(70 days)
The SMV Scientific 2.0mm and 2.4mm Bone Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 2.7mm Bone Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 3.5mm and 4.0mm Bone Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle. scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific 4.5mm Bone Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The SMV Scientific Bone Screws consist of cortical screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided both sterile and non-sterile. Screws are manufactured from stainless steel.
The provided document describes the SMV Scientific Bone Screws and their substantial equivalence to a predicate device, focusing on mechanical performance rather than clinical efficacy studies involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI models, human reader performance, expert ground truth, and training/test set details cannot be extracted from this document, as it pertains to a mechanical device and not an AI/software product.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied for Bone Screws) | Reported Device Performance |
|---|---|
| Static Torsion (per ASTM F543) | Sufficient for intended use, substantially equivalent to predicate device. |
| Driving Torque (per ASTM F543) | Sufficient for intended use, substantially equivalent to predicate device. |
| Pullout Testing (per ASTM F543) | Sufficient for intended use, substantially equivalent to predicate device. |
| Removal Torque (per ASTM F543) | Sufficient for intended use, substantially equivalent to predicate device. |
| Material Conformance | Made from stainless steel that conforms to ASTM F138. |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document refers to "testing" but does not give specific numbers of screws or test runs.
- Data provenance: Not applicable in the context of this device. The testing is described as "non-clinical testing," implying laboratory-based mechanical tests rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a mechanical device, not an AI/software product requiring expert ground truth in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the type of mechanical testing described.
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:
- No, a multi-reader multi-case study was not done. This is a medical device (bone screw), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical tests, "ground truth" would be established by the physical properties and performance metrics defined by standards like ASTM F543. The document states the device was tested "per ASTM F543," indicating conformance to these standardized testing procedures and corresponding acceptance criteria.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
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.