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The ambIT® "PreSet" Ambulatory Infusion Pump is intended for use by surgeons and anesthesiologists for the perioperative and post operative infusion of local anesthetics and narcotics for pain management and regional anesthesia.

Routes of administration include intravenous, subcutaneous, intramuscular, perineural and epidural.

The ambIT® "PreSet" Ambulatory Infusion Pump 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.

Sorenson Medical's ambIT® PreSet Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The amblT® PreSet Ambulatory Infusion Pump differs only slightly from the Palm Pump (K002434) already marketed. Changes have been made to that pump to incorporate a modified printed circuit board and a software revision to provide for ease of pump programming by the user.

This 510(k) summary describes a submission for an infusion pump, which is a Class II medical device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or specific acceptance criteria with quantifiable performance metrics typically seen in AI/ML device submissions.

Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be definitively answered from the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in table format. The evaluation focused on non-clinical tests to verify that design modifications met "documented performance and safety requirements."

• Acceptance Criteria (Implicit): The device (ambIT® PreSet Ambulatory Infusion Pump) must perform safely and effectively for volumetric delivery of medicines/fluids at preset rates and volumes, similar to its predicate devices, particularly the Palm Pump (K002434), and meet all design requirements following software and PCB modifications.
• Reported Device Performance: "All tests will be conducted according to written test protocol, with defined test expectations and documented conclusions." The document claims that "documented verification and validation testing were defined and conducted... to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device." However, no specific performance values (e.g., accuracy of flow rate, battery life, alarm effectiveness) are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not specified in the provided text. The testing mentioned refers to "verification and validation testing" but does not indicate a sample size for any specific clinical or non-clinical test sets.
• Data Provenance: Not specified. The testing was conducted by Sorenson Medical, Inc.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. This device is an infusion pump, and its assessment focuses on engineering performance and safety rather than interpretative tasks requiring expert-established ground truth (like in medical imaging or diagnostic algorithms).

4. Adjudication Method for the Test Set:

Not applicable for a device of this nature. The "testing" referred to is performance and safety verification of the pump's mechanical and software functions, not interpretative data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret medical data, and the AI's impact on their performance is evaluated. This is an infusion pump, which does not involve human interpretation of complex medical data during its primary function.

6. If a Standalone Performance Study Was Done:

The document mentions "documented verification and validation testing were defined and conducted" to verify the design modifications met performance and safety requirements. This implies standalone testing related to the device's functional performance (e.g., accuracy of drug delivery, reliability of software). However, the specific methodology or quantitative results of such standalone functional testing are not detailed in this summary. The focus is on demonstrating substantial equivalence via design modifications and non-clinical testing.

7. Type of Ground Truth Used:

For an infusion pump, "ground truth" would relate to its engineering specifications and the accurate delivery of fluids.

• Ground Truth (Implicit): The ground truth for this device would be established by:
  • Engineering Specifications: Pre-defined standards for flow rate accuracy, pressure limits, alarm thresholds, battery performance, etc.
  • Bench Testing/Metrology: Using calibrated equipment to measure pump output, confirm programmed rates, and verify safety features against these specifications.
  • Predicate Device Performance: The performance characteristics of the legally marketed predicate devices (e.g., Palm Pump K002434) serve as a de-facto "ground truth" or benchmark for substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The device is a traditional electro-mechanical infusion pump with software.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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The ambIT™ Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

Sorenson Medical's amblT™ Continuous Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for continuous fluid delivery to specified output requirements

This document is a 510(k) premarket notification for the ambIT™ Continuous Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device (Palm Pump, K002434) rather than a comprehensive de novo validation study. Therefore, much of the information typically present in a study proving a device meets acceptance criteria (like specific acceptance criteria values, detailed study designs, expert involvement, and ground truth methodologies) is not explicitly provided in the provided text.

However, based on the information available, here's a breakdown of what can be inferred and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with specific numerical targets in the provided text. Instead, the general requirement is that the device "met documented performance and safety requirements specified for the new device" and that "the design modifications made to the subject device met documented performance and safety requirements."

The reported device performance is that the modifications were "fully validated" and "do not raise issues of safety and effectiveness." The core performance claim is "continuous volumetric delivery... at a consistent volume for prescriptive treatment by a physician," which is the intended use shared with the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "All tests were conducted according to written test protocol, with defined test expectations and documented conclusions." However, no specific sample sizes for the test sets are provided.

Given that it's a 510(k) for an infusion pump, the "tests" would likely involve laboratory-based performance testing (e.g., flow rate accuracy, occlusion detection, battery life) rather than clinical data from human patients. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical studies involving patient data is not directly applicable here. The data would be generated in a controlled laboratory environment by Sorenson Medical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a product like an infusion pump, "ground truth" for performance testing is typically established by engineering specifications and objective measurements using calibrated equipment, not by human expert assessment in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not provided and is generally not relevant for device performance testing of this nature. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading), to resolve discrepancies between multiple human reviewers.

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 MRMC comparative effectiveness study was done. This device is an infusion pump, not a diagnostic AI system that would involve human readers interpreting output. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of an infusion pump. While the device has a "microcomputer-controlled" system and "software revision," it is a standalone medical device that operates autonomously to infuse fluids, not an "algorithm" in the sense of a diagnostic or assistive AI that would be evaluated for human-in-the-loop vs. standalone performance. The device itself is the "standalone" entity.

7. The Type of Ground Truth Used

The ground truth for the verification and validation tests would have been engineering specifications and measurable performance parameters (e.g., flow rate accuracy, pressure limits, alarm triggers, battery life). These are objective, quantifiable criteria established during the device's design and development, rather than subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is not directly applicable in the traditional sense of a "training set" for machine learning with large datasets. While the software was revised, it's not described as an AI/ML model being "trained" on data. Any "training" would refer to the internal development and testing cycles of the software and hardware, where parameters are tuned and verified against expected outputs, using internal test data or simulations, rather than a distinct "training set" used for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" and associated ground truth is not applicable in the context of this device in the same way it would be for an AI/ML product. The ground truth for the device's design, software development, and functional verification would have been established through engineering specifications, design requirements, and standard testing methodologies to ensure the device performs according to its intended function (e.g., precise fluid delivery).

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The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.

Sorenson Medical's amblT™ Intermittent Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for intermittent fluid delivery to specified output requirements.

The provided text describes a 510(k) submission for the ambIT™ Intermittent Ambulatory Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device and details non-clinical tests conducted to verify its performance and safety. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC) with human readers.

Here's a breakdown of what can be extracted and what is missing:

Information Extracted from the Document:

• Study Type: Non-clinical verification and validation testing.
• Ground Truth for the Test Set: "Documented performance and safety requirements specified for the new device." These requirements form the ground truth against which the device's performance was compared.
• Sample Size for the Training Set: Not applicable, as this is pre-market non-clinical testing, not an AI/ML device training.
• How the ground truth for the training set was established: Not applicable for the same reason.

Missing Information (and why it's missing based on the document):

1. Table of acceptance criteria and the reported device performance: The document states that "requirements and results of documented verification and validation testing were defined and were conducted," but it does not provide the actual acceptance criteria or the specific performance results in a table format. It only states that the device "met documented performance and safety requirements."
2. Sample size used for the test set and the data provenance: The document mentions "All tests were conducted according to written test protocol," but it does not specify the sample size (e.g., number of devices tested, number of hours of operation, number of cycles). Data provenance (country of origin, retrospective/prospective) is also not applicable as these are non-clinical hardware/software tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. The "ground truth" here refers to pre-defined engineering and safety specifications for the pump's performance rather than expert-labeled data.
4. Adjudication method for the test set: Not applicable. Tests were against engineering specifications, not expert consensus 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: Not applicable. This device is an infusion pump, which does not involve human "readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical tests" conducted on the device, which inherently means standalone performance testing against pre-defined specifications. The entire submission focuses on the device's inherent performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the ground truth was "documented performance and safety requirements specified for the new device" (i.e., engineering and functional specifications for proper fluid delivery).

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence for an infusion pump through standard engineering verification and validation testing. It is not an AI/ML-driven diagnostic device, which is why much of the requested information (like expert input, MRMC studies, training sets, etc.) is not present or applicable. The document confirms that non-clinical tests were performed and that the device "met" its specified performance and safety requirements, but the specific details of these criteria and results are not included in this summary.

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All Pumps are for the infusion of fluids and medications into a body. The 30 Pump is for infusion at a continuous low flow rate. The 200 Pump is for intermittent doses with a keep vein open (KVO) rate between doses, as well as continuous or KVO only capabilities. The PCA Pump is for pain management by intravenous and epidural infusion of fluids and medications. The PCEA Pump is marketed for epidural infusion of fluids and medication for pain management; but the PCEA model can also be used for intravenous infusion as well.

Not Found

I'm sorry, but this document does not contain the information required to fulfill your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (pumps for fluid and medication infusion). It confirms substantial equivalence but does not include details about acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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