Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device