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PALACOS® MV 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® MV 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 X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyllcopper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.

The provided text describes a 510(k) premarket notification for a medical device called PALACOS® MV pro, a polymethylmethacrylate (PMMA) bone cement. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML powered device, or any diagnostic device subject to performance metrics like sensitivity, specificity, AUC, etc. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

Therefore, many of the requested items (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or mentioned in this document.

Here's an analysis based on the information provided in the document:

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

The document doesn't explicitly state acceptance criteria in terms of specific numerical thresholds for performance metrics commonly associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for demonstrating substantial equivalence are based on matching the predicate device's intended use, technological characteristics, and operating principle. The "reported device performance" is demonstrated through various tests designed to show that the subject device functions as intended and is safe and effective, aligning with the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The document refers to various engineering and biological tests conducted on the device itself or representative materials. The 'sample size' for these tests would refer to the number of units tested, but this is not specified for each test.
• Data Provenance: Not applicable in the context of an AI/ML test set. The tests are laboratory-based and follow international standards. The manufacturer is Heraeus Medical GmbH, located in Germany.

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 a diagnostic device or an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for this device's performance is established through adherence to recognized international standards and laboratory testing for physical, mechanical, chemical, and biological properties.

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

Not applicable. There is no expert adjudication process described, as it's not relevant for this type of device and 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 bone cement, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

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

Not applicable. This is a PMMA bone cement, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness, in the context of substantial equivalence, is rooted in:

• International Standards: Adherence to established mechanical (ISO 5833, ASTM F451), sterilization (ISO 11135), biocompatibility (ISO 10993-1), and pyrogenicity (ANSI/AAMI ST72) standards.
• Predicate Device Performance: The demonstrated safe and effective use of the predicate device (PALACOS® R pro) acts as a benchmark. The subject device is shown to be equivalent in its properties to this predicate.
• Laboratory Testing Results: Direct measurements of physical, chemical, and biological properties in controlled laboratory settings.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no "training set" or associated ground truth establishment process for this device as it is not an AI/ML product.

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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 ® 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:

1. 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".

2. 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.

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. "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).

4. 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.

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. 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.

6. 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.

7. 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.

8. 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.

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

   Not applicable, as there is no "training set" for this device.

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