(99 days)
The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.
The proposed device, Insulin Syringe, is a sterile device consisting of a calibrated hollow barrel, needle, needle cover and end cap. The Insulin syringe is intended for medical purpose for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The device is intended to be used for adults only. The needle is fixed on the syringe. The syringes barrel and plunger is made up of Polypropylene, the gasket is of Thermo Plastic Elastomer (TPE) and the needle cover (Top Cap) and end cap (Bottom Cap) is made of polypropylene.
The provided document describes the FDA 510(k) clearance for an Insulin Syringe (K233794). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria for an AI/ML algorithm.
Therefore, the information typically required to answer your request regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" for an AI/ML-powered device is not present in this document.
This document describes a medical device, an insulin syringe, which is a physical product, not an AI/ML software. The performance data presented refers to standard physical and biological tests for such a device (e.g., sterilization, biocompatibility, needle strength, etc.), not the performance metrics of an AI algorithm.
Here's a breakdown of why this document doesn't fit your request and what is actually discussed:
- Type of Device: The device is an "Insulin Syringe," a physical medical instrument for injecting insulin. It does not incorporate AI or machine learning.
- Purpose of the Document: This is an FDA 510(k) clearance letter. Its primary purpose is to establish "substantial equivalence" of a new device to a legally marketed predicate device, allowing it to be marketed. This is a common regulatory pathway for non-novel medical devices.
- "Acceptance Criteria" discussed: The "acceptance criteria" for a physical device like an insulin syringe are generally defined by recognized standards (e.g., ISO standards for sterile hypodermic needles, biocompatibility standards). The document states that performance testing was conducted "to ensure the substantial equivalence...and verify conformity to the applicable parts of ISO standards."
- "Study" discussed: The "study" refers to a series of performance tests (e.g., ISO 7864:2016, ISO 9626:2016, ISO 8537:2016 for physical characteristics; Biocompatibility testing as per ISO 10993-1; Sterilization, shipping, and shelf-life validation). These are laboratory and bench tests, not clinical studies involving AI models.
In summary, as the provided text is for a physical medical device (Insulin Syringe) and not an AI/ML-powered device, it does not contain the information you requested regarding acceptance criteria and study data for AI/ML performance.
To answer your prompt for an AI/ML device, you would need a document detailing the validation of an AI algorithm, which would include information on metrics like sensitivity, specificity, AUC, human-in-the-loop studies (MRMC), ground truth establishment, training data, and more. This document does not pertain to such a 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).