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The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. SPACE CpsXL bone cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.

The provided text is a 510(k) Premarket Notification Summary for the SPACE CpsXL bone cement. This document describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered diagnostic or assistive tool against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document.

Here's what can be extracted and a clear statement about what is not available based on the request:

Acceptance Criteria and Device Performance:

The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device. This is a regulatory standard for medical devices. The performance criteria are therefore primarily related to the physical, chemical, and mechanical properties of the bone cement, ensuring they are comparable to the predicate.

Information NOT available in the provided text, as it pertains to AI/diagnostic studies:

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission.
2. 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 this context would likely refer to material science standards, not clinical interpretations.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through established engineering and biomaterial standards and testing, not clinical consensus or pathology.
7. The sample size for the training set: Not applicable for this type of device submission.
8. How the ground truth for the training set was established: Not applicable.

Study Details (as per the provided document):

The "study" or evaluation described is a series of physical, chemical, and mechanical tests conducted on the SPACE CpsXL bone cement. The purpose of these tests was to demonstrate its performance and substantial equivalence to a legally marketed predicate device (SPACE CpsXL bone cement, cleared under 510(k) K061531).

The document states:

• "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted."
• This testing, along with comparison to the predicate device and commercially available bone cements, formed the basis for the conclusion that the device "performs as intended and is substantially equivalent to the predicate device."

Without the actual detailed testing reports, the specific parameters, methodologies, or quantitative results of these "physical, chemical, and mechanical tests" are not available in this summary.

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The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.

The provided text describes a 510(k) premarket notification for the "DFine SPACE CpsXL Bone Cement." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting an effectiveness study with specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not present in this document.

Here's an breakdown of the available information based on your request:

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device. It does not typically involve setting specific performance acceptance criteria for a new clinical study.

The document states: "Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device." This is a general conclusion of substantial equivalence, not a report against specific performance criteria.

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

This information is not provided in the document. The testing mentioned ("Physical, chemical and mechanical testing") is likely bench testing or non-clinical, not a clinical study with a "test set" in the context of human data.

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

This information is not provided in the document, as there is no mention of a clinical study or human expert review to establish ground truth for a test set.

4. Adjudication method for the test set

This information is not provided in the document, as there is no mention of a clinical study or adjudication process.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a bone cement, not an AI diagnostic tool.

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

This is not applicable as the device is a bone cement, not an algorithm.

7. The type of ground truth used

This information is not directly provided for a "test set" because no clinical effectiveness study is described. The "ground truth" for demonstrating substantial equivalence for this type of device typically revolves around established performance characteristics of the predicate device and relevant industry standards for material properties and biomechanical performance. The document only mentions "Physical, chemical and mechanical testing."

8. The sample size for the training set

This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.

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

This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.

In summary: The provided document is a 510(k) summary for a medical device (bone cement) that focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical testing. It does not include the details of a clinical effectiveness study with acceptance criteria, human reader performance, or ground truth establishment as would be expected for a diagnostic AI device.

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