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510(k) Data Aggregation
(124 days)
The XTEND™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The XTEND™ Anterior Cervical Plate System consists of standard plates, Extender plates and Universal Extender plates. Extender plates may be used for revision surgery in which additional stabilization is required. Extender plates are attached to an adjacent XTEND™ plate, and Universal Extender plates are inserted adjacent to other plates. XTEND™ plates are available in various lengths to be used with either variable angle screws or fixed angle screws. Each XTEND™ plate is attached to the anterior portion of the vertebral body of the cervical spine (levels C2-C7). The XTEND™ Anterior Cervical Plate System implants are composed of titanium allov, as specified in ASTM F136 and F1295.
The provided text is a 510(k) summary for the XTEND™ Anterior Cervical Plate System. This document focuses on demonstrating substantial equivalence to previously approved devices through engineering and mechanical testing, rather than clinical studies involving human or animal subjects or AI/algorithm performance. Therefore, many of the requested categories are not applicable to this type of regulatory submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the XTEND™ Anterior Cervical Plate System are based on mechanical testing in accordance with FDA guidance. The "reported device performance" is the successful meeting of these criteria, which is implied by the 510(k) clearance.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Must meet relevant ASTM standards (e.g., F136 for titanium alloy, F1295 for titanium alloy) and FDA "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. This typically includes: | The device successfully met the mechanical testing requirements to demonstrate substantial equivalence to predicate devices. |
| - Static Compression Bending Test | Met applicable loads/displacements. | |
| - Dynamic Compression Bending (Fatigue) Test | Met applicable cycles/loads without failure. | |
| - Static Torsion Test | Met applicable loads/displacements. | |
| - Pull-out Strength (Screw-bone interface simulation) | Met applicable forces. | |
| Biocompatibility | Materials must be biocompatible (ASTM F136 and F1295 for titanium alloy). | Materials (Titanium Alloy) are well-established as biocompatible for implantable devices. |
| Design Characteristics | Similar design features and operating principles to predicate devices. | The device's design is stated to be similar, with modifications like Extender plates. |
| Material Characteristics | Composed of specified medical-grade materials. | Composed of titanium alloy (ASTM F136 and F1295). |
| Intended Use | Match or be a subset of the predicate device's intended use. | Intended use matches or is a subset of predicate devices. |
The Study that Proves the Device Meets the Acceptance Criteria:
The submission explicitly states: "Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 is presented."
This indicates that a series of in vitro mechanical tests were conducted on the XTEND™ Anterior Cervical Plate System. The purpose of these tests was to demonstrate that the device's performance characteristics (e.g., strength, durability, fatigue resistance) are equivalent to or better than those of the predicate devices. By meeting the benchmarks established in the FDA guidance and through comparison with predicate devices, the XTEND™ system was deemed substantially equivalent.
Non-Applicable Categories based on the provided text:
The following information is not present in the provided 510(k) summary because this type of premarket submission for a spinal implant device typically relies on engineering and material equivalence, rather than clinical trial data or AI performance metrics.
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This refers to test samples for mechanical testing, not patient data. No human or animal data is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" is not established by human experts in the context of mechanical testing for substantial equivalence.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a physical spinal implant, not an AI diagnostic or assistive tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols and material specifications, as well as the performance of predicate devices.
- The sample size for the training set: Not applicable. There is no "training set" in the context of a 510(k) submission for a physical implant.
- How the ground truth for the training set was established: Not applicable.
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