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The BD Vacutainer™ Push Button Blood Collection Set is a sterile, multiplesample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients.

The BD Vacutainer™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids as indicated in 21 CFR §880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.

The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

The BD Vacutainer™ Push Button Blood Collection Set is for venous blood collection and IV administration. It contains a needle that will retract into the body of the device when a button is depressed, helping to prevent accidental needle sticks.

The provided text is a 510(k) summary for the BD Vacutainer™ Push Button Blood Collection Set. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets particular performance metrics.

Instead, it states:
"Based upon previously demonstrated performance and successful completion of biocompatibility testing, Push Button Blood Collection Set will perform as intended."

This indicates that the safety and effectiveness are supported by:

• Previously demonstrated performance: This implies that the device's design is similar to existing, already cleared devices (predicate devices listed in the summary, K980414 and K022875) and is expected to perform comparably. No new performance study with specific acceptance criteria is detailed for this specific submission.
• Successful completion of biocompatibility testing: This is a standard requirement for medical devices that come into contact with the body.

Therefore, many of the requested points regarding acceptance criteria and a specific study cannot be answered from the provided text. The document focuses on regulatory compliance through substantial equivalence, rather than detailing a de novo performance study with quantitative acceptance criteria.

Summary of Information NOT Found in the Provided Text:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth for a test set, and their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
• Details of a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
• Sample size for a training set.
• How ground truth for a training set was established.

Information that can be extracted or inferred:

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

   • Acceptance Criteria: Not explicitly stated as quantitative metrics. The implicit acceptance criterion is that the device "will perform as intended" based on similarity to predicate devices and biocompatibility.
   • Reported Device Performance: No specific quantitative performance data is reported. The document relies on the "previously demonstrated performance" of predicate devices and "successful completion of biocompatibility testing."

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

   • Sample Size (Test Set): Not specified.
   • Data Provenance: Not specified. (The document refers to "previously demonstrated performance," implying reliance on historical data or characteristics of predicate devices, but no details are given for this device's specific testing related to performance.)

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

   • Not applicable/Not specified as no such test set or ground truth establishment process is described beyond biocompatibility testing.

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

   • Not applicable/Not specified.

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:

   • No MRMC study was mentioned. This device is a blood collection set and does not involve AI or human image interpretation.

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

   • Not applicable. This device is a physical medical device, not an algorithm.

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

   • For biocompatibility, the "ground truth" would be established by standardized laboratory tests according to ISO 10993 standards, not expert consensus or pathology in the context of diagnostic accuracy. For performance, it relies on the established performance of predicate devices.

8. The sample size for the training set:

   • Not applicable. No "training set" in the machine learning sense is mentioned or relevant for this type of device submission.

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

   • Not applicable.

In conclusion, the document emphasizes the device's substantial equivalence to previously cleared devices and successful biocompatibility testing as the basis for its safety and effectiveness, rather than providing a detailed performance study with specific acceptance criteria.

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The Vacutainer™ PLUS SST™ Tube is a plastic evacuated blood collection tube with silica clot activator and gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. Blood collected in a Vacutainer™ PLUS SST™ Tube is primarily used for clinical laboratory testing in chemistry using patient serum, but may be used for other assays requiring serum specimens as determined by the laboratory. In addition, the Vacutainer™ PLUS SST™ Tube is compatible with many commonly used therapeutic drugs therefore suitable for therapeutic drug monitoring (TDM). Blood can be collected, processed and stored in a Vacutainer™ PLUS SST™ tube for at least 24 hours for therapeutic drug monitoring without large losses in recovery.

The Vacutainer™ PLUS SST™ Tubes are sterile, plastic, evacuated blood collection tubes. The Vacutainer™ PLUS SST™ Tube consists of: (1) a closure assembly, (2) an inert polyester gel barrier, (3) silica clot activator, and (4) a silicone surfactant coated plastic tube. The specimen is centrifuged and the barrier material forms at the serum/blood clot interface, mechanically separating the serum from cells. The serum portion is used for clinical laboratory assays involving the use of patient serum.

The provided text describes a 510(k) summary for the BD Vacutainer™ PLUS SST™ Tube. This device is a blood collection tube, and the acceptance criteria and study detailed are related to its performance in therapeutic drug monitoring (TDM).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core claim and thus the primary acceptance criterion is related to the stability of therapeutic drugs in blood samples stored in the device.

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

• Sample Size: The document does not explicitly state the sample size (number of patients or blood samples) used for the clinical evaluations.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply states "Clinical evaluations were performed."

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

This information is not provided in the document. The device is a blood collection tube, and its performance is assessed through laboratory assays, not typically by expert interpretation of images or clinical findings that require "ground truth" established by experts in the sense of, for example, radiologists. The "ground truth" here would be the actual concentration of therapeutic drugs in the blood samples, determined by standard laboratory methods.

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

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging) where there might be disagreement among reviewers. For a device like a blood collection tube, performance is measured by objective laboratory assays, which do not typically involve this type of adjudication.

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 information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improving with AI assistance" relate to diagnostic or interpretative AI devices. The BD Vacutainer™ PLUS SST™ Tube is a blood collection device, not an AI-powered diagnostic tool.

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

This information is not applicable and therefore not provided. This question is relevant for AI algorithms. The described device is a physical medical device (blood collection tube).

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

The ground truth for this type of device would be the measured concentration of therapeutic drugs in the collected blood samples using established and validated analytical methods (e.g., mass spectrometry, immunoassay). The document does not explicitly state the specific analytical methods used, but "clinical laboratory testing in chemistry" is mentioned.

8. The sample size for the training set

This information is not provided and is likely not relevant in the context of this type of device submission. Training sets are typically associated with machine learning or AI models. This device's performance is demonstrated through clinical evaluations, which are essentially validation studies, not training studies.

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

This information is not applicable as there is no mention of a training set for an AI model. For the clinical evaluations (which serve as the validation study for the device's claims), the "ground truth" would be established by the analytical results of the therapeutic drug monitoring assays performed on the blood samples.

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