(137 days)
The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.
The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.
The provided text is a 510(k) summary for the D CoLink® Sfx Implant System, a medical device used for temporary fixation and stabilization of bone fractures. It describes "performance testing" but explicitly states that no additional mechanical testing was required. This means the FDA cleared the device based on an "engineering analysis comparing the subject implants to legally marketed predicates" and not on specific acceptance criteria for performance met by a study of the device itself.
Therefore, many of the requested details cannot be extracted from this document, as they pertain to a performance study that was not conducted for this specific device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The submission states: "No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates." This implies that the acceptance criteria for performance were met by the predicate devices, and the subject device was deemed substantially equivalent without direct performance testing against specific criteria.
2. Sample size used for the test set and the data provenance
This information is not available. No mechanical performance study was conducted for this device. The assessment was based on an engineering analysis comparing it to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available. No performance study requiring expert ground truth was conducted.
4. Adjudication method for the test set
This information is not available. No performance study requiring adjudication was conducted.
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
This information is not applicable. This device is a bone fixation implant system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a bone fixation implant system, not an algorithm.
7. The type of ground truth used
This information is not available. No performance study requiring ground truth was conducted. The clearance was based on substantial equivalence to predicate devices, supported by an engineering analysis and non-mechanical validations.
8. The sample size for the training set
This information is not applicable. This device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is a physical implant, not an AI model requiring a training set.
Summary of what was reported regarding "Performance Testing":
The "Performance Testing" section primarily discusses non-mechanical validations and refers to an "engineering analysis" instead of direct performance testing for the subject device's mechanical properties.
- Validations and risk assessments were conducted for:
- Sterilization (ISO 11137-2)
- Biocompatibility (ISO 10993-1)
- Packaging and shelf life (ISO 111607-1)
- Pyrogenicity (ANSI-AAMI ST72)
- Bacterial endotoxin testing (LAL) is performed on each lot.
It's important to note that these are essential validations for medical devices but do not represent performance testing in the sense of functional mechanical performance criteria typically seen for AI/diagnostic devices or even some other classes of implants where specific performance benchmarks must be met by the device itself in a study. In this case, the decision was made on substantial equivalence, relying on the performance of the predicate devices and an engineering comparison.
§ 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.