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The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

The Inviro Medical InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries. The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components: Barrel, Plunger, O-Ring, Stopper, Luer Assembly, Cannula, Locking Ring, Cap. After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container. The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.

The provided text describes the regulatory clearance for the InviroSnap Safety Syringe (K092430). The submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria tied to human or algorithm performance metrics. Therefore, a direct answer to some of the requested points, such as "number of experts used to establish ground truth" or "effect size of human readers with AI," is not applicable as these types of studies were not performed for this 510(k) submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against recognized international standards. The acceptance criteria are implicitly defined by compliance with these standards, not by specific numerical thresholds for, for example, diagnostic accuracy or clinical outcomes.

2. Sample Size for Test Set and Data Provenance

The provided text does not specify a "test set" in the context of clinical data for performance evaluation. The performance testing was based on compliance with international standards, likely involving engineering tests, material evaluations, and sterilization validation, not patient-specific data. Therefore, details like "country of origin" or "retrospective/prospective" are not applicable.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this type of device (a safety syringe) is established through engineering and materials testing to meet specified performance standards and safety features, not through expert consensus on medical images or clinical diagnoses.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this submission.

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

No. An MRMC study is typically performed for diagnostic devices or AI algorithms that analyze clinical data and require human interpretation. This device is a physical medical device (safety syringe); therefore, an MRMC study was not conducted. The submission does not mention AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical safety syringe, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance, as demonstrated in the 510(k) submission, is compliance with established international performance and safety standards (ISO standards). This involves demonstrating that the device physically functions as intended (e.g., proper luer lock, needle retraction, sterilization efficacy) through laboratory and engineering tests, rather than clinical outcomes or expert diagnoses.

8. Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or clinical data analysis for this device. The development and testing of a physical medical device do not typically involve this concept.

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

Not applicable. As there was no training set, this information is not relevant.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The study proving the InviroSnap Safety Syringe meets acceptance criteria was a series of non-clinical performance tests demonstrating compliance with relevant voluntary international standards. The 510(k) submission states: "Performance testing consisted of compliance to the applicable sections of the following voluntary standards: ISO 594-1:1986, ISO 594-2:1986, ISO 7886-1:1993, ISO 7886-4:2006, and ISO 11135:2007."

The rationale for regulatory clearance (510(k)) was based on the demonstration of substantial equivalence to a predicate device (InviroSnap 1, 3, 5 and 10 ml Safety Syringe, K032780). The submitter asserted that "Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness." This means that the device was shown to perform comparably to an already legally marketed device and pass the stipulated engineering and sterilization standards. No clinical studies with human participants were required or conducted as part of this specific 510(k) submission to prove the device's safety or effectiveness beyond its equivalence and compliance with standards.

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