(181 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
This document is a 510(k) Summary for a medical device (Stryker® iVAS Balloon Catheter), which typically demonstrates substantial equivalence to a predicate device rather than presenting a de novo clinical study with strict acceptance criteria for a novel AI algorithm. Therefore, many of the requested fields regarding AI algorithm performance, training sets, and expert adjudication are not applicable or not explicitly detailed in the provided text.
Based on the provided text, here's the information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a medical device, the "acceptance criteria" are not framed as specific performance metrics of an AI model, but rather as meeting established engineering and biocompatibility standards to demonstrate substantial equivalence to predicate devices. The performance is reported as meeting these standards.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Functional & Performance Testing | "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and simulated use." |
| Biocompatibility | "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." |
| Substantial Equivalence (General) | "The Stryker® iVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications." |
| Safety and Effectiveness (General) | "The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes engineering tests (functional, performance, biocompatibility) rather than a clinical human-subject test set. Therefore, "sample size" in a clinical sense and "data provenance" (country/retrospective/prospective) are not applicable or mentioned. The testing seems to involve physical devices or materials.
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 not a study requiring expert ground truth for clinical image analysis or similar tasks. The "ground truth" for engineering tests would be the established performance specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective clinical assessments, which are not described here.
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 document does not describe an AI medical device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For functional and performance testing, the "ground truth" would be the engineering specifications and established test methods, which the device's performance was compared against.
For biocompatibility, the "ground truth" refers to the requirements set forth in the FDA Blue Book Memorandum G95-1 (ISO-10993).
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI training set involved.
§ 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.”