(88 days)
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates,
The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as standalone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the ankle, foot, hand, and wrist.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile and Small Fragment Plates, Humeral Fracture Plates, and Osteotomy Plates.
The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon; humerus, radius, ulna, tibia, calcaneous, femur and fibula.
The Arthrex Low Profile Screw is fully or partially threaded, titanium or stainless steel, self-tapping, headed screw. The screw ranges from 2.0 mm to 4.0 mm in diameter and in length from 8 mm to 80 mm. The screw may be either solid or cannulated.
The provided text describes a 510(k) summary for the Arthrex Low Profile Screws, focusing on their substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of diagnostic accuracy, which would involve concepts like sensitivity, specificity, or reader performance.
Instead, this document is a regulatory submission for a medical device (bone fixation screws) and discusses mechanical testing to demonstrate substantial equivalence, rather than clinical performance or diagnostic accuracy.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance in those terms, sample sizes for test sets (as there's no diagnostic test set), expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in a diagnostic context.
The "study" mentioned in the document is mechanical testing. Here's what can be extracted about that:
-
A table of acceptance criteria and the reported device performance:
The document states: "The submitted mechanical testing data demonstrated that the torque and pull-out force of the proposed devices is substantially equivalent to the torque and pull-out force of the predicate devices."While it indicates that mechanical testing was performed for "torque and pull-out force," it does not provide the specific numerical acceptance criteria or the reported performance values for either the proposed device or the predicate devices. It only states they were found to be "substantially equivalent."
-
Sample size used for the test set and the data provenance:
Not specified for the mechanical testing. "Data provenance" (country of origin, retrospective/prospective) is not applicable to mechanical bench testing. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Mechanical testing does not involve human experts establishing a "ground truth" in the way a diagnostic study would. -
Adjudication method:
Not applicable to mechanical testing. -
If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. This is a medical device (bone screw) not an imaging or diagnostic device that would typically involve a MRMC study. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. -
The type of ground truth used:
For mechanical testing, the "ground truth" would be the direct physical measurement of properties like torque and pull-out force, as measured by testing equipment. There is no biological or diagnostic "ground truth" (like pathology or outcomes data) involved for this type of testing. -
The sample size for the training set:
Not applicable. This is not a machine learning model, so there is no training set. -
How the ground truth for the training set was established:
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.