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The LimaCorporate Kirschner wires are indicated as guide pins for insertion of other implants.

The LimaCorporate Kirschner wire is a metallic smooth wire, intended as non-implantable medical device.
This instrument is needed to guide the surgeon during orthopedic surgeries for the bone preparation in partial or total primary or revision shoulder joint replacement.
The LimaCorporate Kirschner wire is available in single diameter (2.5mm) and various lengths (150mm, 200mm and 240mm).
The LimaCorporate Kirschner wire is made from stainless steel 316L (AISI 316L), according to ISO 5832-1 and it does not have any coating.
The LimaCorporate Kirschner wire is designed for single use. It is supplied sterile and it is sterilized by means of radiation.

This document (K203475) describes a 510(k) premarket notification for a medical device called the "LimaCorporate Kirschner Wire." The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as typically done for new, higher-risk devices.

Therefore, the information provided does not contain the typical acceptance criteria and rigorous study design associated with demonstrating performance for an AI/ML medical device. Instead, it focuses on comparing the new device's characteristics to a predicate device.

Here's an analysis based on the provided document, addressing your points where applicable, and noting where the information is absent due to the nature of a 510(k) for a physical, non-AI device:

Device Name: LimaCorporate Kirschner Wire
Device Type: Smooth or threaded metallic bone fixation fastener (Specifically, a smooth metallic wire for guiding other implants).
Regulatory Class: Class II
Product Code: HTY

This document is a 510(k) submission for a physical, non-AI medical device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of attributes, not a clinical performance study with defined performance metrics like sensitivity, specificity, or AI model accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, the "acceptance criteria" are not performance metrics of an AI model, but rather successful demonstration that the device's technical characteristics are substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable to this 510(k) submission, as it is for a physical medical device (Kirschner wire), not an AI/ML software. There is no "test set" of data in the sense of medical images or patient records used to evaluate an algorithm's performance. The "testing" refers to non-clinical bench testing (sterilization validation, biocompatibility) and direct comparison of physical attributes to the predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There is no AI/ML algorithm or "test set" requiring expert-established ground truth in this submission.

4. Adjudication Method for the Test Set

Not applicable, as there is no AI/ML algorithm or "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study is relevant for imaging devices or AI-assisted diagnostic tools where human interpretation is involved. This submission is for a Kirschner wire (a surgical instrument).

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This pertains to AI/ML devices.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this device, "ground truth" generally refers to verified physical properties, material composition, and functional characteristics validated through engineering testing and adherence to standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model to train for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI/ML model or training set.

Conclusion from the document:

The provided document (K203475) details a 510(k) clearance for the LimaCorporate Kirschner Wire. The basis for clearance is demonstrating substantial equivalence to an existing predicate device (In2Bones® Kirschner Wire, K153204) rather than proving de novo safety and effectiveness through extensive clinical trials or performance studies as would be required for a novel device or AI/ML product. The manufacturer states that "Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires," implying that the comparison of design, materials, size, and indications, alongside standard non-clinical tests (sterilization, biocompatibility), are sufficient evidence for this type of device.

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