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The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

The subject device Zimmer Patient Specific Instruments System 4.0 is an upgrade of the predicate device Zimmer Patient Specific Instruments System 2.5 and is designed to assist a surgeon in the placement of total knee replacement components for Zimmer NexGen CR-FLEX fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-FLEX fixed bearing, Zimmer NexGen LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI). Use of Zimmer Patient Specific Instruments is limited to the treaticular deformities only.

The provided text describes a 510(k) submission for the Zimmer Patient Specific Instruments System 4.0. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment methods, or specific performance metrics.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K111492 and K102795) and describes the device's intended use and technological characteristics.

Here's a breakdown of what can be extracted and what is missing:

What can be extracted:

• Device Name: Zimmer Patient Specific Instruments System 4.0 (Zimmer Patient Specific Instruments Planner, Zimmer Patient Specific Instruments)
• Intended Use: To assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting, provided anatomic landmarks are identifiable on patient imaging scans. It is specifically for use with certain Zimmer NexGen prostheses families.

What is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly stated in the document. The text only vaguely mentions, "Testing verified that the accuracy and performance of the system is adequate to perform as intended." No specific metrics, thresholds, or reported performance values are provided.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The description of the device's function suggests it's an "assistive" system for surgeons ("to assist a surgeon," "assisting the surgeon"), implying a human-in-the-loop scenario. However, a specific standalone performance study is not detailed. The "Zimmer Patient Specific Instruments Planner (ZPSIP)" software generates a pre-surgical plan which is then "inspected, fine-tuned and approved" by a surgeon, indicating human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The system generates a "pre-surgical plan" and then "patient specific templates" are designed based on this plan. The accuracy of these, which would logically be compared to a ground truth, is not described in terms of how that ground truth was established.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion:

While the document confirms that "Non-clinical tests have been performed to assess the safety and effectiveness of the subject device," and that "Testing verified that the accuracy and performance of the system is adequate to perform as intended," it does not provide the specific details of these tests, including acceptance criteria, performance results, study designs, sample sizes, or ground truth establishment methods.

This level of detail is typically found in the full 510(k) submission, specifically in the "Performance Data" section, which is summarized but not fully presented in this 510(k) Summary. The summary focuses on establishing substantial equivalence based on intended use, materials, and technological characteristics without delving into the raw performance data that would address your specific questions.

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