(228 days)
The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance to market the new ChM 4.5mm Cortical screws. The ChM 4.5mm Cortical screws are single-use, stand alone, open reduction and internal fixation devices. They have self-tapping features, hexdrive head recess, and are manufactured from titanium alloy in accordance with ISO 5832-11/ ASTM F1295-16. The ChM 4.5mm Cortical screws are offered non-sterile only and are available in various lengths. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed. Implantation with use of cortical screws should be performed in the operating room conditions.
The applicant, ChM sp. z o.o., submitted a 510(k) premarket notification for their ChM 4.5mm Cortical screws (K210490). This device is a bone fixation fastener intended for the fixation of various long bones and non-unions in adults and children (with fused growth plates or where screw fixation will not cross growth plates).
The provided text does not contain any information about an AI/ML powered medical device or a study involving such a device. The submission is for a traditional medical device (bone screws) and the premarket notification focuses on demonstrating substantial equivalence to a predicate device (Synthes Cortical Screws, K112583) based on material, design, indications for use, patient population, performance requirements, and operational principles.
Therefore, I cannot provide details on acceptance criteria and a study that proves an AI/ML device meets those criteria based on the given information. The concept of "acceptance criteria" in this context pertains to the demonstration of substantial equivalence for a physical medical device, primarily through non-clinical biomechanical and biocompatibility testing, rather than performance metrics for an AI algorithm.
Here's a breakdown of why this information is not present and what was presented instead:
- No AI/ML Device: The entire submission describes a physical medical device (bone screws), not a software or AI-driven diagnostic/therapeutic tool.
- No AI-specific Acceptance Criteria: Consequently, there are no acceptance criteria related to AI performance metrics like sensitivity, specificity, AUC, or the improvement of human readers with AI assistance.
- No AI-related Study: The study mentioned is non-clinical biomechanical testing (ASTM F543-17) and biocompatibility testing (ISO 10993-1). These are standard tests for bone implants, not AI/ML model validation studies.
- No Training/Test Sets for AI: There is no mention of training sets, test sets, ground truth establishment for AI, expert readers for AI adjudication, or MRMC studies, as these concepts are not applicable to the evaluation of a bone screw.
In summary, the provided text is for a traditional medical device (bone screws) and does not involve an AI/ML powered medical device or any associated performance acceptance criteria and studies typical for such AI technologies.
§ 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.