(133 days)
The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.
The StaXx™ FX System is a vertebral fracture reduction device composed of a base wafer and stackable wafers fabricated from preformed Polyetheretherketone (PEEK-OPTIMA) with 6% Barium Sulfate (BaSO4). The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty (20) wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm).
The provided text describes a 510(k) submission for the "StaXx™ FX System," a device intended for reducing spinal fractures. The submission establishes substantial equivalence to a predicate device through mechanical testing. However, the document does not contain specific acceptance criteria, reported device performance data, details of a study demonstrating fulfillment of acceptance criteria, or most of the requested information about sample sizes, ground truth, or expert involvement.
The key statement regarding performance is: "In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use." This is a high-level summary and lacks the detailed information requested.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred or directly stated from the document:
- Table of acceptance criteria and the reported device performance:
- The document only states that "mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use." No specific acceptance criteria (e.g., strength, durability thresholds) or detailed performance metrics (e.g., maximum load, fatigue life) are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met "performance requirements for its intended use" through mechanical testing. |
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document only mentions "mechanical testing."
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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, as this was mechanical testing, not a clinical study involving human interpretation of data where "ground truth" would be established by experts in that context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (mechanical testing).
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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 mechanical implant, not an AI or imaging diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This device is a mechanical implant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical expert-derived ground truth. For mechanical testing, the "ground truth" would be the engineering specifications and material properties against which the device's mechanical performance is measured.
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The sample size for the training set: Not applicable. This is mechanical testing, not a machine learning model.
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How the ground truth for the training set was established: Not applicable. This is mechanical testing.
§ 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.”