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The Exactech Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Cervical Spacer System implants are anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.

The Cervical Spacer System is intended for use as an interbody fusion device and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices features a chamber intended to be filled with autogenous bone graft material.

The provided text is a 510(k) summary for the Exactech Cervical Spacer System, which is an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel AI or medical device with new analytical, clinical, or performance endpoints.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving device meets acceptance criteria cannot be extracted from this document. This type of information is typically found in clinical trial reports, analytical validation studies, or detailed performance testing summaries for devices with more complex functionality or novel claims requiring rigorous quantitative assessment against predefined metrics.

Instead, this document provides the following:

1. Device Description and Intended Use:

• Device Name: Exactech Cervical Spacer System
• Device Type: Anterior cervical interbody devices consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers.
• Intended Use: For anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. It is to be used with autogenous bone graft and supplemental fixation (e.g., an anterior cervical plate) via an open, anterior approach.
• Degenerative Disc Disease (DDD) Definition: Discogenic pain with degeneration of the disc confirmed by history and radiographic studies, where patients have had six weeks of non-operative treatment.

2. Predicate Devices for Substantial Equivalence:

The Exactech Cervical Spacer System claims substantial equivalence to several legally marketed predicate devices, implying similar technological characteristics, indications for use, and materials of manufacture. The predicate devices listed are:

• K121649: CONSTRUX™ MINI Spacer System (Orthofix Spinal)
• K090064: Copperhead System (Eminent Spine)
• K120486: AVS AS System (Stryker Spine)
• K130317, K103034: Apache™ Interbody Fusion System Star Cervical PEEK (Genesys Spine)
• K121103, K113559, K091088: Spine MC+ Cervical Cage (LDR)
• K130948: Cervical IBFD (Southern Spine)

3. Performance Data (Non-Clinical Testing):

The document mentions that the device underwent non-clinical testing to demonstrate its strength for its intended use and substantial equivalence to predicate devices. The performed tests are:

• Static axial compression per ASTM F2077-11
• Static torsion per ASTM F2077-11
• Static Subsidence per ASTM F2267-04
• Static Expulsion per ASTM F-04.25.02.02 (draft)
• Dynamic axial compression bending fatigue per ASTM F2077-11
• Dynamic Torsion per ASTM F2077-11

The document concludes that the results of this non-clinical testing show that the strength of the Cervical Spacer System is sufficient for its intended use and is substantially equivalent to the legally marketed predicate devices.

Missing Information:

The document does not provide:

• Specific numerical acceptance criteria for each test.
• The reported numerical performance values for the Exactech Cervical Spacer System.
• The performance values of the predicate devices for direct comparison.
• Sample sizes for these mechanical tests.
• Any details related to clinical studies, human readers, or methods for establishing ground truth, as these are not relevant for demonstrating substantial equivalence for a mechanical intervertebral fusion device based primarily on non-clinical mechanical testing.

In summary, this document is a regulatory filing focused on demonstrating equivalence through non-clinical mechanical testing and comparison of technological characteristics, not a study evaluating a device against specific clinical or analytical performance acceptance criteria.

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