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Symphony™ VR Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Symphony™ VR Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Advanced Biomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement.

Symphony™ VR Radiopaque Bone Cement is provided as a two-component product. The polymer powder consists of a PMMA copolymer (polymethyl methacrylate and methyl methacrylate-styrene copolymer) with barium sulfate as the radiopacifier and benzoyl peroxide as the initiator. The liquid component consists of methyl methacrylate monomer, which includes hydroquinone as the stabilizer and N:N dimethyl-p-toluidine as the activator.

The provided text is a 510(k) Premarket Notification for a medical device called Symphony™ VR Radiopaque Bone Cement. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria in the way a clinical trial for an AI algorithm would.

Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this type of regulatory submission for a bone cement.

Here's an analysis of the provided information in the context of the questions:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance. Instead, the "acceptance criteria" are implied to be demonstrating substantial equivalence to legally marketed predicate devices in terms of:

  • Intended Use
  • Functional Characteristics (though not quantified with performance metrics)
  • Material Properties (chemical composition)
  • Biocompatibility
  • Clinical Application

• Reported Device Performance:
  The document focuses on comparing the chemical composition of Symphony™ VR Radiopaque Bone Cement to its predicate devices. The key "performance" demonstrated here is the similarity in composition.

  Chemical Composition	Symphony™ VR	KyphX® HV-R	Stryker Spineplex™	Howmedica Osteonics Surgical Simplex® P
  	Powder
  Polymethyl

Methacrylate / Methyl
Methacrylate-styrene
copolymer | 71.3% w/w | 68.0% w/w | 69.1% w/w | Not provided for Simplex® |
| Barium sulfate | 28.0% w/w | 30.0% w/w | 30.0% w/w | Not provided for Simplex® |
| Benzoyl peroxide | 0.7% w/w | 2.0% w/w | 0.9% w/w | Not provided for Simplex® |
| | Liquid | | | |
| Methyl Methacrylate | 99.0% v/v | 99.1% v/v | 97.4% v/v | Not provided for Simplex® |
| N: N Dimethyl-p-
toluidine | 1.0% v/v | 0.9% v/v | 2.6% v/v | Not provided for Simplex® |
| Hydroquinone | 100 ppm | 75 ppm | 75 ± 15 ppm | Not provided for Simplex® |

*Note: The document states "Symphony™ VR Radiopaque Bone Cement is a PMMA bone cement made of the same chemical components as Advanced Biomaterial Systems, Inc. CONCERT® Radiopaque Bone Cement." which is not listed in the comparison table, but implies a known baseline for the manufacturer.*

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

• Not Applicable. This is a medical device (bone cement) submission, not an AI algorithm. There is no "test set" of patient data in the context of diagnostic performance. The "test" here is demonstrating chemical and functional similarity to predicates.

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 is not an AI algorithm for diagnosis or image interpretation. "Ground truth" in the AI sense is not relevant.

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 is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. The "ground truth" for this submission is the established properties of the predicate devices and the chemical synthesis and characterization of the new device.

8. The sample size for the training set

• Not Applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

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

• Not Applicable. See point 8.

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