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The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. The AXIS® Fixation System must be used with autograft or allograft.

The AXIS® Fixation System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the lateral masses of the cervical spine using a posterior approach.

The AXIS® Fixation System implant components are made of titanium alloy. Titanium alloy and stainless steel implants should not be used together in a spinal construct. The AXIS® Fixation System components are supplied non-sterile.

This document, K062254, is a 510(k) premarket notification for the AXIS® Fixation System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Based on the provided text, a formal study with acceptance criteria and reported device performance in the way a clinical trial might be presented is not available. The submission relies on "Substantial Equivalence" to other commercially available posterior cervical fixation systems and pre-enactment devices.

Here's an breakdown based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. 510(k) submissions for devices like this typically do not include a table of acceptance criteria and performance against those criteria in the same way a diagnostic algorithm's submission might. Instead, they demonstrate substantial equivalence through comparison of design, materials, indications for use, and, if applicable, mechanical testing data.

The document states:

"Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of substantial equivalence."

However, the specifics of these mechanical test reports or clinical data, including their acceptance criteria and the device's performance against them, are not detailed in the provided summary.

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

This information is not provided in the document. If "clinical data" was supplied for substantial equivalence, the details regarding sample size and data provenance are not included in this summary. Mechanical tests generally do not use "test sets" in the same way clinical studies do; they test physical samples of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. This concept is typically relevant for diagnostic device submissions where expert consensus establishes a "ground truth" for interpretation of medical images or data. For an orthopedic fixation system, ground truth would relate to clinical outcomes, which are not detailed here.

4. Adjudication Method

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving expert readers interpreting data, which is not the focus of this 510(k) summary for a surgical implant.

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

This information is not applicable and not provided. MRMC studies are typically used for diagnostic imaging devices to assess the impact of AI on human reader performance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance

This information is not applicable and not provided. This device is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used

This information is not provided in detail for any "clinical data" mentioned. For substantial equivalence of a surgical implant, "ground truth" would implicitly relate to the safety and effectiveness of the device as demonstrated by clinical outcomes, often compared to the predicate device's established safety and effectiveness. The document only vaguely mentions "clinical data" without detailing its nature or how outcomes were verified.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical surgical implant, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided. As above, this device is not an AI algorithm.

Summary of What is Present (Regarding "Study" and "Proof"):

The primary "proof" for the AXIS® Fixation System meeting requirements is its demonstration of Substantial Equivalence (SE) to legally marketed predicate devices. This is a regulatory pathway, not a detailed scientific study with specific acceptance criteria outlined in this summary.

The document states:

"Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of substantial equivalence."

This implies that instead of conducting a de novo study with explicit acceptance criteria for this specific device, Medtronic Sofamor Danek provided evidence that:

• The AXIS® Fixation System shares similar technological characteristics and indications for use with existing devices.
• The mechanical properties of the device (likely through in vitro testing) are comparable to those of the predicate devices, ensuring it can withstand expected physiological loads.
• Existing clinical data or literature broadly supports the safety and effectiveness of this type of device for the stated indications, thereby extrapolating that the comparable AXIS® system would also be safe and effective.

In conclusion, this 510(k) summary does not contain the detailed information requested regarding specific acceptance criteria and a structured study demonstrating the device's performance against those criteria. Its approval is based on the concept of substantial equivalence, supported by general categories of evidence (literature, mechanical tests, clinical data) rather than a singular, detailed performance study provided in this specific document.

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