(90 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 and Cortoss® Bone Augmentation Material 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.
The provided text is a 510(k) summary for the Stryker® iVAS Balloon Catheter, intended for use in vertebral augmentation procedures. It primarily details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Based on the information provided, no specific acceptance criteria or detailed study results proving the device meets these criteria are present in the document in the format you requested.
The document states:
- "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and is 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 stimulated use."
- "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1... and is biocompatible."
However, these are high-level statements and do not provide:
- A table of acceptance criteria and reported device performance: While functional tests are mentioned, no specific acceptance values (e.g., minimum or maximum force, burst pressure thresholds) or the actual results achieved (e.g., specific force values, pressure at burst) are provided.
- Sample sizes used for the test set and data provenance: No information is given on the number of devices tested for any of the functional tests.
- Number of experts used to establish the ground truth for the test set and their qualifications: This is not relevant for the type of bench testing described (e.g., insertion force, burst pressure).
- Adjudication method: Not applicable for engineering bench tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is a medical device (catheter) and not an AI or imaging diagnostic tool that would typically involve human readers.
- Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: For physical performance tests, the "ground truth" would be the measured physical properties against established engineering specifications. These specifications are not detailed.
- Training set sample size: No training data is applicable for this type of device and testing.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on regulatory submission for substantial equivalence based on bench testing and biocompatibility, rather than a detailed report of clinical or advanced performance study results with specific acceptance criteria and outcome data.
Therefore, I cannot populate the table or provide the requested details using the given text. The text confirms that testing was performed, and the device met its specifications and performance characteristics, thus establishing substantial equivalence to predicate devices, but it does not detail these specifications or results.
§ 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.”