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The OMI® Occipital Cervical Loop is intended to be used to assist stabilization and fusion of the cervical spine and cervical occipital junction.

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies).
2. Spondylolisthesis of the cervical vertebrae.
3. Spinal stenosis of the cervical vertebrae.
4. Atlanto/axial fracture with instability.
5. Cervical-occipital dislocation.
6. Revision of previous cervical fusion surgery.
7. Tumors.

The OMI® Occipital Cervical Loop, Catalog Number A-1089, consists of the following components: Cervical Support Loop, Cross Link, Compression Blocks (2), Cervical Support Nuts (2), and an implantation instrument, the Cervical Support Wrench [11mm].

The OMI® Occipital Cervical Loop is a single-use, permanent device used to assist in stabilization and fusion of the occipital cervical region of the spine. It consists of the Cervical Support Loop [CSL], a contoured rod made of biocompatible titanium having an alloy composition of 6AL-4V ELI, according to ASTM-F136. The CSL is U-shaped, with a circular loop at one end and two free lengths extending lengthwise, parallel to each other, from the loop end. The profile of the CSL resembles that of a normal cervical lordosis from the cervical region of the spine to the occiput of the skull. The Cross Link can be attached to the free end lengths of the CSL for additional rigidity. The Cross Link is flat, with a slot at each end, and can be attached to the CSL with the Compression Blocks and Cervical Support Nuts. The Cross Link, Compression Blocks, and Cervical Support Nuts are also made from 6AL-4V ELI titanium.

These titanium alloy implants are designed for use with multi-filament braided titanium alloy [6Al, 4V] cable, .045 inch [1.1 mm] diameter, 19 inches in length, with a pure, soft titanium mono-filament lead wire 3 inches in length. This wire is Sofamor Danek Catalog # 826-360, the same type of wire cleared for use with Sofamor/Danek spinal devices.

This document describes the 510(k) submission for the OMI® Occipital Cervical Loop, a spinal implant. The primary method for proving substantial equivalence to a predicate device (Ransford Cervical Fixation System™) is through performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OMI® Occipital Cervical Loop are implicitly defined by performing "substantially the same" as the predicate device, the Ransford Cervical Fixation System™, in static and fatigue testing. The table below summarizes the comparative performance.

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

• Sample Size:
  • Static Tests: Five (5) tests were run for the OMI® Occipital Cervical Loop and five (5) tests for the predicate device.
  • Fatigue Tests: Six (6) tests were run for the OMI® Occipital Cervical Loop and six (6) tests for the predicate device.
• Data Provenance: The data is prospective, generated specifically for this 510(k) submission through physical testing of the devices. The country of origin for the testing data is not explicitly stated in the provided text, but the applicant is Ohio Medical Instrument Company, Inc. in Cincinnati, Ohio, USA.

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

This section is not applicable. The study involves physical testing of the device, not a diagnostic or AI-based system requiring expert consensus on a test set.

4. Adjudication Method for the Test Set

This section is not applicable, as there is no human-based assessment or diagnostic task requiring adjudication. The results are from mechanical laboratory tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, and the study focuses on its mechanical performance compared to a predicate device, not on human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study is the objective mechanical performance of the devices under controlled laboratory conditions. This includes measurements of stiffness, static strength, and fatigue life.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning model but a physical product undergoing mechanical performance testing.

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

This section is not applicable, as there is no training set for a physical device undergoing mechanical performance testing.

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