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The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.

The Unger Quad Injector is a 'needle infusion set' component to a breast tissue expander fill kit. The device is comprised of four 21 gauge hypodermic lumen needles, which are connected to a needle hub, a luer adapter and tubing.

This document is a 510(k) premarket notification for the Unger Quad Injector, indicating it is a device intended for assisting in the delivery of sterile saline into breast tissue expanders. However, the provided text does not contain acceptance criteria or a study that evaluates the device against specific performance metrics for the purpose of demonstrating clinical accuracy or diagnostic performance, which is typically found in documentation for diagnostic or AI-enabled devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical bench testing. The "acceptance criteria" discussed here are primarily related to conforming to established standards and matching the performance of predicate devices in specific non-clinical tests.

Here's a breakdown of the information that can be extracted or inferred from the provided text, adjusted to the context of this device:

Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)

Since this is a non-AI, non-diagnostic device, the "acceptance criteria" are related to manufacturing standards, material properties, and functional performance compared to predicate devices, rather than accuracy metrics like sensitivity or specificity.

1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" indicates whether the device met the stated standard or showed comparability to the predicate/reference device, as described in the "Non Clinical Tests performed" section and the "Summary of the Technological Characteristics" table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for each non-clinical bench test. The studies were non-clinical bench tests, not involving human subjects or real-world data provenance in the sense of patient data. The tests were conducted to verify equivalence.

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):
This is not applicable as this device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The evaluation is based on engineering and material standards and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are bench tests against established standards or direct comparisons, not requiring expert adjudication.

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 not an AI-enabled diagnostic or assistance tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device does not involve an algorithm. The "standalone" performance here refers to the device's functional characteristics in isolation, which were assessed through the bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device is defined by:

• Established Industry Standards: Such as ISO 7864, ISO 9626, ISO 6009, ANSI/AAMI/ISO 11135.
• Performance of Legally Marketed Predicate Devices: The McGhan Tissue Expander Fill System (K870754) and other reference devices served as comparators for technological characteristics, materials, and functional performance.

8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.

Summary of the Study:

The document describes a series of non-clinical bench tests rather than a clinical study. These tests were performed to demonstrate that the Unger Quad Injector is substantially equivalent to legally marketed predicate devices, primarily the McGhan Tissue Expander Fill System (K870754).

The specific non-clinical tests conducted include:

• Pre-clinical Investigational Evaluation of Tissue Expander Inter-operative Filling Device
• Quad Injector Flow Rate Comparison
• Unger Quad Injector Bioburden Test
• Unger Quad Injector Endotoxin Test
• Unger Quad Injector Bioburden Validation Test
• Shelf Life / Expiration Dating – Aging Testing
• ISO 7864 Hub Needle Bond Strength
• ISO 7864 and ISO 9626 Conformance

Purpose of the Studies: The main purpose was to verify the equivalence of the Unger Quad Injector's performance, safety, and specifications with the predicate devices, and to ensure conformance with relevant ISO standards.

Conclusion from the Studies: The data from these tests "supports a finding of substantial equivalence because the data demonstrates that the Unger Quad Injector is safely and effectively indicated for use as the 'needle infusion set' component... Testing results demonstrate the filling, sealing capability and leakage prevention as compared to lawfully marketed predicate devices. Performance testing results also demonstrate safety and efficacy in terms of biocompatibility, sterilization, shelf life, and general device performance."

No clinical tests were conducted. The device's safety and effectiveness were established through comparison of its technological characteristics and performance in bench tests to those of existing, legally marketed devices.

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