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The THINSet 1.8 ml and 3.0 ml Reservoirs are indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

The ThinSet Reservoir is a single use piston style syringe available with a capacity of 1.8 mil or 3.0 mil. It consists of a hollow barrel with a male Luer lock fitting at the distal end, and a plunger with o-rings. This device is designed to deliver medication, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is placed in an external infusion pump. The ThinSet Reservoir comes with a 22 gauge cannula.

Here's a breakdown of the acceptance criteria and study information for the THINSet 1.8 ml and 3.0 ml Reservoirs, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only describes what the tests measure, not the specific quantitative thresholds or results obtained (e.g., "scale accuracy within +/- 5%"). It states that the performance testing consisted of these tests to demonstrate substantial equivalence.

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

The document does not explicitly state the sample size used for each specific test (Scale Accuracy, Plunger Exercise, Dose Accuracy) within the test set.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, as it's part of a 510(k) submission, it's generally assumed industrial testing performed by the device manufacturer.

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

This information is not provided in the document. The tests described are objective performance tests of the device's physical properties and function, not typically relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests described are objective measurements rather than subjective assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests of the device itself, not studies involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone study was not done. This device is a physical medical device (infusion pump reservoir), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.

7. The Type of Ground Truth Used:

The ground truth for the tests described is based on established engineering and regulatory standards and the physical properties of the device.

• Scale Accuracy: Ground truth would be the actual measured volume against the marked scale.
• Plunger Exercise Test: Ground truth would be the force measured by a calibrated instrument against specified force ranges in the ISO standard.
• Dose Accuracy Testing: Ground truth would be the volume of fluid dispensed by the infusion pump against the programmed dose, measured by calibrated equipment, and compared to the requirements of ANSI/AAMI ID26:1998.

8. The Sample Size for the Training Set:

This information is not applicable/provided. This device is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI. The performance testing described is for verification and validation of the device's design and manufacturing.

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

This information is not applicable/provided for the same reason as point 8.

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