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GENTAFIX is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second phase of a two-stage revision after the initial infection has been cleared.

Teknimed's GENTAFIX® cements with gentamicin are a family of surgical cements of various viscosities, each containing the antibiotic gentamicin. GENTAFIX® bone cements are intended for fixation of prosthetic components into bone medullar cavity in cemented arthroplasty procedures. GENTAFIX® can be used with the Teknimed's own Class I 510(k) exempt accessories: bowl and spatula, and a Vacuukit® vacuum mixing and injection system. Following are the GENTAFIX models identified based on their viscosities:

• o GENTAFIX® 1 is a high viscosity bone cement intended for digital use.
• . GENTAFIX® 3 is a low viscosity bone cement intended for syringe application.
• GENTAFIX® 3 MV is a medium viscosity bone cement intended for syringe application.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called Gentafix, a bone cement. It focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, technological characteristics, and performance testing.

However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-based medical device. The product is a physical bone cement, and the testing described (physical, chemical, mechanical, sterilization, biocompatibility) are standard tests for such a material, not for an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request based on the provided text, as it does not describe:

• Acceptance criteria for an AI/ML device.
• The reported device performance for an AI/ML device.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document is entirely about the regulatory clearance for a bone cement, not an AI/ML system.

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The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).

HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.

Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
• Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is a non-clinical (bench) study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a non-clinical (bench) study about a bone cement, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a non-clinical (bench) study of a physical material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."

8. The sample size for the training set

• Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device submission.

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