Search Results

The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following:
· Defect of the pars interarticularis
· Spondylolisthesis
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

Device Description

The Posterior Cable Screw System consists of screws, cables, and grommets utilized for the correction of pars defects. A construct consists of two cable screws with locking set screws and a cable connecting the two screws. The screws are inserted into the pedicles and the cable is passed around the spinous process between the two screws. The grommet surrounds the cable at the location of the spinous process. The cable is tensioned and the set screws are tightened and fully locked per the surgical technique. The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The implants are provided sterile. The Posterior Cable Screw System utilizes Class I manual instruments to facilitate implantation of the device components.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "Frontier Medical Devices Posterior Cable Screw System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant. Therefore, most of the requested information (sample sizes, expert adjudication, MRMC studies, standalone performance for an algorithm, ground truth methods for AI, training set sizes) is not applicable or present in this given text.

However, I can extract the relevant information from the provided text regarding the device's performance in the context of substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device seeking substantial equivalence, "acceptance criteria" and "reported device performance" are evaluated in the context of mechanical and material properties similar to predicate devices, rather than diagnostic accuracy or algorithmic performance.

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Functional/Mechanical Performance	Perform in a manner substantially equivalent to predicate systems under dynamic testing conditions (implies meeting or exceeding the mechanical strength and durability standards of the predicate).	"Dynamic tests were provided to support that the Posterior Cable Screw System performs in a manner substantially equivalent to that of predicate systems. No new issues of safety or effectiveness were raised." "Any differences [in technological characteristics compared to predicates] were not considered significant based on mechanical bench testing."
Material Composition	Utilize medical-grade materials commonly used in similar devices, comparable to predicate devices.	"The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90." (This aligns with industry standards for spinal implants and is implicitly compared to predicate materials).
Safety and Effectiveness	Not raise any new types of safety or efficacy issues compared to legally marketed predicate devices.	"No new issues of safety or effectiveness were raised" by the dynamic tests. "The minor differences in technological characteristics that do exist do not raise any new types of safety or efficacy issues." "There are no significant differences between the subject system and the predicates which would adversely affect the use of the product."
Intended Use	Align with the intended use of predicate devices for specific spinal conditions and anatomical locations.	The "Indications for Use" section explicitly states: "The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following: · Defect of the pars interarticularis · Spondylolisthesis" (This is directly comparable to the predicate's use).

Note: The FDA's 510(k) clearance process for devices like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than establishing completely new performance metrics. The "acceptance criteria" are therefore framed in terms of equivalence.

The following questions are not applicable to this document as it pertains to a physical medical device (spinal implant system) and not an AI/software device. The document describes pre-clinical performance data (dynamic tests) for mechanical properties, not an algorithm's diagnostic performance.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical bench testing, not a dataset of patient cases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering specifications and test results, not expert consensus on medical images/data.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For this device, the "ground truth" for proving substantial equivalence lies in established engineering standards (ASTM F136, ASTM F90) for materials and mechanical testing methodologies accepted by the FDA for spinal implants.
The sample size for the training set: Not applicable. There is no "training set" for physical device manufacturing in this context.
How the ground truth for the training set was established: Not applicable.

Ask a Question

Ask a specific question about this device

Page 1 of 1