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The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

The ADR THINSet Insulin Infusion Set facilitates the flow of medication from an infusion pump reservoir into the subcutaneous tissue of the user. The infusion set consists of a female luer, tubing, Needle Grip with introducer needle and Base Assembly. The Base Assembly consists of three components: the Needle Grip, Connector and Base. The Needle Grip contains the 26 guage introducer needle that penetrates the subcutaneous tissue. The infusion set tubing attaches to the Connector. The Connector may be removed from the Base. The Base houses the 24 gauge Cannual and has a medical grade adhesive dressing attached to the bottom. The infusion set is packaged sterile in a Tray Pack. The infusion set is available with 23 and 43 inch tubing lines and 6 and 9 mm Cannulas.

The provided 510(k) summary for the ADR THINSet Insulin Infusion Set (K033099) describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria values or detailed performance metrics in a quantified format as requested by the user for a comprehensive table.

Instead, the document primarily focuses on qualifying the testing performed and stating that the device "meets the requirements" or that "differences were insignificant." It also lacks details about ground truth establishment, expert qualifications, sample sizes for specific tests, or a multi-reader multi-case (MRMC) study.

Therefore, the response below will reconstruct the information available as closely as possible to the requested format, clearly indicating where specific numerical data is absent in the original document.

1. Table of Acceptance Criteria and Reported Device Performance

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The SureSet 3.0 ml Reservoir is indicated for use for the infusion of medicine, including insulin, from an external infusion pump. The reservoir is not indicated for use with blood or blood products.

The SureSet Reservoir is a single use 3.0 ml piston syringe. It consists of a hollow barrel, movable plunger with O-rings for sealing and a male Luer lock fitting at the distal end. This device is used in conjunction with an external infusion pump and infusion set (e.g. SmartSet Insulin Infusion Device cleared under K012429) to deliver medications, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is connected to the female Luer fitting of an infusion set. The reservoir is placed in an external infusion pump. The SureSet Reservoir is available with a 22 gauge cannula (Model 24-103) or without a cannula (Model 24-104).

The provided text is a 510(k) summary for the SureSet 3.0 ml Reservoir, an infusion pump syringe. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a specific study against predefined acceptance criteria.

Therefore, the requested information elements related to specific acceptance criteria, a study proving performance against those criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document.

The document essentially states that the technological characteristics are similar, and differences are insignificant, leading to the conclusion of substantial equivalence. There is no mention of a standalone performance study with quantifiable results.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning no new issues of safety or effectiveness are raised by any technological differences.
• Reported Device Performance: Not presented in a quantifiable manner from a specific study. The summary states that "Information was submitted to demonstrate that there are no significant differences in technological characteristics between the SureSet 3.0 ml Reservoir and the cited predicate device." This is a qualitative statement of comparison rather than a performance measurement against a benchmark.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no specific test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

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 infusion pump syringe, not an AI-assisted diagnostic tool.

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

• There is no mention of a standalone performance study with quantifiable results for the SureSet 3.0 ml Reservoir. The basis for clearance is substantial equivalence, not independent performance validation described in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. The equivalence is based on technological characteristics and intended use alignment with the predicate, not a ground truth from patient data.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.

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

• Not applicable.

In summary:

This 510(k) summary provides evidence for the substantial equivalence of the SureSet 3.0 ml Reservoir to a predicate device based on its intended use and technological characteristics. It does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, or ground truth methodologies that would typically be associated with an AI/diagnostic device or a de novo submission requiring extensive performance data. The device's clearance is based on the FDA's determination that it is "substantially equivalent" to an already legally marketed device (K991936).

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The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.
Indication for Use: Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump

The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place. The pump end of the Smart-Set tubing is attached to an external infusion pump. Following the pump manufacturer's instructions, the tubing is primed until medication drips from the connector needle. The SmartSet end of the tubing is aligned with the SmartSet hub and then firmly locked together.

The provided text is a 510(k) summary for the SmartSet Insulin Infusion Device. It explicitly states that "Appropriate information relative to the biocompatibility of the device's components and the sterilization of the finished device, but not clinical study findings, were submitted."

Therefore, based on the provided document, there are no clinical study findings, acceptance criteria, or performance data available to address the requested points. The device's substantial equivalence was determined based on its similarity to a predicate device and non-clinical data (biocompatibility and sterilization).

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