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PALACOS® R is indicated 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 pro is indicated 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+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® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® MV+G is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to PALACOS® R, PALACOS® R pro, PALACOS® R+G, PALACOS® R+G pro, and PALACOS® MV+G previously cleared in K030902, K150119, K031673, K142157 and K050855.

Modifications include changes of instructions for use (IFU) and labels as well as the addition of MRI safety information.

This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data.

PALACOS® bone cements without Gentamicin:
PALACOS® R and PALACOS® R pro are polymethylmethacrylate (PMMA) bone cements.
PALACOS® R: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery.
PALACOS® R pro: is a PMMA based PALACOS® R bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix).
The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

PALACOS® bone cements with Gentamicin:
PALACOS® R+G, PALACOS® R+G pro and PALACOS® MV+G are PMMA bone cements, containing the antibiotic Gentamicin.
PALACOS® R+G (previously cleared under the name PALACOS® G); is a standard-setting. high-viscosity, PMMA-based bone cement for orthopaedic surgery.
PALACOS® R+G pro is a PMMA based PALACOS® R+G bone cement, packed in a closed mixing and application system ready for processing (ready-to-mix) and
PALACOS® MV+G (previously cleared under the name PALAMED G) is a standard-setting, medium-viscosity, radiopaque, poly(methyl methacrylate)-based bone cement for orthopaedic surgery.
The bone cements consist of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

The provided document is a 510(k) premarket notification for PMMA bone cements (PALACOS® R, PALACOS® R pro, PALACOS® R+G, PALACOS® R+G pro, and PALACOS® MV+G). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting a clinical study to prove device performance against specific metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for training sets.

Instead, the document states:

"A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications to the labelling... The modified IFUs do not alter the previously validated packaging or sterilization data as well as the existing results of non-clinical performance testing and biocompatibility in accordance with the FDA Class II Special Controls Guidance Document 'PMMA Bone Cement'. The risk-based assessment concludes that the IFU changes do not significantly affect the device's risk profile because no new risks or significantly modified existing risks are identifically based rationale has been prepared to designate the bone cements as "MR Safe"."

And, for each device: "No clinical testing... has been conducted."

The substantial equivalence determination is based on a comparison of technological characteristics with predicate devices, confirming that the subject devices are modified versions with no significant changes to their safety or effectiveness.

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Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.

This document describes a 510(k) premarket notification for the "Refobacin Bone Cement R" and does not contain information about an AI/ML powered device. As such, I cannot extract information related to acceptance criteria, study plans, or ground truth for an AI-based system.

The document pertains to a medical device in the field of orthopedics, specifically bone cement used in arthroplasty procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Palacos® G Bone Cement) based on non-clinical testing of mechanical, chemical, physical, and handling characteristics. Clinical data was explicitly not required for this determination of substantial equivalence.

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PALACOS® R pro 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 pro 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 bone cement powder and liquid of PALACOS® R pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R pro is available in one size: 75 g and is for single use. The PALACOS® R pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun.

The provided document is a 510(k) summary for a medical device called PALACOS® R pro, a PMMA bone cement. It is a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence, rather than a clinical study with acceptance criteria for device performance in human patients.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable within the context of this document, as it focuses on demonstrating bio-mechanical and material equivalence to an already approved device.

Here's an attempt to address your request based on the provided text, noting where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the standards and tests applied to the predicate device and the reference device. The "reported device performance" indicates that PALACOS® R pro (or its relevant precursors) met these criteria, supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for the individual non-clinical tests (e.g., number of specimens for compressive strength testing). It states that the tests were performed "per ISO 5833" and "per ISO 10993," which would implicitly define testing protocols and sample sizes within those standards.

• Test set sample size: Not explicitly stated for each test, but implied by adherence to ISO standards.
• Data Provenance: The manufacturer, Heraeus Medical GmbH, is located in Wehrheim, Germany. The tests appear to be conducted as part of the product development and regulatory submission process, which is inherently prospective for demonstrating compliance. The data refers to non-clinical laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This concept is not applicable here. The "ground truth" for these tests are the established parameters and thresholds defined by international standards (ISO 5833, ISO 11135, ISO 10993) for bone cement properties and sterilization/biocompatibility. These are objective measurements, not subjective expert assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for reconciling differing expert opinions in clinical ground truth establishment. Here, the "truth" is determined by direct physical and chemical measurements against defined standard limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not done. MRMC studies are associated with evaluating diagnostic imaging devices where human readers interpret results, often to assess AI's impact on reader performance. This document concerns a bone cement, which is a therapeutic device, not a diagnostic one.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a bone cement, a material used in surgery, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and measurement methodologies for material properties, sterilization efficacy, and biocompatibility. For instance, compressive strength has a defined physical measurement and an acceptable range per ISO 5833.

8. The Sample Size for the Training Set

Not applicable. This device is a material product, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as point 8.

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