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The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Kit Mendec Spine and delivery system contains an acrylic resin for vertebroplasty and a delivery system. The acrylic resin consists of exportion of acryic Tosh 101 vercent. The delivery system consists of a syringe-like device with a "gun-system", an Extension tube, an Extension tube and may include, depending on the variant, a Needle.

This 510(k) premarket notification (K062452) describes the "Kit Mendec Spine and Delivery System," a convenience kit for percutaneous vertebroplasty. This submission is a "Special 510(k)," indicating that it likely relies on its substantial equivalence to a previously cleared predicate device, the "Mendec Spine" (K042415), and that any modifications are minor and do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary (and the full submission, by its nature as a Special 510(k)) does not specify quantifiable acceptance criteria or detailed device performance metrics in the format typically seen with clinical studies for novel devices or significant modifications. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.

For a Special 510(k), the acceptance criteria are implicitly that the new device performs "as intended" and is "substantially equivalent" to the predicate, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness concerns. Performance is generally demonstrated through comparisons to the predicate, often involving:

• Materials comparison: Demonstrating that the materials used in the new device are the same as or equivalent to those in the predicate, or are well-established for this application.
• Design comparison: Showing that the design features are either identical or that any changes do not adversely affect performance or safety.
• Performance testing (if applicable to changes): For a Special 510(k), this typically involves bench testing to ensure modified components meet established standards or perform comparably to the predicate. Clinical studies are rare for Special 510(k)s unless a significant change warranted it.

Based on the provided information, typical "acceptance criteria" and "reported device performance" in the sense of clinical accuracy or outcome rates are not present, as the submission relies on substantial equivalence and non-clinical demonstrations.

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

• Test Set Sample Size: Not applicable. For a Special 510(k) demonstrating substantial equivalence, a traditional "test set" with patient data (as one would use for AI performance evaluation) is not typically required or described. The evaluation relies on demonstrating equivalence to the predicate through materials, design, and performance testing data (e.g., mechanical, biocompatibility, sterilization studies), which are not clinical test sets.
• Data Provenance: Not applicable for a clinical test set. The data supporting this submission would primarily be non-clinical (bench testing, material characterization, design specifications) provided by the manufacturer (Tecres S.p.A., Italy).

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

• Not applicable. This device is a medical device (acrylic resin and delivery system), not an AI diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. This is not a study assessing diagnostic performance against a ground truth established by experts.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a vertebroplasty kit, 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 is not an algorithm or AI device.

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

• Not applicable. This is a physical medical device. The "ground truth" for its safety and effectiveness is established through adherence to standards, biocompatibility testing, mechanical testing, and comparison to the predicate device's established performance, rather than an expert consensus on patient data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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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