LogoFDA 510(k) Search
K Number
K192316
Device Name
Matrix HA PEEK Cervical Implant System
Manufacturer
Sapphire Medical Group
Date Cleared
2019-10-17

(52 days)

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

The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK Cervical Implant System is intended to be used with a supplemental fixation system.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical device (Matrix HA PEEK Cervical Implant System). It outlines the device's classification, regulation, and indications for use.

The document does not contain any information about the acceptance criteria, study design, or performance data for a device that relies on AI or machine learning. Therefore, I cannot extract the details requested in your prompt regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test and training sets, data provenance.
  • Number of experts for ground truth establishment and their qualifications.
  • Adjudication methods.
  • MRMC comparative effectiveness study results.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for the training set was established.

This document pertains to a physical implant system, not a software device or AI-driven system requiring such detailed performance validation against acceptance criteria as might be expected for an AI/ML medical device.

§ 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.