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K Number
K060425
Device Name
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
Manufacturer
ARTHROCARE CORP.
Date Cleared
2006-07-12

(145 days)

Product Code
NDN
Regulation Number
888.3027
Type
Traditional
Panel
OR
Reference & Predicate Devices
K050864,K053180
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Parallax® Acrylic Resin Cartridge with TRACERS-Ta is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

Parallax® Acrylic Resin Cartridge with TRACERS-Ta is an opacified polymethylmethacrylate bone cement.

AI/ML Overview

This 510(k) summary is for a medical device called "Parallax® Acrylic Resin Cartridge with TRACERS-Ta," which is a PMMA bone cement. The document establishes substantial equivalence to existing predicate devices (K050864 and K053180).

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document is a traditional 510(k) submission for a physical medical device (bone cement), focusing on:

  • Device Description: What the device is.
  • Intended Use: What the device is used for (fixation of pathological vertebral body fractures).
  • Substantial Equivalence: How it is similar to previously cleared devices.
  • Classification: Its regulatory classification.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI/MRMC studies. This type of information is typically found in submissions for AI/ML-driven devices, which this document is not.

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”