(110 days)
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty to scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is a device used to disrupt cancellous bone by scraping and scoring the bone as and creating a void within a vertebral body. After the bone is disrupted, Radiopaque Bone Cement is injected through the AVAflex Vertebral Augmentation Needle to fill the previously created void.
This is a 510(k) premarket notification for a medical device, the AVAflex Vertebral Augmentation Needle, from 2007. It is not an AI/ML device, and therefore, many of the requested criteria (like ground truth, expert opinions, AI assistance, etc.) are not applicable. The study described focuses on non-clinical performance and biological safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". | Materials were evaluated and found to be "acceptable for the intended use." |
| Functional Characteristics | Performance testing demonstrating substantial equivalence to currently marketed curettes. | Performance testing demonstrated that the proposed device is "substantially equivalent to the currently marketed curettes with regard to functional characteristics." |
| Material Properties | Industry-recognized test methods for materials. | Materials were tested and found to be "acceptable for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical laboratory testing of the device itself (materials, performance), not a study on human or clinical data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical or image data are not applicable. The "test set" here refers to the actual physical devices or materials undergoing laboratory evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for a non-clinical device performance and biocompatibility study. "Ground truth" in this context refers to established standards and test methodologies (e.g., ISO 10993 for biocompatibility) rather than expert consensus on medical findings.
4. Adjudication Method for the Test Set
This is not applicable as the study involves objective laboratory testing against established standards, not human interpretation or a need for adjudication.
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
No, an MRMC study was not done. This device is a surgical tool, not an AI diagnostic/imaging device. Therefore, the concept of AI assistance for human readers is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" was established
by international standards such as ISO 10993 Part-1.
For functional characteristics, the "ground truth" was established by comparison to predicate devices and industry-recognized test methods.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML device and therefore does not have a "training set" in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative physical testing, for which sample sizes are determined by engineering and quality assurance standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not an AI/ML device. The "ground truth" for the development of such a device is rooted in engineering principles, material science, and established medical requirements for surgical tools.
§ 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.”