(188 days)
KYPHON® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor.
KYPHON® Xpede™ Bone Cement is provided as a two- component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl- methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.
The provided 510(k) summary for Kyphon® Xpede™ Bone Cement does not contain information about acceptance criteria or a study proving its performance against such criteria for a clinical application using AI. This document is a premarket notification for a medical device (bone cement), and the testing described is primarily focused on bench testing and biocompatibility to demonstrate substantial equivalence to previously approved predicate devices, not clinical performance metrics measured in a study with a test set of data.
Therefore, many of the requested categories related to AI performance, ground truth, and human reader studies cannot be populated from this document.
However, I can extract the relevant information regarding the testing that was conducted to demonstrate substantial equivalence.
Here's the breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not define specific acceptance criteria values in a table format for the mechanical, physical, chemical, or handling tests. Instead, it states that "The results of this testing support the determination of substantial equivalence." This implies that the performance of the Kyphon® Xpede™ Bone Cement fell within acceptable ranges or was comparable to the predicate devices for these various tests.
What is reported is the type of testing conducted to support substantial equivalence:
| Test Category | Description of Test | Reported Performance |
|---|---|---|
| Mechanical | Compressive, tensile, flexural, fatigue | Results supported determination of substantial equivalence to predicate devices. |
| Handling | Dough time, working time | Results supported determination of substantial equivalence to predicate devices. |
| Physical | Viscosity, exotherm, water absorption | Results supported determination of substantial equivalence to predicate devices. |
| Chemical | Monomer elution, molecular weight, glass transition temperature | Results supported determination of substantial equivalence to predicate devices. |
| Biocompatibility | Cytotoxicity, acute systemic toxicity, intracutaneous reactivity | Results supported determination of substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes for each of the bench tests (mechanical, handling, physical, chemical, biocompatibility). These are typically laboratory tests performed on a certain number of material samples.
- Data Provenance: The tests are described as "Testing was conducted to verify the performance of Kyphon® Xpede™ Bone Cement for in vivo applications." This indicates laboratory-based testing, not clinical data from patients. The country of origin for the data is not explicitly stated but can be inferred to be from the manufacturer (Medtronic Spine LLC) or a contracted lab. This is a retrospective analysis of the material properties, not a prospective clinical study.
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 involving human interpretation of data where expert ground truth is established. The "ground truth" for material properties is derived from standardized laboratory measurements.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data for adjudication.
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 submission for a bone cement, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a bone cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation is based on objective, standardized laboratory measurements of material properties (e.g., strength, viscosity, chemical composition, biocompatibility testing against established safety profiles). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.”