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When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

1. The CONFIDENCE™ High Viscosity Spinal Cement is a self-curing, high viscosity, radiopaque acrylic bone cement (PMMA), previously cleared by FDA in premarket notifications K060300 and K112907. The formulation of the spinal cement has not changed from the original clearance.
2. The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).

This FDA 510(k) summary describes the submission for the CONFIDENCE™ High Viscosity Spinal Cement and the VIPER® and EXPEDIUM® Fenestrated Screw Systems. It mostly focuses on establishing substantial equivalence to predicate devices and describes the materials and intended use. However, it does not provide detailed acceptance criteria or the specific studies that prove the device meets these criteria in the format requested.

The document states that "Non-clinical testing and clinical data were submitted to characterize the subject components in this notification. The data provided supports the substantial equivalence of the subject devices," and "The performance testing, clinical literature, and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device." However, the specifics of these tests, including acceptance criteria, outcome measures, sample sizes, ground truth establishment, or expert qualifications, are not disclosed in this summary.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be gathered and what cannot:

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

• Cannot be filled. The document does not provide a table of acceptance criteria or specific performance metrics from studies. It broadly states that "performance testing" was done to demonstrate substantial equivalence.

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

• Cannot be filled. The document mentions "clinical literature" and "clinical data" but does not specify sample sizes, provenance, or study design (retrospective/prospective) for any test sets.

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)

• Cannot be filled. The document does not discuss the establishment of ground truth or the involvement/qualifications of experts in any testing.

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

• Cannot be filled. No information on adjudication methods is present.

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

• Cannot be filled. This device is a bone cement and screw system, not an AI device for image interpretation. Therefore, an MRMC study comparing human readers with/without AI assistance would not be applicable.

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

• Cannot be filled. Not applicable as this is a physical medical device (bone cement and screws), not an algorithm or AI system.

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

• Cannot be filled. The document does not describe how ground truth was established for any studies mentioned.

8. The sample size for the training set

• Cannot be filled. Not applicable as this is a physical medical device, not an algorithm that requires a training set. If "training set" refers to mechanical testing or animal studies, those specifics are not provided.

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

• Cannot be filled. Not applicable for the reasons stated in point 8.

Conclusion:

This 510(k) summary serves to demonstrate substantial equivalence for a bone cement and fenestrated screw system. It highlights the physical characteristics, intended use, and similarities to predicate devices. However, it does not contain the detailed performance study information, acceptance criteria, or methodological specifics typically found in a clinical study report or a 510(k) summary for a diagnostic or AI-based device, which would address the points raised in the prompt. The document explicitly states "Non-clinical testing and clinical data were submitted," but the summary itself does not contain the specifics of these submissions.

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