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The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump is a medical device used to pump fluids into a patient in a controlled manner. It is suitable for delivering a wide range of infusions, including medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia) operating modes. It is also compatible with the majority of IV procedures and most standard IV sets.

This 510(k) summary describes a medical device, an infusion pump, which does not typically involve the types of acceptance criteria and study designs that are common for AI/ML-driven diagnostic devices (e.g., those involving image analysis or predictive analytics). Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from the provided text.

Specifically, there is no mention of algorithms, AI, machine learning, ground truth, experts establishing ground truth, training sets, test sets, or comparative effectiveness studies with human readers. The document focuses on the substantial equivalence of a physical medical device (an infusion pump) based on its technological characteristics and performance testing against predicate devices.

However, I can extract information related to the device's function and the general nature of its performance evaluation, as much as is available in the provided text.

Acceptance Criteria and Study for Definitive Medical Technologies AFF (MARK I) Volumetric Infusion Pump

Based on the provided 510(k) summary, the device is an infusion pump, and its acceptance criteria and study are focused on its mechanical and functional performance, safety, and substantial equivalence to existing predicate devices.

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

   The document does not provide specific quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Extensive testing has confirmed the performance and safety of the AFF (MARK I) Volumetric Infusion Pump" and that it is "substantially equivalent to its predicate devices" with respect to technology and safety features.

   • Note: For this type of device, performance criteria typically relate to flow rate accuracy, occlusion pressure detection, air-in-line detection, alarm functions, battery life, material biocompatibility, electromagnetic compatibility (EMC), and mechanical durability, as outlined in relevant standards for infusion pumps (e.g., IEC 60601-2-24). However, these specific details are not present in the 510(k) summary.

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 for this type of device and submission. The "test set" in this context would refer to the physical testing of the infusion pump itself, not a dataset for an algorithm. The document does not specify the number of units tested, the origin of such testing, or whether it was prospective or retrospective.

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. The concept of "ground truth" established by experts for a test set is relevant to diagnostic or AI/ML devices. For an infusion pump, performance is measured against engineering specifications and international standards, not against expert consensus on a dataset.

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

   Not applicable. This concept pertains to resolving discrepancies in expert interpretations of data, which is not relevant to the performance evaluation of an infusion pump.

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. An MRMC study involves human readers (e.g., radiologists, pathologists) interpreting cases, often with or without AI assistance, to assess diagnostic performance. This is irrelevant for an infusion pump, which is a physical device for delivering fluids.

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

   Not applicable. There is no mention of an algorithm or AI component in this infusion pump.

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

   Not applicable. The performance of an infusion pump is assessed against its functional specifications and safety standards, not against "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

   Not applicable. There is no training set or ground truth for a training set discussed.

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