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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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G1 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G1 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the G1 40 Radiopaque Bone Cement, a medical device intended for use in arthroplasty procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore,
No information is available regarding acceptance criteria and a study proving a device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document details performance testing conducted to show that the G1 40 Radiopaque Bone Cement has comparable characteristics and performs similarly to its predicate devices. This type of testing is common for demonstrating substantial equivalence for Class II devices.

Here's a breakdown of the available information regarding the performance comparison, addressing the relevant parts of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" for clinical performance (e.g., a certain percentage of successful fixation). Instead, the "acceptance criteria" are implied by compliance with established international and ASTM standards for bone cement properties. The "reported device performance" is framed as "comparable" to predicate devices and "in compliance" with these standards.

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

• Test Set Sample Size: Not explicitly stated as a number of samples or patients. The testing involved material samples for mechanical and material characterization, and biological samples for biocompatibility. The standards listed (e.g., ASTM F451-08, ISO 5833:2002) would dictate appropriate sample sizes for each specific test, but these are not enumerated in the document.
• Data Provenance: Not specified. Given the nature of material and biological testing, it would be laboratory-generated data, likely from the manufacturer or a contracted testing facility. No information on country of origin or whether it's retrospective/prospective is provided, as these terms are more relevant to clinical studies.

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

• Not Applicable. This document describes laboratory and material testing, not human-read clinical data where expert ground truth would be established. The "ground truth" for these tests is based on objective measurements against established international and industry standards.

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

• Not Applicable. See point 3.

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 device is a bone cement, not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's material properties and biological effects, which were indeed tested directly.

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

• The "ground truth" for these material and biological performance tests is objective physical and chemical measurement against established international and industry standards. For example, compressive strength is objectively measured and compared to the acceptable range defined in ASTM F451. Biocompatibility is assessed through standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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OSTEOPAL® plus bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833.

This document describes the FDA's clearance of OSTEOPAL® plus, a polymethylmethacrylate (PMMA) bone cement, based on its substantial equivalence to a predicate device (OSTEOPAL® V). The information provided does not detail an AI-powered device or a study involving AI performance. Instead, it focuses on the materials science and biocompatibility of the bone cement.

Therefore, many of the requested fields related to AI device performance are not applicable based on the provided text.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not applicable/Not provided. The document describes non-clinical laboratory testing of material properties, not a clinical study with human subjects or a test set for an AI algorithm.
• Data provenance: Not applicable/Not provided in terms of country of origin for a "test set." The testing was conducted by Heraeus Medical GmbH in Germany. The data is from laboratory testing of the device itself.

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

• Not applicable. This device is not an AI algorithm and does not rely on expert-established ground truth for its performance assessment in this document. Its performance is assessed against material standards.

4. Adjudication method for the test set:

• Not applicable. This device is not an AI algorithm and does not involve adjudication of a test set.

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:

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

7. The type of ground truth used:

• Material Standards & Benchmarking: The "ground truth" for this device's performance is established by recognized international standards (ISO 5833 for bone cement properties, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and comparison to a legally marketed predicate device (OSTEOPAL® V). For genotoxicity, it was based on the transferability of results from a predicate's predicate (PALACOS® R) due to shared material constituents.

8. The sample size for the training set:

• Not applicable. This is not an AI-powered device and therefore does not have a training set.

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

• Not applicable. This is not an AI-powered device and therefore does not have a training set.

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BonOs 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.

BonOs R is a fast-setting acrylic resin for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radlopaque bone cement which fixes the implant and transfers stressesevenly to the bone.

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as an initiator is Included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

When the powder and liquid components are mixed together, the activator, DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - A.

As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermlc reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which Is common for all acrylic bone cements.

The provided text describes the 510(k) summary for the BonOs R PMMA bone cement, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study design elements requested in your prompt.

The document primarily focuses on demonstrating "substantial equivalence" of BonOs R to a predicate device, Palacos R. This type of submission relies on showing that the new device has the same intended use, materials, and operational principles as a legally marketed device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for the detailed study information based on the provided text. The document only states:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document only compares the constituent materials of BonOs R and Palacos R, and states: "BonOs R bone cement is as safe and effective for the declared indications as the predicate device, Palacos R." This is a conclusion of equivalence, not a report of specific performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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 device is a bone cement, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone cement, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The "ground truth" for a bone cement would typically be established through in vitro mechanical testing and preclinical/clinical studies, but details of such studies are not in this 510(k) summary.

8. The sample size for the training set: Not mentioned. (Again, this isn't an AI device with a "training set").

9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding equivalence:

The document states that BonOs R is substantially equivalent to Palacos R (K030902) in regard to:

• Intended use: Both are for "arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone."
• Materials: The major components (polymer powder, initiator, radiopacifier, liquid monomer, activator) are listed as being the same for both devices, with Palacos R additionally containing "Chlorophyll Copper Complex."
• Operational principles: Both are "self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together."

The document mentions that "Intellate ably materified by physical, chemical and mechanical comparative tests to Palacos R" were performed, but it does not detail the results, acceptance criteria, or methodology of these tests.

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