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The subject device can be used with the TRIGEN META-TAN Trochanteric Antegrade Nailing System, TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System, and the TRIGEN META-NAIL Retrograde Femoral Nail System therefore the indications for use for all three systems are applicable to the subject TRIGEN Stable Lock Nut & Washer.

TRIGEN META-TAN Trochanteric Antegrade Nailing System

The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.

In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.

TRIGEN TAN FAN Trochanteric Antegrade and Femoral Antegrade Nailing System

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; and nonunions. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures and intertrochanteric fractures.

TRIGEN META-NAIL Retrograde Femoral Nail System

The TRIGEN META-NAIL Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures.

The device in scope of this submission is the TRIGEN Stable Lock Nut & Washer.

The TRIGEN Stable Lock Nut & Washer is intended to be used as an aid to normal fracture healing for fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures; simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; nonunions; for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated; and for fractures of the femur that include stable and unstable distal metaphyseal fractures, diaphyseal fractures, intra-articular fractures, and peri-prosthetic fractures. The TRIGEN Stable Lock Nut & Washer is made from Ti-6Al-4V material. The device is Gamma sterilized and intended for single-use only.

The provided FDA 510(k) Clearance Letter for the TRIGEN Stable Lock Nut & Washer does not pertain to an Artificial Intelligence (AI) or machine learning (ML) device. Instead, it describes a mechanical bone fixation appliance.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) cannot be extracted or inferred from this document.

The clearance letter focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical bench testing:

• Acceptance Criteria and Reported Device Performance: This document does not present quantitative acceptance criteria or performance metrics in a table format that would be typical for an AI/ML device validating its inferential accuracy (e.g., sensitivity, specificity, AUC). Instead, for this mechanical device, the performance is implicitly demonstrated by the successful completion of the following non-clinical tests:

  • Theoretical Failure Analysis
  • Torque to Failure/Insertion/Extraction Torque Testing and Analysis
  • MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)

• Study That Proves the Device Meets Acceptance Criteria: The study that proves the device meets acceptance criteria consists of the non-clinical bench tests listed above. The conclusion states: "The results of the equivalence testing demonstrate that the differences in design of the subject device does not raise any difference in safety or effectiveness as compared to the predicate devices." This implies that the 'acceptance criteria' were met if these tests demonstrated performance comparable to, or better than, the predicate devices without compromising safety or effectiveness.

In summary, as this is a traditional mechanical medical device, the concepts of acceptance criteria, test sets, ground truth, and study methodologies related to AI/ML device validation are not applicable here.

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