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The A.T.S. 4000TS Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including; Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

The Zimmer A.T.S. 4000TS Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 4000TS control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A. T.S. 4000TS's connector ports.

The provided text describes a medical device, the Zimmer A.T.S. 4000TS Tourniquet System, and its regulatory submission. However, it does not contain the specific information requested about acceptance criteria for device performance and a study proving the device meets those criteria, particularly in the context of an AI/algorithm-based device.

The document states that the device is a "non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures". It is a pneumatic tourniquet.

Here's what can be extracted and what is missing:

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

• Missing. The document mentions "predetermined acceptance criteria" were met for various tests (Electrical safety, Environmental, Software, Usability, Hardware, and Software validation), but it does not specify what those criteria were or detail the reported performance against them. This is a pneumatic tourniquet, not an AI/algorithm-based diagnostic device, so typical metrics like sensitivity, specificity, or AUC are not applicable here.

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

• Not applicable. This device is a pneumatic tourniquet system, not a diagnostic or AI-based device that would typically involve test sets of patient data. The "testing" referred to in the document is for hardware, software, electrical safety, usability, etc., not for analyzing patient data.

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

• Not applicable. See point 2.

4. Adjudication method for the test set:

• Not applicable. See point 2.

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:

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is a hardware and software system for controlling a pneumatic tourniquet, not a standalone AI algorithm for diagnosis or interpretation.

7. The type of ground truth used:

• Not applicable for performance validation in the AI/data sense. The "ground truth" for this device would relate to the accuracy and reliability of its mechanical and software functions (e.g., pressure regulation, alarm functionality). These are typically validated through engineering tests and simulations, not patient data ground truth.

8. The sample size for the training set:

• Not applicable. The device's software and hardware undergo development and testing, not "training" in the machine learning sense.

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

• Not applicable. See point 8.

Summary of what the document does state about performance and testing:

• Non-Clinical Performance and Conclusions:
  • During development, the following testing was completed:
    • Electrical safety and Environmental testing in accordance with IEC 60601-1, 60601-1-2, 60601-1-8.
    • Software and device development conducted in accordance with IEC 62304:2006 and AAMI/ANSI HE-75:2009.
    • Device Usability testing conducted in accordance with IEC 60601-1-6 and IEC 62366:2007.
    • Hardware and Software testing, including validation.
  • Conclusion: "All tests passed according to predetermined acceptance criteria." (Specific criteria and performance details are not provided).
• Clinical Performance and Conclusions:
  • "Clinical data and conclusions were not needed for this device." This statement is crucial and indicates that no human clinical study was conducted to demonstrate safety or effectiveness for this 510(k) submission, likely because it was deemed substantially equivalent to a predicate device based on its design and non-clinical performance.

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