(62 days)
- Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.
- Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision.
- Insulclock® is designed for use in any home environment.
- Using a compatible App.
INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin dose-related data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature.
Models:
- INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®)
- INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®)
The provided FDA 510(k) summary for the INSULCLOCK® v2.0 PRO focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and does not contain information about acceptance criteria and a study proving those criteria are met in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, accuracy against a ground truth dataset).
This document mainly describes:
- The device's intended use and technological characteristics.
- Comparison of the device with a predicate device (Tempo Smart Button K212217).
- Summary of non-clinical testing performed to meet various safety, performance, and software standards (e.g., Biocompatibility, Software and Cybersecurity, Electrical Safety and EMC, Performance standards like UNE-EN 11608-1 for dose accuracy).
- A brief mention of a Human Factors validation study.
- A statement that clinical testing was not required for substantial equivalence.
Therefore, most of the information requested in your prompt regarding acceptance criteria for device performance/AI metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML models cannot be extracted from this document.
However, I can provide what information is available concerning the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, or accuracy that would be relevant to an AI/ML device's diagnostic or predictive capabilities. Instead, it refers to compliance with established industry standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-1 (Biocompatibility) | Meets requirements |
| IEC 62304 (Software Life Cycle) | Meets requirements |
| UL 2900-1, UL 2900-2-1 (Cybersecurity) | Meets requirements |
| IEC 60601-1, IEC 60601-1-2 (Electrical Safety & EMC) | Meets requirements |
| ANSI C63.27, AIM 7351731, AAMI TIR69:2017 (Wireless Coexistence) | Meets requirements |
| UNE-EN 11608-1 (Dose Accuracy) | Meets requirements when evaluated with compatible pens |
| Human Factors validation study | Intended users were able to operate the device as intended |
2. Sample size used for the test set and the data provenance
Not applicable to the information provided. The document outlines non-clinical engineering and usability testing, not performance evaluation against a labeled dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no ground truth establishment for a diagnostic or predictive AI/ML model is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device, INSULCLOCK® v2.0 PRO, is a hardware device with an SDK that detects and transmits data, rather than a standalone AI algorithm making diagnostic or predictive decisions. Its performance is related to accurate data capture and transmission, which is evaluated through engineering standards compliance.
7. The type of ground truth used
For the specific performance aspect mentioned (Dose Accuracy via UNE-EN 11608-1), the ground truth would be the actual dose delivered by the compatible insulin pens, measured by standard metrological methods defined within that standard. For other standards, compliance is verified against the requirements of the standard itself (e.g., electrical safety tests, biocompatibility tests). There is no "expert consensus" or "pathology" ground truth described here.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI/ML model on a dataset.
9. How the ground truth for the training set was established
Not applicable.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).