(56 days)
The AcroMed Anterior Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma (including fracture), post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The AcroMed Anterior Cervical Stabilization System, in its fully assembled form, consists of two laterally placed rods joined by platforms which lie on the anterior vertebral surface. The system is anchored to the vertebrae with screws. The implanted construct provides rigid stability in all planes.
The following types of components are available in the system: Rods, Platforms, Screws and Cross Connectors. All components are manufactured from implant grade Titanium allov which conforms to ASTM F136 specifications. Assemblies are also available for convenience of the surgeon. These are pre-assembled partial constructs consisting of one Platform, one Cross Connector, two Rods and two Locking Screws.
An instrument set is available specifically designed for use with the AcroMed Anterior Cervical Stabilization System.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
Based on the provided text, the document is a 510(k) summary for the AcroMed Anterior Cervical Stabilization System. This type of document is a pre-market notification to the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, rather than establishing specific performance acceptance criteria and then proving the device meets them through clinical studies with defined outcomes.
Therefore, many of the requested sections (like explicit acceptance criteria for device performance, clinical sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) are not present in this document because it describes a mechanical implant that is cleared based on mechanical testing and substantial equivalence, not clinical performance metrics in the same way a diagnostic AI device would be.
The document primarily describes the device's components, materials, and intended use. The "Performance Data" section specifically states "Non-Clinical" data was gathered.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (from document) |
|---|---|
| Not explicitly stated in terms of measurable clinical outcomes or specific benchmarks. The criteria are implicitly tied to the safety and efficacy demonstrated by the predicate device and the mechanical properties of the AcroMed system itself. | Mechanical Properties: |
- "Static and dynamic bending compression and torsion were performed on the system to characterize its mechanical properties."
- "Additionally, testing was also performed to characterize fatigue life."
- "The implanted construct provides rigid stability in all planes." (This is a design goal, not a quantifiable performance outcome in this text). |
| Material Compliance: - Conformity to relevant standards. | - "All components are manufactured from implant grade Titanium alloy which conforms to ASTM F136 specifications." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable/not provided. The "Performance Data" section describes non-clinical mechanical testing, not a clinical test set with patient data.
- Data Provenance: Not applicable, as it's non-clinical mechanical testing, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/not provided. Ground truth, in the context of clinical performance evaluation, refers to the definitive determination of a condition (e.g., presence of disease). This document reports on mechanical testing, which doesn't involve "ground truth" in the same way. The design and testing would be conducted by engineers and materials scientists.
4. Adjudication Method for the Test Set
- Not applicable/not provided. Adjudication methods are used in clinical studies, typically for resolving discrepancies in expert interpretations of clinical data. This document doesn't describe such a clinical study.
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
- No. This device is a surgical implant, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant or described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable/not provided in the context of clinical outcomes. For the mechanical testing, the "ground truth" would be the measured physical properties and endurance of the manufactured components compared against engineering specifications and industry standards for spinal implants.
8. The Sample Size for the Training Set
- Not applicable/not provided. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/not provided. As above, no training set is described for this type of device.
Summary of what can be inferred from the document:
The device's acceptability is based on:
- Material Compliance: Adherence to ASTM F136 specifications for implant grade Titanium alloy.
- Mechanical Performance: Characterization through static and dynamic bending, compression, torsion, and fatigue life testing. These tests are performed to ensure the device is robust enough for its intended use and comparable to predicate devices in terms of mechanical stability.
- Substantial Equivalence: The primary "study" or justification for market clearance is the demonstration of substantial equivalence to a legally marketed predicate device (the "TOP Cervical Spine Stabilization System"), implying similar safety and effectiveness based on similar design, materials, and intended use. The results of the mechanical tests would support this claim of equivalence.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.