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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.

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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.

Ask a specific question about this device

Ask a specific question about this device