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The Lobster device is intended for use with a ImL glass syringe, containing a fixed needle of 27G to 29G gauge, and drug product solutions with a viscosity between 1 and 4 mPa*s. The Lobster auto-injector is a reusable injection device for the subcutaneous injection of FDA approved drugs.
For single patient or individual use only.

The Lobster Auto-injector is a reusable, spring-loaded injection device that is for use with 1.0 ml pre-filled glass syringes with staked needle. Lobster Auto-injector consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection.

The provided text describes the 510(k) summary for the Lobster Auto-injector, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with an AI component.

Therefore, the information required to answer the prompt (acceptance criteria, details of a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, and training set details) is not present in the provided text.

The text does mention performance data in Section 5.8:

"Lobster Auto-injector was assessed using the applicable sections and methods specified in the ISO standard, ISO 11608:2012, "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems". Activation force, needle extension, injection time, completeness of injection, functionality, and robustness were assessed; Lobster auto-injector met all requirements and specifications."

However, this is a general statement about meeting ISO standard requirements for mechanical performance, not a detailed description of an AI-driven system's study. The ISO standard itself would contain the "acceptance criteria," but those are not explicitly stated here.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves an AI-driven device meets them. The Lobster Auto-injector is a mechanical auto-injector, not an AI or imaging device.

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