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The coflex-F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

Device Description

The coflex-F Implant System is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, Ushaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add small- and medium-sized coflex-F Short devices to the coflex-F Implant System. The modifications are intended to allow the operating surgeon to better accommodate various patient anatomies. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the changes introduced by the modified coflex-F Short implant system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Performance	No new worst-case scenario introduced by new components.	Finite element analysis and engineering rationale demonstrated that the addition of new components did not introduce a new worst case.
Biocompatibility	Meet acceptance criteria defined in the Design Control Activities Summary for irritation and sensitization (per ISO 10993).	Biocompatibility tests per ISO 10993 (irritation and sensitization) were conducted on materials for device-specific instruments. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Substantial Equivalence	Be substantially equivalent to the predicate coflex-F Implant (K093438) in terms of indications, design, function, and materials.	The modified coflex-F Short is substantially equivalent to the predicate coflex-F Implant (K093438) with respect to indications, design, function, and materials.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes an engineering and biocompatibility study for a medical device modification, not a clinical trial with a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data are not applicable to this submission.

The "test set" here refers to the new small- and medium-sized coflex-F Short devices themselves, which were subjected to:

Finite Element Analysis: This is a computational simulation, not a test on a physical sample size in the traditional sense. The "sample" is the digital model of the device.
Biocompatibility Tests: These tests would have used samples of the materials of the device-specific instruments. The exact number of material samples isn't specified, but it would be according to ISO 10993 standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described study is a non-clinical evaluation of device modification (mechanical and biocompatibility), not a study involving human interpretation of clinical data where expert ground truth would be established. The "ground truth" for the engineering analysis would be the established principles of mechanics, and for biocompatibility, it would be the ISO 10993 standards themselves.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. There was no human interpretation of data requiring adjudication.

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

This is not applicable. The device described is a spinal implant, and the study focuses on its mechanical integrity and biocompatibility, not on an AI-based diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Mechanical Performance: The ground truth for the finite element analysis is the established principles of mechanical engineering and physics as applied to the finite element models, and comparison of the results against the predicate device's established performance parameters.
Biocompatibility: The ground truth for biocompatibility is conformance to ISO 10993 standards for irritation and sensitization.
Substantial Equivalence: The ground truth for substantial equivalence is the predicate device's (K093438) cleared specifications regarding indications, design, function, and materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device modification study. The study involves engineering analysis and biocompatibility testing of physical materials, not machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

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