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K Number
K111354
Device Name
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)
Manufacturer
GS MEDICAL CO., LTD.
Date Cleared
2011-10-17

(157 days)

Product Code
MAX
Regulation Number
888.3080
Type
Special
Panel
OR
Reference & Predicate Devices
K100516
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Device Description

The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.

AI/ML Overview

The provided text describes the 510(k) summary for the GS Medical AnyPlus PEEK Lumbar Fusion Cage. It details the device's characteristics, intended use, and the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe a study involving a test set, human readers, or an AI algorithm.

Instead, the submission focuses on non-clinical performance standards for an intervertebral body fusion device. Therefore, many of the requested points regarding acceptance criteria and studies are not applicable in this context.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating mechanical performance and safety, primarily through non-clinical testing in accordance with established ASTM (American Society for Testing and Materials) standards. The "device performance" reported is that the device met these standards.

Acceptance Criteria (ASTM Standard)Reported Device Performance
ASTM F2077-03:
  • Static Axial Compression | Tested according to ASTM F2077-03 and ASTM F2267-04.
    Demonstrated compliance with specific tests including:
  • Static and Dynamic Axial Compression
  • Static and Dynamic Compression-Shear Testing
  • Static and Dynamic Torsion Testing |
    | - Dynamic Axial Compression | |
    | - Static Compression-Shear Testing | |
    | - Dynamic Compression-Shear Testing | |
    | - Static Torsion Testing | |
    | - Dynamic Torsion Testing | |
    | ASTM F2267-04:
  • Expulsion Testing | - Expulsion Testing
  • Static Subsidence testing under Axial Compression |
    | - Static Subsidence Testing under Axial Compression | |
    | Overall Goal: Substantial equivalence to predicate devices in terms of performance and safety for intended use. | "The information discussed above demonstrates requested changes to the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices." |

Study Details (Applicable points from the Request)

Since this is a non-clinical, mechanical performance study of an implantable device, most of the requested points related to AI, human readers, and ground truth establishment in a diagnostic context are not relevant or present in this document.

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

    • This document describes non-clinical laboratory testing of the device itself (e.g., mechanical strength, durability), not a "test set" of patient data. The "sample size" would refer to the number of devices tested in the lab for each specific test, which is not detailed in this summary.
    • Data provenance: Not applicable in the sense of patient data. The "data" comes from mechanical testing performed on the fabricated devices.

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

    • Not applicable. There is no "ground truth" in the diagnostic sense for this type of non-clinical device testing. Performance is evaluated against engineering standards (ASTM F2077, ASTM F2267).

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. This is not a study involving human adjudication of clinical data.

  4. 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. This document is for a physical medical implant, not an AI-powered diagnostic device.

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

    • Not applicable. This is not an algorithmic device. The "standalone performance" is the mechanical performance of the implant itself under specified test conditions.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Not applicable in the clinical sense. The "ground truth" for this device's performance is compliance with the specified ASTM mechanical testing standards and comparison to the predicate device's known performance.

  7. The sample size for the training set:

    • Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

    • Not applicable.

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.