(110 days)
The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.
The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.
The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.
All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.
This document describes the TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System, comparing them to a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to mechanical testing per a standard (ASTM F543-17) and computational analysis, implying that the performance met the requirements set forth by these methods and their associated thresholds. The discussion section states, "the testing supports that these differences do not raise any new questions of safety and effectiveness," indicating successful performance without providing specific numerical results.
However, based on the provided text, we can infer the tested performance aspects:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Inferred from successful testing) |
|---|---|
| Insertion Torque (per ASTM F543-17) | Performed successfully, no new safety/effectiveness questions raised. |
| Removal Torque (per ASTM F543-17) | Performed successfully, no new safety/effectiveness questions raised. |
| Pull-out Force (per ASTM F543-17) | Performed successfully, no new safety/effectiveness questions raised. |
| Ultimate Torque (per ASTM F543-17) | Performed successfully, no new safety/effectiveness questions raised. |
| Cross sectional Analysis (Computational) | Performed successfully, no new safety/effectiveness questions raised. |
| Axial Pullout (Computational per Chapman et al.) | Performed successfully, no new safety/effectiveness questions raised. |
| Cleaning and Sterilization Validation (against ANSI/AAMI/ISO 17665-1) | Performed successfully, no new safety/effectiveness questions raised. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the mechanical or computational tests, nor does it provide information on the data provenance (country of origin, retrospective/prospective).
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 is a medical device (screw system) that relies on mechanical and computational testing, not diagnostic performance tied to interpretations by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable here. The "ground truth" would be established by the engineering standards and validation protocols used in the mechanical and computational analyses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., medical image reading). This document describes performance testing of a physical medical device (bone screws) and computational analyses. Therefore, an adjudication method in this context is 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) that involve human interpretation of cases. The TITANEX™ systems are bone fixation screws, and their acceptance is based on mechanical and computational performance, not diagnostic accuracy or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the TITANEX™ Screw System. The device is a physical implant, not an algorithm. The "standalone performance" here refers to its mechanical integrity and function as a standalone product. The performance data does describe standalone (algorithm-only) performance in the context of the computational analysis, which includes "Cross sectional Analysis" and "Axial Pullout per Chapman et al." These computational models would run independently without human-in-the-loop performance for their execution, although their validation and interpretation would involve human engineers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the physical properties and behavior of the screws measured against established engineering standards and specifications (ASTM F543-17). For computational analysis, the "ground truth" would be the mathematical models and scientific principles (e.g., Chapman et al. for axial pullout) that govern the expected behavior of the device under simulated conditions. It's not expert consensus, pathology, or outcomes data in the traditional medical sense, but rather adherence to validated engineering and scientific principles.
8. The sample size for the training set
The concept of a "training set" is applicable to machine learning or AI models. Since the TITANEX™ Screw System is a physical medical device (bone screws) and not an AI/ML product, there is no "training set."
9. How the ground truth for the training set was established
As there is no training set for this device, how its ground truth was established is not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.