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The ONX Large External Fixation System is indicated for the following:

• Stabilization/fixation of:
  • Long bone fractures in tibia and femur
  • Fractures of pelvis and ankle
  • Peri-articular and intra-articular fractures of knee and ankle
• Joint arthrodesis
• Non-unions and mal-unions
• Osteotomies

The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.

The provided text is a 510(k) summary for the ONX Large External Fixation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance metrics, study design, and data provenance cannot be extracted from this document.

However, I can extract information related to the device type and the type of performance data provided for this specific medical device, which is a physical external fixation system, not an AI/ML diagnostic tool.

Here's what can be extracted:

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

The document does not explicitly state "acceptance criteria" in a tabular format for clinical performance or diagnostic accuracy. Instead, it relies on demonstrating substantial equivalence in mechanical performance to a predicate device.

• Construct fatigue testing under axial load per ASTM F1541 Annex 7 was performed.
• The results show that the subject device is substantially equivalent to the predicate in mechanical performance.
• The overall technology characteristics and mechanical performance data lead to the conclusion that the ONX Large External Fixation System is substantially equivalent to the predicate device. |
  | Intended Use | - Has the same intended use as the predicate device. |
  | Operating Principle | - Uses the same operating principle as the predicate device. |
  | Design | - Incorporates the same design as the predicate device. |
  | Materials | - Incorporates the same or very similar materials as the predicate device (connecting rods from unidirectional carbon fiber reinforced epoxy; pins, components, and posts from ASTM F136 and ASTM F138 conforming materials). |
  | Packaging & Sterilization | - Has similar packaging and is sterilized using the same materials and processes as the predicate device. |

Regarding the other points, the provided document does not contain the requested information as it pertains to an orthopedic hardware device, not an AI/ML-based diagnostic or assistive device:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here would refer to the physical devices tested for mechanical properties, not a dataset of medical images or patient records. The document only mentions "engineering analysis" and "construct fatigue testing."
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 mechanical testing is established through physical measurements and engineering specifications, not expert interpretation.
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, as 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, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical performance, the ground truth is based on engineering standards (ASTM F1541, ASTM F1541 Annex 7) and physical measurements of material properties and construct strength/fatigue.
8. The sample size for the training set: Not applicable. This device does not use a training set in the AI/ML sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) pertains to a physical orthopedic device and its substantial equivalence based on mechanical, material, and design comparisons, not on AI/ML performance metrics.

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