(19 days)
The Jet-X TiN Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
The Jet-X TiN Coated Half Pin is a modification of the Hex-Fix Half Pin that was cleared for market under K953397. This submission provides for a titanium nitride (TiN) coated stainless steel half pin.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies that would typically be described with the details you are requesting (e.g., sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details).
The document is a 510(k) premarket notification for a medical device (Jet-X® TiN Coated Half Pins). Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to present a detailed performance study with statistical acceptance criteria.
The key points from the provided text are:
- Device Description: The Jet-X TiN Coated Half Pin is a modification of a previously cleared device (Hex-Fix Half Pin) and features a titanium nitride (TiN) coating.
- Intended Use: Used with an external fixation system for fracture fixation, pseudoarthrosis/nonunion, limb lengthening, deformity correction, and joint arthrodesis.
- Technological Characteristics: Its principles of operation, design, and material (316L stainless steel with TiN coating) are stated to be identical or similar to predicate devices.
- Substantial Equivalence Information: The submission argues that the device's intended use, shape, design, and material are identical or similar to predicate devices.
The FDA's letter (K023134) confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on the comparison to predicate devices, not on specific performance data against a set of acceptance criteria from a standalone study.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary and FDA letter.
§ 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.