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The GII spinal fixation system when used as a pedicle screw system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative or severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar/first sacral (L5-S1) joint with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(6) Spinal tumor, and/or

(7) Failed previous fusion (pseudoarthrosis).

The GII spinal fixation system when used as a hook and sacral/iliac screw fixation system in the non-cervical posterior spine, the GII spinal fixation system is to be used in skeletally mature patients as an adjunct to fusion using autograft and/or allograft for one or more of the following:

(1) Degenerative spondylolisthesis with objective evidence of neurologic impairment,

(2) Fracture,

(3) Dislocation,

(4) Scoliosis,

(5) Kyphosis,

(7) Spinal tumor, and/or

(8) Failed previous fusion (pseudoarthrosis).

The new GII-Ti-Poly-Axial Screw is intended to be used with the existing components, nuts, washers, cross-links and instrumentation as currently provided with the cleared GII Spinal Fixation System. The previously cleared indications for use of the GII Spinal Fixation System are unchanged.

Acceptance Criteria and Device Performance Study for GII-Ti-Poly-Axial Screw

This document describes the acceptance criteria and the study that proves the GII-Ti-Poly-Axial Screw meets these criteria, based on 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 document states, "Samples were tested according to accepted engineering and scientific principals." However, it does not provide specific details on:

• The exact sample size used for the mechanical testing of the GII-Ti-Poly-Axial Screw.
• The data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a mechanical device test, it is highly likely that the testing was performed in a laboratory setting, likely in Switzerland or at a contract testing facility, and therefore prospective in nature.

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

For a mechanical device like a spinal screw, "ground truth" in the context of clinical outcomes or expert consensus on images is not directly applicable. The "ground truth" here is established by engineering standards and validated testing methodologies to confirm mechanical equivalence. The document does not specify the number or qualifications of experts involved in defining these engineering standards or conducting the tests. It broadly states, "Testing is complete. Samples were tested according to accepted engineering and scientific principals."

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., image reading). Since this study involves mechanical testing of a device's performance against established engineering standards, an adjudication method is not applicable in the traditional sense. The equivalence is demonstrated through objective mechanical measurements and data analysis.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed to assess the impact of a device or AI on human reader performance, typically in diagnostic imaging. This type of study was not performed for the GII-Ti-Poly-Axial Screw, as it is a mechanical implant and not an imaging or diagnostic AI device. Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) is relevant for AI/software devices. Since the GII-Ti-Poly-Axial Screw is a physical medical implant, a standalone performance study is not applicable in this context. Its "performance" is demonstrated through physical and mechanical testing, not algorithmic output.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and validated mechanical testing protocols. The performance of the new GII-Ti-Poly-Axial Screw is compared directly against the performance characteristics of previously cleared predicate devices (K980852, K032604, K051089) within the GII Spinal Fixation System. This includes characteristics like design, material composition, and mechanical properties determined through testing.

8. Sample Size for the Training Set

For a mechanical device undergoing performance testing for substantial equivalence, a "training set" as understood in machine learning is not applicable. The device is not learning from data; its physical properties are being tested. If "training set" were to broadly refer to the predicate devices and their established performance data that serve as a benchmark, the document references several existing screw components from the GII Spinal Fixation System (K980852, K032604, K051089). The specific number of individual units of these predicate devices used to establish their performance is not provided in this summary.

9. How Ground Truth for the Training Set Was Established

Again, a "training set" in the AI sense does not apply here. However, if we interpret "ground truth for the training set" as the established performance baseline of the predicate devices, this baseline was established through:

• Prior mechanical testing of the predicate devices according to accepted engineering and scientific principles.
• Regulatory clearance (e.g., via previous 510(k) submissions K980852, K032604, and K051089) which confirmed their safety and effectiveness based on their design, materials, and performance data at the time of their clearance.
• Adherence to recognized standards relevant to spinal implants (though specific standards are not cited in this summary).

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