Search Results

The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively and subtractively manufactured implants and associated instruments for surgical site preparation and implantation. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. The subject screws are machined from Ti-6Al-4V per ASTM F136. The F3D Cervical Stand-Alone Interbody Fusion System includes additively manufactured interbody spacers. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The acceptance criteria and study proving the device meets these criteria can be inferred from the provided FDA 510(k) summary for the F3D Cervical Stand-Alone Interbody Fusion System.

It's important to note that this document is a 510(k) summary for a medical device (interbody fusion system), not an AI/ML software device. Therefore, the questions related to AI/ML specific performance metrics (like human reader improvement with AI, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, etc.) are not applicable to this submission. The "device" in question here is a physical implant, and its performance is assessed via mechanical testing, not clinical imaging or diagnostic accuracy.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" and "reported device performance" are based on a series of non-clinical mechanical tests, demonstrating structural integrity and functional suitability. The specific quantitative acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not explicitly stated with numerical values in this summary. Instead, the document states that the testing shows the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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

• Sample Size for Test Set: This refers to the number of physical devices or components tested. The summary does not specify the sample size (number of units tested) for the mechanical tests.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For a physical device, the "data" comes from engineering testing conducted under controlled laboratory conditions, likely at a testing facility. The document implicitly indicates this by listing "Empirical Testing Corp." as the contact for the submitter.

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

Not applicable. Ground truth in this context is established by engineering standards (ASTM standards) and physical measurements from mechanical testing, not by expert human interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" in the sense of reconciling multiple human interpretations for ground truth. Testing follows defined ASTM protocols.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML software device.

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

Not applicable. This is not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Established ASTM (American Society for Testing and Materials) standards: F2077 (for static/dynamic axial compression, compression-shear, torsion), F2267 (for subsidence). These are widely accepted engineering standards for testing spinal implant devices.
• Physical measurements and material properties: Conformance to material standards (ASTM F3001, ISO 5832-3, ASTM F136 for Ti-6Al-4V).
• Benchmarking against predicate devices: Performance is compared to "legally marketed predicate devices" to demonstrate substantial equivalence, implying that the predicates' performance serves as a comparative "truth" for acceptable safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device using a training set. The device is designed and manufactured based on engineering principles and materials science, then tested.

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

Not applicable. There is no AI/ML training set for this physical implant.

Ask a specific question about this device