(21 days)
The Apex Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.
The provided document describes a 510(k) submission for Apex Kirschner Wires and Steinmann Pins, focusing on changing the offering from "sterile" to "non-sterile" with validated sterilization instructions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10^-6 | Achieved with recommended sterilization instructions. |
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 does not explicitly state the sample size used for the sterility validation study, nor does it specify the data provenance (country of origin, retrospective or prospective). It only mentions that "a sterility validation study was performed."
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 information is not applicable and not provided in the document. The device is a physical medical instrument (Kirschner Wires and Steinmann Pins), and its performance in this context relates to sterilization effectiveness, not diagnostic interpretation requiring expert medical review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective medical interpretations (e.g., image reading), which is not relevant for a sterility validation study of a medical 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
There was no MRMC comparative effectiveness study done. This type of study relates to diagnostic aids, particularly AI-assisted ones, which is not relevant for Kirschner Wires and Steinmann Pins.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI or diagnostic software, not for basic medical instruments like Kirschner Wires and Steinmann Pins.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the sterility validation study would be the absence of viable microorganisms after the sterilization process, meeting the defined Sterility Assurance Level (SAL) of 10^-6. This is established through microbiological testing.
8. The sample size for the training set
This information is not applicable and not provided in the document. The concept of a "training set" is relevant for machine learning or AI models, not for traditional medical device manufacturing and sterilization validation.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document. As mentioned above, "training set" and its associated ground truth establishment are not relevant to this type of device and study.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that a sterility validation study was performed to support the change from "sterile" to "non-sterile" Kirschner Wires and Steinmann Pins. The acceptance criterion for this study was achieving a Sterility Assurance Level (SAL) of 10^-6 with the recommended sterilization instructions. The study successfully confirmed that this SAL was achieved.
The specific details of the sterility validation study, such as the protocol, the number of samples tested, or the methods used to determine the SAL, are not provided in this summary. However, the FDA's acceptance of the 510(k) submission indicates that the agency found the validation study results sufficient to demonstrate that the device, when sterilized according to instructions, meets the required sterility standards.
§ 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.