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The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

• Raw materials
• Manufacturing processes
• Sterilization procedures
• Nature of body contact
• Design and function

The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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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.

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