(183 days)
Palamed* 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.
Palamed® is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
This document is a 510(k) Summary for a bone cement device (PALAMED®), rather than a study report describing acceptance criteria and device performance based on a study. Therefore, most of the requested information cannot be extracted from the provided text.
The document states that the PALAMED® device is "substantially equivalent" to a legally marketed predicate device (PALAMED® 510k (Merck) K010586). This substantial equivalence is based on the comparison of technological characteristics, implying that the device's performance is expected to be similar to the predicate device, which has already met regulatory requirements.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the 510(k) summary. The summary focuses on substantiating equivalence to a predicate device rather than detailing specific acceptance criteria and reporting performance against them. For bone cement, acceptance criteria would typically involve various mechanical, physical, and chemical properties (e.g., setting time, strength, porosity, biocompatibility), but these specific values are not listed here. The "reported device performance" in this context is implicitly that it performs equivalently to the predicate device.
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 to this document. The 510(k) summary does not describe a new study with a test set in the way a clinical trial or a performance study would. It relies on the equivalence to an already marketed device.
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. There's no test set in the described context for which ground truth was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 not a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (bone cement), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of establishing ground truth for a new algorithm or diagnostic test. For bone cement, the "ground truth" would be established by validated test methods for its physical, chemical, and mechanical properties, and its safe and effective clinical use as demonstrated by historical data on the predicate device.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe a machine learning algorithm or a training set.
In summary, the provided text is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report demonstrating performance against specific acceptance criteria for a new device design.
§ 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.”