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Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Kyphon® Xpede™ Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate 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 powder and liquid components are mixed prior to use.

This document is a 510(k) premarket notification for a medical device (Kyphon® Xpede™ Bone Cement), and as such, it does not contain the type of detailed study information typically found in a clinical trial report or a performance study for AI/AI-assisted devices.

The document states that the subject device is "substantially equivalent" to a legally marketed predicate device (Kyphon® Xpede™ Bone Cement K102397 S.E. 2/28/2011). This means the manufacturer is asserting that the new device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, and has not raised new issues of safety or effectiveness with its revised indications for use.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance, training set details) are not applicable (N/A) because the FDA's clearance is based on substantial equivalence to an existing device, rather than a de novo clinical performance study against specific acceptance criteria.

However, I can extract the relevant information regarding the device itself and the basis of the clearance.

Here's a breakdown based on your request, with N/A for information not present in a 510(k) substantial equivalence determination:

1. Table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, there are no specific "acceptance criteria" defined in the way one would for a novel device's performance study against a predefined threshold. The "performance" is based on its similarity to the predicate device and the fact that its design features, materials, chemical composition, and manufacturing are equivalent.

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

• Sample Size for Test Set: N/A (No specific "test set" in the context of a de novo performance study is mentioned for this substantial equivalence). The evaluation is based on comparison to the predicate device.
• Data Provenance: N/A

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

• Number of Experts: N/A
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: N/A

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

• MRMC Study: No, this is not an AI/AI-assisted device. It is bone cement.
• Effect Size: N/A

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

• Standalone Performance Study: No, this is not an AI/AI-assisted device. It is bone cement.

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

• Type of Ground Truth: N/A (The "ground truth" for this submission is the established safety and effectiveness of the predicate device).

8. The sample size for the training set

• Sample Size for Training Set: N/A (No "training set" in the context of an AI/ML model or a de novo performance study is mentioned).

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

• Ground Truth Establishment for Training Set: N/A

Summary of what the document does provide:

• Device Name: Kyphon® Xpede™ Bone Cement
• Regulation Number: 21 CFR 888.3027 (Polymethylmethacrylate (PMMA) bone cement)
• Regulatory Class: Class II
• Product Code: NDN
• Indications for Use: Treatment of pathological fractures of the vertebral body due to osteoporosis, cancer (multiple myeloma, metastatic lesions from breast/lung cancer, lymphoma), or benign lesions (hemangioma, giant cell tumor) using cementoplasty (kyphoplasty or vertebroplasty). Pathologic fracture may include a symptomatic vertebral body microfracture without obvious loss of vertebral body height.
• Predicate Device: Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011)
• Basis for Clearance: Substantial equivalence to the predicate device, stating that the subject device has the same fundamental scientific technology, equivalent implant materials, sterilization methods, design features, chemical composition, device performance, packaging, manufacturing, and that the revision/modification of the indications for use does not raise new issues of safety or effectiveness.

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