(105 days)
This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
- Previously failed hip surgery.
- Proximal femoral neck fractures or dislocation.
- Idiopathic avascular necrosis of the femoral head.
- Non-union of proximal femoral neck fractures.
- Treatment of fractures that are unmanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.
This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.
Here's an analysis of the provided information, focusing on the available details:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.
However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":
| Category | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137. | "validated to a sterility assurance level of 10^-6 in accordance with the ISO 11137." |
| Shelf Life | Packaging validated to maintain integrity and sterility over the defined shelf life (Implied). | "packaging for Trivicta was validated in accordance with ISO 11607." |
| Biocompatibility | Meet requirements of ISO 10993-1, ensuring no adverse biological reactions. | "biocompatibility was established according to the requirements of ISO 10993-1 and found to be safe for its intended use." |
| Mechanical Testing | Meet specified performance standards for hip prostheses as outlined in relevant ISO/ASTM standards (e.g., adequate range of motion, resistance to shear fatigue, neck fatigue, distal stem fatigue, and impingement performance). | "The following non-clinical mechanical tests and analyses were conducted... |
- Range of Motion Test (ISO 21535:2023)
- Shear Fatigue Test (ASTM F1160-14)
- Neck Fatigue Test (ISO 7206-6:2013)
- Distal Stem Fatigue Test (ISO 7206-4:2010)
- Engineering analysis of impingement performance (ASTM F2582-20)"
The overall conclusion states: "The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates." This implies that the device met the performance requirements of these tests relative to the predicate devices and applicable standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.
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
This question is not applicable. MRMC studies are used to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as it pertains to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical device, the "ground truth" for its performance is based on:
- Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
- Objective physical and chemical measurements obtained during laboratory testing.
- Comparison to predicate devices that have established safety and effectiveness.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable as this is not an AI/ML device.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.