(25 days)
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.
The Novo Nordisk PDS290 Injection pens compatible for growth disorder treatment are:
- Sogroya (somapacitan-beco)
- Norditropin FlexPro
The MallyaG Injection Pen Adapter is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the MallyaG device, is also provided in the package. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected.
The MallyaG Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors. The manufacturer, Biocorp Production, claims that the device is 99% accurate in matching recorded doses with dialed doses, with a margin of error of +/- 1 increment. This claim is supported by performance data from bench testing guided by ISO 11608-1.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Reported Device Performance |
|---|---|
| Device accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment. | Performance data from bench testing (ISO 11608-1 as a guide) was generated to verify the design. (No specific numerical reporting of the test result against the 99% claim is provided in the summary, but the general statement suggests it met the criteria). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing (bench testing). It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The performance testing appears to be bench-based, guided by a standard (ISO 11608-1), which typically relies on calibrated equipment and defined procedures rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given the nature of bench testing for dose accuracy against a standard, an adjudication method for human interpretation would likely not be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The MallyaG Injection Pen Adapter is a device for capturing and transmitting dose information, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was done in the form of "Bench testing on performance, using ISO 11608-1 as a guide." This type of testing evaluates the device's ability to accurately capture and transmit dose information independently of human interaction beyond the initial setup and use.
7. The Type of Ground Truth Used
The ground truth for the performance testing (dose accuracy) was implicitly established by the dailing of specific increments on the injection pens and then comparing the device's recorded dose against that known dialed dose. This is a form of measurement against a known input/standard as guided by ISO 11608-1.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device performance. This device is an adapter for capturing data, not a machine learning or AI model that typically requires a training set. The performance testing focuses on verifying the device's accuracy in capturing physical actions.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this device.
§ 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).