(142 days)
Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.
Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.
The provided text describes a medical device submission (K043518) for "Radiopaque Bone Cement". However, the document does not contain the specific information required to answer the requested questions about acceptance criteria, study details, and performance metrics.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria and specific outcomes for an AI/algorithm-based device.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be inferred from the document:
- Device: Radiopaque Bone Cement
- Intended Use: Fixation of pathological fractures of the vertebral body.
- Predicate Device: Stryker Spineplex Radiopaque Bone Cement (K032945).
- Summary of Testing: "Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics." This implies non-clinical tests were done, but no specific performance data or acceptance criteria are listed.
- Type of Study (General): Non-clinical performance testing for substantial equivalence.
What cannot be answered from the document:
The following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The document states that performance testing was done to show substantial equivalence but does not provide any specific criteria (e.g., tensile strength, viscosity ranges, setting time, radiopacity levels) or the numerical results of those tests for either the new device or the predicate.
- Sample sizes used for the test set and the data provenance: No sample sizes are mentioned for any testing. Data provenance (country of origin, retrospective/prospective) is also not stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a bone cement as it's a physical material, not an interpretative AI/image analysis device. There's no ground truth in the sense of expert consensus on images.
- Adjudication method for the test set: Irrelevant, as above.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: This information is not relevant because the device is a physical bone cement, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable as it's not an AI algorithm.
- The type of ground truth used: For a physical material like bone cement, "ground truth" typically refers to established physical properties (e.g., material standards, mechanical test results) rather than expert consensus, pathology, or outcomes data in the context of interpretation. The document only mentions "functional characteristics" for comparison.
- The sample size for the training set: Not applicable; this device is not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) documentation confirms the substantial equivalence of the Radiopaque Bone Cement based on "performance testing" related to "functional characteristics," but it does not detail the specific acceptance criteria, test results, or study methodologies that would be relevant for an AI/algorithm-based medical device performance description.
§ 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.”