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The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.

The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.

Here's a breakdown of the acceptance criteria and study information for the Ascendx™ VCF Repair System, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a discrete set of quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" values for the clinical study endpoints. Instead, it describes various tests and states that the device "conforms to its design specifications," "functioned as intended," and "met the necessary specifications for its intended use." For the clinical study, it concludes that the device achieved "pain and functional relief" and that its "safety and effectiveness supported substantial equivalence to the predicate."

Given the information, a table of the reported performance from the clinical study would look like this:

For non-clinical/bench testing, the document states:
"All bench testing confirmed that the product met the necessary specifications for its intended use."
This implies that for each of the numerous tests listed (e.g., compressive strength, maximum balloon inflation pressure, bond strength, fatigue testing, radiopacity, etc.), the device performed within predefined acceptable limits. Specific numerical acceptance criteria and performance values are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Test Set Sample Size: 60 subjects treated with the Ascendx™ System and Ascendx™ Cement.
• Data Provenance: The document does not explicitly state the country of origin. It describes "clinical testing included evaluation of 60 subjects," which implies a prospective clinical study carried out by the manufacturer. It also mentions comparisons to "an investigation using the same cement without the Ascendx™ in 113 subjects" and "an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty." These comparison groups are likely from separate studies, but their temporal nature (retrospective/prospective) and provenance are not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. Clinical trials typically involve physicians assessing patient outcomes, but the specific number and qualifications of experts establishing "ground truth" (e.g., through blinded assessment of imaging or adjudicated outcomes) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

This device is a medical device (VCF Repair System), not an AI/software device for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

As stated above, this is a medical device, not an AI/software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the ground truth was based on patient outcomes data including:

• Acute procedural success
• Pain levels
• Functional status
• Adverse events (leakage, subsequent fractures)
  These are typically assessed by treating physicians and reported by patients.

8. The Sample Size for the Training Set

This information is not applicable to this type of medical device. The device is a physical product, not an algorithm that requires a "training set" in the machine learning sense. The device was likely designed and refined through engineering iterations and bench testing, rather than an algorithmic training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as it's not an AI/software algorithm. The "training" for such a device would involve engineering design, prototyping, and testing against design specifications, often in a lab setting (bench testing).

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