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The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.

The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order: Chamber 1

Here's an analysis of the provided text regarding the AutoDose™ Infusion System, focusing on acceptance criteria and the supporting study information:

Key Takeaways from the Document:

• This submission is a 510(k) for substantial equivalence, meaning the device is being compared to an existing, legally marketed predicate device (itself, but with a new "for use with" claim). This type of submission often relies on demonstrating that the new use doesn't introduce new safety or effectiveness concerns, rather than comprehensive standalone clinical trials or AI performance evaluations.
• The document describes a physical medical device (an infusion system) and its accessories, not an AI/software as a medical device (SaMD). Therefore, many of the typical AI-specific criteria (like expert consensus, adjudication, MRMC studies, training set details) are not applicable to this document.
• The performance criteria are related to the physical function of the infusion system, device compatibility, and solution stability.

Acceptance Criteria and Study Information for the AutoDose™ Infusion System

Given that this is a 510(k) for an infusion system and not an AI/software device, the request for AI-specific metrics (such as MRMC, standalone algorithm performance, number of experts, etc.) is not directly applicable. However, I will interpret the request in the context of the provided document by extracting the performance criteria and how the device met them.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical 'sample size' in the context of rigorous clinical trials. The document refers to "tests were performed" and "performance testing...verified." For a physical device like this, testing typically involves multiple units or cycles to demonstrate reliability and meet specifications. Specific numbers of units tested or cycles run are not provided.
• Data Provenance: Not applicable in the context of human data. The testing was performed on the device itself and the solutions in question (0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP). The "data" are results from physical and chemical tests.

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

• Not Applicable. This is a physical device, and "ground truth" as it applies to expert interpretation of medical images or patient data (which is relevant for AI devices) does not apply here. The "ground truth" is established through engineering and chemistry standards (e.g., USP monographs, pressure gauges, flow rate measurements).

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/software device, there is no expert adjudication process for image interpretation or clinical decision-making. Performance is determined by direct physical measurement and chemical analysis against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is designed to evaluate how human readers' diagnostic performance changes with and without AI assistance. This concept is not applicable to a physical IV infusion system.

6. Standalone (Algorithm Only) Performance

• Not Applicable. This device is hardware for infusion. There is no standalone "algorithm" in the sense of an AI model to evaluate without human-in-the-loop performance. Its "performance" is its physical ability to infuse fluids correctly.

7. Type of Ground Truth Used

• The "ground truth" for the performance claims in this document is based on:
  • USP 24/NF 19 monographs: For demonstrating compatibility and stability of the solutions.
  • Engineering specifications/measurements: For infusion flow rates, predetermined volumes, and pressures (e.g., pressure not exceeding 25 psi).
  • Biocompatibility testing standards: For confirming material safety in contact with fluids.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI model requiring a "training set" of data. Device development and testing follow engineering design and validation processes, not machine learning training.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided information.

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The AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.

The AutoDose Infusion System is a general use infusion system that is intended to infuse intravenous solutions of predetermined volumes in an order based on the AutoDose Bag configuration. It is intended that this system will infuse multiple intravenous solutions of predetermined volumes without user interaction. The system is comprised of the AutoDose, a mechanical roller device design in conjunction with the AutoDose Bag, a multiple chambered IV container, and the AutoDose Bag Administration Set. The single use multiple chambered IV container is designed to fit within the reusable AutoDose device with the end user pushing a start button once the AutoDose Bag Administration Set has been connected to the patient's indwelling access device. The AutoDose Bag Administration Set size will determine the system flow rate and will be offered in rates of 50 ml/hr, 100 ml/hr, and 200 ml/hr.

It is intended that the AutoDose Bag be provided empty and sterile to the end user. The AutoDose Bag can then be appropriately filled on the order of a physician by a pharmacy. The filling of the AutoDose Bag is performed using standard procedures, equipment and the AutoDose Filling Fixture. The AutoDose Filling Fixture is a tool developed to hold the AutoDose Bag for the pharmacist during the filling process. A clamp is automatically activated by the AutoDose Filling Fixture to securely close the bag after it has been filled.

The AutoDose Infusion System has been designed to simplify user interaction in the administration of multiple solutions safely with a reduction of a number of steps and a number of supplies typically used by healthcare providers.

The AutoDose Bag and the AutoDose Bag Administration Set will be sterilized per AAMI guidelines to a 10 6 sterility assurance level (SAL). Pyrogenicity will be LAL assessed per production lot in accordance with USP guidelines.

The provided text describes the AutoDose Infusion System and its premarket notification, but it does not contain the detailed acceptance criteria or the full study report that would enable a comprehensive description of how the device meets all acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the AutoDose Infusion System was evaluated to verify it met product specifications. It lists key performance characteristics that were tested.

Missing Information: The specific quantitative acceptance criteria (e.g., "Flow Rate Accuracy ±5%") and the exact measured performance values are not provided in this summary. The document only states that the device "performed to the requirements in the specifications."

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

The document mentions that "The AutoDose, AutoDose Bag and AutoDose Administration Set was tested". However, it does not specify the sample size used for this testing (e.g., number of units, number of tests performed).

Data Provenance: The study was conducted at the "Final Design Phase" by the manufacturer, Tandem Medical, Inc. This indicates it was an internal validation study and likely prospective, as it was done to verify product specifications before market release. The country of origin is Tandem Medical, Inc.'s location: San Diego, CA, USA.

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

This is not applicable as the device is an infusion system, and its performance is evaluated against engineering specifications (e.g., flow rate, pressure) rather than subjective human assessment requiring expert consensus on a 'ground truth'. The "ground truth" here is the objective measurement of device output against predefined engineering and performance standards.

4. Adjudication Method for the Test Set

This is not applicable for a device that relies on objective physical measurements against engineering specifications. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done, nor would it be relevant for this type of device. MRMC studies are used to evaluate the impact of a new diagnostic technology on human reader performance, typically in fields like medical imaging. The AutoDose Infusion System is a therapeutic device with objective performance metrics.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The performance data discussed (Average Flow Rate, Flow Rate Accuracy, Maximum Infusion Pressure, Residual Volumes) refers to the standalone performance of the AutoDose Infusion System. The system's design is described as "simplifying user interaction" and infusing "without user interaction" once initiated, suggesting its performance is primarily intrinsic to the device's mechanics and design. The testing would therefore be focused on the device's ability to meet its specifications independently.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of the AutoDose Infusion System is based on objective engineering and product specifications. This involves direct measurement of physical parameters like flow rate, pressure, and residual volumes using appropriate calibration and measurement equipment.

8. Sample Size for the Training Set

This information is not applicable in the context of the provided document. The AutoDose Infusion System is a mechanical device, not an AI/machine learning algorithm that requires a "training set" of data. The "design phase" would involve engineering and prototyping, possibly with iterative testing, but not in the sense of an ML training set.

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

This question is not applicable as there is no "training set" for this type of mechanical medical device.

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