SMARTSET GMV GENTAMICIN BONE CEMENT

• K Number: K081163
• Device Name: SMARTSET GMV GENTAMICIN BONE CEMENT
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Date Cleared: 2008-05-14 ( 20 days)
• Product Code: MBB , LOD
• Regulation Number: 888.3027
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K041656 , K033563
• Predicate For: N/A

Intended Use

SmartSet GMV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

SmartSet GMV Gentamicin Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement, containing the antibiotic gentamicin sulfate. The bone cement is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SmartSet GMV Gentamicin Bone Cement) and an FDA clearance letter. It is not a study report or a description of a study that establishes acceptance criteria and proves a device meets them in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information, particularly items 1-9, which are relevant to the evaluation of AI/ML performance.

The document discusses:

• Device Description: SmartSet GMV Gentamicin Bone Cement is a self-curing, radiopaque, polymethylmethacrylate based cement, containing the antibiotic gentamicin sulfate. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures.
• Intended Use/Indications For Use: It is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
• Substantial Equivalence: The primary basis for clearance is substantial equivalence to predicate devices (SmartSet GMV Endurance Gentamicin Bone Cement (K041656) and SmartSet GHV Gentamicin Bone Cement (K033563)), meaning its indications, intended use, formulation, and finished product specifications are equivalent.

This type of submission relies on demonstrating similarity to already approved devices and often involves bench testing (physical and chemical properties) and biocompatibility testing, but not the kind of clinical performance or AI/ML evaluation implied by your detailed questions.

Regulation Number and Section

§ 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.”