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K Number
K211903
Device Name
Shoreline Threaded TruProfile® Plate
Manufacturer
SeaSpine Orthopedics Corporation
Date Cleared
2021-08-30

(70 days)

Product Code
KWQ
Regulation Number
888.3060
Type
Traditional
Panel
OR
Reference & Predicate Devices
K202064,K190885,K173521
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Shoreline Threaded TruProfile® Plate is intended for anterior cervical fixation (C2-T1) for the following indications: · Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),

· Spondylolisthesis,

  • · Trauma (i.e., fracture or dislocation),
    · Spinal Stenosis,

  • · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

  • · Tumor,

  • · Pseudarthrosis.

  • · Failed previous fusion.

Device Description

The Shoreline Threaded TruProfile" Plate (referred to as the TruProfile Plate) is a spinal fixation system that consists of a variety of non-sterile, single-use plates, screws, and locking covers. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Shoreline plates include locking covers that cover the heads of the bone screws to reduce the potential for screw back-out. The TruProfile Plate implant components are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The TruProfile Plate implant components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine (C2- T1) during the development of a cervical spinal fusion. Associated instruments are available to facilitate the implantation of the device. The instruments are placed in system-specific tray components for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided FDA 510(k) summary (K211903) for the Shoreline Threaded TruProfile® Plate describes a medical device, specifically a spinal fixation system. It does not describe an AI/ML powered medical device or a study involving such a device.

Therefore, the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical mechanical performance testing.

Here's a breakdown of what is present, in case there was a misunderstanding:

  1. A table of acceptance criteria and the reported device performance:

    • No formal table of "acceptance criteria" is presented in the context of an AI/ML device.
    • The "performance" for this spinal plate device is mechanical performance testing.
    • Reported Device Performance: "The TruProfile Plate has demonstrated equivalent mechanical performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."

  2. Sample size used for the test set and the data provenance:

    • Not applicable as this is a mechanical device, not an AI/ML system tested with a data set of patient cases.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. Ground truth as typically understood for AI/ML devices involves expert annotations of medical images or other clinical data. For a mechanical device, performance is evaluated against engineering standards.

  4. Adjudication method:

    • Not applicable to a mechanical device.

  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:

    • Not applicable as this is not an AI/ML device.

  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

    • Not applicable as this is not an AI/ML device.

  7. The type of ground truth used:

    • For the mechanical testing, the "ground truth" would be the specified mechanical limits and benchmarks set by the ASTM F1717 standard and the predicate device's performance.

  8. The sample size for the training set:

    • Not applicable as this is not an AI/ML device.

  9. How the ground truth for the training set was established:

    • Not applicable as this is not an AI/ML device.

§ 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.