(94 days)
PALAMED® G is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
PALAMED® G 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) premarket notification for a medical device (Palamed® G bone cement), not a study report or clinical trial. Therefore, it does not contain the structured information typically found in a study describing acceptance criteria and device performance based on a specific study.
The document primarily focuses on establishing "substantial equivalence" to a predicate device (PALACOS® R BONE CEMENT), meaning it asserts that the new device is as safe and effective as a legally marketed device.
Here's a breakdown of why the requested information is not available in this document:
- No Acceptance Criteria or Reported Device Performance Table: The document does not present a table of specific acceptance criteria (e.g., mechanical strength thresholds, elution rates, etc.) nor does it report detailed performance metrics for Palamed® G against such criteria. The comparison is made at a higher level, stating "Palamed® G performs very similar to Palacos R."
- No Specific Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth for Test or Training Sets): Since this is a 510(k) summary focusing on equivalence, it does not describe a clinical study or a detailed technical performance study with the granularity you've requested.
- There is no mention of a specific test set sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
- No MRMC comparative effectiveness study is described. The concept of "human readers improving with AI" is not applicable here as Palamed® G is a bone cement, not an AI-powered diagnostic device.
- The document does not describe a "standalone" algorithm performance study for the same reason – it's a physical device, not an algorithm.
- The type of ground truth used (e.g., pathology, outcomes data) is not discussed because no such study is presented.
- There is no information on a training set sample size or how ground truth was established for a training set, as the device is not machine-learning based.
What the Document DOES provide related to performance:
- Comparison to Predicate Device: "Palamed® G is similar to Palacos R except for the additional gentamicin sulphate and a lower initial viscosity. Palamed® G performs very similar to Palacos R." This is the core "proof" of performance in a 510(k) – that it's equivalent to an already approved device.
- Intended Use: The cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. This defines the clinical context in which its performance is relevant.
- Reference to another 510(k): "See also K030904 (PALAMED)." This implies that some data or comparison for a similar device (PALAMED, without the 'G' perhaps) was submitted previously, and this submission might leverage or build upon that.
In summary, this document is a regulatory submission for substantial equivalence, not a detailed technical or clinical study report. It doesn't contain the granular information about acceptance criteria and study methodologies that you are seeking. To find such information, one would typically need to review the full 510(k) submission (which is usually much more extensive than the summary provided) or any associated pre-clinical or clinical study reports that were conducted to support the safety and effectiveness claims.
§ 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.”