(110 days)
The TriMed Omnitech Large System is indicated for fracture fixation of large bone and large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.
The Omnitech Large screws are cannulated titanium compression screws available in diameters of 4.5 mm and 7.3 mm. The screws utilize two different thread pitches allowing the distal fragment to be drawn towards the proximal fragment with each turn of the screw. The conical shaped head increases the surface contact area with the cortical bone avoiding piercing of the cortical bone and the subsequent loss of compression. Currently the screws are made of TA6V ELI titanium alloy. Surgical grade stainless steel screws complying with ASTM F138 may be made available in the future.
This 510(k) summary describes a bone fixation device, not an AI/ML powered device, therefore, many of the requested categories are not applicable.
Here's an analysis of the provided text in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document describes the device and its intended use but does not present a table of acceptance criteria or performance data. Instead, it focuses on demonstrating substantial equivalence to predicate devices. For a conventional medical device like a bone screw, acceptance criteria are typically related to mechanical properties (e.g., tensile strength, torsion, fatigue life) and biocompatibility, which are usually covered by recognized standards. These specific test results are not detailed in this summary.
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Inferred from substantial equivalence) |
|---|---|
| Mechanical properties (e.g., strength, fatigue) | Assumed to meet or exceed those of predicate devices. |
| Material biocompatibility | Assumed to be equivalent to predicate devices made of TA6V ELI titanium alloy or ASTM F138 stainless steel. |
| Clinical performance (e.g., successful fracture fixation) | Assumed to be equivalent to predicate devices for stated indications. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The submission is for a conventional medical device (bone fixation screw) and likely relies on bench testing and comparison to existing predicate devices, rather than a "test set" in the context of an AI/ML model. No clinical data or human subject test sets are mentioned.
- Data Provenance: Not applicable in the context of AI/ML data provenance. The device's substantial equivalence is based on its design, materials, and intended use, compared to legally marketed predicate devices.
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 not an AI/ML device relying on expert-annotated data, there is no "ground truth" establishment in this manner described.
4. Adjudication method for the test set:
Not applicable. This is not a study involving adjudication of performance against human experts.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the AI/ML context. For this device, the "ground truth" for its safety and effectiveness is established by its adherence to recognized standards for medical device design and manufacturing, and its demonstrated substantial equivalence to predicate devices that have a history of safe and effective use.
8. The sample size for the training set:
Not applicable. This is not an AI/ML training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML training set.
§ 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.