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Insignis® Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.

The Insignis® Subcutaneous Needle Sets are sterile, single use, packaged subcutaneous needle sets. Each Subcutaneous Needle Set has a luer lock at one end and a 90-degree 26G (0.46mm) needle mounted to a closing wing-stabilizer (or butterfly wings) at the distal end of one or more needles. The needles are available in four different lengths: 6mm, 9mm, 12mm, and 14mm. Each set has a slide clamp to stop the flow immediately as well as a butterfly wing that can be closed around the needle upon completion of the infusion. The Insignis® Subcutaneous Needle Sets is available as a single set, as well as a two, three and four needles sets.

The Insignis® Subcutaneous Needle Sets is designed to be used for less than 24 hours

This document is a 510(k) Premarket Notification from the FDA regarding the "Insignis Subcutaneous Needle Sets." It is a regulatory document to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the performance of an AI-powered diagnostic device.

Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth adjudication, MRMC studies, standalone algorithm performance, and training set details for an AI/diagnostic device is not present in this document.

This document describes a medical device (subcutaneous needle sets) and its equivalence to a predicate device based on physical characteristics, intended use, and conformance to various industry standards for manufacturing, materials, sterility, and biocompatibility.

To directly answer your request based only on the provided text, and noting the mismatch between the prompt's focus on AI/diagnostic acceptance criteria and the document's content:

Based on the provided FDA 510(k) document (K202279) for Insignis Subcutaneous Needle Sets:

The document describes the acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, not for an AI-powered diagnostic device. The performance claimed is related to the physical and functional attributes of the needle sets for medication delivery.

Here's an attempt to map the prompt's questions to the available information, while explicitly stating where the information is not applicable or present for an AI/diagnostic device:

1. Table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly met by conformance to recognized industry standards and comparison to a predicate device. The "performance" is demonstrating that the device functions as intended and is safe and effective when used as described.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI/diagnostic algorithm testing. Performance data is derived from product testing against various ISO standards. The sample size for each specific test (e.g., fluid flow rates, pull force testing, biocompatibility) is not detailed in this summary.
• Data Provenance: The data originates from performance testing conducted by the manufacturer (Innovative Health Sciences LLC) and its consultants to demonstrate conformance with international standards and substantial equivalence. The country of origin for the data (where the tests were performed) is not specified, but the applicant is based in New York, USA. The studies would be considered prospective as they are conducted specifically for this regulatory submission.

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. This document is for a physical medical device (needle sets), not an AI-powered diagnostic device requiring expert interpretation for ground truth establishment. Performance is evaluated against objective engineering and biocompatibility standards.

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

• Not Applicable. There is no expert adjudication process described or needed for this type of device's performance evaluation.

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 is not an AI-powered diagnostic device, and no MRMC study was performed.

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

• Not Applicable. This is not an AI-powered diagnostic device.

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

• Ground Truth: The "ground truth" for this device's performance is established by conformance to established international standards (ISO series) for medical devices. This includes verifiable physical, chemical, and biological properties, as well as functional performance metrics (e.g., flow rates, material strength, sterility levels) measured objectively by laboratory testing. There is no qualitative "ground truth" derived from human interpretation or patient outcomes data described in this 510(k) summary beyond the standards themselves.

8. The sample size for the training set:

• Not Applicable. This document describes a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. This document describes a physical medical device, not an AI model requiring a training set.

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