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The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes.

The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.

The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutancous.

The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. Pain Management routes of administration may be intramuscular, subcutaneous or epidural. Antibiotic routes of administration may be intramuscular or subcutaneous.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device which mainly discusses the device's substantial equivalence to other legally marketed devices, its indications for use, and regulatory information. It does not include details on acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications related to device performance evaluation.

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PainPump1 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.

PainPump1 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

PainPump1 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes.

PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medication to the patient for pain management an/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate. The routes of administration may be intramuscular or subcutaneous.

PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. The routes of administration may be intramuscular or subcutaneous.

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

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

The provided text does not contain explicit acceptance criteria in a numerical or categorical format, nor does it present device performance data against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance or clinical study results with acceptance criteria.

The "device description" and "indications for use" sections describe what the devices (PainPump1 and PainPump2) are intended to do and how they function (deliver medication at an hourly flow rate, PainPump2 also offers bolus dosing). They also mention an intended outcome: "significantly decrease narcotic use and pain when used to deliver local anesthetics...when compared with narcotic only pain management." However, these are statements of intent and claims, not specific, measurable acceptance criteria with performance statistics.

Therefore, I cannot populate a table with acceptance criteria and reported device performance from this document.

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

The document does not mention a test set sample size or data provenance (e.g., country of origin, retrospective or prospective). As a 510(k) summary, it focuses on comparing the proposed device to predicate devices rather than detailing independent clinical or performance studies with a distinct test set.

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

The document does not provide information about experts used to establish ground truth or their qualifications. This type of detail is typically found in study protocols or results, which are not present in this 510(k) summary.

4. Adjudication method for the test set

The document does not describe any adjudication method for a test set.

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

The devices are "Infusion Pumps" (PainPump1 and PainPump2), which are mechanical devices for drug delivery. They are not AI-powered imaging or diagnostic devices that would involve "human readers" or "AI assistance" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study, as typically understood in the context of AI in healthcare, was not performed and is not relevant to these devices.

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

Again, as mechanical infusion pumps, the concept of a "standalone algorithm" is not applicable. The devices are physical instruments that deliver medication. Performance would be assessed through engineering tests (e.g., flow rate accuracy, pressure limits, battery life, alarm functionality), not through purely algorithmic assessment. The document does not provide details on such standalone performance tests for these mechanical functions, beyond implying they meet safety and efficacy standards for infusion pumps.

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

Given that these are infusion pumps, "ground truth" would relate to the accuracy of medication delivery, safety features, and clinical outcomes (e.g., pain reduction, decreased narcotic use) as stated in the indications for use. However, the document does not specify the type of "ground truth" data used for performance or clinical validation. It merely claims the devices are intended to achieve certain outcomes, but doesn't detail the studies or the ground truth against which those claims were evaluated.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning algorithms. Since the PainPump devices are mechanical infusion pumps and not AI/ML-driven, there is no training set in the sense of data used to train an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable to the devices described.

In summary:

The provided 510(k) summary for the Stryker PainPump1 and PainPump2 devices primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K031249, K030661, K040337). It describes the devices' functions and indications for use. However, it does not contain the detailed clinical study design, performance metrics, acceptance criteria, sample sizes (for test or training sets), expert qualifications, or adjudication methods typically found in documents describing performance studies for diagnostic or AI-powered devices. The acceptance is based on the devices being functionally equivalent to already-approved devices, rather than on new, independent, detailed performance studies with explicit acceptance criteria provided in this summary.

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PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. The Stryker PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. The Stryker PainPum2 is a kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories.

The provided document is a 510(k) premarket notification for the Stryker PainPump2, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This type of submission generally does not include detailed studies with specific acceptance criteria and performance metrics in the way a clinical trial for a novel device or software exhibiting AI/ML capabilities would.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in this document. The submission relies on a comparison of intended use, safety, and effectiveness to already cleared devices rather than providing new performance data from a clinical study.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Applicable / Not Provided: The submission does not present specific quantitative acceptance criteria or performance metrics for the Stryker PainPump2 in the way a diagnostic device or AI algorithm would. Its primary claim is substantial equivalence to predicate devices (I-Flow Corporation infusion pump systems and I-Flow/Sims Portex catheters) based on intended use, safety, and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The document does not describe a "test set" in the context of performance evaluation with specific sample sizes. There's no mention of a study involving patient data to assess the device's performance. The substantial equivalence argument is based on comparing the device's design and intended use to existing, cleared devices.

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 / Not Provided: As there is no described test set or ground truth establishment process related to a performance study, this information is not relevant to this 510(k) submission.

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

• Not Applicable / Not Provided: No test set or adjudication method is described.

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 / Not Provided: This question is relevant for AI/ML-powered diagnostic tools. The Stryker PainPump2 is an electromechanical ambulatory infusion pump; it does not involve human readers or AI assistance in the way a diagnostic imaging system would.

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

• Not Applicable / Not Provided: This device is a physical infusion pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is relevant.

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

• Not Applicable / Not Provided: No performance study with a "ground truth" is described in the document.

8. The sample size for the training set

• Not Applicable / Not Provided: As this is an electromechanical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning.

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

• Not Applicable / Not Provided: This question is not relevant for the type of device and submission provided.

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PainPump2 is an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous, or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump II unit by the physician. The PainPump II is contraindicated for infusion of blood and blood products, insulin, or life-supporting medication.

The Stryker PainPump2 is intended an electromechanical pump which delivers a controlled amount of medication to the patient for the purpose of managing pain. The pump delivers medication using one or both of the following drug delivery profiles: an hourly flow rate and a bolus PCA (patient controlled anesthetic) dosing option. Routes of administration may be intraoperative, subcutaneous or percutaneous. Dosage rates and patient lock out times are programmed into the PainPump2 unit by the physician.

This document, K030885, concerns a 510(k) premarket notification for the Stryker PainPump2. It is a submission for substantial equivalence to legally marketed predicate devices, not a study proving device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available within this document.

Here's a breakdown of the available information:

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

This document does not contain a table of acceptance criteria or reported device performance. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document does not describe a clinical study or a test set with sample sizes.

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 document does not describe the establishment of a ground truth by experts.

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

Not applicable. This document does not describe an adjudication method for a test set.

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 document is for an electromechanical infusion pump and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This is not an AI or algorithm-based device.

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

Not applicable. This document does not refer to a ground truth as it pertains to a performance study.

8. The sample size for the training set

Not applicable. There is no mention of a training set for an algorithm.

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

Not applicable. There is no mention of a training set or ground truth for it.

Summary of what the document does provide:

• Device Name: Stryker PainPump2
• Intended Use: An electromechanical pump to deliver a controlled amount of medication for pain management, using hourly flow rates and/or bolus PCA dosing. Routes of administration can be intraoperative, subcutaneous, or percutaneous.
• Contraindications: Infusion of blood products, insulin, or life-supporting medication.
• Regulatory Basis: The submission is a 510(k) premarket notification, seeking substantial equivalence to existing infusion pump systems marketed by I-Flow Corporation.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new safety and efficacy concerns compared to existing devices.

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