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.

Device Description

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.

AI/ML Overview

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.

Summary

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APR -3 1997

1970462 164 4

AcroMed Anterior Cervical Stabilization System 510(k) Summary

AcroMed Corporation COMPANY: 3303 Carnegie Avenue Cleveland, Ohio 44115

AcroMed Anterior Cervical Stabilization System TRADE NAME: CLASSIFICATION:

Orthosis, fixation, spinal cervical intervertebral body. Class II

DESCRIPTION:

An instrument set is available specifically designed for use with the AcroMed Anterior Cervical Stabilization System.

Rod:

Precontoured Rods comprise the longitudinal structures of the system. All Rods have a 3mm outer diameter and an integral head. Eight lengths are available: 21mm, 36mm, 43mm, 51mm, 65mm, 65mm, 85mm and 110mm. Two rods are required for each construct. Rods may be cut to the appropriate length during the procedure if required. The Rods are precontoured to a curvature consistent with the cervical lordosity, but additional contouring using the Construct Bender contained in the instrument set may be performed if required.

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Platform:

Five Platform designs are available which are designed to connect the Rods and anchor to the vertebral bodies with bone screws. All Platforms may be used with either Solid Bone Screws (for bicortical fixation) or the combination of Outer and Inner Bone Screws (a hollow outer bone screw used with a solid inner locking screw designed for unicortical fixation). Screw selection is determined by physician preference. All Platforms are designed to be used with two Rods in forming the construct.

Three Platforms are designed for angled insertion of the screw into the vertebral body. The resulting screw angle is thirty degrees and may be directed either rostrally or caudally. These Platforms have a fin feature on one side which engages the vertebra from within the disk space for optimal positioning and fixation. Two of these three Platforms are lockable and thus may be utilized at either the rostral or caudal end of the construct. Lockable Platforms (Type C and Type H)-have extensions which accept Platform / Cross Connector Locking Screws for securing the Platform to the Rods. Selection of Type C versus Type H Platforms is based on physician preference and patient anatomy. The third Platform for Angled Screws does not lock to the Rods, and is intended for fixation to intermediate vertebral bodies in multilevel constructs.

Two Platforms are designed for straight (perpendicular) insertion of the screw into the vertebral body. They are available in both lockable and non-locking designs. As described above, the Lockable Platform for Straight Screws may be used on either the rostral or caudal end of the construct, as it provides for fixation of the Platform to the vertebral body and it connects and locks to the Rods. The Non-Locking Platform for Straight Screws provides fixation to intermediate vertebral bodies in multilevel constructs.

One Platform design is available for fixation of the construct to an intervertebral graft. This Platform features a horizontal slot and spherical nest to accommodate variation in screw entry site and in trajectory into the graft.

Assembly:

As mentioned in the overall device description, Assemblies are pre-assembled, partial constructs consisting of one Platform, one Cross Connector, two Rods and two Platform / Cross Connector Locking Screws. They are provided for the convenience of the surgeon. Assemblies are provided in five lengths ranging from 36mm to 65mm. All five available Assemblies utilize a Platform for Angled Screws, Lockable, Type H.

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Cross Connector:

Cross Connectors are used to connect and lock to the two Rods. They have a "band clamp" design in which the upper and lower halves of the Cross Connector are squeezed together by the Platform / Cross Connector Locking Screws, clamping the Cross Connector to the Rod. The Cross Connector does not provide for fixation to the vertebra. It is intended to provide torsional stability in longer constructs.

Outer Bone Screw:

Outer Bone Screws are designed to be used in conjunction with Inner Bone Screws. They are available in three diameters: 3.75mm, 4.0mm and 4.35mm. Each diameter is available in four lengths: 10mm, 12mm, 14mm and 16mm. The Outer Bone Screw has an expanding screw head which locks to the Platform. It also has a screw tip which, like the screw head, expands upon full insertion of the Inner Bone Screw. The combination of Outer and Inner Bone Screws is intended for unicortical fixation.

Inner Bone Screw:

Inner Bone Screws are available in four lengths: 10mm, 12mm, 14mm and 16mm. Insertion of the Inner Bone Screw into the Outer Bone Screw results in expansion of the Outer Bone Screw head (thus, locking the screw to the Platform) as well as expansion of the Outer Bone Screw tip.

Solid Bone Screw:

Solid Bone Screws are available in two diameters: 3.75mm and 4.0mm. Each diameter is available in eight lengths ranging from 16mm to 24mm. The Solid Bone Screw is designed for bicortical fixation.

Platform / Cross Connector Locking Screw:

The Platform / Cross Connector Locking Screw is designed for two purposes. First, it is used to tighten together the two sides of the Cross Connector ("band clamp" design), thus locking it to the Rods. Second, it is used to lock a Platform to the Rods. It is available in only one size.

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Graft Screw:

The Graft Screw is a solid screw design which is specifically designed to be used with the Platform for Graft Fixation. It is available in only one size, with a diameter of 3.5mm and a length of 10mm. The head of the Graft Screw is designed to match the Platform for Graft Fixation.

PERFORMANCE DATA:

Non-Clinical:

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.

INTENDED USE:

SUBSTANTIAL EQUIVALENCY

TOP Cervical Spine Stabilization System

Regulation Number and Section

§ 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.