(123 days)
The t:slim® 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 12 years of age and greater.
The t:slim® Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The scope of this 510(k) is limited to a new software version and minor changes to the pump component of the t:slim System.
The modified t:slim System, like the predicate device, consists of the following components and accessories:
- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump");
- a dedicated, disposable 3mL (300 unit) insulin cartridge ("cartridge");
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
- accessories, including a Becton Dickenson 3mL sterile syringe (K941562) and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply and DC car adapter power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driver mechanism to deliver insulin from within a disposable cartridge. through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). The graphical user interface ("GUI") of the t:slim Pump is a capacitive touch screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
The t:slim cartridge is a single-use device. individually packaged and provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3 mL, or 300 units, of insulin. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
This document is a 510(k) premarket notification for the t:slim Insulin Delivery System, specifically for a new software version and minor hardware changes. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and device performance tables in the format typically used for novel AI/ML devices.
Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment, particularly in the context of an AI/ML device, is not directly available or applicable within this specific 510(k) summary.
However, I can extract information related to the performance data as described for this modified insulin pump.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and reported device performance in a quantitative manner as you might expect for an AI/ML imaging device. Instead, it states that:
- "Hardware changes were supported by verification testing per previously established acceptance criteria."
- "The new software version and minor changes to the pump component of the t:slim System were verified and/or validated per Tandem's design control process and shown to meet design requirements."
The document focuses on the types of testing performed rather than specific quantitative performance metrics against acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "human factor formative and summative studies" for verifying the user interface. However, it does not specify:
- The sample size used for these studies.
- The data provenance (e.g., country of origin, retrospective or prospective).
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 provided in the document. For an insulin pump, "ground truth" would likely refer to clinical outcomes or accurate insulin delivery, but the document doesn't detail how this was established or by whom for the purpose of testing the modifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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 type of study is relevant for AI/ML diagnostic tools. The t:slim Insulin Delivery System is an infusion pump, not a diagnostic imaging AI/ML device. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an insulin pump with human interaction. The "software-controlled, programmable insulin infusion pump" operates based on user input. While the software has standalone functions (e.g., controlling insulin delivery rates), the overall system performance is inherently with human-in-the-loop. The document confirms "Tandem completed verification of the t:slim System's user interface through a series of human factor formative and summative studies," indicating that human interaction was part of the testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the "type of ground truth" used for performance assessment in terms of a single, definitive reference standard. For an insulin pump, performance is assessed through various engineering and functional tests:
- Verification and validation testing: Ensures the device meets design requirements.
- Hardware changes supported by verification testing: implies comparison against expected device behavior and specifications.
- Software verification and validation testing: per FDA guidance document for infusion pumps.
- Other specific tests: mechanical, environmental conditioning, water ingress, simulated aging testing, electrical safety, and electromagnetic compatibility testing.
The "ground truth" for these tests would be the established specifications, regulatory standards, and expected physical/electrical behavior of the device.
8. The sample size for the training set:
The document describes a modification to an existing device, not the development of an AI/ML model that typically involves a distinct "training set." Therefore, a "training set sample size" in that context is not applicable and not provided.
9. How the ground truth for the training set was established:
As above, this concept of "training set" and its ground truth establishment is not applicable to this type of device modification submission.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).