(135 days)
The Caliber Intramedullary Fixation System is indicated to repair an acute fracture, mal-union or non-union of the clavicle.
The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm in lengths from 50mm to 120mm. Additionally, the subject device is self-tapping and self-tapping and is made from Titanium Alloy.
The provided text is a 510(k) premarket notification document for a medical device called the "Caliber Intramedullary Fixation System." This document aims to demonstrate the substantial equivalence of the new device to legally marketed predicate devices.
The information provided does not contain any data related to the acceptance criteria and study proving device performance for an AI/ML-driven medical device. Instead, it focuses on the physical and mechanical properties of an orthopedic implant.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable (N/A) to the information presented in this document.
For the items that are relevant to this type of medical device 510(k) submission, here is the information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Tests Performed) | Reported Device Performance/Conclusion |
|---|---|
| Torsion (per ASTM F543) | Results indicate equivalence to specified standards. |
| Driving torque (per ASTM F543) | Results indicate equivalence to specified standards. |
| Axial pullout (per ASTM F543) | Results indicate equivalence to specified standards. |
| Static bending (per ASTM F1264) | Results indicate equivalence to specified standards. |
| Dynamic bending (per ASTM F1264) | Results indicate equivalence to specified standards. |
| Engineering analysis of device characteristics | "Engineering analysis of device characteristics, indicate that Caliber Intramedullary Fixation System is equivalent to specified standards." Also, "does not raise new issues of safety or efficacy compared to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices. The document refers to standard testing protocols (ASTM F543, ASTM F1264) which would define sample sizes for mechanical testing.
- Data Provenance: Not specified (e.g., country of origin). The testing was "performed to demonstrate safety based on recognized consensus standards and current industry practice."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for mechanical device testing.
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:
- N/A. This is a mechanical orthopedic implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a mechanical orthopedic implant, not an AI algorithm.
7. The type of ground truth used:
- For mechanical properties, the "ground truth" is established by adherence to recognized consensus standards (ASTM F543, ASTM F1264) and direct measurement of physical performance within specified acceptance limits. The conclusion is based on the device meeting the performance criteria of these standards.
8. The sample size for the training set:
- N/A. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this type of device.
§ 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.