(246 days)
Spineplex™ Radiopaque Bone cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Stryker Spineplex™ Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Stryker Simplex® P.
The provided text is a 510(k) summary for the Stryker Spineplex™ Radiopaque Bone Cement. It focuses on demonstrating substantial equivalence to a predicate device (Stryker Simplex® P) rather than presenting a detailed study with acceptance criteria and performance metrics in the way one might expect for a diagnostic AI device.
Therefore, many of the requested points regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as it describes a medical device (bone cement) and its regulatory approval based on equivalence.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the context of a study demonstrating numerical performance against specific acceptance criteria. The submission is a 510(k) summary for a PMMA bone cement, claiming substantial equivalence to a predicate device. The "performance" assessment is based on the chemical similarity and modified ratios for improved working time and visualization, rather than quantitative clinical performance metrics with predefined acceptance thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not mentioned. This document does not describe a "test set" in the context of evaluating a device's performance through a study involving patient data or specimens. The evaluation is based on the device's composition and comparison to a predicate.
3. 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/Not mentioned. There is no "ground truth" establishment described, as this is not a diagnostic device evaluation requiring interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned.
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/Not mentioned. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not mentioned. This is not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a bone cement would relate to its material properties, biocompatibility, and clinical outcomes for fracture fixation, which are assessed through different types of studies (e.g., mechanical testing, biocompatibility studies, implant registries for long-term outcomes), but these details are not provided in this 510(k) summary. The summary focuses on the inherent properties and modifications of the substance itself.
8. The sample size for the training set
Not applicable/Not mentioned. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable/Not mentioned.
§ 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.”