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The AutoMed 3200 ambulatory infusion pump with integrated administration set is intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. The AutoMed 3200 infusion pump is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The AutoMed 3200 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set, AM 330, and accessories are part of the overall system. The system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

This document describes the AutoMed 3200 infusion pump, a rotary peristaltic pump intended for general infusion use, including patient-controlled infusion. The device is significantly similar to several predicate devices. The information provided does not include acceptance criteria or a study that proves the device meets specific performance criteria. The document is primarily a 510(k) premarket notification summary and an FDA clearance letter for the device, focusing on its intended use and substantial equivalence to existing products.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating device performance based on the input text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts used for ground truth or adjudication methods.
4. Information on multi-reader multi-case (MRMC) studies or effect sizes.
5. A standalone algorithm performance study.
6. The type of ground truth used (e.g., pathology, outcomes data).
7. Sample size for a training set.
8. How ground truth was established for a training set.

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The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir is intended for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The AutoMed 3000 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set AM 330 and accessories are part of the overall system. The system is suitable for use as ambulatory devices and is intended for use in the hospital, home environment or alternative care sites.

This 510(k) summary for the AutoMed 3000 infusion pump does not contain the detailed acceptance criteria or a study proving that the device meets those criteria, nor does it provide information relevant to AI/ML device evaluations.

The document is a traditional 510(k) submission for an infusion pump, which focuses on demonstrating substantial equivalence to legally marketed predicate devices based on device description, intended use, and technological characteristics. The provided text is a summary of the 510(k) notification and the FDA's response letter determining substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI comparative effectiveness studies. These are not typically part of a 510(k) summary for a non-AI medical device like an infusion pump.

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The AutoMed 3300 and 3400 ambulatory infusion pumps and dedicated administration sets and accessories are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intraoperative (soft tissue / body cavity) sites. The AutoMed systems are also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The AutoMed Systems presented in this product notification include the AM 3300 and AM 3400 rotary peristaltic pumps and associated dedicated administration sets (AM 320, AM 330 and AM 340) and accessories. The systems are suitable for use as ambulatory devices and that are intended for use in the hospital, home environment or alternative care sites.

This looks like a 510(k) submission for infusion pumps (AutoMed 3300 and 3400). It focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than a clinical study evaluating specific performance claims or AI integration.

Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI performance cannot be extracted from the provided text because these elements are not present. The document is primarily a regulatory submission demonstrating substantial equivalence, not a clinical performance study.

Here's why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: This document describes the device and its intended use but does not present specific performance metrics or acceptance criteria that a study would aim to meet.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all aspects of a clinical or performance study designed to evaluate a device against specific metrics. This document does not describe such a study.
• Type of Ground Truth: This is relevant for studies where a device's output is compared against a definitive standard. This document does not describe such a comparison.
• Training Set Sample Size and Ground Truth Establishment (Relevant for AI): This document does not mention any artificial intelligence (AI) component in the infusion pumps. Therefore, information about training sets or how ground truth for training was established is not applicable.

In summary, the provided text is a 510(k) premarket notification for infusion pumps, establishing substantial equivalence, and does not contain the details of a performance or clinical study with the elements you've requested.

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