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Harvard 1: The Harvard 1 is designed to provide, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less.

Harvard 1 with PCA: Harvard 1 with PCA is designed provide patient controlled analgesia, intravenous, intra-arterial, or epidural delivery of drugs, blood or blood products, or other parenteral fluids when administered by a health care professionals such as physicians and nurses. The Harvard 1 with PCA is compatible for use inside the MRI room when mounted outside the 150 gauss line with MRI systems of 1.5 tesla or less.

The Harvard Pump is intended for the delivery of parenteral fluids. It accommodates syringe sizes from 1 through 60 ml from multiple manufacturers. Its user interface consists of an active matrix color LCD display with two rotary knobs for controling pump operation. The rotary Data Entry knob provides scrolling and selection of data and memu items as well as state selection. The knob is turned to scroll, and pressed for selection. The rotary Function knob controls the state (Purge, Setup, Stop, Run and Bolus) of the pump. The pump has several microprocessors, one master which controls operation of the device, one pump processor which controls the operation of the motor and sensors specific to the syringe drive mechanism, and one supervisor which monitors the status of the system. The pump has sensors which permit its microprocessors to determine the syringe size loaded, determine if the syringe plunger is securely captured by the pusher block assembly, measure occlusion force and calculate the proper rate and distance the plunger of the syringe must travel to cause an infusion of fluid at a given rate and volume. The pump provides for bidirectional remote communications via an RS232 serial port. The Harvard 1 with PCA extends the Harvard 1 functionality to include Patient Controled Analgesia capability through the addition of an optional PCA pendent and PCA cover and lock assembly. PCA capability allows the patient to request delivery of a dose of pain medication from a regimen prescribed by the physician. The pump may be used with The Harvard Library, an optional computer program which runs on MS Windows based personal computers. The Harvard Library is capable of downloading and uploading drug information in the form of a drug library to and from the pump. After downloading, the drug library is resident in flash memory within the pump, enabling the pump to provide drug specific defaults for drug concentrations, pumping rates, bolus amounts, and bolus times. Barcode versions of the pump provide a laser scanning barcode reader is used to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. In an effort to minimize user input errors.

The provided text describes a 510(k) premarket notification for the Harvard 1 Syringe Pump and Harvard 1 with PCA Syringe Pump, not an AI/ML powered medical device. Therefore, a direct response to many of the requested criteria (such as MRMC studies, training set details, expert qualifications for ground truth) is not applicable or cannot be extracted from the document.

However, I can extract information related to performance testing and acceptance criteria as much as possible for a traditional medical device like a syringe pump.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Performance testing using prototype pumps". It does not specify a numerical sample size for the test set.

• Data Provenance: Not explicitly stated, but the testing was conducted on "prototype pumps" developed by Harvard Clinical Technology Inc. This implies internal testing.
• Retrospective/Prospective: Implied prospective, as it was "performance testing" of prototypes.

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

Not applicable. For a syringe pump, performance is typically measured against established physical and engineering standards, not through expert consensus on qualitative data.

4. Adjudication Method for the Test Set

Not applicable. Performance testing for a syringe pump relies on objective measurements against engineering standards, not an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This is not an AI/ML powered device, and therefore, MRMC studies are not relevant.

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

The device is a physical syringe pump. Its performance is inherently "standalone" in terms of its mechanical and electronic functions. The performance measurements mentioned (gravimetric rate accuracy, occlusion system) relate to the device's intrinsic operation.

7. The Type of Ground Truth Used

The ground truth for the performance testing cited (Gravimetric Rate Accuracy and Occlusion System) would be based on:

• Physical and Engineering Standards: Specifically, the document references "IEC-601-2-24 - Particular requirement for safety of infusion pump," indicating that the device performance was measured against the requirements of this international standard.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable. No training set for an AI/ML model is involved.

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