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K Number
K081155
Device Name
SMARTSET MV BONE CEMENT
Manufacturer
DEPUY ORTHOPAEDICS, INC.
Date Cleared
2008-05-14

(21 days)

Product Code
LOD
Regulation Number
888.3027
Type
Special
Panel
OR
Reference & Predicate Devices
K023012
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SmartSet MV Bone Cement is indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Description

SmartSet MV Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement. The bone cement is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that "SmartSet MV Bone Cement" meets those criteria. The document is a 510(k) summary for a premarket notification for a medical device, which focuses on establishing substantial equivalence to a predicate device rather than presenting performance criteria and a study to meet them.

The text includes:

  • Device Name: SmartSet MV Bone Cement
  • Intended Use: Fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures.
  • Equivalency to Predicate Devices: SmartSet MV Endurance Bone Cement and SmartSet HV Bone Cement.
  • Regulatory information: Product Code LOD, 21 CFR 888.3027.

However, it does not contain:

  • A table of acceptance criteria and reported device performance.
  • Details of a study's sample size, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, or how ground truth was established for either a test or training set.
  • Any mention of AI or machine learning.

Therefore, I cannot fulfill your request for a description of acceptance criteria and a study proving the device meets them based on the provided text.

§ 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.”