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Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of instruments and implants into the skeletal system.

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are metal K-Wires and Pins in a variety of lengths, diameters, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile and are intended to be sterilized at the point of use. All devices are manufactured from medical grade Stainless Steel.

The provided document is a 510(k) summary for Pacific Instruments' Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not typically found in a 510(k) summary for this type of device.

Based on the document, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in the format of a clinical or performance study with specific metrics and thresholds. Instead, it states that the device was evaluated for conformance to dimensional, material, and mechanical property standards: ASTM F138-13, ASTM F36-10, and ISO 5838-1.

Acceptance Criteria (Implied by Conformance to Standards):

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of a clinical study. It refers to the "items in the scope" that were tested for conformance to standards. The sample size for these conformance tests is not specified, nor is the provenance of any data beyond indicating that these are standards for medical grade stainless steel and implants.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not present in the document. The "ground truth" for this device type is established by the industry standards for materials and mechanical properties, not by expert interpretation of clinical data in a test set.

4. Adjudication method for the test set

This information is not applicable and not present in the document as no clinical test set requiring adjudication was described.

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. MRMC studies are typically for diagnostic imaging devices involving human interpretation, often with AI assistance, which is not the nature of this device (orthopedic fixation pins and wires).

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 physical medical instrument, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for evaluating this device's performance is adherence to established industry standards for medical device materials and mechanical properties:

• ASTM F138-13 (Standard Specification for Wrought 17Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673))
• ASTM F36-10 (Standard Test Methods for Bendability of Metallic Flat-Rolled Materials (This may be a typo and meant to refer to a relevant standard for mechanical properties of pins/wires used in orthopedics, as ASTM F36 is generally not for surgical implants. Often, specific ASTM or ISO standards for mechanical testing of orthopedic implants, like bending or tensile strength for fixation devices, are cited. However, the document explicitly states F36-10)).
• ISO 5838-1 (Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements)

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for physical medical devices like fixation pins and wires, as they do not involve machine learning algorithms.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.

The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.

The provided text is a 510(k) premarket notification for an Orthopedic Fixation Pin. It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, primarily through non-clinical performance data (bench testing and biocompatibility).

Crucially, this document does not describe a study that uses an AI/ML device, nor does it contain acceptance criteria or performance data for such a device. The "Orthopedic Fixation Pin" is a physical medical device, not a software or AI-driven diagnostic or assistive tool.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not pertain to an AI/ML device.

Here's why the information you're asking for is absent in the document:

• Device Type: The "Orthopedic Fixation Pin" is a physical implant used for bone fixation. It is not an AI/ML algorithm or system.
• Performance Data: The performance data presented (static pullout, static torsion, tensile testing, biocompatibility) are standard engineering and materials tests for physical medical implants, not metrics like sensitivity, specificity, AUC, or reader performance improvement typically used for AI/ML devices.
• Clinical Studies: The document explicitly states, "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Orthopedic Fixation Pin, as clinical studies are not required for this medical device." This confirms that no clinical performance data, let alone data relevant to AI/ML device evaluation (like MRMC studies or human-in-the-loop performance), was generated or submitted.
• Ground Truth: The concept of "ground truth" as it applies to AI/ML (e.g., expert consensus on image interpretation, pathology reports) is not relevant to a physical pin. The "ground truth" for the pin is its adherence to material specifications and mechanical properties.

If you have a document describing an AI/ML medical device, please provide that, and I would be able to answer your questions.

Ask a specific question about this device