(44 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.
This document, K113477, is a 510(k) summary for the Stryker® iVAS Balloon Catheter, seeking clearance for a modification to a previously cleared device. As such, the study described is primarily focused on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing, rather than a clinical trial with acceptance criteria for disease detection or diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for each test or detailed performance metrics in a table format as might be seen for a diagnostic device. Instead, it makes a general statement of compliance and equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing (e.g., Insertion and Retraction Force, Force to Puncture, Burst, Simulated Use) | Meets specified performance characteristics and is substantially equivalent to predicate devices. (Implies meeting established engineering specifications for safety and effectiveness, and performing comparably to the predicate devices). | "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 | Meets applicable requirements of FDA Blue Book Memorandum G95-1 and ISO-10993 Part -1. (Implies no unacceptable biological reactions and safe for contact with the body). | "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." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests (functional or biocompatibility). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not relevant for benchtop and biocompatibility testing for medical device clearance of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing described. The document pertains to engineering performance and biocompatibility of a medical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 medical device clearance for a physical catheter, not an AI or imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
For functional testing, the "ground truth" would be established engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the requirements of the FDA Blue Book Memorandum G95-1 and ISO-10993.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/machine learning model that undergoes training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
§ 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.”