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The Bone Screw Line Addition is intended to be used for the following indications:

• · Bone fractures
  • o Jones fractures
  • o Acute fractures
  • o Avulsion fractures
  • o Repetitive stress fractures
  • o Malleolar fractures
  • o Talus fractures
  • o Greater tuberosity fractures
    · Fixation of malunions and non-unions
• · Osteotomies
• · Arthrodesis

The Vilex Bone Screw Line Addition includes an implantable device system intended for fixation of bone fractures and osteotomies of the upper and lower extremities. The Bone Screw Line Addition (BSLA) system consists of cannulated and solid screws. The implants are offered fully or partially threaded and in 4.5, 5.5, and 6.0 mm thread diameters. The BSLA implants are fabricated from either titanium or stainless steel.

Based on the provided text, the device is a medical implant (Bone Screw Line Addition) intended for bone fixation, and the document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through clinical or analytical studies as one might find for an AI/Software as a Medical Device (SaMD).

Therefore, the provided document DOES NOT contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/SaMD. This document describes a physical medical device and its mechanical equivalence to existing devices.

The sections for AI/SaMD performance (e.g., sample sizes, expert ground truth, MRMC studies, training set details) are not applicable to this type of device and submission.

However, I can extract the information that is present and explain why the other requested information is not available in this document.

Acceptance Criteria and Device Performance (for a physical Bone Screw Line Addition)

Since this is a physical medical device (bone screw) and not AI/SaMD, the "acceptance criteria" are related to its mechanical performance and substantial equivalence to legally marketed predicate devices, as assessed through engineering analyses.

• Acceptance Criteria: The device must demonstrate mechanical equivalence (e.g., torsional strength, shear strength, bending strength, pull-out strength) to the cleared predicate devices and not introduce any new questions of safety or effectiveness due to differences in technological characteristics (e.g., thread form, screw head geometry).
• Reported Device Performance: "Engineering analyses demonstrated that the BSLA does not introduce an added risk when compared to the cleared predicate devices. Analysis was used to demonstrate substantially equivalent mechanical strength (i.e., torsional strength, shear strength, bending strength, and pull out strength)."

Why the requested AI/SaMD information is not in this document:

This document is a 510(k) summary for a physical medical device, not a software or AI-driven diagnostic/therapeutic device. The FDA's requirements for demonstrating substantial equivalence for a physical device like a bone screw typically involve:

• Comparison of technological characteristics: Material, design, mechanical performance, intended use.
• Performance data: Often bench testing (mechanical strength, durability) and sometimes biocompatibility testing.
• No clinical trials are usually required if substantial equivalence can be demonstrated through non-clinical means.

Therefore, the specific quantitative details about "acceptance criteria" and "study that proves the device meets acceptance criteria" as defined for AI/SaMD (e.g., sensitivity, specificity, AUC, human reader improvement) are not relevant to this submission type and are not present in the provided text.

Absence of Requested Information (Specific to AI/SaMD):

1. A table of acceptance criteria and the reported device performance: As explained above, for this physical device, the "acceptance criteria" are related to mechanical equivalence to predicates, not specific numerical diagnostic performance metrics. The performance is stated as "substantially equivalent mechanical strength."
2. Sample sizes used for the test set and the data provenance: Not applicable. No test set of patient data (e.g., images) was used for performance validation in the AI/SaMD sense. This involves mechanical testing or analyses, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for a bone screw.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document describes the FDA 510(k) clearance process for a physical medical device (bone screw) based on substantial equivalence principles, which are fundamentally different from the performance evaluation requirements for AI/SaMD.

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