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The VACUETTE® SAFELINK Holder with male luer lock is for use in blood collection procedures in combination with devices with a female luer port.

The VACUETTE® SAFELINK Holder with male luer lock is a sterile, single-use, non-invasive device, which consists of a cylinder made from polypropylene plastic with a centric molded male luer lock at the top. The centric location of the male luer lock is to facilitate the connection to non-needle devices with a female luer port. A stainless steel needle with a sleeve is bonded to the inside of the holder to facilitate blood draw by puncturing the cap of an attached blood collection device. The sleeve is made from Synthetic Polyisoprene Compound.

The provided document describes the predicate device equivalence testing for the VACUETTE® SAFELINK Holder with male luer lock (K180545). The device is a blood collection holder intended for use with female luer port devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each performance test. It only states that "Performance testing was conducted to demonstrate and support our substantial equivalency claim". Given that this is a 510(k) submission for a physical medical device, the data provenance is likely from laboratory testing conducted by the manufacturer (Greiner Bio-One GmbH) or a contracted testing facility. This would typically be prospective testing conducted specifically for regulatory submission.

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

This information is not applicable to this type of device. The "ground truth" for the performance criteria of a blood collection holder is established by engineering specifications, recognized consensus standards (like ISO 80369-7:2016), and comparison to a legally marketed predicate device. This doesn't involve human expert judgment in the way that, for example, a diagnostic imaging AI would.

4. Adjudication Method for the Test Set:

This information is not applicable. As there are no human "readers" or interpretations involved in the performance tests of this device, there is no need for an adjudication method. The results are typically quantitative measurements against defined thresholds or comparisons to the predicate.

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. An MRMC study is relevant for medical devices that utilize Artificial Intelligence (AI) or assist human interpretation (e.g., radiologists reading images). The VACUETTE® SAFELINK Holder is a physical medical device and does not involve AI assistance or human interpretation in its function.

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

This is not applicable. The device is not an algorithm or software. It is a mechanical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests of the VACUETTE® SAFELINK Holder is primarily based on:

• Engineering Specifications: Internal design and performance requirements set by the manufacturer.
• Recognized Consensus Standards: Specifically, ISO 80369-7:2016 for fitting assembly requirements.
• Predicate Device Performance: Direct comparison and equivalence to the performance characteristics of the Greiner HOLDEX® Single-use Holder PP (K160532).

8. The Sample Size for the Training Set:

This is not applicable. The VACUETTE® SAFELINK Holder is a mechanical device and does not involve machine learning or AI, so there is no "training set" in this context.

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as point 8.

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