(183 days)
Palacos® R 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.
Palacos® R 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.
The provided text is a 510(k) summary for the Palacos® R bone cement, which is a medical device. This type of document is for regulatory clearance and does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance in the way a clinical trial or a machine learning model's validation study would.
Specifically, for a medical device cleared via the 510(k) pathway, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics from a de novo clinical study. The "study that proves the device meets the acceptance criteria" refers to the submission of data (often pre-clinical testing or a review of existing literature/predicate device data) that supports this claim of substantial equivalence.
Therefore, many of the requested points are not applicable or cannot be extracted from this document, as it is not a report of a performance study in the context of AI/ML or a new clinical device.
Here's a breakdown based on the information provided in the 510(k) summary:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: "Substantial Equivalence" to the legally marketed predicate device, PALACOS® R BONE CEMENT (PMA Number: P810020). The specific criteria for substantial equivalence typically involve demonstrating similar technological characteristics, intended use, and safety/effectiveness profiles.
- Reported Device Performance: The document states, "This is the well known Palacos® R being marketed for more than 25 years (PMA by Merck)." This implies that its long-standing market history and prior PMA approval serve as evidence of its performance. The 510(k) summary confirms that the device meets the requirements for substantial equivalence to its predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Device is the "well known Palacos® R being marketed for more than 25 years (PMA by Merck)" and determined substantially equivalent to PALACOS® R BONE CEMENT (PMA P810020). |
| Intended Use | Fixation of prostheses in bone for arthroplastic procedures. |
| Technological Characteristics | Similar to the predicate; formed from powder and liquid by exothermic polymerization to secure fixation. |
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This is a 510(k) summary for a bone cement, not a study involving a test set of data like in an AI/ML context. The clearance is based on comparison to a predicate device, not primary clinical data for "testing" in this manner.
-
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. This is not an expert-driven validation study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device as determined by the FDA (through its PMA process).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" and no adjudication process in the context of comparing human readers or AI in this 510(k) submission.
-
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 medical device (bone cement), not an AI/ML-driven diagnostic tool that would involve human readers or MRMC studies.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (bone cement), not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the identified predicate device, PALACOS® R BONE CEMENT (PMA Number: P810020), which has been marketed for over 25 years and previously approved under a PMA. The substantial equivalence argument relies on the predicate's known performance rather than new, primary ground truth data from this submission.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set is relevant for this type of device and submission.
§ 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.”