Search Results

The Antineedle Stick Protector is a non-sterile, single use accessory device intended to minimize accidental needle stick injuries when used as an active safety device to shield port access needles.

The Antineedle Stick Protector is a non-sterile, single use, active accessory device manufactured from polymeric material. The protector has two rectangular sides connected by a hinge. It is positioned over the port access wings, and is activated by snapping closed the hinged sides that will enclose and shield the port access infusion set needle within the protector.

The provided document does not contain sufficient information to fully answer all aspects of your request regarding acceptance criteria and performance studies. Specifically, it offers very limited details on the "simulated use study."

However, based on the available text, here's what can be extracted:

Acceptance Criteria and Device Performance

Missing Information: The document does not specify quantitative acceptance criteria (e.g., a specific percentage reduction in needlestick injuries, or a predefined pass/fail rate for the simulated use study). It only states that the study was "successful" and the device "is suitable."

Study Details

1. Sample size used for the test set and the data provenance:
   • Sample Size: Not specified.
   • Data Provenance: The study was a "simulated use study," implying it was conducted experimentally, likely in a controlled environment, rather than using retrospective or prospective clinical data from patients. The country of origin for the study is not explicitly stated, but the submitter is based in Tokyo, Japan, and the authorized contact is in Tampa, FL, USA.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not specified. The document only mentions a "simulated use study" but provides no details on how "ground truth" or "acceptability" was specifically measured or by whom.
3. Adjudication method for the test set:
   • Not specified.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done:
   • No. There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a physical safety mechanism, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   • N/A. This question is irrelevant as the device is not an algorithm or AI. It is a physical accessory. The "simulated use study" would inherently involve human interaction with the device.
6. The type of ground truth used:
   • Based on "successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries," the ground truth was likely related to performance in preventing simulated needlesticks or ease of use/functionality in preventing such injuries. The exact methodology for defining "ground truth" or "success" in this simulation is not detailed. It's not pathology, outcomes data, or expert consensus in the typical sense applied to diagnostic tools, but rather an assessment of functional safety.
7. The sample size for the training set:
   • N/A. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."
8. How the ground truth for the training set was established:
   • N/A. As above, no training set for a physical device.

Ask a specific question about this device