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The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.

The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.

The provided text is a 510(k) summary for the I.T.S. CONNEXX Locking Tibia Nail. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead of performance criteria and a study to prove it, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical device approval in the United States, where a new device is shown to be as safe and effective as a predicate device already on the market, rather than necessarily performing a specific quantitative benchmark study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: No specific test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proof" and "acceptance":

The "proof" for this device's safety and effectiveness, as per the 510(k) process, is its substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly that the device's design, materials, and intended use are comparable to these predicate devices.

Basis of Substantial Equivalence (from the text):

• "The I.T.S. CONNEXX Locking Tibia Nail is substantially equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems."
• The comparison likely involves:
  • Intended Use: The indications for use are very similar to those of the predicate devices.
  • Technology/Design Principles: It's an intramedullary rod with locking/nonlocking cross-screw fixation, a common design for such devices.
  • Materials: High strength 6-4 ELI Titanium Alloy (ASTM F-136) is a standard material for orthopedic implants.
  • Performance Characteristics: While not explicitly detailed, the equivalence would imply that its mechanical performance (e.g., strength, fatigue resistance) is comparable to the predicate devices, likely demonstrated through bench testing as part of the 510(k) submission (though not described in this summary).

Conclusion:

This 510(k) summary does not describe a study with explicit acceptance criteria and device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it leverages the concept of substantial equivalence to predicate devices as its primary justification for safety and effectiveness. The "acceptance criteria" are met by demonstrating that the new device is sufficiently similar to already approved devices.

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