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The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

The Zimmer Ambulatory Pump Pain Management System is a convenience kit that is comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged in tray kits by Zimmer. Once packaged, the kit will be sent to a contract sterilizer for irradiation sterilization. The proposed convenience kit does not change the intended use of the legally marketed devices which comprise the kit.

The Zimmer Ambulatory Pump Pain Management System (kit) does not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. The Zimmer Ambulatory Pump Pain Management System should therefore be considered substantially equivalent to the existing predicate devices.

The Zimmer Ambulatory Pump Kit Pain Management System is a convenience kit that combines existing legally marketed devices. The study to prove the device meets acceptance criteria primarily focused on the impact of sterilization on these pre-existing devices.

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

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

• Sample Size: Not explicitly stated in the provided text, but implies testing was conducted on samples of the devices within the kit.
• Data Provenance: The devices themselves are "previously cleared," suggesting the data for their independent performance (e.g., biological evaluation) predates this submission. The sterilization impact testing would have been done for this specific kit. The text does not specify the country of origin or whether the data was retrospective or prospective, though it would likely be prospective testing for sterilization.

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

This information is not provided in the given text. The evaluation seems to be based on adherence to established standards and guidance documents rather than expert consensus on individual cases.

4. Adjudication method for the test set:

This information is not applicable as the evaluation primarily involved technical testing against standards, not subjective assessment requiring adjudication.

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:

No. This is a medical device (infusion pump kit) and not an AI or imaging device, so an MRMC study is not relevant.

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

No. This is a medical device and not an algorithm.

7. The type of ground truth used:

The ground truth used was compliance with established standards and guidance documents for sterilization and biological evaluation (e.g., "Sterilized convenience kits for clinical and surgical use; final guidance for industry" and ANSI/AAMI/ISO 10993-1:1997).

8. The sample size for the training set:

Not applicable. This device is not an AI-driven system that requires a "training set." Its evaluation focused on the physical components and their properties after being assembled into a kit and sterilized.

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

Not applicable. As stated in point 8, there is no training set for this type of device.

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