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Parallax® Acrylic Resin Cartridge with TRACERS-Ta is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Parallax® Acrylic Resin Cartridge with TRACERS-Ta is an opacified polymethylmethacrylate bone cement.

This 510(k) summary is for a medical device called "Parallax® Acrylic Resin Cartridge with TRACERS-Ta," which is a PMMA bone cement. The document establishes substantial equivalence to existing predicate devices (K050864 and K053180).

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document is a traditional 510(k) submission for a physical medical device (bone cement), focusing on:

• Device Description: What the device is.
• Intended Use: What the device is used for (fixation of pathological vertebral body fractures).
• Substantial Equivalence: How it is similar to previously cleared devices.
• Classification: Its regulatory classification.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI/MRMC studies. This type of information is typically found in submissions for AI/ML-driven devices, which this document is not.

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Parallax® Acrylic Resin Cartridge with TRACERS is intended for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Parallax® Acrylic Resin Cartridge with TRACERS is an opacified polymethylmethacrylate bone cement.

This document is a 510(k) summary for a medical device (Parallax® Acrylic Resin Cartridge with TRACERS) and an FDA clearance letter. It is for a bone cement and describes its intended use and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance characteristics (like strength, setting time, etc.). The document is focused on regulatory clearance based on substantial equivalence.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in a more detailed technical report or study protocol, which is not provided in the given text. The 510(k) process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo studies against specific performance criteria for every new submission, especially for material modifications.

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