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The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The AccelFix Spinal Fixation System is comprised of six different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, AccelFix -SAI Screw, and Accessory.

The provided text describes the 510(k) premarket notification for the AccelFix Spinal Fixation System. This document focuses on the substantial equivalence of and mechanical testing for a medical device (spinal fixation system), not an AI/ML-driven diagnostic or image analysis device.

Therefore, the information required to answer your query about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.

The document states that the additional components for the AccelFix Spinal Fixation System "do not require additional mechanical testing" because none of the additional components is the worst case, and they are substituting mechanical test data from the predicate device (K182544). It cites compliance with ASTM standards for mechanical testing (ASTM F17-15, ASTM F1798-13, ASTM F543-17).

To summarize, for an AI/ML device, your requested information would typically include details on diagnostic performance, reader studies, and dataset characteristics. This document, however, pertains to the mechanical and material equivalence of an implantable medical device.

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The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, connectors and hooks. The components of this system are manufactured of Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) or CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The AccelFix Spinal Fixation System is comprised of five different groupings; AccelFix-S, AccelFix-DS, AccelFix-SS, AccelFix-MIS, and Accessory.

The provided text is a 510(k) summary for the "AccelFix Spinal Fixation System," a medical device. It focuses on demonstrating substantial equivalence to existing predicate devices, primarily through mechanical and material performance testing, not through clinical or AI-driven diagnostic accuracy studies.

Therefore, the information required to answer your prompt about AI device acceptance criteria, study design, expert ground truth, etc., is not present in this document. This typically applies to devices like AI-powered diagnostic software, not spinal implants.

The document describes:

1. Device Type: A spinal fixation system (pedicle screws, rods, etc.).
2. Indications for Use: Stabilization of spinal segments, fixation for various spinal conditions.
3. Materials: Titanium Alloy and CoCrMo alloy.
4. Performance Data: Lists ASTM standards for various mechanical tests (static compression, torsion, fatigue, cantilever, pullout, axial grip force).
5. Conclusion: The device is substantially equivalent to predicates based on similar design, materials, performance characteristics, and intended use.

In summary, this document does not contain any information about:

• Acceptance criteria for an AI-driven or diagnostic device.
• "Reported device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for AI test sets.
• Data provenance for clinical imagery.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or human reader improvement with AI.
• Standalone algorithm performance.
• Types of ground truth (beyond mechanical testing per ASTM standards).
• Training set details for an AI model.

The "study" mentioned refers to engineering and biocompatibility testing required for a mechanical orthopedic implant, not a clinical trial for an AI diagnostic tool.

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