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

Vspspn is a two-part (powder and liquid) radiopaque, polymethyl methacrylate acrylic resin. The powder and liquid components are mixed together at the point of use to form the resin. The product is supplied sterile, for single use.

This 510(k) submission (K063438) for Vspspn, an acrylic resin for treating pathological vertebral body fractures, does not include information about acceptance criteria or a study proving device performance against such criteria.

The submission focuses entirely on demonstrating substantial equivalence to a predicate device, Mendec Spine (K042415). It asserts that Vspspn has the "same design, incorporate the same materials, have the same performance and mechanical characteristics, have the same shelf life and equivalent packaging, and are sterilized by the same method" as the predicate.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used for performance evaluation.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific criteria.

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