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The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting in programming insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump. It is intended to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-512).
The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.

The Medtronic MiniMed ParadigmPAL is data transfer software designated by Medtronic MiniMed to interface with hardware models 7304 (ComLink) and HS-3222 (Paradigm Link); personal computer and a Paradigm insulin infusion pump.
The ParadigmPAL system is designed for use with Medtronic MiniMed infusion pumps (model 512 and model 712).

The provided text is a 510(k) summary for the Medtronic MiniMed ParadigmPAL, model 7330, and related FDA correspondence. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement that would typically be found in a detailed study report. The document primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the given text. The K031541 filing is a submission demonstrating equivalence rather than a study with performance metrics against pre-defined acceptance criteria.

To elaborate, the document states:

• Device Description: The ParadigmPAL is data transfer software designed to interface with specific hardware models, personal computers, and Paradigm insulin infusion pumps.
• Intended Use: For patients at home and clinicians in a medical office setting to "program insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump" and "communicate with devices that utilize Paradigm pump compatible RF telemetry."
• Comparison to Predicate: The key difference from the predicate device (Com-Link™ Communication System) is the ParadigmPAL's ability to "upload of information to the pump" in addition to downloading the information, which the predicate device could only do.
• FDA Determination: The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.

This is a regulatory pathway that largely relies on demonstrating that the new device is as safe and effective as a legally marketed device, often without requiring new clinical performance studies if the technological characteristics and intended use are very similar.

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The Medtronic MiniMed Paradigm Model 712 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Paradigm Model 712 is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal bolus. This pump will include a bolus estimator feature that can be tailored to an individual user's insulin sensitivity, insulin to carbohydrate ratio, and target BG (Blood Glucose). Also, there is a BG reminder feature, allowing the user to set daily and post-bolus reminders to check BG readings. The insulin programming step size will allow users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units for basal delivery. The Model 712 accommodates a proprietary 3.0 ml reservoir. This new reservoir mates with the existing and future Paradigm infusion sets.

The provided text is a 510(k) premarket notification for the Medtronic MiniMed Paradigm Model 712 Insulin Pump. It establishes substantial equivalence to a predicate device (Medtronic MiniMed Paradigm Model 511 Insulin Pump) rather than presenting a standalone study with acceptance criteria and performance data.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document discusses the device's features, but not specific performance metrics against predefined acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set or data provenance details are mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information regarding ground truth establishment or experts is present.
• Adjudication method: Not applicable as no test set evaluation is described.
• Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
• Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not described.
• The type of ground truth used: No ground truth is discussed.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: Not applicable as no training set ground truth is discussed.

The document focuses on:

• Device Name: Medtronic MiniMed Paradigm Model 712 Insulin Pump
• Indications for Use: Continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
• Predicate Device: Medtronic MiniMed Paradigm Model 511 Insulin Pump
• Key Differences from Predicate: Larger case, software modifications including a Bolus Wizard feature (which assists users in calculating insulin boluses based on personalized settings like insulin sensitivity, insulin to carbohydrate ratio, and target blood glucose), and a 3.0 ml reservoir.
• Insulin Programming Step Size: 0.1 units for boluses and 0.05 units for basal delivery.

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Model 512 Insulin Pump: The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. BD Paradigm Link Glucose Monitor: The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellius in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertin. Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor: When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication, The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump's Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission. The BD Link Glucose Monitor can also serve as a radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.

The Paradigm Model 512 external insulin pump is an ambulatory, battery operated, rateprogrammable microinfusion pump, designed for continuous delivery of insulin. A reservoir is driven by a drive motor to deliver preset basal profiles and patient programmed bolus amounts of insulin through infusion sets into subcutaneous tissue. This pump incorporates new software improvements over the predicate model and is designed to allow installation of upgraded software with new features through radio frequency telemetry without the need to replace any pump components. The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device for use in the quantitative measurement of glucose in capillary blood collected from fingertips. The BD Paradigm Link™ is designed to be simple and easy to use. It provides accurate blood glucose test results in 5 seconds while requiring a very small (0.3 µL) sample. When the BD Paradigm Link Glucose Monitor is used together with the Medtronic MiniMed 512 External Insulin Pump, blood glucose test values obtained using the BD Paradigm Link Glucose Monitor can be automatically transmitted to the insulin pump for use in the pump's Bolus Wizard feature. Consumers or healthcare practitioners may also use the meter as a communication device to facilitate transfer of information between the pump and a personal computer.

This K030531 document is a 510(k) summary for the Medtronic MiniMed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Monitor. The document describes the devices and their intended use, and states that they were found substantially equivalent to predicate devices. However, this document does not include a study or acceptance criteria related to device performance.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on the provided text. The document focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results and acceptance criteria.

Missing Information from the Provided Text:

• Acceptance Criteria: The document does not specify any quantitative or qualitative acceptance criteria for the performance of either the insulin pump or the glucose monitor.
• Device Performance Data: No specific study data, results, or reported device performance metrics (e.g., accuracy, precision, clinical efficacy) are provided.
• Sample Size for Test Set: There is no mention of a test set sample size for a performance study.
• Data Provenance: Without a study, there's no data provenance to report.
• Number of Experts/Qualifications for Ground Truth: Not applicable as no performance study with ground truth establishment is described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and generally not applicable to the type of devices described (insulin pump and glucose monitor).
• Standalone Performance: While the functions of the devices are described, the document does not present data from a standalone performance study with specific metrics.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable as no machine learning algorithm development (with a training set) is described for the purpose of a performance study.
• How Ground Truth for Training Set was Established: Not applicable.

The provided document serves as a regulatory summary for substantial equivalence determination, not a detailed technical report on performance studies.

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For use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.

The Medtronic MiniMed Communication System is a data transfer system consisting of a hardware component designated by Medtronic MiniMed model number 7304 and a software component designated by model number 7311. The system is designed for use with Medtronic MiniMed infusion pump (model 511). The hardware component of the ComLink consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one female RS-232 compatible serial communications port. Data is downloaded via RF telemetry to transfer data from the pump to a personal computer. The Converts RF signals into RS-232 compatible electrical pulses, which are sent through a serial port to the PC.

The provided text is a 510(k) summary for the Medtronic MiniMed ComLink Communication System. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.

A 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. While this involves ensuring the new device is safe and effective, the detailed study design, performance metrics, and statistical analyses that would typically be found in a comprehensive clinical or performance study report are not part of this summary document.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the input provided. The requested information is simply not present in this 510(k) submission.

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