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Spine Fix cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painfull vertebral compression from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Spine-Fix is a self hardening and ready to use cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. This type of 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. The liquid component is mainly composed of methyl methacrylate. The major powder component is polymethylmethacrylate (PMMA). Benzoyl peroxide which initiates the polymerisation is included in the polymer powder

Here's an analysis of the provided text regarding the Spine-Fix® Biomimetic Bone Cement, focusing on acceptance criteria and the supporting study:

This document is a 510(k) summary for a medical device (Spine-Fix® Biomimetic Bone Cement). It primarily discusses the device's substantial equivalence to predicate devices and presents a summary of non-clinical and clinical tests. It does not explicitly define specific "acceptance criteria" with numerical thresholds or metrics that the device needed to meet to be cleared. Instead, it describes general positive outcomes from a clinical study.

Therefore, the table below will reflect the "reported device performance" as described in the summary, and the "acceptance criteria" column will indicate what was assessed rather than explicit numerical targets.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Study (Test Set): 113 patients
• Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address (Teknimed S.A., 11 rue Apollo, Z.I. Montredon, 31240 L'Union, France), it is likely the study was conducted, at least in part, in France or Europe.
• Retrospective or Prospective: Not explicitly stated, but the mention of "24 months post-op" suggests a prospective follow-up of patients after surgery. However, the exact study design (e.g., randomized controlled trial) is not detailed.

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

There is no information provided about experts establishing ground truth for the clinical study. The "effectiveness" and "safety" assessments seem to be based on patient self-reports (pain, function) and clinical observation/reporting of adverse events, rather than an independent expert review establishing a ground truth for the test set itself.

4. Adjudication Method for the Test Set

There is no information provided about an adjudication method for the clinical study's assessments. The outcomes appear to be direct reports or classifications from the clinical team involved in the study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically relevant for diagnostic imaging devices where different readers interpret cases. The Spine-Fix® cement is a therapeutic device, and the clinical study focuses on patient outcomes post-procedure.

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

N/A. This device is a bone cement, not an algorithm or AI. Standalone performance refers to the performance of an algorithm without human intervention, which is not applicable here.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for effectiveness appears to be:

• Patient-reported outcomes: Mild/no pain, normal/mildly dysfunctional function.
• Clinical observation/reporting: Absence of serious complications, patient survival.

For the non-clinical tests, the ground truth was:

• Standard reference: ISO 5833 "implants for surgery - acrylic resin cements".

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device. Training sets are relevant for machine learning algorithms. The clinical study of 113 patients serves as the primary evidence for this device.

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

Since there is no training set, there is no information on how its ground truth was established.

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