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K Number
K132126
Device Name
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
Manufacturer
SPECTRUM SPINE, LLC
Date Cleared
2013-10-28

(110 days)

Product Code
MRW
Regulation Number
N/A
Type
Traditional
Panel
OR
Reference & Predicate Devices
K073515,K123932
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SS Fenestrated Facet Screw System (FFS) is indicated for the posterior surgical treatment at L1-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability. The system is intended for use with only autogenous bone graft material.

Device Description

The SS Fenestrated Facet Screw System (FFS) is a permanent implant device made from Cobalt Chrome Alloy Per ASTM 1537. It is to be implanted from the posterior approach. The device is provided in one diameter and multiple lengths to accommodate the various anatomy of the spine. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The SS Fenestrated Facet Screw System is cannulated and fenestrated which allows it to be used as a delivery system for bone graft. The system is not to be used with bone cement.

AI/ML Overview

The provided text describes the regulatory submission for a medical device called the "SS Fenestrated Facet Screw System." It does not contain information about a study involving software or AI. Therefore, I cannot extract details about acceptance criteria or a study proving device performance in the context of AI.

The document discusses the substantial equivalence of the SS Fenestrated Facet Screw System to predicate devices based on performance testing for mechanical properties. However, this is for a physical implantable device, not an AI software.

Here's a breakdown of what is present in the document related to performance and testing for the physical device:

Device: SS Fenestrated Facet Screw System (FFS)

Acceptance Criteria and Reported Device Performance (for the physical device):

The document states:

  • "Testing of the FFS to demonstrate substantial equivalence included static and dynamic 3-point bending, screw axial pullout, and torque to failure."
  • "The testing standards utilized were, ASTM F543-07 'Standard Specification and Test Methods for Metallic Medical Bone Screws', F2193-02, 'Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System,' and ASTM F1264-03 'Standard Specification and Test Methods for Intrameduliary Fixation Devices.'"

While the specific numerical acceptance criteria and reported performance values are not detailed in the provided text, the successful 510(k) clearance implies that the device met the requirements outlined in these ASTM standards and was deemed substantially equivalent to its predicate devices in terms of safety and effectiveness.

Regarding your specific questions related to AI/Software:

  1. A table of acceptance criteria and the reported device performance: This information is not present for an AI/software device. The document describes mechanical testing of a physical implant.
  2. Sample sized used for the test set and the data provenance: Not applicable for an AI/software study.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/software study.
  4. Adjudication method: Not applicable for an AI/software study.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for an AI/software study.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/software study.
  7. The type of ground truth used: Not applicable for an AI/software study.
  8. The sample size for the training set: Not applicable for an AI/software study.
  9. How the ground truth for the training set was established: Not applicable for an AI/software study.

In summary, the provided text is a 510(k) summary for a physical medical implant (a facet screw system) and does not describe an AI or software device, nor does it contain the type of study data you are asking for regarding AI acceptance criteria and performance.

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