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The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.

The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.

This document is a 510(k) summary for the Ally Blood Collection Device, a blood specimen collection device. It outlines the device's technical characteristics, its comparison to a predicate device, and the performance testing conducted to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or detailed numerical results for each test. Instead, it broadly states that "The subject Ally device met all predetermined acceptance criteria." The table below summarizes the listed performance tests:

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

The document does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "Performance Testing included the following," suggesting they were conducted specifically for this submission.

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

This document does not describe a test set that required expert ground truth establishment in the traditional sense (e.g., image interpretation). The tests listed are primarily engineering performance and biocompatibility assessments, which are evaluated against defined scientific and regulatory standards rather than expert consensus on a diagnostic outcome. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

As the performance and biocompatibility tests are against defined standards and criteria, a specific "adjudication method" like 2+1 or 3+1 (often used in clinical studies with human assessors) is not described or applicable. The determination of whether the device "met all predetermined acceptance criteria" would be based on the results of the specific laboratory tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human reader performance is a key metric. The Ally device is a blood collection device, and its evaluation focuses on physical performance and biocompatibility, not interpretive tasks.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Since the Ally device is a physical medical device for blood collection and not an algorithm or AI system, the concept of "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance tests evaluate the device's physical and biological characteristics.

7. Type of Ground Truth Used

The "ground truth" for the performance tests would be the established scientific and engineering standards and specifications against which the device's performance was measured (e.g., tensile strength requirements, flow rate targets, ISO 10993 series for biocompatibility). For biocompatibility, this involves specific laboratory assays with established positive/negative controls and interpretation guidelines.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set" in the context of data-driven model development. All tests performed are considered verification and validation tests against established specifications and regulatory standards.

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

Not applicable, as there is no "training set" for this type of medical device.

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