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

The purpose of this submission is to submit a new bone cement that is a modification of Vertecem and Opacity+ bone cements, previously cleared on K090435 and K080873, respectively. Cohesion has the same indications for use as the predicate devices. Another similarity is that the cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box. Cohesion is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. Like its predicates Cohesion allows an excellent consolidation of the vertebral body and an effective and rapid pain relief.

This document is a 510(k) Pre-Market Notification for a medical device, specifically bone cement. It describes the device, its intended use, and compares it to previously cleared predicate devices to establish substantial equivalence.

Here's an analysis of the document to extract the requested information, specifically noting that this is not an AI/ML device, so some questions will not be applicable.

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

The document does not explicitly list "acceptance criteria" as pass/fail thresholds against specific performance metrics for the Cohesion Bone Cement. Instead, it states that the device's properties were evaluated against the "standard reference for bone cement: ISO 5833 'implants for surgery - acrylic resin cements'" and were found to be "in compliance" and "similar to predicate devices."

The reported device performance is indicated by the types of tests performed and the general statement of compliance.

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

This document describes a pre-market notification for a medical device (bone cement), not an AI/ML algorithm. Therefore, the concepts of "test set," "sample size," and "data provenance" in the context of AI/ML are not directly applicable.

The tests conducted are non-clinical, involving material science and mechanical properties, likely performed on manufactured samples of the bone cement in a laboratory setting. There is no information provided about the specific number of cement samples used for each test.

The data provenance for these non-clinical tests would typically be from the manufacturer's labs (Teknimed SAS, France) and could be considered prospective as they were performed to characterize the new device.

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)

This question is not applicable to this device submission. This is a non-clinical evaluation of a physical medical device (bone cement) based on engineering and material science standards (ISO 5833), not an AI/ML diagnostic or prognostic tool that requires expert human interpretation to establish ground truth for a test set.

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

This question is not applicable to this device submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for AI/ML performance evaluation where disagreements among human readers need to be resolved to establish ground truth or evaluate algorithmic performance. This submission focuses on non-clinical, in-vitro material testing.

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 question is not applicable. The submission explicitly states: "No clinical studies were performed." Furthermore, this is a bone cement, not an AI/ML diagnostic or assistive device that would involve human readers or an MRMC study.

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

This question is not applicable. This is a physical medical device (bone cement), not an algorithm or AI system.

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

For the non-clinical tests performed, the "ground truth" (or reference standard) is the established engineering and material science standard, specifically ISO 5833 "implants for surgery - acrylic resin cements." The device's performance metrics were compared against the requirements and specifications outlined in this international standard.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable. As stated above, this is a physical medical device and does not involve AI/ML training concepts or a "training set."

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