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510(k) Data Aggregation
(197 days)
AFFIRM (TM) VCF SYSTEM
The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
The AFFIRM™ Inflatable Bone Tamp is a bone tamp with an inflatable balloon attached to the distal end, designed to create a void in cancellous bone. The Inflatable Bone Tamp is a sterile, single-use device manufactured from polvurethane.
The system also contains access instruments (including drills, cannulas, jamshidi needles, and K-wires), biopsy needle, cavity preparation instruments (expanding scraper), sleeve, an inflation device, and cement delivery instruments (cement mixer, cement guns, and filler delivery needles).
Here's an analysis of the provided text regarding the AFFIRM™ VCF System, structured to address your specific questions.
Important Note: The provided 510(k) summary (K110998) is for a medical device (an inflatable bone tamp system), not a diagnostic AI software. Therefore, many of your questions related to AI performance metrics, ground truth, expert consensus, and specific clinical study designs (like MRMC) are not applicable to this type of submission. This document focuses on the mechanical and biological performance of the physical device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Functional specifications | "The AFFIRM™ VCF System meets the specification and performance characteristics..." |
| Fatigue resistance during insertion and withdrawal | "...functional testing, such as fatigue insertion and withdraw..." |
| Inflation capabilities | "...inflation..." |
| Burst strength | "...burst..." |
| Bond strength of components | "...bond strength." |
| Biocompatibility with human tissue (meeting FDA and international standards) | "Biocompatibility testing confirmed that the AFFIRM™ VCF System components are biocompatible and meet the applicable requirements of the FDA Blue Book Memorandum G95-1: Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." |
| Substantial equivalence to predicate device (KyphX® Inflatable Bone Tamps, K041454) | "The AFFIRM™ VCF System is substantially equivalent to the legally marketed predicate KyphX Inflatable Bone Tamps in terms of intended use, technological characteristics, safety, and effectiveness." |
| No new concerns regarding safety and efficacy compared to predicate | "The AFFIRM™ VCF System does not raise any new concerns of safety and efficacy when compared to the legally marketed predicate device." |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes (e.g., number of devices tested) for the functional testing. It refers to "functional testing" and "biocompatibility testing" in general terms.
Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or mentioned as this involves testing of a physical medical device, not analysis of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for this device relates to its engineering specifications and biological safety, which are evaluated through standardized tests and material science, not human expert consensus.
4. Adjudication method for the test set
Not applicable. There is no mention of adjudication, as this pertains to the evaluation of a physical device's performance against engineering and biological standards, not a diagnostic interpretation.
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 device is a physical medical instrument (an inflatable bone tamp system), not an AI-powered diagnostic tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device would be established by:
- Engineering specifications and standards: For functional tests like fatigue, inflation, burst, and bond strength. These are objective measurements against predefined thresholds.
- International biocompatibility standards (ISO-10993): For biocompatibility testing, which involves laboratory tests on materials (e.g., cytotoxicity, sensitization, irritation).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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