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The FOCUS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation for the following indications; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); turnor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

FOCUS Spinal System consists of cannulated polyscrews, straight rods, curved rods, crosslinks and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and performance study details:

The provided document describes a 510(k) submission for the FOCUS Spinal System. It is a Class III medical device, specifically a pedicle screw spinal system.

Based on the content, the acceptance criteria and the study proving the device meets these criteria are primarily focused on mechanical performance and substantial equivalence to a predicate device, rather than clinical performance or AI-assisted diagnostic capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Performance Demonstrated
Mechanical Performance	Static Compression Bending (ASTM F1717)	Performed (details not given, but concluded as "performs as well as the predicate device")
	Static Tension (ASTM F1717)	Performed (details not given, but concluded as "performs as well as the predicate device")
	Static Torsion (ASTM F1717)	Performed (details not given, but concluded as "performs as well as the predicate device")
	Dynamic Compression Bending (ASTM F1717)	Performed (details not given, but concluded as "performs as well as the predicate device")
Substantial Equivalence	Equivalence in design, function, and intended use to legally marketed devices.	"No significant differences... which would adversely affect the use of the product. It is substantially equivalent to these other devices."

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

The document does not specify a "test set" in the context of clinical data or patient studies. The "test set" for this device refers to physical samples of the FOCUS Spinal System components used for mechanical testing.

Sample Size: The document states that "Static compression bending, tension, torsion and dynamic compression bending were performed according to ASTM F1717 on a worst-case, screw construct." The exact number of constructs tested is not specified.
Data Provenance: The tests are mechanical in nature, performed on the device itself. There is no mention of human subjects, patient data, country of origin of data, or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: This information is not provided as the study described is a mechanical performance study, not a clinical study requiring expert assessment for ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method

Adjudication Method: Not applicable, as there is no clinical data or image interpretation requiring adjudication.

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

MRMC Study Done?: No. The provided text does not mention any MRMC study or any comparison of human readers with or without AI assistance. The device is a physical spinal fixation system, not an AI diagnostic tool.
Effect Size of Human Readers Improvement with AI: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done?: No. This device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The ground truth for this device is based on mechanical engineering standards (ASTM F1717) and a comparison of the mechanical performance of the FOCUS Spinal System to a predicate device. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the device's substantial equivalence determination.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI model, and therefore does not involve a "training set" in the machine learning sense.

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

How Ground Truth Was Established: Not applicable, as there is no training set for an AI model. The "ground truth" for the device's safety and effectiveness relies on its mechanical properties meeting established standards and being comparable to legally marketed predicate devices.

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