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The OrthoPro Steinman Pins and Kirschner Wires 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.

The OrthoPro Steinman Pins and Kirschner Wires are offered in a variety of lengths, diameters, tip styles, and threading. These devices are constructed of implant grade 316LVM stainless steel conformant to ASTM F138, are provided non-sterile, and are intended for single-use only. The OrthoPro Pins and Wires product family is available in a range of lengths, diameters, and tip styles, with and without threading. All pins and wires are manufactured from 316LVM surgical implant grade stainless steel certified to ASTM F138. The devices will range in diameter from 0.028 inches to 0.1875 inches. The devices range in length from 4 inches to 12 inches. The devices are available in a variety of tip styles, including but not limited to trocar point, diamond point, and cove point. The devices will have proximal tip styles including but not limited to trocar point, diamond point, check point, and round. The devices will be provided in fully threaded, partially threaded and nonthreaded versions.

Here's an analysis of the provided 510(k) summary for the OrthoPro Steinman Pins and Kirschner Wires, focusing on the acceptance criteria and supporting studies as requested:

Summary of Acceptance Criteria and Device Performance:

The 510(k) submission for the OrthoPro Steinman Pins and Kirschner Wires does not present specific quantitative acceptance criteria or a detailed "study" in the traditional sense (e.g., performance metrics with benchmarks). Instead, it relies on the concept of substantial equivalence to predicate devices. The primary "acceptance criteria" and "device performance" are centered around meeting the general characteristics of existing, legally marketed devices.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided 510(k) summary does not describe a clinical study or a non-clinical performance study with quantitative results to establish specific acceptance criteria and then demonstrate the device meets those criteria. Instead, it relies on the concept of substantial equivalence to predicate devices through a comparison of technological characteristics.

Here's why many of your detailed questions are not directly applicable or cannot be answered from this specific document:

1. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The device's characteristics are compared directly to the specifications of predicate devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment process is described as there isn't a performance test set.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 device (Steinman Pins and Kirschner Wires) is a mechanical orthopedic fixation device, not an AI or imaging diagnostic tool. MRMC studies are irrelevant here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm or AI component in this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense of a performance study. The "ground truth" for substantial equivalence is the established characteristics and performance of the legally marketed predicate devices.
7. The sample size for the training set: Not applicable. No AI/machine learning component to train.
8. How the ground truth for the training set was established: Not applicable.

Explanation of the "Study" and Approach:

The document explicitly states:

• "Summary of Non-Clinical Tests: The non-clinical testing to be conducted on the OrthoPro Steinman Pins and Kirschner Wires will include material and dimensional verification."
• "The OrthoPro Steinman Pins and Kirschner Wires are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the "study" for this 510(k) submission primarily involved:

• Engineering Analysis and Documentation: Verification of the device's material composition (316LVM stainless steel per ASTM F138) and its physical dimensions (lengths, diameters, tip styles, threading options) against its own specifications and in comparison to the publicly available characteristics of predicate devices (DePuy Steinman Pins and Kirschner Wires K960385, Smith and Nephew Pins and Wires K994143, and a pre-amendment Smith and Nephew device).
• Predicate Comparison: The core of the submission is a detailed comparison demonstrating that the new device shares the same intended use, materials, and fundamental technological characteristics as already cleared devices, thus establishing substantial equivalence.

In essence, for this type of medical device (a well-understood mechanical component), "substantial equivalence" allows manufacturers to leverage the regulatory history and safety/effectiveness profile of existing predicate devices rather than conducting new, extensive clinical or performance studies, provided the new device does not raise new questions of safety or effectiveness. The "acceptance criteria" are implicitly met by being demonstrably equivalent to devices that have already met regulatory requirements.

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