(90 days)
XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).
XeliteMed VertehighFix High Viscosity Spinal Bone Cement is provided as a twocomponent system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The provided text describes the 510(k) summary for a medical device, XeliteMed VertehighFix High Viscosity Spinal Bone Cement. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The acceptance criteria and study that proves the device meets those criteria are focused on non-clinical performance testing rather than clinical study data involving AI or human readers, as the device is a bone cement, not an AI-powered diagnostic tool. Therefore, many of the requested points regarding AI and human reader studies (MRMC, standalone AI, training set details) are not applicable to this type of device and submission.
Here's an interpretation of the text for the applicable criteria:
1. A table of acceptance criteria and the reported device performance
The document states that "Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements' and are substantially equivalent to the predicate device."
While a specific table of numerical acceptance criteria and reported device performance values is not explicitly provided in this public summary, the general acceptance criterion is compliance with ISO 5833 and substantial equivalence to the predicate device (Mendec Spine K042415) for the following non-clinical tests:
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Compliance with ISO 5833 standards for bone cement | "in compliance with the standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements'" |
| Substantial Equivalence to Predicate Device (Mendec Spine K042415) | "substantially equivalent to the predicate device" |
| Met predefined limits for Bacterial Endotoxins Testing | "met the limits ( LAL test method) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of test specimens) used for each non-clinical test. The data provenance is from Xelite Biomed Ltd. in New Taipei City, Taiwan (R.O.C.), and the tests are inherently prospective as they are conducted on the newly manufactured device to demonstrate its properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the "ground truth" for bone cement performance is established by objective, standardized laboratory measurements according to ISO standards, not by expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no human interpretation or subjective adjudication involved in the objective non-clinical performance testing of bone cement.
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
This question is not applicable as the device is a bone cement, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a bone cement, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established international standards (ISO 5833) and objective physical and chemical measurements of the bone cement's properties (e.g., mechanical strength, setting time, chemical composition, biocompatibility). For bacterial endotoxin testing, the ground truth is established by the USP Bacterial Endotoxins Test limits.
8. The sample size for the training set
This question is not applicable as the performance testing described is for a physical medical device (bone cement), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.”