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The TAP Blood Collection® Device is a lithium heparin coated single use device intended to collect capillary blood from the upper arm of adults (21 years of age or older). The TAP Blood Collection® Device is for measurement of HbAlc on blood specimens which can be collected by self-administration of the TAP Device by a layperson or by a healthcare worker in a healthcare setting. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin Alc (HbA1c) using tests intended for monitoring glycemic control.

The TAP Blood Collection® Device (herein “TAP Device”) is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to obtain a capillary blood sample from the upper arm. The device contains lithium heparin as an anticoagulant. The device is intended for self-administration by a layperson or by a healthcare worker. When the TAP Device is actuated, it collects the sample in an integrated reservoir and provides a visual indicator (fill indicator window) to the end user to confirm that the collection is complete and sufficient blood has been collected to conduct HbA1c testing. The sample collection time is 7 minutes or less and typically takes 2-3 minutes. The TAP Device is then sent to the laboratory for testing. The sample must be tested within 6 hours from time of collection or as indicated in the HbA1c test system package insert (whichever is less).

The provided text describes the TAP Blood Collection® Device, focusing on its re-submission for an expanded indication of use, specifically for self-administration by laypersons for HbA1c testing. The device itself (K161521) was previously cleared, and this submission (K190225) aims to add layperson use.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list "acceptance criteria" in a table format with specific numerical targets. Instead, it describes general performance goals for the additional testing supporting the layperson use indication. The reported device performance is presented as conclusions from these studies.

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

The provided text does not specify the sample size for either the usability study or the analytical performance study. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

This device is a blood collection device, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC comparative effectiveness study regarding human readers and AI assistance is not applicable and not mentioned.

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

This device is a blood collection device. Its primary function is to collect a blood sample. The "performance" being evaluated here is the ability to collect a suitable sample for laboratory analysis and the comparability of the collected sample to a standard collection method. There is no "algorithm only" performance that would be applicable to this type of device.

7. The Type of Ground Truth Used

• For the usability study, the "ground truth" was likely defined by successful completion of specified tasks by laypersons according to instructions. This would be assessed through observation and potentially questionnaires.
• For the analytical performance testing, the "ground truth" for HbA1c values was established by venous blood samples collected by a healthcare worker, considered the reference standard for HbA1c measurement.

8. The Sample Size for the Training Set

This information is not provided in the given text. The studies described are performance validation studies, not AI model training.

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

As this is not an AI algorithm, there is no "training set" in the context of machine learning. The studies are evaluating the device's ability to facilitate sample collection and the quality of those samples.

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The TAP Blood Collection® Device is a lithium heparin coated single intended to be used to collect capillary blood from the upper arm of adults (21 years of age or older) by a healthcare worker. The collected sample is then transported for analysis in a clinical laboratory for determination of Hemoglobin A1c (HbA1c) using tests intended for monitoring glycemic control.

The TAP Blood Collection® Device (herein "TAP Device") is a single-use, sterilized whole blood specimen collection and transportation device that uses a combination of two mechanisms, capillary action and vacuum extraction, to obtain a capillary blood sample from the upper arm. The device contains lithium heparin as an anticoagulant.

The device is intended for use by a healthcare worker. When the TAP Device is actuated, it collects the sample in an integrated reservoir and provides a visual indicator (fill indicator window) to the end user to confirm that the collection is complete and sufficient blood has been collected to conduct HbA1c testing. The sample collection time is 7 minutes or less and typically takes 2-3 minutes. The TAP Device is then sent to the laboratory for testing. The sample must be tested within 6 hours from time of collection or as indicated in the HbA1c test system package insert (whichever is less).

The provided document describes the TAP Blood Collection® Device, its indications for use, and the studies conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a separate table with pass/fail thresholds. However, it presents various performance metrics and concludes that the device is "equivalent" or "no significant differences" exist compared to established methods. We can infer the de-facto acceptance criteria from the reported performance which demonstrates equivalence to venipuncture blood samples for HbA1c testing.

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

• Pivotal Study: 143 participants.
  • Data Provenance: Prospective study conducted at multiple hospital clinic sites by healthcare workers. The country of origin is not explicitly stated but implied to be the USA given the FDA submission. Participants spanned representative age, gender, ethnicity, race, and health status (healthy and diabetic).
• Analyte Stability Study: "multiple TAP Device samples were collected" and "A total of two or three samples were tested from each participant." The exact number of participants is not given.
  • Data Provenance: Prospective study. Country of origin not explicitly stated.
• Usability Study: The number of participants is not explicitly stated, but it assessed "intended users of the product."
  • Data Provenance: Prospective study. Country of origin not explicitly stated.
• Sample Quality Studies (Collection time, volume, clotting, hemolysis):
  • Collection time, volume, clotting: 209 TAP Devices.
  • Hemolysis: 69 TAP Device blood samples.
  • Data Provenance: Not explicitly stated whether these were distinct studies or part of the pivotal study, but implied to be prospective. Country of origin not explicitly stated.

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

The ground truth for the HbA1c levels was established by venipuncture blood samples analyzed in a clinical laboratory using "HbA1c analyzers." The document does not specify the number of experts or their qualifications for interpreting these venipuncture samples, as it relies on standard clinical laboratory procedures and FDA-cleared analyzers. The "healthcare workers" collected samples, but the analysis establishing the "ground truth" (the comparator) was performed by laboratory instruments.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of expert adjudication for diagnostic imaging or clinical endpoints. The primary comparison in the pivotal study was between HbA1c levels derived from the TAP Device and those from venipuncture, both analyzed by standard laboratory methods. Discrepancies would be handled by statistical methods (bias, correlation).

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:

Not applicable. This device is a blood collection system, not an AI-assisted diagnostic tool that requires human interpretation of outputs. The studies focused on device performance (e.g., sample equivalence, variability between lots/operators) and usability by healthcare workers, not on improving human reader performance.

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

Not applicable. The device is a physical blood collection tool. Its "performance" is measured by the quality and accuracy of the sample it collects when analyzed by an external laboratory process, not by an internal algorithm's standalone output.

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

The ground truth for the primary effectiveness evaluation (HbA1c levels) was established using venipuncture blood samples analyzed by FDA-cleared HbA1c analyzers in a clinical laboratory. This represents a recognized standard method for measuring HbA1c.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical blood collection device, not an algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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