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Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:

Total or Hemi-Hip Arthroplasty (Primary and Revision)
Minimally Invasive Hip Orthopedic Procedures
Tumor Resection and Bone/Joint Reconstruction
Stabilization of Repair of Pelvic/Femoral Fractures

This submission is for:
Zimmer orthopedic manual hip instruments that each have a slot which accommodates a Medtronic electromagnetic tracking sensor, and
The addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.

The provided document describes a 510(k) premarket notification for the Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Hip Instrumentation. This submission is for accessory instruments used in image-guided hip surgery systems.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative device performance metrics are explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined performance benchmarks.

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

The document explicitly states: "No testing was needed for these devices." and "Clinical data and conclusions were not needed for this device." Therefore, there was no test set used for this submission.

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

Since no test set was used, no experts were needed to establish ground truth.

4. Adjudication Method for the Test Set

Since no test set was used, no adjudication method was applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was conducted or mentioned. The device's purpose is to assist surgeons with navigation, not to interpret medical images or influence human reader performance in diagnostic tasks.

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

No standalone performance study was conducted or mentioned. The device is described as "accessories to Image Guided Surgery systems," implying that it operates with human oversight and interaction, not as a standalone algorithm.

7. The Type of Ground Truth Used

No ground truth was used as no performance studies were conducted.

8. The Sample Size for the Training Set

No training set information is provided, as no machine learning algorithm development (in the sense of requiring a training set for performance evaluation) is described. The device is a navigation instrument, not an AI / machine learning diagnostic or predictive tool.

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

Not applicable, as no training set was used.

Summary of the Document's Stated Performance and Compliance:

The submission explicitly states that no non-clinical or clinical testing was needed for these devices, and therefore no performance data (acceptance criteria, test sets, or ground truth) is presented from such studies. The basis for clearance is substantial equivalence to an existing predicate device: "Zimmer Ortho Guidance Systems - Hip Instruments, K033223, cleared February 18, 2004." The primary changes described are:

• Addition of Zimmer orthopedic manual hip instruments with slots for Medtronic electromagnetic tracking sensors.
• Addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.

The FDA's letter confirms substantial equivalence, allowing the device to proceed to the market subject to general controls and existing regulations.

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