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The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form. This device's target population is people who require insulin.

The Medicool Insulin Protector™ is a capsule-like portable container designed to transport insulin in a temperature controlled environment and protect it from environmental shock and other trauma. The Insulin Protector™ essentially consists of three main parts: the cooling tray, the foam insulation, and the outer casing. The cooling tray is a hollow-walled plastic container which has a cavity formed therein. The cooling tray is filled with water, which can be refrigerated in an ordinary household refrigerator. The cavity in the cooling tray receives up to two bottles of liquid insulin. The bottom and sides of the cavity include a plurality of ribbed members to prevent direct contact between the insulin bottles and the side walls of the cooling tray. The cooling tray fits inside the foam insulation snuggly to minimize heat transfer and loss, thus effectively stabilizing the inside temperature. This sleeve insulating foam is manufactured by Marko Foam and referenced as BI-99. The foam is flexible and helps provide protection from shock and trauma to the insulin bottles being stored in the cooling tray. The foam has cavities in both the top and bottom sections to receive the removable cooling tray. When the cooling tray is inserted into the cavity, a portion of the cooling tray extends above the surface of the foam. However, when the top section is closed, the cooling tray extends into the cavity of the top foam. The foam insulation containing the cooling tray fits snuggly inside the outer casing. The outer casing is stitched together using Cordura material, which is quality fabric known for its durability and resistance to abrasion. A zipper is used to open and close the main compartment that holds the foam insulation and the cooling tray. On the outside of the bag are two smaller pockets that close the cooling these pockets are designed to hold accessories, such as syringes, alcohol wipes, swabs, etc.

This document describes the Insulin Protector™, a device for transporting insulin in a temperature-controlled, protected environment. The information provided is primarily focused on the device's physical and functional characteristics and the testing conducted to support its 510(k) submission.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Durability Test): "several trials using different methods of generating shock" - specific number not provided.
• Sample Size (Cooling Test): "Insulin vials in the only 2 variations that we have seen in our 22 years in business, a 10mL US vial and a 10mL EU vial." - This indicates the use of two types of insulin vials.
• Data Provenance: The tests were conducted internally by Medicool, Inc. ("Our test was conducted..."). The document does not specify a country of origin for the data beyond the company's location in Torrance, CA, USA. The studies appear to be prospective tests performed on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. The described tests are performance verification studies for a physical device, not diagnostic or clinical studies requiring expert ground truth for interpretation. The "ground truth" here is the physical state of the insulin bottles (intact vs. damaged) and the temperature of the insulin over time.

4. Adjudication Method for the Test Set

• Not Applicable. As these are physical performance tests, there is no mention of an adjudication process for subjective interpretation. The results are objective measurements (e.g., presence/absence of damage, temperature readings).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. This device is a physical container, not an AI or diagnostic tool that would typically involve human readers or MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• Not Applicable. This is a physical product, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Physical Observation/Measurement:
  • For the durability experiment: The "ground truth" was the physical condition of the insulin bottles after various shock tests (e.g., whether they were damaged or preserved).
  • For the cooling experiment: The "ground truth" was the measured temperature of the insulin vials over a 12-hour period, compared against the manufacturer's safe temperature limit.

8. The Sample Size for the Training Set

• Not Applicable. As a physical device, there is no "training set" in the context of an algorithm or AI system. The device was likely designed and developed through iterative prototyping and engineering, not machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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