(56 days)
Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):
- There is destruction of the joint surfaces, with or without significant bone deformity.
- The cruciate and/or collateral ligaments do not stabilize the knee joint.
- The ligaments are inadequate and/or the musculature is weak. And/or
- Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:
- Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.
When used with compatible GMRS components:
- Where segmental resection and/or replacement of femur and/or proximal tibia is required
The subject THK components are a line extension of the previously cleared Triathlon® Hinge Knee System (K223528, K230416). The THK System (K223528, K230416) is a tricompartmental knee system consisting of a stemmed femoral component and a stemmed tibial bearing component connected by a set of previously cleared MRH or THK Bushings and an MRH or THK Axle (K994207, K002552, K223528, K230416). A bumper locks this assembly. This assembly provides motion through the MRH or THK Axle/Bushings combination in the flexion/extension plane. The articulation between the bearing surfaces on the underside of a tibial bearing component and a tibial insert provides motion in the rotating plane. A hinge tibial insert is assembled to a Triathlon® Hinge Revision Tibial Baseplate that incorporates a longitudinal bore to accept a previously cleared MRH Tibial Sleeve (K994207, K002552) or Triathlon Tibial Sleeve (K223528, K230416). Optional distal femoral and tibial augments are available to fill bone defects.
The subject Triathlon® Hinge Small Proximal Tibial Bearing Component and Triathlon® End Cap are sterile, single use devices intended for cemented use only and are being added to the previously cleared THK system (K223528, K230416) as an extension. They can be used with previously cleared MRH Knee components (K994207, K002552), GMRS (K023087, K222056), and Triathlon® Knee System components (K172634, K172326, K190991, K143393, K141056, K132624, K070095, K061521, K053514, K052917, K051948, K051146, K040267).
This FDA 510(k) clearance letter is for a mechanical medical device (a knee implant system), not an AI/software as a medical device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" using metrics relevant to AI/software (like sensitivity, specificity, MRMC studies, ground truth for training/test sets, etc.) is not applicable here.
The document provided details about the substantial equivalence of the "Triathlon® Hinge Knee System" to previously cleared predicate devices. The "study" proving the device meets acceptance criteria for a mechanical implant typically involves non-clinical (benchtop) testing and engineering analyses to demonstrate performance, material compatibility, and safety, rather than clinical trials or AI performance evaluations with ground truth.
Here's how the provided information relates to the typical evaluation of such a device, addressing the closest analogues to your requested points:
Acceptance Criteria and Device Performance for a Mechanical Implant:
For mechanical implants like the Triathlon® Hinge Knee System, "acceptance criteria" are generally tied to the successful completion of various non-clinical (benchtop) tests and analyses. These tests simulate the physical stresses and conditions the implant will experience in the human body. The "study" proving the device meets these criteria is the execution and successful outcome of these non-clinical tests.
No direct table of "acceptance criteria" vs. "reported device performance" in the AI sense is provided in this 510(k) summary. Instead, the summary lists the types of non-clinical tests performed to demonstrate performance and substantial equivalence to predicate devices. The implied acceptance is that the device passed these tests, meaning its performance in these simulated scenarios was deemed acceptable and comparable to existing, legally marketed devices.
Table of Non-Clinical Tests (Analogous to Performance Metrics):
| Acceptance Criteria (Test Type) | Reported Device Performance (Implied "Pass") | Notes |
|---|---|---|
| Triathlon Hinge Bearing Component Varus/Valgus Fatigue | Met performance standards | Tests the component's ability to withstand repeated bending stresses in side-to-side directions, simulating loading during gait. |
| Triathlon Hinge Bearing Component Chair Rise Testing | Met performance standards | Simulates stresses experienced during a common activity (standing up from a chair). |
| Triathlon Hinge Full Construct Fatigue | Met performance standards | Evaluates the fatigue life of the entire assembled knee system under cyclic loading. |
| Wear Test Rationale for New Constructs | Acceptable wear characteristics demonstrated | Rationale provided to show that wear performance is acceptable, likely through comparison to predicate devices or established standards. Direct wear testing is implied by "wear test rationale". |
| Analysis of Contact Area/Contact Stress & Constraint Analysis | Acceptable contact mechanics & constraint | Computer modeling and/or benchtop tests to evaluate how the components interact under load, ensuring appropriate stress distribution and constrained movement. |
| Range of Motion and Rotational Freedom Analysis (ASTM F1223-20) | Met specified ranges and freedoms | Tested for flexion/extension, internal/external rotation, varus/valgus, and translation (medial/lateral, proximal/distal, anterior/posterior) to ensure physiological movement. |
| Total Femur Construct Compatibility & Triathlon Hinge Bushing/Axle Compatibility | Compatible with legacy components | Ensured new components integrate properly with existing cleared femoral and tibial components. |
| Triathlon Revision Baseplate-End Cap Locking Strength Analysis | Adequate locking strength | Evaluated the mechanical strength of the connection points. |
| Triathlon End Cap Tightening Analysis | Optimal tightening confirmed | Ensured secure fixation of the end cap. |
| Triathlon End Cap Load Carrying Capacity Rationale | Acceptable load capacity | Analysis provided to demonstrate the end cap can withstand expected loads. |
| Triathlon End Cap Stability Analysis | Stable under normal use | Evaluated the end cap's ability to remain in place and function without loosening. |
| MRI Testing (Safety for imaging) - Displacement, Torque, Artifacts, RF Heating | All MRI safety criteria met | Performed to confirm the device is safe for patients undergoing MRI procedures (e.g., no excessive magnetic pull, acceptable image distortion, no dangerous heating). Standards: ASTM F2052-15, ASTM F2213-17, ASTM F2119-07 (reapproved 2013), ASTM F2182-191ae. |
| Biocompatibility (ISO 10993-1:2020) | Biocompatible with human tissue | Testing to ensure the materials used in the implant do not cause adverse biological reactions in the body. |
| Shelf-life Validation (ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980-21) | Validated shelf-life | Ensures the sterility and integrity of the packaging system and the device itself are maintained over the specified shelf-life. Methods: ASTM F1886/F1886M-16, ASTM F88/88M-21, ASTM F2096-11(2019). |
| Bacterial Endotoxin Testing (ANSI/AAMI ST72:2019) | Endotoxin limit |
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.