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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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BonOs R Genta 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 when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.

BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate 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, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.

The provided text describes the BonOs R Genta bone cement and claims substantial equivalence to the predicate device Palacos R+G. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report.

Instead, the document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new efficacy study with defined acceptance criteria. The equivalence here is based on material composition, mechanical safety, and performance characteristics compared to an existing device, not on clinical performance against a specific set of outcomes with acceptance thresholds.

Therefore, the requested information cannot be fully extracted from the provided text. I will explain what information is present and what is missing.

Missing Information:

• 1. A table of acceptance criteria and the reported device performance: This is not present as it's not a clinical performance study.
• 2. Sample size used for the test set and the data provenance: No test set in the context of clinical performance is described. The "test set" for equivalence was likely material testing and characterization.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's not a diagnostic or prediction study.
• 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, as this is a bone cement, not an AI diagnostic device.
• 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 in the context of clinical ground truth for a diagnostic device. The "ground truth" here is the established properties of the predicate device.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding "study" and "criteria":

The document claims substantial equivalence based on:

• Scientific concepts, significant physical and performance characteristics: The device is described as a self-polymerizing two-component system, similar to other bone cements.
• Summary of technological characteristics: A direct comparison table is provided between BonOs R Genta and the predicate device Palacos R+G.
  • Shared characteristics: Common name (PMMA Bone Cement), Responsible manufacturer (aap Biomaterials vs. Heraeus Kulzer), Product Code (LOD, MBB), Classification (Class II), Regulation no. (21 CFR 888.3027), Materials (Polymer, Initiator, Radiopacifier, Antibiotic, Monomer, Activator).
  • Specific material comparison:
    • Powder: Both use Poly(methyl acrylate, methyl methacrylate) polymer, Di-benzoyl peroxide initiator, Zirconium dioxide radiopacifier, and Gentamicin antibiotic.
    • Liquid: Both use Methylmethacrylate (stabilized with hydroquinone) monomer and N,N-dimethyl-p-toluidine activator.
    • Note: Palacos R+G is mentioned to contain "Chlorophyll Copper Complex," which is not listed for BonOs R Genta, but the overall conclusion is still substantial equivalence.
• Equivalence verification: "Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G." This implies laboratory-based testing of properties rather than a clinical trial. The specific results of these tests are not provided in this summary.

Conclusion:

This document is a regulatory submission demonstrating substantial equivalence for a bone cement based on material composition and physical/mechanical properties compared to a predicate device. It does not contain information about clinical performance against specific acceptance criteria, nor does it describe a clinical study with human subjects, expert adjudication, or AI performance metrics.

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The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.

The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.

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 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 - D.

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

This document is a 510(k) Premarket Notification for the Vertecem II Mixing Kit, a PMMA bone cement. It is not an AI/ML device, therefore, the requested information regarding acceptance criteria, study data analysis, and expert involvement is not applicable. The device relies on physical, chemical, and mechanical comparative tests to establish substantial equivalence to predicate devices, not on AI/ML performance metrics.

Summary of Device and Regulatory Context:

The Vertecem II Mixing Kit is a radio-opaque, injectable acrylic bone cement designed for Vertebroplasty or Kyphoplasty procedures to treat pathological vertebral body fractures (e.g., from osteoporosis, hemangioma, metastatic cancers, myeloma). The 510(k) submission seeks to demonstrate substantial equivalence to two predicate devices: Vertecem (K090435) and BonOs Inject (K090460).

Acceptance Criteria and Device Performance (Not Applicable - Non-AI/ML Device):

This device is a medical material (PMMA bone cement) and its regulatory clearance is based on demonstrating substantial equivalence to existing predicate devices through physical, chemical, and mechanical comparative tests, not on an algorithm's performance in a diagnostic or predictive task. Therefore, the concept of "acceptance criteria" for AI/ML performance metrics, such as sensitivity, specificity, or AUC, and the associated study designs (e.g., MRMC studies, standalone studies) are not applicable.

The document states: "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data."

Table of Comparison (Based on the provided text, but note this is for material properties, not AI/ML performance):

(Note: The document states "Vertecem II bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices BonOs Inject and Vertecem," and "The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data." Specific numerical values for these properties are not provided in the summary, but were part of the full submission.)

Regarding the specific questions about AI/ML device studies:

1. Sample size for the test set and data provenance: Not applicable. The study involved comparative physical, chemical, and mechanical testing of the bone cement, not a test set of data for an AI algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of material science refers to validated laboratory test results and established material standards, not expert consensus on medical images or patient outcomes.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance with AI assistance, which is irrelevant for a bone cement product.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
6. The type of ground truth used: For bone cements, the "ground truth" would be established physical, chemical, and mechanical properties determined through standardized testing methods, such as those outlined in ISO or ASTM standards, and their comparison to the predicate devices and regulatory requirements. It is a material science "ground truth," not a clinical "ground truth" established by experts.
7. The sample size for the training set: Not applicable. There is no AI model to train.
8. How the ground truth for the training set was established: Not applicable.

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BonOs® Inject 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.

BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liquid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study with specific performance metrics. Therefore, the information typically requested for acceptance criteria and a study proving device performance (like sensitivity, specificity, or reader improvement with AI) is not directly available in this document.

Instead, the submission focuses on demonstrating that the new device, BonOs® Inject, is as safe and effective as the predicate device, OSTEOPAL® V, through comparative physical, chemical, and mechanical tests.

Here’s a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:

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

Since this is a 510(k) submission proving substantial equivalence, explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not provided. Instead, the "performance" revolved around demonstrating equivalence to the predicate device in key physical, chemical, and mechanical properties.

Note: The document states, "The effectiveness and substantial equivalence of BonOs® Inject was determined by physical, chemical and mechanical comparative tests to OSTEOPAL®V and by comparing the results of the relevant data." The specific values or direct comparisons for each property are not detailed in this summary.

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

This submission does not detail a clinical "test set" in the way a diagnostic AI device would. The "tests" likely refer to bench-top laboratory tests for physical, chemical, and mechanical properties.

• Sample Size for Test Set: Not specified. The submission refers to "comparative tests" and "relevant data" but does not provide numbers for specimens or batches used in these tests.
• Data Provenance: Not specified, but the applicant is from Germany, so it's likely the tests were conducted in Germany or a related clinical setting. The device is also "successfully marketed in Europe."
• Retrospective or Prospective: Not applicable as these are not human subject studies in the traditional sense for evaluating device performance. These would be laboratory studies.

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 device is a bone cement, not a diagnostic imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here would be established by validated laboratory testing methods and standards for material properties.

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

Not applicable. This is not a study involving human readers or subjective assessments.

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 a medical device involving AI or human readers for diagnostic interpretation.

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

Not applicable. This device is a medical implant (bone cement), not an algorithm.

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

The "ground truth" in this context would be the established material properties and performance characteristics of the predicate device (OSTEOPAL® V), determined through standard laboratory testing methods and industry specifications for bone cements. The new device was then tested against these established benchmarks to demonstrate equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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