(205 days)
The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.
The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.
The provided FDA 510(k) summary for the SoloSmart Injection Pen Adapter does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-based medical device. This document describes a traditional medical device (an adapter for injection pens) and its substantial equivalence to a predicate device, focusing on its physical and functional characteristics, rather than AI performance.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.
The document discusses performance data related to the physical device and its ability to accurately record and transmit dosing information, but not the performance of an AI algorithm.
Here's a breakdown of what is in the provided text, and why it doesn't align with the request for AI/ML device performance:
- Device Type: SoloSmart Injection Pen Adapter, a physical device that attaches to insulin pens to capture and transmit dosing data. It is not described as an AI/ML device.
- Performance Data (Section 13): This section outlines "Bench testing on performance" for the physical adapter, including:
- Dose accuracy of pen not affected by SoloSmart®.
- Recording and transmission Accuracy.
- Dose Prime Differentiation.
- Complete Dose Notification.
- Incomplete Injection Identification.
- Physical Interaction with pen.
- Other Testing: Biocompatibility, Lifetime, Electrical safety, EMC and Radiocommunication, Cybersecurity Testing and Software Verification and Validation. These are standard tests for medical devices, not specific to AI/ML performance.
- Human Factor Validation (Section 14): Confirms usability of the device form factor and instructions for use.
- Substantial Equivalence (Section 8 & 12): The core of the 510(k) submission is to demonstrate that the SoloSmart® is substantially equivalent to a legally marketed predicate device (Mallya Injection Pen Adapter). This comparison focuses on indications for use, intended use, fundamental scientific technology, and technological characteristics (e.g., Bluetooth Low Energy communication, mechanism for recording dose).
In summary, the provided text does not describe an AI/ML-based medical device or any studies related to its AI performance. Thus, it is impossible to extract the requested information regarding AI acceptance criteria and proof of meeting those criteria.
§ 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).