FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Pelvis II Implant System. The Pelvis II Implant System is an internal fixation device that consists of three different types of plates used with compatible screws to fit different types of fractures in the pelvis. The subject components will be available sterile and non-sterile.

AI/ML Overview

The provided text describes a 510(k) submission for the Pelvis II Implant System, which is an internal fixation device for pelvic fractures. It details the device's intended use, indications for use, and a comparison to a predicate device. The document explicitly states that clinical testing was not required for this submission.

Therefore, the study information requested (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document as no such clinical study was conducted or referenced for demonstrating the device meets performance acceptance criteria. The approval was based on non-clinical laboratory testing demonstrating substantial equivalence to a predicate device.

Here's a breakdown based on the provided text's limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission states, "Clinical testing was not required for this submission." The approval was based on substantial equivalence demonstrated through non-clinical testing.

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

Not applicable. No clinical test set was used.

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

Not applicable. No clinical test set with expert ground truth was used.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical testing was not required for this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a medical implant device, not an AI/algorithm device.

7. The Type of Ground Truth Used:

Not applicable. No clinical ground truth was established as clinical testing was not required. The "ground truth" for substantial equivalence was based on predefined mechanical properties and performance standards for similar orthopedic implants, demonstrated through non-clinical laboratory testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

Summary of Device Performance and Acceptance Criteria from Non-Clinical Testing:

The document briefly mentions non-clinical testing:

Acceptance Criteria (Implied): Mechanical performance standards and characteristics deemed substantially equivalent to the predicate device (K001614 - Stryker Trauma Pelvic Set). These would typically involve metrics like static strength, fatigue life, and possibly material properties, all of which are common for orthopedic implants.
Reported Device Performance: "Testing demonstrated that the Pelvis II Implant System is substantially equivalent to the predicate device currently cleared for marketing."
Study: "Stryker Pelvis II Static and Fatigue Plate Testing" was performed.

This 510(k) submission relied on demonstrating substantial equivalence through mechanical and material testing, rather than clinical performance data against specific acceptance criteria relevant to diagnostic accuracy or clinical outcomes.

Summary

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.