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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. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN LPS-FLEX 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 Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer Gender Solutions Natural – Knee Flex fixed bearing prostheses families.

The provided text describes the Zimmer Patient Specific Instruments System, which includes a software component (Zimmer Patient Specific Instruments Planner) and a hardware component (Zimmer Patient Specific Instruments). The system is designed to assist surgeons in the placement of total knee replacement components.

However, the 510(k) summary does not contain detailed information about specific acceptance criteria or a comprehensive study report proving the device meets particular benchmarks. The performance data section is very brief, stating:

"Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended."

And for clinical data: "Not applicable."

Therefore, based solely on the provided text, a full table of acceptance criteria and a detailed study description cannot be generated. The document primarily focuses on regulatory submission details, device description, and substantial equivalence to a predicate device, rather than a detailed performance study.

Here's an attempt to answer the questions based on the limited information available in the provided document, acknowledging significant gaps:

Acceptance Criteria and Device Performance Study (Based on Limited Information)

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

Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics are not explicitly stated. The document only provides a high-level qualitative statement regarding performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify any sample sizes for test sets or data provenance. The "non-clinical tests" are mentioned without further detail regarding the nature of data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information about experts used for establishing ground truth or their qualifications. The "non-clinical tests" are not described with this level of detail.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide any information about adjudication methods.

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

The document does not describe an MRMC study, nor does it mention any comparison of human readers with or without AI assistance. The system is described as assisting the surgeon, but no comparative effectiveness data is presented. The device is a planning and guiding system, not an AI for interpretation that would involve "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The software component (Zimmer Patient Specific Instruments Planner) is used pre-operatively by a qualified surgeon to "inspect, fine-tune and approve the pre-surgical plan." This indicates a human-in-the-loop process. The document does not describe a standalone algorithm-only performance evaluation for the planning software. The hardware component (Zimmer Patient Specific Instruments) is a patient-specific template, which is by nature a standalone manufactured item based on the approved plan.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used for its "non-clinical tests." For a device that assists in positioning, ground truth would typically relate to anatomical accuracy of the generated plan or the delivered template's guidance, but no details are provided.

8. The sample size for the training set

The document does not mention a training set sample size. Given the submission date (2009) and the description, it's unclear if "AI" in the modern sense of machine learning was heavily involved in a way that would necessitate a large training set as understood today. The software generates a pre-surgical plan based on MRI data, which could imply rule-based algorithms or image processing, rather than deep learning requiring extensive training data.

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

The document does not provide any information about a training set or how its ground truth might have been established.

Conclusion:

The provided 510(k) summary for K093533 is very high-level regarding performance data. It explicitly states "Clinical data: Not applicable" and provides only a generic statement about non-clinical tests verifying "adequacy" of accuracy and performance. It lacks the detailed information typically found in study reports for specific acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.

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