Search Results

The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.

The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.

The provided text describes the Safe Connect™ Drug Dispensing Spike and its substantial equivalence to a predicate device, the Safe Connect™ Vial Dispensing Spike. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the other requested details regarding sample sizes, ground truth establishment, or multi-reader multi-case studies.

Based on the provided text, here is what can be inferred or stated:

Acceptance Criteria and Reported Device Performance

The submission focuses on substantial equivalence rather than meeting specific performance acceptance criteria. The "Summary of Testing" section is very brief and general.

Study Details

1. Sample size used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
4. 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 a physical medical device (drug dispensing spike), not an AI-powered diagnostic or interpretive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. The summary only mentions "biocompatibility testing."
7. The sample size for the training set: Not applicable (not an AI/learning algorithm).
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.

The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.

The provided text does not contain detailed information about specific acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) for an AI/device, nor does it describe a study (including sample sizes, expert ground truth, adjudication methods, or MRMC studies) designed to prove the device meets such criteria.

Instead, the document is a 510(k) premarket notification for the "FLOSTAR Needleless Connector," a medical device, with a focus on demonstrating "substantial equivalence" to a predicate device.

Here's a breakdown of what the document does provide, and what is missing based on your request:

What is present in the document:

• Device Type: FLOSTAR Needleless Connector (not an AI-driven diagnostic or image analysis device).
• Intended Use: Sterile, disposable, needle-less I.V. access valve for intravenous fluid administration and aid in preventing needle stick injuries.
• Predicate Device: Safe-Connect Valve.
• Demonstration of Substantial Equivalence: The document states the FLOSTAR Needleless Connector is substantially equivalent to the Safe-Connect Valve because they:
  • have the same intended use.
  • use the same operating principle.
  • incorporate the same final design configuration.
  • are both labeled as single patient use.
  • are packaged and labeled using the same materials and processes.
• Summary of Testing (General): "All materials used in the fabrication of this FLOSTAR Needleless Connector were evaluated with the original design through physical testing and biocompatibility testing." This is a general statement about material and design testing, not performance metrics based on clinical data or AI evaluation.

What is missing from the document (as it pertains to your request for AI/device performance criteria and studies):

1. A table of acceptance criteria and the reported device performance: This document does not provide specific performance metrics (like accuracy, sensitivity, specificity, etc.) with corresponding acceptance criteria. It primarily focuses on equivalence to a predicate device in terms of design and material.
2. Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) notification demonstrating substantial equivalence for a physical medical device (a needleless connector), not an AI-driven device requiring performance evaluation based on clinical data, ground truth establishment, or specific diagnostic metrics as envisioned by your detailed request. Therefore, it does not contain the information needed to fill out the requested table regarding acceptance criteria and study details for an AI-enabled device.

Ask a specific question about this device