(258 days)
Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head. The applicant devices are not sterile. No new materials are used in the development of this implant.
This document describes the 510(k) submission for the Trauson Bone Screw, indicating that it's a medical device (a bone screw) and that its approval is based on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, independently established acceptance criteria through a clinical or performance study that would generate the kind of data requested in the prompt.
Here's a breakdown based on the provided text, highlighting what can be answered and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (if discernible) | Reported Device Performance |
|---|---|---|
| Material Composition | Medical grade 316L stainless steel meeting ASTM 138 | Device is made of Medic 11 grade 316L stainless steel meeting ASTM 138 (Note: discrepancy "Medic 11 grade 316L" vs. "medical grade 316L" appears, but the intent is material compliance). |
| Biocompatibility | Compliance with ISO 10993 standards | "all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993" |
| Mechanical Properties | Not explicitly stated (e.g., specific torque values, pullout strength) | Bench tests conducted for Torsional properties, Insertion Torque, Pullout Test; results are referenced generally as being "similar physical and mechanical specifications" to the predicate, with "slight" variants not influencing effectiveness/safety. Specific numerical results are not provided in this summary. |
| Substantial Equivalence | Similar classification, intended use, sterilization, performance, biocompatibility, chemical specifications, and physical/mechanical specifications to predicate device. | The device "has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications" with the predicate device. "The only difference... is some physical specifications variant which is too slight to influence the effectiveness and safety." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of the provided information. This submission relies on "substantial equivalence" to a predicate device, which typically involves bench testing rather than clinical performance (patient) studies with sample sizes.
- Data Provenance: The bench tests were "conducted" as part of the submission process, but the country of origin of the testing data itself is not specified beyond the manufacturer being in China. The nature of these tests is prospective for this specific device.
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. Ground truth and expert consensus are concepts typically associated with diagnostic AI or image analysis. This submission is for a physical orthopedic implant. The "ground truth" for the material and mechanical properties would be established by industry standards (ASTM, ISO) and laboratory testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are usually relevant for expert review in clinical studies or assessment of diagnostic outcomes. Bench testing for mechanical properties would involve standardized measurement and verification against pre-defined specifications.
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 not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by material standards (ASTM 138) for its composition and biological evaluation standards (ISO 10993) for biocompatibility. For mechanical properties, it would be the physical and mechanical specifications of the predicate device as the benchmark for substantial equivalence, determined through laboratory bench tests.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of medical device submission.
§ 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.