(113 days)
The Little Grafter™ Screw is intended for fixation of fractures of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articualar fractures of the tarsals, metatarsalsm carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
The Little Grafter™ Screw is a cannulated, sterile, single use bone fixation screw manufactured from a composite mixture of a calcium salt and a bioabsorbable polymer
The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
The document is a 510(k) summary for a bone fixation screw (Little Grafter™ Screw) and the FDA's clearance letter. It primarily describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.
Here's what can be extracted and what is missing based on your request:
Missing Information:
The document explicitly states: "Test results confirm that this composite screw has the requisite strength to provide both early and sustained fixation of the fracture site. Test results compare favourably with the predicate devices." However, it does not provide any specific acceptance criteria (numerical thresholds for strength, fatigue, etc.) nor the detailed results of the tests. It also doesn't disclose information about sample sizes used for testing, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance details, or specifics about training sets for any AI/ML component (which is not relevant for this type of device, as it's a physical medical implant).
Therefore, I cannot populate the table or answer most of your detailed questions about the study design.
Available Information (related to Performance Data):
- Device Name: Little Grafter™ Screw
- Performance Data Summary: "Test results confirm that this composite screw has the requisite strength to provide both early and sustained fixation of the fracture site. Test results compare favourably with the predicate devices."
- Type of Ground Truth Used: Not applicable in the context of AI/ML. For a physical device like a screw, "ground truth" would relate to mechanical testing standards and potentially in vivo or ex vivo biomechanical studies. The text vaguely refers to "requisite strength" but without specific metrics.
Given the nature of the device (a bone fixation screw), the "study" referred to would be mechanical and possibly biomechanical testing, not a diagnostic or AI-driven study involving human readers or extensive data sets in the way your prompt's questions imply.
Conclusion:
The provided document, while serving as a 510(k) summary, does not offer the level of detail required to complete your request regarding specific acceptance criteria, study methodology, sample sizes, or expert involvement, as these details are typically found in the full 510(k) submission, not the public summary.
§ 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.