(290 days)
IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.
Acutec Headless Compression Screw:
Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.
Cannulated Screw:
Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.
IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than on clinical safety and effectiveness studies with acceptance criteria as typically understood for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study types, ground truth, and expert involvement is not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary "acceptance criteria" here are established through mechanical testing to demonstrate that the new device (IRENE Cannulated Screw System) is at least as safe and effective as the predicate devices. The standard used is ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
- Reported Device Performance: The document states: "Results of testing indicates no difference between the level of performance of proposed device and the predicate device, through which the differences are deemed not relevant to device performance and has been justified, and the conclusion of Substantial Equivalence is reached." Specific numerical performance metrics (e.g., specific torque values, pullout strengths) are not provided in this summary document. The summary indicates that the tests conducted were:
- Torsional properties
- Driving torque test
- Axial pullout test
2. Sample Size Used for the Test Set and Data Provenance:
- This is not applicable as there is no "test set" in the context of an AI/ML device for diagnostic or prognostic performance. The "test set" here refers to physical samples of the screws used for mechanical testing. The specific number of screws tested is not mentioned in this summary.
- Data provenance: The mechanical tests were performed on the proposed device (IRENE Cannulated Screw System) and the predicate devices. The manufacturing location for the proposed device is Tianjin, P.R. China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for AI/ML diagnostic studies, not for mechanical testing of bone screws. The "ground truth" for mechanical properties is determined by physical measurement instruments according to established engineering standards.
4. Adjudication Method for the Test Set:
- This is not applicable. Adjudication methods are specific to subjective human assessment in diagnostic or clinical studies. Mechanical tests have objective measurement outcomes.
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 is not applicable. This is a 510(k) for a physical medical device (bone screws), not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable. This is not an algorithm.
7. The Type of Ground Truth Used:
- For the mechanical tests, the "ground truth" is the physical measurement taken by calibrated instruments in accordance with the specified standard (ASTM F543-13). This is an objective, quantitative ground truth.
8. The Sample Size for the Training Set:
- This is not applicable. There is no "training set" as this is a physical device, not an AI/ML model that is trained on data.
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable for the same reason as point 8.
In summary, the provided document is a 510(k) summary for a conventional medical device (bone screws). The "study" referenced is a series of mechanical tests comparing the proposed device to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI/ML performance study with traditional acceptance criteria for diagnostic accuracy.
§ 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.