(50 days)
The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. 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.
This document describes the Zimmer Ambulatory Pump Pain Management System, a convenience kit comprising legally marketed devices for continuous infusion of medications for postoperative pain management.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics with numerical thresholds. Instead, it relies on the concept of substantial equivalence to predicate devices. The performance data presented focuses on the impact of sterilization and biological evaluation for the components of the kit.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Kit components maintain intended use after sterilization. (Implied: Sterilization process does not degrade the functionality or safety of individual components.) | "The devices in this kit have been tested to determine the impact of sterilization as per the guidance document, 'Sterilized convenience kits for clinical and surgical use; final guidance for industry,' January 7, 2002 was utilized as guidance for this submission." |
| Kit components meet biological evaluation standards. (Implied: Components are biocompatible and safe for patient contact.) | "The previously cleared devices have been tested and does meet the applicable sections of the ANSI/AAMI/ ISO 10993-1:1997, 'Biological evaluation of Medical Devices.'" |
| Overall safety and effectiveness equivalent to predicate devices. (Implied: The convenience kit, formed by packaging existing devices, does not introduce new safety or effectiveness concerns compared to existing, cleared products.) | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific "test sets" in the context of a typical clinical study with patient samples. The performance data is primarily focused on non-clinical testing related to sterilization effects and biocompatibility of the components. Therefore, information on sample size and data provenance in a clinical sense is not applicable to this submission's provided performance data.
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)
This information is not applicable to this submission. The "ground truth" here is established through regulatory guidance and validated standards (e.g., sterilization protocols, ISO 10993-1). There is no mention of human experts interpreting data or establishing clinical ground truth for novel findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this submission. Adjudication methods are typically used in clinical studies where multiple human readers or evaluators assess data, which is not the case here.
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
This information is not applicable. The Zimmer Ambulatory Pump Pain Management System is a medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-assisted performance improvements are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical kit and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
* Regulatory Guidance Documents: Specifically, "Sterilized convenience kits for clinical and surgical use; final guidance for industry," January 7, 2002.
* International Standards: ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices."
* Predicate Device Performance and Clearance: The fact that the individual components are "legally marketed devices" and the predicate devices (Accufuser, Accufuser Plus, Standard Procedure Kit, PainPump® Local Anesthesia Kit) have already demonstrated safety and effectiveness.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device submission.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).