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PALACOS 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.

Palacos® 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.

The provided text is a 510(k) summary for a medical device called PALACOS® G, which is a bone cement. This document describes the device, its intended use, and its equivalence to a predicate device.

However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. This type of information is typically found in the clinical or performance data sections of a 510(k) submission, which are not present in this summary.

Therefore, I cannot provide the requested table or detailed study information based on the provided text.

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Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.

Osteopal® 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 the medical device OSTEOPAL®, a bone cement. The purpose of a 510(k) summary is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device's technological characteristics, indications for use, and performance to an existing device rather than presenting extensive de novo clinical trials to establish acceptance criteria and prove its meeting.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format typically found for AI/ML device submissions. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: This document explicitly states that the new device, Osteopal®, is the known Osteopal® marketed by Merck (or Palacos E-Flow by S.-P.) and refers to an existing PMA (P810020). This implies equivalence to a previously approved device, not validation against new performance criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: These are all elements typically found in studies for novel devices, especially those incorporating AI/ML, where performance metrics like sensitivity, specificity, or AUC are evaluated against a defined ground truth derived from expert review or pathology. Since this is a 510(k) for a bone cement claiming equivalence, such detailed performance studies with human interpretation or AI assistance are not part of this submission.

In summary, the provided 510(k) summary for OSTEOPAL® is a regulatory submission for a traditional medical device (bone cement) claiming substantial equivalence to a predicate device. It is not an AI/ML device submission and therefore does not contain the information requested about acceptance criteria and associated performance studies as typically understood for such technologies.

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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:

1. 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.

2. 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.

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. 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).

4. 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.

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 a medical device (bone cement), not an AI/ML-driven diagnostic tool that would involve human readers or MRMC studies.

6. 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.

7. 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.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. No training set is relevant for this type of device and submission.

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PALABOND 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.

Palabond® 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 Palabond bone cement. It does not describe an AI medical device or a study involving acceptance criteria for AI performance. Instead, it focuses on the substantial equivalence of Palabond to an existing bone cement (Palacos R) based on chemical identity and mechanical performance.

Therefore, I cannot extract the information requested about acceptance criteria, study details, ground truth, or training sets for an AI device from this document.

The document indicates:

• Device Trade Name: PALABOND®
• Classification Name: Bone Cement
• Intended Use: Fixation of prostheses in the bone (partial or total hip joint replacement at the hip, knee or other joints).
• Comparison: Palabond® is chemically identical to Palacos® R, with the only difference being the addition of bigger particles (granules) of copolymer to the powder.
• Performance Claim: The mechanical performance is equivalent (see test report).

The "test report" mentioned in the last point would contain the actual mechanical performance data and acceptance criteria used to establish equivalence, but this report is not included in the provided text.

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