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The Stryker PainPump 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 through intramuscular or subcutaneous routes,

The Stryker PainPump 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 PainPump 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 through intramuscular or subcutaneous routes.

The Stryker PainPump 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 PainPump kit models are available in fill volumes from 120 to 270 cc and flow rates from 0.60 - 8.32 cc/hr. Each pump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories.

This document is a 510(k) premarket notification for the Stryker PainPump, which is a medical device for infusing medication. The document asserts the device's substantial equivalence to previously marketed devices rather than presenting a study to prove its performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from the provided text because it describes a regulatory submission, not a performance study.

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

Acceptance Criteria and Device Performance Study Information

Summary of the Document's Approach:

The provided text is a 510(k) Premarket Notification, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process does not typically involve conducting new large-scale clinical trials or detailed performance studies against specific acceptance criteria in the way a PMA (Premarket Approval) might.

Instead, the submission for the Stryker PainPump relies on:

• Comparison of Intended Use: The Stryker PainPump's intended use (delivering medication for pain management and/or antibiotic administration) is equivalent to existing infusion pump systems.
• Comparison of Technological Characteristics/Design: The document indirectly implies structural and functional similarity by stating it "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
• Comparison to Predicate Devices: The document explicitly names competitors' devices (Stryker, I-Flow Corporation, Sgarlato for pumps; Styker, I-Flow, and Sims Portex for catheters) as benchmarks for equivalence in intended use, safety, and effectiveness.

Therefore, the "study" proving the device meets criteria is effectively the 510(k) submission itself, where "meeting criteria" means demonstrating substantial equivalence to already approved predicate devices. The acceptance criteria in this context are those required by the FDA for 510(k) clearance, primarily proving that the device is as safe and effective as a legally marketed predicate device.

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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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