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The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

The Genie™ is intended for use as an accessory to an I.V. set. The Genie™ is used to adapt a standard medication vial for needle free access and to maintain the sterile system. In addition, the Genie™ automatically equalizes vial pressure as fluids are withdrawn and therefore reduces the risk for health-care workers for exposure to potentially hazardous drug aerosols, spills or needle sticks that can occur during the preparation, administration and dispensing process.

The provided text describes a 510(k) submission for the Genie™ vial access device, which is an accessory to a syringe. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be fully addressed from the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

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

The document states: "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." However, the specific acceptance criteria (e.g., maximum leakage, pressure equalization rate, sterility maintenance duration) and the quantitative results (reported device performance) are not provided in this summary.

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

This information is not provided in the document. The text only mentions that the device "has been tested," but does not detail the testing methodology, sample size, or the nature of the data (e.g., if it was from real-world usage or laboratory testing).

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 information is not provided as the document describes a device submission based on substantial equivalence and testing, not a study involving expert assessment or ground truth establishment in a clinical context.

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

This information is not provided.

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

This is not applicable to this device. The Genie™ is a physical accessory designed to improve user safety by reducing exposure to hazards, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device as it is a physical medical accessory, not an algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies does not directly apply here. Instead, the device's performance would be judged against functional and safety standards (e.g., sterility, pressure equalization, leakage) through laboratory testing. The document implies that the "ground truth" for demonstrating safety and effectiveness was based on passing these established acceptance criteria.

8. The sample size for the training set

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

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

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the "study" demonstrating the device meets acceptance criteria appears to be a series of "post sterilization" tests to ensure functionality, safety, and effectiveness.

• Study Type: The document describes the process as "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." This implies a laboratory-based testing regimen and engineering verification/validation rather than a human-centered clinical trial or an AI performance study.
• Purpose: To demonstrate that the Genie™ vial access device functions as intended (providing sterile access, equalizing pressure, reducing exposure to hazards) and is safe, thereby establishing substantial equivalence to predicate devices (K001368, specifically mentioned for its pressure equalization mechanism).
• Key Finding: The device "passed all acceptance criteria" and "meets the functional claims and intended use."

The document focuses on explaining that the device is substantially equivalent to existing predicate devices due to shared intended use, indications for use, and materials, with the main difference being the internal versus external balloon for pressure equalization. The overall claim for safety and effectiveness is tied to passing these unspecified acceptance criteria.

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