Search Results

SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This FDA 510(k) clearance letter is for a bone cement, not a medical device that utilizes AI or requires complex studies to demonstrate performance through acceptance criteria in the way you've described.

The document indicates that SPECTRUM® GV Bone Cement is substantially equivalent to a previously cleared predicate device (K231556), and therefore, extensive new studies to prove acceptance criteria in the context of device performance metrics (like sensitivity, specificity, or reader improvement with AI) were not required.

Here's why and what information is provided:

• Device Type: This is a Polymethylmethacrylate (PMMA) bone cement, a physical material used for fixation. It's not a diagnostic imaging device, a software as a medical device (SaMD), or an AI algorithm.
• Substantial Equivalence: The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined it is as safe and effective as the predicate, often due to identical or very similar technological characteristics and intended use.
• No New Performance Data (for the requested criteria): The document explicitly states: "Non-clinical testing was not required as the subject device is identical to that of the predicate." This confirms that specific performance metrics, sample sizes for test sets, expert adjudication, or AI-related studies were not performed for this specific submission because the device itself hasn't changed.

Therefore, I cannot provide the detailed information requested in your prompt because the provided 510(k) letter does not contain the type of acceptance criteria and study analysis that would be relevant for an AI-powered diagnostic device. The questions about sensitivity, specificity, MRMC studies, ground truth establishment, and training/test set sizes are pertinent to AI/software device clearances, not to the material science and manufacturing consistency demonstrated for a bone cement via substantial equivalence.

Ask a specific question about this device

SPECTRUM® GV Bone Cement is indicated for the fixation of a REMEDY SPECTRUM® GV Spacer, and for the fixation of prostheses to living bone in the second stage revision of a total hip arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

The provided text describes a 510(k) premarket notification for a medical device called "SPECTRUM® GV Bone Cement." This document focuses on the substantial equivalence of the new bone cement to a legally marketed predicate device (SPECTRUM® GV Bone Cement, K172906).

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.

The content details the regulatory clearance process for a traditional medical device (bone cement) and the performance testing conducted to demonstrate its physical, chemical, and biological properties, as well as its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth, MRMC studies, or training set details from the provided text.

The closest relevant sections in the provided text are "Performance Testing of Subject SPECTRUM® GV Bone Cement," which lists the types of tests performed (mechanical, elution, biocompatibility, sterilization, shelf life), but these are for a physical substance, not a software algorithm.

In summary, the provided document is not about an AI/ML medical device, and thus does not contain the information requested regarding AI/ML device acceptance criteria and validation studies.

Ask a specific question about this device