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The ATS 5000 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 ATS 5000 is a non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument 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 ATS 5000 instrument is used in conjunction with available dual port tourniquet cuffs and hoses distributed/supplied by Zimmer Biomet Inc. A cuff is applied to a patient prior to the beginning of a procedure. Connective tubing is then attached to the cuff and then plugged into the ATS 5000 connector ports. The instrument is controlled via a touchscreen user interface.

The provided document is a 510(k) summary for the ATS 5000 Automatic Tourniquet Instrument. It details the device's indications for use, its substantial equivalence to a predicate device (Zimmer ® A.T.S. ® 4000 Automatic Tourniquet System, K123553), and includes non-clinical performance data.

However, the document explicitly states that clinical performance data was not needed for this device. This means there was no study conducted to assess device performance against specific clinical acceptance criteria. Instead, the submission relies on non-clinical testing and the established safety and performance of the base technology and predicate device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from the given text in the way you've requested for typical AI/ML medical devices, as this device (a pneumatic tourniquet) underwent a different regulatory pathway that did not require such a clinical study.

I can, however, extract details about the non-clinical performance data and the rationale for not requiring clinical data, as well as the overall conclusion regarding the device's safety and performance from the provided text.

Here's a breakdown of the information that can be extracted:

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

• Acceptance Criteria: The document mentions that "All tests passed according to predetermined acceptance criteria" for the non-clinical testing. However, the specific quantitative acceptance criteria for each test are not listed in this summary.
• Reported Device Performance:

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

• Not applicable as no clinical study was performed. The non-clinical tests would have their own sample sizes (e.g., number of units tested), but these are not provided in the summary.

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

• Not applicable as no clinical study was performed and thus no "ground truth" was established with experts in a clinical context.

4. Adjudication method for the test set:

• Not applicable as no clinical study was performed.

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 device is a pneumatic tourniquet, not an AI/ML diagnostic tool.

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

• Not applicable. This device is a pneumatic tourniquet; it's an instrument, not an algorithm. Its operation involves human interaction (qualified medical professionals).

7. The type of ground truth used:

• Not applicable since no clinical study was conducted. For the non-clinical tests, "ground truth" would be defined by the technical specifications and standards (e.g., a pressure reading is accurate if it matches a calibrated reference).

8. The sample size for the training set:

• Not applicable. This device did not involve machine learning with a training set.

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

• Not applicable. This device did not involve machine learning with a training set.

Summary of why clinical data was not required:
The document states: "Clinical Performance – Clinical data was not needed for this device. Expanded functionality which falls outside the 510(k) exemption classification, does not require additional clinical data as the base technology safety and performance is well established. Existing literature, alongside the non-clinical performance data support the safety and performance of the proposed device."

This indicates that because the device is largely a modification or update to an existing, well-understood technology (pneumatic tourniquets), and the new features (Deflation Protocols, Cuff ID, EZ Method to measure LOP) were either considered minor enhancements or had their safety and performance supported by non-clinical testing and existing literature, a clinical study was not deemed necessary for substantial equivalence.

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