Search Results

The Axis Plating System is indication and fixation of fractures or osteotomies, reconstruction procedures, nonunions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathy (Charcot).

The Axis Plating System is a bone fixation system consisting of Titanium Alloy (Ti-6AL-4V) plates, locking and non-locking plate screws, which meet ASTM F136, and a set of instruments used for implant site preparation and delivery. The plates are available in various configurations, essentially differing by geometry and number of holes. The plate screws are provided in diameters of 3.5mm and 4.5mm in lengths from 8mm to 50mm. The System offers 4.0mm cannulated screws and beams in various lengths to be used as adjunctive fixation. The 4.0mm cannulated screws and beams can also be used with a specialized locking screw ("Post") which contains a locking feature at the distal end for compression/stabilization.

This document is a 510(k) summary for the Axis Plating System, a medical device for bone fixation. It explicitly states: "No clinical testing was performed."

Therefore, based on the provided text, it's impossible to describe acceptance criteria or a study that proves the device meets those criteria from an AI/algorithm perspective, as no clinical study involving an AI or algorithmic component was conducted or described in this submission.

The document is about a hardware medical device (plates and screws), and its substantial equivalence is based on non-clinical testing (engineering analysis for plate and screw properties) and comparison to predicate devices, not on the performance of a diagnostic algorithm or AI.

If this was a misunderstanding and you intended to ask about the acceptance criteria and non-clinical testing specifically for the Axis Plating System (a physical device), then here's a summary of what's provided:

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

The document doesn't provide a table of acceptance criteria with specific numerical targets and results for device performance. Instead, it lists the types of non-clinical engineering analyses performed. The "performance" is implicitly deemed acceptable if these tests demonstrate equivalence to predicate devices and satisfy relevant ASTM standards (ASTM F136 mentioned for Titanium Alloy).

• Pullout
• Torsion/bending
• Torque to failure |
  | Acceptable Mechanical Performance of Plates | Plate Engineering Analysis |
  | Equivalence in Design, Principle of Operation | Comparison to predicate devices (K190365, K180808, K140792) |

Regarding the other points, as they relate to an AI/algorithm study, they are not applicable to this submission:

• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set or data described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth.
• 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...: Not applicable. This is not a diagnostic AI 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 concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's substantial equivalence is based on engineering principles, material standards, and comparison to existing legally marketed devices.
• 8. The sample size for the training set: Not applicable. No AI model trained.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical medical device (bone fixation system) and explicitly states "No clinical testing was performed" for its substantial equivalence determination. Therefore, no information regarding acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI or human readers can be extracted from this text.

Ask a specific question about this device