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The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is an FDA 510(k) premarket notification for the Accu-Chek Safe-T-Pro Uno Lancing Device. It does not describe a study with acceptance criteria in the manner typically found in clinical trials or AI/software validation studies. Instead, it details a "non-clinical bench testing" approach to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance for specific metrics. Instead, it refers to "design verification and validation testing" performed per "applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)." The conclusion states the device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

The closest approximation to "device performance" mentioned is:

• The Accu-Chek Safe-T-Pro Uno lancing device is designed for a single use only and has a sharps injury prevention feature where the lancet is retracted and concealed before and after use, and is rendered inoperative after use.
• It uses a 28 Gauge needle with a 1.5 mm depth and is spring-driven.
• Loading/priming is not required; activation is via a press release button.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size used for the test set" or "data provenance" in terms of subject populations or data collection methods (retrospective/prospective). This is because the described testing is "non-clinical bench testing," meaning it was likely conducted in a laboratory setting on the device itself, rather than on human subjects or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as no "ground truth" established by experts for a test set is mentioned. The testing involves mechanical and design verification, not expert evaluation of results from human or image data.

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

Not applicable. No adjudication method is mentioned as there's no expert review of outcomes.

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. A MRMC comparative effectiveness study is relevant for AI or diagnostic imaging devices evaluating human performance. This document is for a medical device (lancing device) and does not involve AI or human readers.

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

Not applicable. This is not an AI or algorithm-based device.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical bench testing would be engineering specifications, regulatory standards (like ISO or FDA special controls for sharps injury prevention), and the performance characteristics of the legally marketed predicate and reference devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of what is present:

• Type of Study: Non-clinical bench testing (design verification and validation testing).
• Purpose: To demonstrate the mechanical functions, safety (sharps injury prevention), and performance are suitable for use and are substantially equivalent to legally marketed predicate and reference devices.
• Applicable Standards: FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850).
• Conclusion: The device is "safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices."
• Clinical Testing: "Not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

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The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The Accu-Chek Safe-T-Pro Uno lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Uno lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only.

The provided text describes a 510(k) summary for the Accu-Chek Safe-T-Pro Uno Lancing Device. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study that proves the device meets those criteria, such as sample size, data provenance, expert qualifications, or adjudication methods.

The document outlines the device's indications for use, its description, and compares it to a predicate device (SurgiLance Safety Lancets) to establish substantial equivalence. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification & validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." A "Verification Summary" is mentioned as an attachment, which presumably contains the detailed test results, but this summary is not provided in the given text.

Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than detailing a specific performance study with acceptance criteria and results.

Disclaimer: Without the "Verification Summary" mentioned in the document, it is impossible to provide the requested details about acceptance criteria and reported performance. The information below is based solely on what is explicitly stated or can be inferred from the provided text, which is limited regarding specific performance metrics.

Based on the provided text, the following information can be extracted or inferred:

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

The provided text does not explicitly state specific acceptance criteria or reported device performance metrics in a quantifiable manner. It mentions "nonclinical bench testing" and "design verification & validation testing" were performed to ensure risks were appropriately managed and verify mechanical functions are suitable for use over the lifetime of the device. The conclusion states the device "performs as well or better than the legally marketed predicate device," which is a general statement rather than specific performance data with corresponding acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not provide any information about the sample size used for the test set, data provenance, or whether the study was retrospective or prospective. It only refers to "nonclinical bench testing" and "design verification & validation testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the provided text describes non-clinical bench testing for a lancing device, not a study evaluating human interpretation or a diagnostic algorithm requiring expert ground truth establishment.

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

This information is not applicable as the provided text describes non-clinical bench testing for a lancing device and does not involve adjudication of results from multiple reviewers.

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 as the device is a lancing device and does not involve AI assistance or human readers.

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

This information is not applicable as the device is a lancing device and does not involve an algorithm.

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

This information is not applicable in the traditional sense of medical image analysis or diagnostic algorithms. For a lancing device, "ground truth" would refer to established engineering and mechanical standards, as implied by "design verification & validation testing" and compliance with "FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)."

8. The sample size for the training set

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

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

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

Ask a specific question about this device