Search Results

The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.

The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set. Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped. Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy. Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use.

The Nipro Amigo® Insulin Pump's acceptance criteria and performance are detailed in the provided 510(k) summary. The submission argues for substantial equivalence to predicate devices based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the proposed Amigo® Insulin Pump's performance characteristics directly against three predicate devices. The implicit acceptance criterion is that the new device performs "similarly" or "favorably" compared to the predicate devices, with noted minor differences not being clinically significant.

The table below summarizes key relevant performance characteristics from the comparison table (Table 2 in the original document) that relate to device functionality and safety. The values for the "New Amigo® Insulin Pump (This Submission)" column indicate the reported device performance.

The study supporting these claims is described under "NON-CLINICAL PERFORMANCE DATA" and involved testing against various IEC and ISO standards.

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

The document describes non-clinical performance data based on engineering tests, not human subject testing. Therefore, there is no "test set" in the context of patient data or clinical trials, nor is there data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted on the device itself.

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

Not applicable. This was a non-clinical, engineering-based performance assessment against established standards, not a ground truth established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, engineering-based performance assessment, not requiring adjudication of human expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technical specifications and non-clinical performance testing of the device itself, not on human-in-the-loop performance or reader improvement.

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

Yes, a standalone performance assessment was done. The "NON-CLINICAL PERFORMANCE DATA" section describes the testing of the Amigo® Insulin Pump for its electrical safety and infusion pump performance and safety according to various international standards (IEC and ISO). This testing evaluates the device's inherent functional characteristics without human intervention beyond setting up the tests.

7. The type of ground truth used

The "ground truth" for this submission are the performance specifications and safety requirements defined by international standards (IEC 60601-1, IEC 60601-2-24, IEC 60601-1-2, IEC 60601-1-4, ISO 14971) and the performance characteristics of legally marketed predicate devices. The new device's performance was measured against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a medical device submission based on product engineering and testing, not an AI/algorithm submission that would involve a "training set" of data for machine learning.

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

Not applicable, as there is no "training set."

Ask a specific question about this device

The Amigo Insulin Pump is intended for the subcutaneous infusion of insulin.

The Amigo Insulin Pump is a small, lightweight, battery-operated programmable Insulin infusion pump. The pump houses a replaceable Nipro GlucoPro™ single-use insulin syringe containing up to 300 units of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set.

This document is a 510(k) summary for the Amigo Insulin Pump. It describes the device and its intended use, and argues for its substantial equivalence to a previously cleared device, the GlucoPro EVA Pump (K013309).

Based on the provided information, the following answers can be given:

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

The document does not provide acceptance criteria or detailed device performance metrics in the way one would typically find for an AI/software device undergoing validation studies with specific performance targets (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GlucoPro EVA Pump K013309) by comparing key characteristics. The "performance" in this context refers to the functional equivalence of the Amigo Insulin Pump to the predicate device.

Study Proving Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence. It does so by directly comparing the Amigo Insulin Pump's specifications and features to those of the legally marketed predicate device, the GlucoPro EVA Pump (K013309). The FDA's letter (K050312) confirms that based on this comparison, the device is deemed substantially equivalent. This is not a clinical study in the traditional sense, but rather a regulatory comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided in the given document. The submission is for a physical medical device (an insulin pump), not an AI/software device that would typically rely on a "test set" of data for performance evaluation in the context of AI. The "test" here is the comparison of device specifications to a predicate.

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)

This information is not applicable/not provided. As above, this is a physical device submission, not an AI/software validation involving expert ground truth for a test set.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. This type of study is relevant for AI-assisted diagnostic or decision-making tools, not for an insulin pump.

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

This information is not applicable/not provided. The device is an insulin pump; it does not perform an "algorithm only" function in the way an AI diagnostic tool would. It is inherently a "human-in-the-loop" device in that a patient or caregiver programs and uses it.

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

This information is not applicable/not provided. In the context of "substantial equivalence" for a physical device, the "ground truth" is established by the predicate device's cleared specifications and performance, which the new device aims to match. There isn't an external "ground truth" in the AI sense.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical insulin pump, not an AI model that undergoes training on a dataset.

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

This information is not applicable/not provided.

Ask a specific question about this device

The Glucopro syringe is intended for use in the subcutancous infusion of insuline to tast "Inte GlucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syringe. The insulin is infused from an external infusion pump.

The Glucopro Syringe is a medication reservoir placed within an infusion pump and attached to an infusion set for infusion of medicine solutions, such as insulin. The materials used for the components include: stainless steel; polypropylene; and, silicone. All of these materials are typically used in medical devices.

The provided text is a 510(k) summary for the Glucopro™ Syringe, a medical device intended for subcutaneous infusion of medicine solutions, such as insulin. This document does not contain information on acceptance criteria or a study proving device performance against such criteria. It is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data from a specific study.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information based on the given text.

The document primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Product Code.
• Contact Information: Manufacturer and contact person.
• Date of Summary Preparation.
• Legally Marketed Substantially Equivalent Device (Predicate Device): Disetronic Medical Systems AG, 3.15mL cartridge.
• Description of Device: Materials used (stainless steel, polypropylene, silicone) and general function (medication reservoir within an infusion pump).
• Intended Use: Subcutaneous infusion of medicine solutions, such as insulin.
• Comparison of Technical Characteristics: Stating similarity to legally marketed devices.
• FDA Correspondence: Official letter acknowledging review and determination of substantial equivalence.
• Indications for Use Statement: Specifies the use with an external infusion pump and connection to an infusion set (e.g., Insta GlucoPro) inserted into subcutaneous tissue.

Ask a specific question about this device

The GlucoPro Infusion Pump is intended for the subcutaneous infusion of insulin.

The Gluc. Pro Infusion Pump is intended for use with the disposable compatible infusion sets and the GlucoPro syringe for subcutaneous delivery of insulin. The catheter or needle of the compatible infusion set is inserted into the subcutaneous tissue of the user and is connected to the syringe that it the drug reservoir. The syringe is installed in the infusion pump and attached by means of screw threads. The medicine solution is delivered and infused info the user continuously. The user sets continuous basal infusion rate and selects bolus delivery. The infusion punip contains many safety teatures including alarms to indicate infusion error or system malfunction.

The pump is 91 mm wide, 52 mm in leight, and 21 mm in depth. It weighs 80 grams. The power is supplied by a Duracell CR-2 (3V) ba tery (or equivalent) that should last 30 - 60 days.

The provided document is a 510(k) summary for the Glucopro Infusion Pump, submitted to the FDA in 2002. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices.

However, this document does not contain the specific information required to answer your request about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices, primarily on technical characteristics and intended use, rather than presenting a detailed performance study with quantifiable acceptance criteria.

Therefore, I cannot populate the table or provide the specific details you've requested based on the information provided in this 510(k) summary. The document does not describe a clinical study or a study specifically designed to prove device performance against predefined acceptance criteria for a new AI or diagnostic device. It's a regulatory document for an infusion pump, which typically relies on comparisons to predicate devices and engineering/bench testing rather than the detailed clinical performance studies you're inquiring about.

I can tell you the following based on the provided document:

• Device Name: Glucopro Infusion Pump
• Intended Use: For the subcutaneous infusion of insulin.
• Predicate Devices: Disetronic H-Tron Plus V100 infusion pump (K973044) and Minimed Model 507 (K960001).
• Study Type: This document describes a 510(k) premarket notification, which is a process to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo study proving novel device performance against acceptance criteria. It primarily compares technical characteristics and intended use.

Ask a specific question about this device

Ask a specific question about this device