(27 days)
PALACOS ® MV 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® MV 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. It is currently marketed in a 44 g packaging size in the United States.
The provided document is a 510(k) summary for a medical device called PALACOS® MV, which is a polymethylmethacrylate (PMMA) bone cement. This document details the device's characteristics and its substantial equivalence to a predicate device, but does not describe "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the rigorous validation of AI/ML-based medical devices for regulatory clearance. Since PALACOS® MV is a physical bone cement, these types of evaluations are not applicable.
Instead, the document focuses on demonstrating the substantial equivalence of PALACOS® MV to a previously cleared predicate device (Palamed®, K030904) through preclinical testing of its physical and mechanical properties. The "acceptance criteria" in this context would refer to the standards outlined in ISO 5833 and Heraeus's internal final test requirements, which the device met.
Here's an attempt to answer the questions based on the provided text, while highlighting the irrelevance of some questions to this type of device:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria (Standards Met) Reported Device Performance (PALACOS® MV) ISO 5833 Doughing time, maximum temperature, setting time, intrusion, compressive strength, bending modulus, and 4-point bending strength were characterized. Met ISO 5833 standards. Heraeus final test requirements Tested for impact and bending strength (Dynstat test method). Met Heraeus final test requirements. ANSI/AAMI ST72:2011 (Bacterial Endotoxin Test) Bacterial endotoxin evaluated (LAL test). Test results met endotoxin limits (20 endotoxin units (EU)/Device). Stability/Shelf Life Data compared between subject and predicate devices. No specific quantitative criteria or results are detailed beyond "data were also compared". -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the preclinical tests conducted to characterize the physical and mechanical properties of the bone cement. The tests were presumably conducted in a laboratory setting, likely in Germany, where Heraeus Medical GmbH is located. This would be considered prospective controlled laboratory testing, not data provenance in the AI/ML sense.
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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. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant for evaluating the physical properties of bone cement. The "ground truth" for bone cement performance is based on established engineering and materials science principles, and international standards (like ISO 5833).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of data, particularly in complex medical image interpretation or clinical outcomes. This is not
relevant for standardized mechanical and chemical testing of a material. -
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. MRMC studies are used to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic tasks. This device is a physical bone cement, not an AI/ML algorithm, so an MRMC study was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The concept of "standalone performance" refers to the evaluation of an AI algorithm independent of human interaction. PALACOS® MV is a physical product. Its performance is evaluated through material science tests, not as an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of PALACOS® MV is based on objective measurements and established international standards for bone cement (e.g., ISO 5833) and bacterial endotoxin testing (ANSI/AAMI ST72:2011). This is material science and chemistry, not clinical "outcomes data" or "pathology" in the diagnostic sense.
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The sample size for the training set
Not applicable. As a physical product, there is no "training set" in the context of AI/ML. The device's properties are inherent to its formulation and manufacturing process, evaluated through testing.
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How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 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.”