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MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, MCH, MCH, MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.

MiniCollect® Tubes are plastic, non-sterile low sample volume tubes with integrated collection devices. The closure is color-coded to identify the additives which are present in varying concentrations depending on the tube type and stated volumes. The caps of the MiniCollect® Tubes are pierceable for automated instruments with cap-piercing functionalities. The interior of the tube wall is coated with dipotassium EDTA binds calcium ions thus blocking the coagulation cascade. Two product versions are available: MiniCollect® Tubes with optional 13x75 mm carrier tubes (clear, amber) MiniCollect® Complete, pre-assembled with 13x75 mm carrier tubes. The product is to be used by appropriately trained healthcare professionals in accordance with these instructions.

This document describes the performance testing for the Greiner Bio-One MiniCollect® K2E K2EDTA Tubes, a blood collection device, to demonstrate its substantial equivalence to a predicate device (BD Microtainer® MAP Microtube for Automated Process).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily for Precision (Repeatability) and Stability, expressed as percentage variations. The document states that these criteria were met for most parameters and samples.

Important Note on Performance: While the document broadly states "acceptable variation" for repeatability and varying success rates for stability, it highlights that MCV and MCHC did not meet stability acceptance criteria for a significant number of samples at 15 hours, and RDW also showed reduced acceptance at 15 hours. Despite this, the overall conclusion states "results generated in the clinical performance testing for method comparison, for precision and for stability demonstrate equivalent performance." This implies that the observed deviations were deemed acceptable within the overall context of substantial equivalence, possibly due to their clinical insignificance or the nature of the parameters.

2. Sample Sizes Used for the Test Set and Data Provenance

• Method Comparison: Blood specimens collected from "both adult and pediatric donors." The exact number of donors is not explicitly stated. The study was conducted at "three external clinical sites." The provenance (e.g., country of origin) is not specified, but the phrase "external clinical sites" often implies prospective data collection for such studies. It is a prospective study.
• Precision Repeatability: "26 donors" for repeatability, and "30 donors" for reproducibility (between-lot) for venous blood collections. This also appears to be prospective data.
• Stability: Blood samples collected from "25 adult donors." This is also prospective data.
• Data Provenance: The document does not explicitly state the country of origin. Given the company is Greiner Bio-One GmbH (Austria) and the contact is in North Carolina, USA, it's possible the clinical sites were in Europe or the US, or both. It is a prospective study.

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

This type of device (blood collection tube for hematology parameters) does not rely on expert adjudication for ground truth, unlike imaging AI. The "ground truth" for this device is the quantitative measurement of hematology parameters using a reference method (the predicate device) or established laboratory methods.

• Ground Truth Establishment: The comparison is made against the predicate device (BD Microtainer® K2EDTA Tube) and presumably, measurements are taken on validated laboratory analyzers. The "truth" is the measured value of the hematology parameters.
• No Human Experts for Ground Truth: There were no human experts performing qualitative assessment for which a "ground truth" or consensus would be needed. The evaluation is purely quantitative.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, the ground truth is established by quantitative laboratory measurements, not by human expert assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This study is for a medical device (blood collection tube), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study and
effects on human reader performance are not relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI algorithm. It is a physical medical device. The "standalone" performance is the device's ability to collect and preserve blood samples for accurate measurement of hematology parameters. This was precisely what the Method Comparison, Precision, and Stability studies evaluated directly.

7. The Type of Ground Truth Used

The ground truth for this study is quantitative laboratory measurements of hematology parameters.

• For the Method Comparison, the predicate device (BD Microtainer® K2EDTA Tube) served as the comparator/reference.
• For Precision and Stability, the "truth" is the consistent and stable measurement of the parameters over time and between lots, with acceptance criteria defined as a tolerable percentage of variation from the initial or average measurements, or from the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a physical device, this question is irrelevant.

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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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The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.

Vacuette Urine CCM tubes are tubes made of PET with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps. The tube interior is sterile. The evacuated tube contains a fine particle granulate stabilizer to preserve the urine sample at 20-25°C for up to 48 hours. The stabilizer helps to preserve and protect the level of bacteria at collection and maintain typically formed elements in urine sediment.

The provided document describes the Greiner Vacuette Urine Count and Culture, Mannitol tube, a device intended for the collection, transport, and storage of urine for bacterial and yeast culture. The performance data section outlines the study conducted to demonstrate the device's suitability.

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

2. Sample size used for the test set and the data provenance

   • Sample size: All analyses were performed in triplicates (for each organism, at room temperature and refrigerated temperature). The organisms tested were 10 potential pathogens (Escherichia coli, Enterococcus faecalis, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus saprophyticus, Enterobacter cloacae, Klebsiella pneumoniae, Streptococcus agalactiae, Candida albicans, Candida glabrata). Therefore, the total number of samples processed for recovery testing was 10 organisms * 3 replicates * 2 temperature conditions = 60 samples.
   • Data provenance: Not explicitly stated, but the study used ATCC cultures (American Type Culture Collection), which are standardized and universally recognized reference strains. The urine used was "sterile filtered urine." The study was conducted in accordance with CLSI M40-A2, a globally recognized standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   This information is not applicable as the study did not involve human interpretation or expert medical assessment for establishing ground truth. The study focused on the performance of the device in maintaining organism viability, which is a quantitative laboratory measurement.

4. Adjudication method for the test set

   This is not applicable, as the study does not involve expert review or interpretation of results that would require an adjudication method. The ground truth (original spiked concentration) is a predefined quantitative value.

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. The device is a urine stabilization tube, not an AI-assisted diagnostic tool for human readers.

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

   This is not applicable. The device is a physical product (a urine stabilization tube), not an algorithm or AI. The study evaluated the standalone performance of the device in maintaining microbial concentrations.

7. The type of ground truth used

   The ground truth was the original spiked concentration of ATCC cultures in sterile filtered urine. This is a form of controlled experimental data.

8. The sample size for the training set

   This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

   This is not applicable, as there is no training set for this type of device and study.

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The HOLDEX® Single-Use Holder PP is for use in venous blood collection procedures in combination with blood collection devices with a female luer port.

The Greiner HOLDEX Single-Use Holder PP is a disposable plastic holder, which consists of a cylinder made from polypropylene plastic with an off-center molded male luer at the top. The off-center location of the male luer is to facilitate venipuncture when using luer needles. 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 Greiner HOLDEX® Single-Use Holder PP is a disposable plastic holder used for venous blood collection procedures with blood collection devices featuring a female luer port. The submission aims to extend its indication for use.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The test set used 180 blood collection devices with female luer ports. The devices were of common brands legally marketed in the US market. The study appears to be retrospective in the sense that it tested the device with existing, commercially available blood collection devices. The document does not specify if the testing was performed on actual human subjects or simulated laboratory conditions (though "simulated venous blood draw testing" suggests a laboratory setting).

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

This document does not mention the use of experts to establish ground truth for the test set. The performance data is based on engineering and simulated testing rather than expert clinical assessment of outcomes.

4. Adjudication Method for the Test Set

No adjudication method is mentioned in the document as it does not rely on human assessment of findings. The testing involves observing for failure and leakage.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component. The Greiner HOLDEX is a medical device for blood collection, and its performance is assessed through physical and functional testing.

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

This question is not applicable to the Greiner HOLDEX® Single-Use Holder PP. This device is a physical medical device, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that its mechanical function is evaluated, but it doesn't involve "human-in-the-loop" performance in the context of an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing was based on objective criteria of mechanical integrity and functionality: absence of failure and absence of leakage during simulated use, and conformity to an international standard (ISO 594-1).

8. The Sample Size for the Training Set

This product is a physical medical device; therefore, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve engineering specifications and quality control, but not a training set for an algorithm.

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

Since there is no training set for an algorithm, this question is not applicable.

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