Search Results

The Modular Medical MODD1 Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

The Modular Medical MODD1 Insulin Delivery System (i.e., MODD1 System) consists of the following:

• A reusable, software-controlled programmable Pump,
• A single-use, disposable 3.0mL (300 unit) Insulin Cartridge with an integrated battery to supply power to the Pump, infusion tubing, and Tubing Cap for attaching to the Infusion Set.
• . A single-use, disposable Adhesive Pad for affixing the MODD1 System to the user's body and allowing for temporary removal of the MODD1 System,
• A single-use, disposable Infusion Set inserted into the patient's subcutaneous tissue, and
• The MMI App, a smartphone application used to program the basal delivery schedule on the Pump.

Accessories to the MODD1 System are FDA-cleared and include the following:

• A single-use disposable syringe (K110771) and needle (K021475) used to fill the Insulin Cartridge reservoir, and
• A reusable Inserter (K163400), optionally used to insert the Infusion Set into the patient's subcutaneous tissue.

The MODD1 System has been demonstrated to be compatible with Humalog U-100 insulin.

The MODD1 System can deliver insulin at basal rates between 0.5 - 4 units per hour (programmable in 0.1-unit increments) and user-selected bolus doses of between 2 and 20 units (in 2-unit increments). Basal insulin delivery may also be suspended for a set period of 30 minutes when required by the user.

The delivery of insulin is achieved by gear motor rotation of a single fixed-position camshaft (components of the Pump controlled by software) that interfaces with the Insulin Cartridge pistons to control the movement of insulin from the insulin reservoir, into an interim chamber, and into the infusion tubing towards the Infusion Set inserted into the patient's subcutaneous tissue. Software monitors dispense output via feedback provided by multiple sensors, providing an alarm when issues with delivery (e.g., malfunctions, low reservoir volume, occlusions) are detected.

The Pump serves as the primary user interface of the MODD1 System. A Control Button is used to prime the fluid path, program bolus deliveries, check system status, and to temporarily suspend insulin delivery. The multi-color LED and piezo buzzer of the Pump provide audio-visual feedback to the user during the set-up process, programming of a bolus delivery, and changing of delivery modes (e.g., bolus, basal, suspend). Audio-visual feedback is also used to inform the user of system alarms (automatically generated) and system status (when requested by the user).

The MMI App is downloaded directly onto an Apple® iPhone 12 Pro Max running iOS version 16. The MMI App allows for the configuration of a basal delivery schedule on the Pump, consisting of up to two basal rates in a 24-hour period. The MMI App and Pump communicate using Bluetooth® Low Energy (BLE) and Near Field Communication (NFC). After the basal delivery schedule has been programmed on the Pump, all insulin delivery functions are controlled using the Pump user interface. Optional features of the MMI App include a dashboard display of current and historical Pump information and delivery history.

The provided text is a 510(k) Summary for the Modular Medical MODD1 Insulin Delivery System. It details the device, its indications for use, comparison to a predicate device, and a summary of non-clinical performance data.

However, the document does not provide information on an AI-driven medical device, nor does it conduct a study involving human readers or expert ground truth. It describes the regulatory submission for an insulin pump.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details from the provided text.

The text describes compliance with various medical device standards (e.g., ISO 14971, IEC 62366-1, ISO 10993-1, IEC 60601-1, IEC 62304) and includes bench testing for infusion delivery accuracy and occlusion detection, but these are part of standard medical device validation, not specific to AI performance as requested in the prompt.

Ask a specific question about this device

The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer connectors.

The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe.

The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used.

This document describes the Luer-Jack Slip/Lock syringe, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices. It is not an AI/ML powered device, therefore, some of the requested information (like number of experts, AI effect size, training set) is not applicable.

Here's the breakdown of the acceptance criteria and the study as presented in the document:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

The document mentions "Design Verification tests were performed based on the risk analysis." However, it does not specify the exact sample sizes used for each individual test. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) beyond stating that "Design Verification tests were performed." Given this is a physical medical device, not an AI/ML algorithm, the concept of "data provenance" as typically applied to algorithms is not directly relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a physical medical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for these performance tests is defined by the objective standards themselves (e.g., ISO, EN ISO standards).

4. Adjudication method for the test set:

This information is not applicable as the device is a physical medical device, not an AI/ML system requiring adjudication of expert opinions. The performance is measured against established technical standards.

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 as the device is a physical medical device and not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is based on objective technical standards and regulatory requirements, primarily the ISO and EN ISO standards mentioned in the acceptance criteria. For example, "Per ISO 7886-1:1997" defines the ground truth for the sustaining force.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device