where substantial equivalence to a legally marketed predicate device is the primary pathway.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of test samples (e.e. rods, screws, hooks) used for the static and fatigue mechanical testing.
• Data Provenance: Not explicitly stated, but the testing would have been conducted in a laboratory setting, likely in the US, as the company is based in Austin, Texas. It is a prospective test in the sense that the device was manufactured specifically for these tests. It is not related to patient data.

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

• This question is not applicable in the traditional sense for this type of mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and comparative data with predicate devices, not by expert consensus on clinical cases. The comparison was to published data of predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. Mechanical testing data is evaluated against pre-defined engineering standards and comparative data, not through an adjudication process by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This is a mechanical device, and its approval is based on substantial equivalence to predicate devices through material and mechanical performance, not through a comparative effectiveness study involving human readers or clinical outcomes in the way AI/radiology devices might.

6. Standalone Performance Study

• Yes, a standalone study was done, but it's mechanical. The "Mechanical Testing" section (VII) describes static and fatigue testing performed solely on the BacFix™ System. The results of this standalone testing were then compared to published data of "various other hook, rod and screw spinal fixation systems." This is a standalone performance of the device's mechanical properties, not a standalone algorithm performance.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is based on:
  • Engineering Standards: Implied standards for static and fatigue strength for spinal fixation systems.
  • Predicate Device Performance Data: Published mechanical testing data from the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As above, there is no "training set" for a physical medical device.

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