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The intended use of the SimpleChoice reservoir Pro is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

The SimpleChoice reservoir Pro (3.0mL), Reference Number RP-30, is a single use reservoir system used to deliver medications subcutaneously. The user fills the reservoir via a standard hypodernic needle provided with the device. The 3.0 ml reservoir Pro then attaches to an SimpleChoice infusion set having a female luer lock with a retainer feature, and is placed in an external infusion pump. If the reservoir will be used with a Paradigm pump the plunger rod is detached and the reservoir is secured with the retainer feature.

This 510(k) summary describes a device modification rather than a new device, and as such, the study conducted focused on demonstrating equivalence to the predicate device. Therefore, the information provided within the document does not contain all the details typically found in studies for novel devices, especially concerning detailed acceptance criteria and standalone performance metrics.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The new device is as safe, as effective, and performs the same as the original device, the SimpleChoice reservoir." and "The tests performed show such equivalence."

Study Details:

The provided document is a 510(k) summary for a device modification (SimpleChoice reservoir Pro) to an already legally marketed device (SimpleChoice reservoir). The entire premise of this submission is to demonstrate substantial equivalence to the predicate device, not to establish novel performance against specific quantitative criteria.

The summary states: "The modifications which are the subjects of this premarket notification have no untoward effect on the safety and effectiveness of the device." and "The tests performed show such equivalence." However, it does not detail the specific tests conducted, their methodologies, or the raw results (e.g., specific leakage rates, flow accuracy, material strength tests) that led to this conclusion. The focus is on the administrative aspects of obtaining 510(k) clearance based on equivalence.

Therefore, many of the requested details about the study cannot be extracted from this summary.

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

• Sample Size: Not specified in the provided document. The summary only mentions "tests performed."
• Data Provenance: Not specified. Given it's a device modification and likely bench testing, it would generally be considered prospective testing conducted by the manufacturer, but country of origin or specific lab is not mentioned.

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

• This is not applicable to this type of 510(k) submission. For a device modification seeking substantial equivalence, the "ground truth" is typically established by comparing the modified device's performance against the known and acceptable performance of the predicate device through engineering tests, rather than expert interpretation of medical data.
• No experts (e.g., radiologists) would be used in this context to establish a "ground truth" in the way one might for diagnostic AI.

4. Adjudication Method for the Test Set:

• Not applicable. This type of submission relies on objective engineering and performance testing, not subjective adjudication of cases.

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

• No. This is explicitly not an MRMC study. MRMC studies are typically for diagnostic imaging devices or algorithms where human readers' performance is being evaluated or compared, often with and without AI assistance. This device is an infusion reservoir.

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

• Not applicable in the typical sense. A standalone study, as usually understood in the context of AI, refers to the algorithm's performance independent of human input. This device is a mechanical component of an infusion system.
• However, if interpreted as "bench testing of the device itself without human intervention affecting its inherent function," then the undisclosed "tests performed" would likely fall into this category (e.g., pressure tests, flow rate consistency, material compatibility). The document does not provide details of these tests.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is the established safety and performance of the predicate device. The tests (though not detailed) would have aimed to demonstrate that the modified device's performance metrics are equivalent to or better than those of the predicate. This is based on engineering specifications and established performance characteristics of the original SimpleChoice reservoir, rather than pathology, expert consensus, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. As above, this is not an AI/machine learning device.

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