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The Pro-Ject 2000 is indicted for self-injection of Insulin

Auto Injector Pro-Ject 2000

This letter is a decision letter for a 510(k) submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and study designs that would typically be found in a clinical study report or a premarket approval (PMA) submission.

The letter states that the device, the "Auto-Injector, Sure-Inject 2000™" (later referred to as "Auto Injector Pro-Ject 2000" in the Indications for Use), has been found "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination is the primary "acceptance criterion" for 510(k) submissions.

Here's what can be inferred or stated based on the provided document:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.
• Reported Device Performance: The letter states, "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This implies that the data submitted by Mighty Mo, Corporation met the FDA's requirements for demonstrating substantial equivalence.
• Specific performance metrics (like accuracy, precision, etc.) are NOT detailed in this letter. These would have been part of the technical documentation submitted by the manufacturer.

2. Sample size used for the test set and the data provenance:

• NOT APPLICABLE / NOT PROVIDED: The letter does not describe a specific "test set" or data provenance as it's a regulatory decision letter, not a study report. Any testing performed would have been part of the manufacturer's submission to demonstrate substantial equivalence, but the details are not disclosed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• NOT APPLICABLE / NOT PROVIDED: This information pertains to establishing ground truth for a clinical study, which is not detailed in this regulatory letter.

4. Adjudication method for the test set:

• NOT APPLICABLE / NOT PROVIDED: Similar to point 3, this is for clinical study design and not present in this document.

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:

• NOT APPLICABLE: This device is an auto-injector for insulin, not an imaging or diagnostic device that would typically involve "human readers" or AI assistance in interpretation. The letter does not mention any AI components.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• NOT APPLICABLE: As mentioned above, this device is an auto-injector, not an algorithm-based diagnostic or assistive system.

7. The type of ground truth used:

• NOT APPLICABLE / NOT PROVIDED: The concept of "ground truth" as used in relation to study data (e.g., pathology, outcomes data) is not detailed in this regulatory letter. The "truth" for this submission is based on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• NOT APPLICABLE / NOT PROVIDED: If any training was performed for the device's development (e.g., in engineering tests), those details are not in this letter. This term is also more commonly associated with machine learning models.

9. How the ground truth for the training set was established:

• NOT APPLICABLE / NOT PROVIDED: Similar to point 8.

In summary:

This document is an FDA 510(k) clearance letter. It confirms that the "Auto-Injector, Sure-Inject 2000™" (also referred to as "Pro-Ject 2000") for self-injection of insulin was found substantially equivalent to a predicate device. The letter itself does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth establishment that would be part of the manufacturer's 510(k) submission. These details would be found in the technical report or summary of data submitted by the company to the FDA.

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