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

PALACOS® R pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® R+G pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® MV+G pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid). A ductile dough forms that sets within a few minutes.

This FDA 510(k) Premarket Notification is for PALACOS® R pro, PALACOS® R+G pro, and PALACOS® MV+G pro bone cements. It does not describe an AI/ML device, a clinical study with human readers, or a ground truth established by experts. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance testing.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported numerical performance values in the way you might expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it states that the devices meet existing industry standards and guidance documents. The "acceptance criteria" are implied by adherence to these standards, and the "reported performance" is that the devices meet them.

• Concluded that possible transfer of leachables is low.
• Cytotoxicity test performed to support this conclusion.
• No negative impact estimated from changes. |
  | Mechanical & Functional | FDA Guidance document Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement - Guidance for Industry and FDA (July 17, 2002) (Annex I and Annex II) | - Tests conducted to demonstrate intended function, safety, and effectiveness.
• Data provided to state substantial equivalence to predicate device. |
  | Sterilization | ISO 11135 | - Validation performed using ethylene oxide gassing.
• Cycle designed for sterile units with a sterility assurance level (SAL) of 10⁻⁶.
• Chosen sterilization process considered valid, showing equivalence to predicate device. |
  | Pyrogenicity | ANSI/AAMI ST72 (LAL test) | - Subject device meets endotoxin limit specification of ≤ 20 EU/device.
• Shows equivalence to 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)

This document details non-clinical laboratory testing, not a test set of patient data. Therefore, the concepts of "sample size used for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to patient data or imagery do not apply. The testing was conducted in a laboratory setting, likely in Germany where the manufacturer is located, or by authorized testing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this type of device (bone cement) is not established by human experts in the context of medical image interpretation. The "truth" is determined by established physical, chemical, and biological testing standards and measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no human adjudication process described, as the testing is based on objective laboratory measurements against defined standards.

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 an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

• Established objective standards: International Standards (e.g., ISO 10993-1, ISO 11135, ANSI/AAMI ST72) and FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement").
• Laboratory measurements: Results from specific tests (cytotoxicity, mechanical property measurements, sterility assurance level determination, LAL test for endotoxins) designed to objectively evaluate the device's conformance to these standards and demonstrate substantial equivalence to predicate devices.
• Chemical and material analysis: Confirmation of identical (or acceptably different) chemical composition and materials compared to predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context.

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

Not applicable. As above, there is no "training set" for this type of device.

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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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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® R+G 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+G 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+G pro is available in one size: 75 g and is for single use. The PALACOS® R+G 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

Based on the provided text, the device is PALACOS® R+G pro, a radiopaque bone cement with gentamicin. This document is a 510(k) summary for its premarket notification.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format as would be seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it describes a series of nonclinical tests performed according to international standards (ISO standards) to demonstrate that the PALACOS® R+G pro is substantially equivalent to a legally marketed predicate device (PALACOS® R+G, K031673). The reported device performance is that it characterized per ISO 5833, measured according to Dynstat test method, validated per ISO 11135, and performed per ISO 10993. The conclusion is that it is "substantial equivalent to PALACOS® R+G."

Given the nature of this medical device (bone cement), the "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.

2. Sample size used for the test set and the data provenance

The document indicates that nonclinical tests were performed. No specific sample sizes for these tests (e.g., number of test specimens for mechanical strength) are detailed in this summary. The data provenance is from Heraeus Medical GmbH, Germany. The tests are inherently prospective as they are conducted specifically for the purpose of demonstrating equivalence for this new product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a bone cement, not a diagnostic or AI device that requires expert adjudication for ground truth establishing. The "ground truth" for this device's performance is established through physical and biological testing against established standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as point 3. Testing of physical properties and biocompatibility does not involve human adjudication in the described manner.

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

This question is not applicable. The device is a bone cement, not an AI or diagnostic tool. No MRMC study was performed or is relevant for this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a bone cement, the "ground truth" for its performance and safety is established through:

• Compliance with international standards: ISO 5833 for mechanical properties, ISO 11135 for sterilization, and ISO 10993 for biocompatibility.
• Physical and chemical characterization: Direct measurements of properties like stability, temperature, setting time, strength, etc.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical medical device like bone cement. The manufacturing process and formulation are developed, and then the final product is tested against standards.

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

This question is not applicable for the same reason as point 8.

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