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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 or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous 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 healthcare provider 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 Accessory Kits are convenience kits that are comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged into double-pouched kits by Zimmer . Once packaged, the kit will be sent to a contract sterilizer for irradiation sterilization. The proposed accessory kit does not change the intended use of the legally marketed devices which comprise the kit.

The Zimmer Ambulatory Pump Pain Management System Kits are comprised of approved Zimmer systems with the addition of the convenience kits. comprised of legally marketed devices. The devices are purchased non-sterile and subsequently packaged into tyvek-sealed trays sealed by Zimmer . Once packaged, the System will be sent to a contract sterilizer for irradiation sterilization. The proposed addition of the convenience kit(s) does not change the intended use of the legally marketed devices which comprise the kit.

The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous or subcutaneous administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, or subcutaneous 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 healthcare provider to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Here's an analysis of the provided text regarding the Zimmer Ambulatory Pump Pain Management System, focusing on acceptance criteria and supporting studies:

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

   The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on the concept of substantial equivalence to predicate devices. The primary "performance" reported is that the devices in the kit have been tested to determine the impact of sterilization, and that previously cleared devices meet applicable sections of ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices."

   Since specific quantitative acceptance criteria are not provided, this table will reflect the general nature of the claims made.

   Acceptance Criterion (Implicit)	Reported Device Performance
   Impact of sterilization on device components	Devices in the kit have been tested to determine the impact of sterilization as per "Sterilized convenience kits for clinical and surgical use; final guidance for industry," January 7, 2002. (Specific results or acceptance thresholds for impact are not detailed, but the submission implies acceptable results based on the clearance.)
   Biocompatibility	Previously cleared devices (which comprise part of these kits) have been tested and do meet applicable sections of ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices." (Again, specific detailed results or acceptance criteria of this testing are not provided, but the statement implies compliance and acceptability.)
   Consistency with predicate device's intended use and safety	The proposed accessory kit/system does not change the intended use of the legally marketed devices which comprise the kit. The Zimmer Ambulatory Pump Pain Management System Kits do not raise any new safety and effectiveness concerns when compared to the similar legally marketed devices. (This is a statement of claim rather than a quantifiable performance metric.)
   Substantial Equivalence to Predicate Devices	The Zimmer Ambulatory Pump Pain Management Kit (with and without PCM) and flow splitter wye and fenestrated catheter kits are substantially equivalent to legally marketed pain management kits (specifically Zimmer Ambulatory Pump Pain Management Systems, McKinley Accufuser; Accufuser Plus, Standard Procedure Kits) in that the kits are similar in design, materials, and indications for use.

2. Sample sizes 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 a "test set" in the context of clinical or performance data for AI/software. The evaluation is focused on substantial equivalence for a medical device (infusion pump and accessory kits) rather than a software algorithm.

   • Sample Size: Not applicable in the traditional sense of a clinical trial or algorithm test set. The devices themselves were tested for sterilization impact and biocompatibility, but the document doesn't provide specific sample sizes for these engineering tests.
   • Data Provenance: Not specified, but likely refers to internal testing by the manufacturer (Zimmer Orthopaedic Surgical Products, based in Dover, Ohio, USA).
   • Retrospective or Prospective: Not applicable as there is no clinical data or mention of a study involving patients over time.

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)

   Not applicable. This device is a hardware medical device (infusion pump and accessories), not an AI or imaging diagnostic tool that would require expert-established ground truth.

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

   Not applicable. There is no mention of a test set requiring expert 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

   Not applicable. This is not an AI/imaging device. No MRMC study was conducted or is relevant.

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

   Not applicable. This is a hardware medical device.

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

   Not applicable. The "ground truth" here would relate to the physical and biological integrity of the device components after sterilization and their biocompatibility, which are assessed through engineering and laboratory testing, not clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

   Not applicable. This is a hardware medical device, not an AI/machine learning model that requires a training set.

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

   Not applicable. No training set is involved.

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