(244 days)
The 4.0 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with medium fragments, e.g .: - tarsal and metatarsal fractures and fixation in metatarsal and phalangeal osteotomies - tarsometatarsal and metatarsophalangeal arthrodeses - ligament fixations - hallux valgus corrections. Additionally, the 4.0 SMV Scientific Cancellous Screw and Washer is intended for arthrodesis and osteotomies of small joints, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 6.5 SMV Scientific Cancellous Bone Screw and Washer is intended for fixation of fractures with large fragments, e.g.: - femoral neck fractures - intercondylar femoral fractures epiphyseolysis of the femoral head - ankle arthrodeses. Additionally, the 6.5 SMV Scientific Cancellous Screw and Washer is intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are manufactured from medical grade stainless steel. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are offered in various diameters and lengths. The SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer are intended to provide fracture fixation. Implants are provided nonsterile with instructions for sterilization.
This document is a 510(k) summary for a medical device (SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer). This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a large clinical study.
Therefore, the information typically requested in your query (e.g., sample size for test/training sets, number of experts, MRMC studies, ground truth types) is primarily relevant for AI/ML-based diagnostic or prognostic devices, not for a bone fixation fastener that is evaluated based on mechanical performance.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics; rather, it indicates that the device's strength is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strength sufficient for intended use (e.g., fracture fixation) | "The results of this non-clinical testing show that the strength of the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is sufficient for its intended use." |
| Substantial equivalence to predicate devices for mechanical performance | "The overall technology characteristics and mechanical performance data lead to the conclusion that the SMV Scientific 4.0 and 6.5 Cancellous Bone Screw and Washer is substantially equivalent to 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)
The document mentions "non-clinical testing" and specific ASTM standards (F543) for evaluating mechanical properties. It does not specify the sample size for these tests, nor the data provenance (country of origin, retrospective/prospective). Such details would typically be in the full test reports, not a 510(k) 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)
This is not applicable as the evaluation is based on mechanical testing of a physical device, not on expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for mechanical testing of a physical device.
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. This is a medical device (bone screw) and not an AI/ML diagnostic or prognostic tool that would involve human readers.
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 testing, the "ground truth" is defined by the objective measurements obtained from standardized tests (e.g., torque values, pullout strength) against predefined specifications or comparison to predicate devices, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML model.
§ 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.