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V-STEADY and V-FAST bone cements are indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

V-STEADY and V-FAST are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty . Bone cements are self-curing systems consisting of liquid and powder components:

• the powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
• The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.
  The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-STEADY bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-FAST has a low initial viscosity and a long working time allowing to work extremely carefully when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.

The provided document is a 510(k) Premarket Notification for medical devices, specifically bone cements (V-STEADY and V-FAST). It describes the chemical composition, intended use, and comparison to a predicate device. However, this document does not contain information about the performance of a device that relies on artificial intelligence (AI) or machine learning (ML), nor does it detail a study that would involve acceptance criteria, human reader performance, ground truth establishment for AI/ML models, or sample sizes related to such studies.

The "Performance Data" section (Page 6) focuses on:

• Biocompatibility: Compliance with ISO-10993.
• Sterilization: Validation of the sterilization process according to various ISO standards.
• Material, Mechanical and Performance Characterization: Comparison of V-STEADY and V-FAST bone cements to the predicate device and reference devices based on mechanical properties (e.g., viscosity, setting time, strength) as per ASTM and ISO standards for bone cements.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on this document. The document describes a traditional medical device (bone cement), not an AI/ML powered device.

To answer your specific questions, if this were an AI/ML driven device submission, one would look for:

1. A table of acceptance criteria and the reported device performance: This would typically involve metrics like sensitivity, specificity, AUC, recall, precision, etc., for an AI algorithm against a defined ground truth, with specific thresholds for acceptance.
2. Sample sizes used for the test set and the data provenance: Details on the number of cases/patients in the test set, where the data came from (e.g., specific hospitals, regions), and whether it was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on how many clinical experts (e.g., radiologists, pathologists) independently reviewed the test cases to establish the correct diagnosis or finding, and their experience levels.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert arbitration, additional review).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: A study setting where human readers interpret cases both with and without AI assistance to measure the improvement AI brings. The effect size would quantify this improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The performance of the AI algorithm by itself, without human input or review.
7. The type of ground truth used: Whether the ground truth was established by expert consensus, confirmed by pathology reports, based on long-term patient outcomes, or other methods.
8. The sample size for the training set: The number of cases/patients used to train the AI model.
9. How the ground truth for the training set was established: Similar to the test set, but for the data used during the development phase of the AI model.

None of this information is present in the provided 510(k) filing because the device in question is PMMA bone cement, not an AI-powered diagnostic or therapeutic device.

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