(78 days)
The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur and fibula.
The 3.5 mm cortex screws are self-tapping, have a stardrive recess, and are manufactured from stainless steel and titanium. The self-tapping screws are available in various lengths ranging from 10-150 mm.
This document is a 510(k) Summary for Synthes 3.5mm Cortex Screws, which are a physical medical device (bone fixation fastener). It is not an AI/ML-driven device but rather a traditional medical device. Therefore, the specific information requested in the prompt regarding acceptance criteria for AI models, study types (MRMC, standalone), ground truth details, sample sizes for test and training sets, and expert qualifications for AI model validation is not applicable to this document.
The document mainly describes the device, its intended use, classification, and its substantial equivalence to a predicate device, which is the basis for its clearance by the FDA.
Here's the relevant information that can be extracted, framed within the context of a traditional device clearance:
1. A table of acceptance criteria and the reported device performance
For traditional devices like this, explicit "acceptance criteria" against quantifiable performance metrics in the same way an AI model would have them are not typically stated in a 510(k) summary. Instead, the "acceptance" is implicitly based on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves:
| Acceptance Criteria (Implied for Traditional Devices) | Reported Device Performance (from document) |
|---|---|
| Similar Intended Use | The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur and fibula. (This is identical to the assumed intended use of the legally marketed predicate device, Synthes 3.5 mm Cortex Screws (which already exists, hence the name similarity implying it's an updated version or specific iteration of an existing product)). This is a crucial aspect of substantial equivalency. |
| Similar Technological Characteristics (Material) | Manufactured from stainless steel and titanium. (This would be compared to the predicate device's materials.) |
| Similar Technological Characteristics (Design) | Self-tapping, stardrive recess, available in various lengths ranging from 10-150 mm. (This would be compared to the predicate device's design features.) |
| Safety and Effectiveness (Implied Equivalence) | "Information presented supports substantial equivalence." This statement is the reported performance in the context of a 510(k) – it means the device is considered as safe and effective as the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in a 510(k) summary for a mechanical device. There isn't typically a "test set" of data in the sense of a data set used to evaluate an algorithm. The "testing" for such devices often involves mechanical and biocompatibility testing, but specifics are not in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment by experts in the context of an algorithm for this type of device. The clearance is based on engineering specifications, material properties, and comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is a mechanical device, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For a mechanical device, "ground truth" would relate to its physical properties meeting design specifications and clinical performance in terms of fracture fixation, which is generally established through mechanical testing, biocompatibility studies, and clinical experience with similar predicate devices, rather than expert consensus on a data set.
8. The sample size for the training set
Not applicable. There is no "training set" for physical medical devices of this nature.
9. 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.