(133 days)
The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.
The F3 Fractured Finger Fixator is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint. This device exerts a volarly translating force on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the F3 is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.
Included with the F3 is a custom designed Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. The Dorsal Bone Pin inserted vertically into the middle phalanx. The F3 device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating force that holds the joint concentrically reduced. A Tension Adjust Screw on the F3 allows the surgeon to "fine frune" the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to me ' tain joint alignment.
The F3 Fractured Finger Fixator is manufactured using metal and plastic. The bone pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only.
The provided document is a 510(k) summary for the F3 Fractured Finger Fixator. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission for novel devices.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information on a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Summary of available information related to performance and testing (though not presented as acceptance criteria or a formal study):
The document mentions that the F3 Fractured Finger Fixator is designed to "obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint." It also states that the device allows "full active flexion and extension during healing of the bone and soft tissues."
The comparison to the predicate device (Compass PIP Joint Hinge) indicates that "The F3 is comparable to the predicate device with respect to function and application technique." However, this is a statement of design and intended use equivalence, not a direct measurement against predefined performance acceptance criteria from a clinical study. The FDA's 510(k) review determines "substantial equivalence" based on similar intended use, technological characteristics, and safety and effectiveness, rather than requiring new clinical data demonstrating performance against specific quantitative criteria if substantial equivalence can be shown otherwise.
§ 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.