(427 days)
The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App).
The Tempo Smart Button is indicated for single-patients 18 years or older who are:
- . diagnosed with type 1 or type 2 diabetes mellitus,
- using prefilled insulin Tempo Pens [Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev®
- Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog® Tempo Pen (insulin lispro injection) 100 units/mL],
- using a compatible application (App).
The Tempo Smart Button is a reusable data transmitter that detects and stores insulin doserelated data when attached to a disposable Tempo Pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology. The insulin dose-related data is used by the mobile application which can display the brand of insulin, dose amount, date, and time.
Additionally, the Tempo Smart Button is available as part of a Welcome Kit. The Tempo Welcome Kit and Refill Kit provide the convenience of having a single kit that contains devices needed for insulin administration and blood glucose monitoring.
The provided text does not contain specific acceptance criteria or a detailed study description for the Tempo Smart Button's performance related to its primary function of detecting, storing, and transferring insulin dose-related data. While general statements about meeting acceptance criteria and various tests are made, the specifics requested in your prompt are largely absent.
Here's an analysis of what information is available:
1. A table of acceptance criteria and the reported device performance:
The document broadly states:
- "Lilly completed module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture. In all instances, the module met the acceptance criteria."
- "Bench Testing: Testing confirms that the module does not impact Tempo Pen compliance to specifications for dialing torque, injection force, and dose accuracy, nor does it impact Tempo Pen compliance to ISO 11608-1."
However, specific numerical acceptance criteria (e.g., accuracy percentage, tolerance levels) and the corresponding reported performance values for "accuracy of electronic dose capture" or other key functions are not provided in the text.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Bench Testing" and "module testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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 device is an "injection data capture device" and not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable or expected for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device's core function is autonomous data capture and transfer. The statement "accuracy of electronic dose capture. In all instances, the module met the acceptance criteria" implies standalone performance testing was conducted for this functionality. However, detailed results are missing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "accuracy of electronic dose capture," the ground truth would likely be the actual dose dialed on the pen, measured independently, or validated through mechanical means, rather than expert consensus or pathology. This is inferred from the bench testing context, but not explicitly stated.
8. The sample size for the training set:
- The document mentions "Software Verification and Validation" but does not refer to machine learning model training or a "training set" in the context of data used for algorithm development. This suggests the primary function is not based on a learnable AI model from a training set, but rather on direct electronic sensing and data processing.
9. How the ground truth for the training set was established:
- As a "training set" in the context of machine learning is not mentioned, this information is not applicable and hence not provided.
Summary of Available Information from the Provided Text:
The document confirms that the Tempo Smart Button underwent "Bench Testing" and "module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture," and "In all instances, the module met the acceptance criteria." It also states the device "does not impact Tempo Pen compliance to ISO 11608-1."
However, the specific quantitative acceptance criteria and the detailed results of these tests (e.g., specific accuracy rates for dose capture), along with the sample sizes, data provenance, and ground truth establishment methods for those specific performance aspects, are not disclosed in the provided FDA letter and 510(k) summary. The information focuses more on regulatory compliance (biocompatibility, electrical safety, software validation, cybersecurity) and substantial equivalence to a predicate device rather than in-depth performance study results for the core data capture function.
§ 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).