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The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The TAP Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The TAP Lancet comprises a lancing module and a vacuum creation module which operate in an entirely mechanical fashion. The device uses a lancet and vacuum to initiate blood flow from the capillary bed in the upper arm. To use the device, the user removes that TAP Lancet from a sterile barrier package. Next, the user removes a protective liner from the bottom of the device to expose a layer of medical adhesive and places the device onto the

Let's break down the information regarding the acceptance criteria and the study proving the device meets them for the TAP Lancet.

The provided text is a 510(k) Summary for the TAP Lancet, a blood lancing device. The summary focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical and clinical performance testing.

Here's the breakdown of the acceptance criteria and study as presented in the document:

1. Acceptance Criteria and Reported Device Performance

The document describes the performance of the device in a clinical study primarily under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section. The key metric reported related to the device's functional performance in producing blood samples.

Note: The document doesn't explicitly state quantitative 'acceptance criteria' in a table format for the clinical study results, but rather presents the study outcome as meeting the overall performance goals.

2. Sample Size and Data Provenance

• Test Set (Clinical Study):

  • Sample Size: Not explicitly stated as a number of subjects. The text mentions "human subjects" and "The devices had a total success rate of 95.0%". From the information on the training set (380 samples), this seems to be a separate smaller study for usability.
  • Data Provenance: Not specified regarding country of origin. The study was an "actual-use study" where "Subjects produced their blood samples following the TAP Lancet instructions for use," indicating a prospective study design.

• Training Set (Usability Study, from context of "clinical testing" section related to usability):

  • Sample Size: 380 samples (This is the only specific number of "samples" mentioned in relation to a study that isn't device/material testing).
  • Data Provenance: Not specified regarding country of origin. The study was a "human use study" that also seems prospective, as subjects were producing blood samples using the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not indicate the use of experts to establish ground truth for the clinical performance. The "ground truth" for the clinical study appears to be the successful production of microliter capillary whole blood samples by the device itself when used by human subjects according to instructions. This implies a direct observational assessment of the device's primary function rather than interpretation by human experts.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The success of blood sample production is likely a direct, measurable outcome, not requiring interpretation or adjudication by multiple reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. The study focused on the performance of the device itself (ability to produce blood samples) and its usability, not on comparing human readers with and without AI assistance. This device is a physical lancing device, not an AI/imaging diagnostic tool.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a physical medical device (lancet), not an algorithm or software. Its performance is inherent to its mechanical function.

7. Type of Ground Truth Used

The ground truth for the clinical performance assessment was outcomes data related to the device's primary function: the successful production of microliter capillary whole blood samples. This was a direct, observable outcome of the device's use.

8. Sample Size for the Training Set

As mentioned above, if we interpret "training set" as the data used for the usability study which informed product improvements or finalized the design:

• Sample Size: 380 samples.

9. How Ground Truth for the Training Set Was Established

The "training set" (presumably the samples from the usability study) ground truth was established by direct observation and assessment of the device's ability to produce blood samples and its usability when used by human subjects. The phrase "Subjects produced their blood samples following the TAP Lancet instructions for use" and "The devices had a total success rate of 95.0% and demonstrated that they performed as intended" suggests that success was a direct observation of whether a sample was obtained as specified. The usability portion would have involved feedback or evaluation based on the instructions for use.

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