ANTERIOR DYNAMIZED SYSTEM by ACROMED CORP.

The Anterior Dynamized system is intended for use in anterior instrumentation and afusion for for kyphotic decompression deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

Device Description

The Anterior Dynamized system is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The Anterior Dynamized construct allows continual compression of the bone graft while avoiding hyperextension type forces on the The components of the Anterior Dynamized system construct. have been designed with anatomic limitations in mind.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "ALC Dynamized Fixation System." It describes the device, its components, indications for use, and a brief mention of non-clinical performance data.

Crucially, the document explicitly states "PERFORMANCE DATA: Non-Clinical" and then describes static and dynamic mechanical testing. There is no mention of clinical studies, human performance data, acceptance criteria related to a specific clinical outcome, or any of the detailed information requested in your prompt regarding clinical performance, ground truth, expert involvement, or sample sizes related to patient data.

Therefore, I cannot provide the requested information from the given text as it only discusses mechanical testing, not clinical performance.

Here's a breakdown of why each requested point cannot be answered based on the provided input:

A table of acceptance criteria and the reported device performance: The document only mentions mechanical tests (static compression bending, torsion, dynamic bending compression) to characterize properties like stiffness, strength, maximum applied moment, and fatigue life. It does not state specific acceptance criteria for these mechanical properties nor does it report the numerical performance values against any such criteria. It certainly doesn't provide clinical acceptance criteria or performance data.
Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical samples of the device, not a set of patient data. The document does not specify the number of constructs or components tested for the non-clinical evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical studies, involves expert assessment of patient data. This document describes mechanical testing, which does not involve human experts establishing a "ground truth" in that sense.
Adjudication method for the test set: Not applicable. Adjudication methods are for reconciling differences in expert opinions on clinical data.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is a clinical study involving human readers evaluating cases. The provided data is for non-clinical, mechanical testing.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is for a physical medical device, not a software algorithm.
The type of ground truth used: Not applicable for mechanical testing.
The sample size for the training set: Not applicable. This refers to the training of an algorithm, which is not the subject of this document.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses solely on the description of a spinal fixation device and its non-clinical mechanical performance testing. It does not contain any information regarding clinical studies, patient data, or the clinical performance metrics you are asking about.

Summary

{0}------------------------------------------------

ALC Dynamized Fixation System 510(k) Summary

COMPANY:	AcroMed Corporation3303 Carnegie AvenueCleveland, Ohio 44115
TRADE NAME:	ALC Dynamized Fixation System

	FEB 1 9 1997
--	--------------

CLASSIFICATION: Spinal intervertebral body fixation orthosis. Class II

DESCRIPTION:

Dynamized Closed Screws:

The dynamized closed screw is manufactured from a single rod of implant grade titanium alloy material into two distinct sections; the cancellous thread and rod interface. Multiple lengths are available to allow for surgeon latitude. The closed screw allows superior to inferior or inferior to superior placement of a rod. Closed screws used in the caudal portion of the construct contain a set screw which is designed to affix the rod into the opening of the closed screw. Closed screws used in the cephalad portion of the construct do not use a set screw to allow for longitudinal movement of the construct along the rods. The set screw is precision machined from the same implant grade titanium alloy material. The dynamized closed screw is placed into the vertebral body of the spine. Four dynamized closed screws are used per construct.

{1}------------------------------------------------

Closed Transverse Fixator Connector:

The closed transverse fixator connector is composed of two closed transverse connectors and a transverse fixator plate. The closed transverse connectors are designed with the patented V-Groove Hollow-Ground (VHG) design to allow proper seating of the titanium rod. A transverse fixator plate is used to span the gap between the connectors. The fixator plates are machined with two elongated slots which facilitate horizontal positioning of the plate. The transverse plates are available in two sizes, small and large. The rod is secured to the connector and transverse plate with a set screw and hex nut. Two closed transverse fixator connectors are used per construct.

Closed Blocker:

The closed blocker is of the same design as a closed transverse connector. Using a set screw, the closed blocker is attached to the anterior rod above the dynamized closed screw. The closed blocker is designed to stop hyperextension type forces on the construct. One closed blocker is required per construct.

Anterior Rod:

The titanium alloy rod is offered in 1/4 inch outer diameter and two lengths are available for that diameter; 18.0mm and 24.0mm. Two rods are required in the construct and are cut to the appropriate length during the procedure

PERFORMANCE DATA:

Non-Clinical:

Static compression bending and torsion were performed on the Anterior Dynamized bi-level construct to characterize the properties of stiffness, strength, and maximum applied moment Dynamic bending compression testing was also (torque). performed to characterize fatigue life.

{2}------------------------------------------------

INDICATIONS:

SUBSTANTIAL EQUIVALENCY:

Dwyer Spinal Instrumentation Kaneda Anterior System ISOLA Anterior 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.