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OSTEOPAL® V 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® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.

Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:

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

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 primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified device).

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)

This is not applicable as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.

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

This is not applicable as there is no "test set" requiring adjudication by experts.

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 is not applicable. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.

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

This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.

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

For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.

8. The sample size for the training set

This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).

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

This is not applicable as there is no "training set."

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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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OSTEOPAL® V 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® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization.

This 510(k) summary for Osteopal® V, a PMMA bone cement, does not contain the kind of study information requested.

The document is a premarket notification for a medical device (bone cement) that is claiming substantial equivalence to a predicate device (Osteopal®) based on a change in a material characteristic (higher zirconium dioxide content for better X-ray contrast and lower viscosity). Therefore, the provided text describes the device, its intended use, and its comparison to a predicate device but does not include any studies related to its performance in terms of diagnostic accuracy or clinical effectiveness, which would typically involve acceptance criteria and performance data.

Specifically, the requested information elements are not present because this is a 510(k) submission for a physical device that is not an AI/ML diagnostic tool, and thus does not involve "acceptance criteria and reported device performance" in the way that an AI model would be evaluated.

Therefore, I cannot provide the requested information from the given text.

Here's why the specific questions cannot be answered:

1. A table of acceptance criteria and the reported device performance: This document is about a material (bone cement) and its physical characteristics, not a diagnostic device with performance metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: There is no "test set" in the context of an AI/ML algorithm being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.

Osteopal® 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.

This document is a 510(k) summary for the medical device OSTEOPAL®, a bone cement. The purpose of a 510(k) summary is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device's technological characteristics, indications for use, and performance to an existing device rather than presenting extensive de novo clinical trials to establish acceptance criteria and prove its meeting.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format typically found for AI/ML device submissions. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance: This document explicitly states that the new device, Osteopal®, is the known Osteopal® marketed by Merck (or Palacos E-Flow by S.-P.) and refers to an existing PMA (P810020). This implies equivalence to a previously approved device, not validation against new performance criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: These are all elements typically found in studies for novel devices, especially those incorporating AI/ML, where performance metrics like sensitivity, specificity, or AUC are evaluated against a defined ground truth derived from expert review or pathology. Since this is a 510(k) for a bone cement claiming equivalence, such detailed performance studies with human interpretation or AI assistance are not part of this submission.

In summary, the provided 510(k) summary for OSTEOPAL® is a regulatory submission for a traditional medical device (bone cement) claiming substantial equivalence to a predicate device. It is not an AI/ML device submission and therefore does not contain the information requested about acceptance criteria and associated performance studies as typically understood for such technologies.

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