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The Spinal Concepts, Inc. BacFix™ ti 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 (T1-SI).

When intended for pedicle screw fixation, the implants are intended for use in Grade 3 and 4 sponylolisthesis at L5-S1, utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid fusion is attained. Levels of pedicle screw attachment for this indication range from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation, the system is intended for hook and/or sacral/iliac screw fixation from the thoracic spine to the ileum/sacrum. The indications are:

1. Idiopathic scoliosis.
2. Neuromuscular 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. Revision surgery.

The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of titanium 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 (T1-S1). The BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in diameters of 5.5 and 6.0mm, in two hardnesses, and a variety of lengths; spinal anchor components, hooks and screws (mono-axial and multi-axial) of various diameters (5.0. 6.0. 7.0 and 8.0mm) and lengths; locking connectors (threaded wedge and nut or non-threaded wedge and locking clip) 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. Wedges are used to connect the spinal rods to screws (hooks and links). These components are preassembled outside the wound, eliminating the need to pre-plan the position of each eyebolt on the spinal rod. A spinal rod is positioned within the open face of the wedge. Fixation of the construct is accomplished using an instrument that applies a three point shear clamp. Addition of the hex nut (when using threaded wedge) and optional use of the locking clip (when using the non-threaded wedge) complete the implant. Anchor components may be added to (or removed from) the construct at any time during the procedure.

The provided document K973687 is a 510(k) premarket notification for a medical device called the "BacFix™ ti Spinal Fixation System." This type of submission is for demonstrating substantial equivalence to a previously approved predicate device, not for proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested categories for acceptance criteria and study design are not applicable to this type of regulatory submission for a spinal fixation system. However, I can extract the information related to how substantial equivalence was established, which serves a similar purpose in this context.

Here's an analysis based on the provided document:

BacFix™ ti Spinal Fixation System Acceptance Criteria and Study to Prove Conformance

1. Table of Acceptance Criteria and Reported Device Performance

For a spinal fixation system, "acceptance criteria" are typically related to mechanical performance and material properties being comparable to predicate devices. There are no clinical performance metrics like sensitivity/specificity for diagnosis in this type of submission.

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

• Test Set Sample Size: Not applicable. This is a medical device for implantation, and the "test set" in this context refers to mechanical testing of the device components, not a clinical study on patients. The document does not specify the number of test articles used for static and fatigue testing.
• Data Provenance: The document does not state the country of origin for the mechanical testing data. The testing was conducted internally or by a contracted lab as part of the manufacturer's submission. It is retrospective in the sense that the testing was performed on the device prototypes for regulatory submission.

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

• Not applicable. For mechanical testing of a spinal fixation system, "ground truth" is established through engineering standards, test methods (e.g., ASTM standards, though not explicitly cited beyond material specs), and direct measurement of physical properties, not expert clinical consensus.

4. Adjudication Method for the Test Set

• Not applicable. This involves engineering testing, not clinical data requiring adjudication.

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

• No. An MRMC study is relevant for diagnostic imaging interpretation or other scenarios where human readers make subjective assessments. This is a spinal fixation system, for which such a study is not appropriate.

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

• Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• For the mechanical testing, the "ground truth" would be the physical properties and mechanical strength measurements (e.g., yield strength, fatigue life, stiffness) of the device components compared against established engineering standards and the performance of predicate devices. This is based on direct physical measurement.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a physical medical device submission for substantial equivalence. The device design and materials are based on established engineering principles and existing predicate devices.

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

• Not applicable. As there is no training set, this question is not relevant. The "ground truth" for the device's design and materials comes from established engineering and biocompatibility standards, and the known characteristics of the predicate devices.

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