(85 days)
SmartSet GHV Gentamicin Bone Cement is indicated for use in the second stage of a two-stage rovision for total joint arthroplasty after the initial infection has been cleared.
SmartSet GHV Gentamicin Bone Cement is a self-curing cement, to which one gram of (active) gentamicin is included in 40 grams of bone cement powder and 0.5 gram of (active) gentamicin is included in 20 grams of bone cement powder, for allowing the seating and securing of a metal or plastic prosthesis to living bone.
The provided text is a 510(k) summary for the SmartSet GHV Gentamicin Bone Cement. It describes the device, its indications for use, and establishes substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for training or testing sets.
This document is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study report detailing clinical performance or algorithm validation. Therefore, I cannot extract the requested information from the provided text.
Here's why the information isn't present:
- 510(k) Substantial Equivalence: This type of submission primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing device design, materials, sterilization, packaging, and indications for use. It typically does not require new clinical performance studies demonstrating precise metrics against acceptance criteria in the way a novel AI or diagnostic device would.
- Bone Cement: The device in question is a bone cement with an antibiotic. Its performance is typically assessed through material properties (e.g., mechanical strength, setting time, drug elution) and biocompatibility, not through diagnostic accuracy metrics like sensitivity or specificity that are common for AI-driven devices.
- Missing Study Details: The text states, "The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards." While "product testing" is mentioned, the document does not describe what those tests were, their acceptance criteria, or the results in a quantifiable manner as you've requested.
In summary, the provided document does not contain the information requested in your prompt because it is a regulatory document focused on substantial equivalence for a bone cement, not a clinical study report for a diagnostic or AI-powered device.
§ 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.”