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The MP 101 Micropump is a battery-operated portable infusion pump designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

MP 101 is not indicated to infuse blood.

Ambulatory Infusion Pump, battery operated, for use with any syringe type from 10 ml to 20 ml, set at a particular speed. The LCD and units are displayed on the front panel. The Pump has an up-down-enter keyboard user interface

The provided document describes the Micropump MP-101, an ambulatory infusion pump, and its clearance process through a 510(k) submission to the FDA. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a dedicated study to prove it.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical validation study report might. It instead states:

• Acceptance Criteria (Implied): The device "will meet specified requirements and is substantially equivalent to the predicate devices." This implies that the performance of the Micropump MP-101 should be comparable to or not significantly different from the A. Cane S.r.l. Crono H and Smiths Graseby MS-16 (K830423) in key aspects like flow rate accuracy and safety.
• Reported Device Performance:
  • "Performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices."
  • "Product Safety testing demonstrates single fault condition for software/hardware interaction."
  • "Software safety tests demonstrate that alarms meet safety specifications."
  • "An enhanced safety feature of the Proposed device uses a magnetic drum and two hall-effect sensors."
  • "The devices meet the IEC60601-1 standard covering the single fault condition and IEC60601-2-24, except for clause 54.101 which is addressed by both manufacturer with similar counter measures..."
  • It mentions "flow rate reading, accuracy and materials are identical to the Predicate devices."
  • "Infusion Rate range: 01 to 99 mm/Hr" (same as predicates).

Summary of Implied Acceptance Criteria & Performance:

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

The document does not provide details on specific sample sizes for performance testing. The provenance of the data is not explicitly stated beyond the submitter being "Micrel Medical Devices, S.A." in Greece. It is implied that the testing was conducted by the manufacturer for the purpose of the 510(k) submission. There is no indication whether the data is retrospective or prospective, though performance testing for regulatory submission is typically prospective.

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

This information is not provided. The document focuses on technical safety and performance characteristics compared to predicate devices, not on human-interpreted ground truth from experts for diagnostic purposes.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This information is not provided. The nature of the device (infusion pump) suggests that technical performance parameters (like flow rate accuracy) would be measured by instruments rather than requiring expert 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

An MRMC study was not done. This device is an infusion pump, which is a hardware medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable.

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

This concept is not applicable in the context of an infusion pump. The device itself is "standalone" in its operation. However, the performance is in the context of delivering medication, not in generating an "algorithm only" output that would then be evaluated by a human. Performance studies focus on the pump's mechanical and electronic accuracy and safety.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For an infusion pump, the "ground truth" would be objective, measurable physical parameters. Examples would include:

• Measured flow rate: Compared against the programmed flow rate.
• Alarm functionality: Verification that alarms trigger correctly under specified conditions (e.g., occlusion, air-in-line, low battery).
• Syringe compatibility and detection: Verification that the pump correctly identifies and works with specified syringe types.
• Safety standards compliance: Verification against specific clauses of standards like IEC60601-1 and IEC60601-2-24.

The document implicitly states that these types of "ground truth" were used through phrases like "flow rate reading, accuracy... are identical to the Predicate devices" and "Product Safety testing demonstrates single fault condition... Software safety tests demonstrate that alarms meet safety specifications."

8. The Sample Size for the Training Set

This information is not applicable. The Micropump MP-101 is a conventional medical device whose performance is based on its engineering and design, not on machine learning or AI that would require a "training set" of data.

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

This information is not applicable, as there is no "training set" for this type of device.

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