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

The Accu-Chek Safe-T-Pro Plus 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 Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus 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. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.

The provided text is a 510(k) premarket notification for the "Accu-Chek Safe-T-Pro Plus Lancing Device". It focuses on establishing substantial equivalence to predicate and reference devices rather than presenting specific acceptance criteria and a detailed study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML devices.

However, based on the information provided, I can extract the non-clinical testing performed and infer the acceptance criteria and details about the study.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for comparison within a table, as one would expect for an AI/ML device. Instead, it describes "nonclinical bench testing" and "design verification and validation testing" to ensure risk management and mechanical function. The "reported device performance" is broadly stated as "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

However, we can infer acceptance criteria related to safety and functionality from the types of testing mentioned and the characteristics of the device.

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 primarily describes non-clinical bench testing. It does not provide details on a "test set" in the context of clinical data for performance metrics. For the "nonclinical bench testing," the sample size of devices tested is not specified. The data provenance is also not specified, but it would typically be internal testing conducted by the manufacturer. Since it's bench testing, concepts of retrospective or prospective data usually don't apply in the same way as clinical studies.

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 section is not applicable as the document describes a physical medical device (lancing device) and its mechanical and safety performance, not an AI/ML algorithm that requires expert-established ground truth for a test set. There is no mention of experts or ground truth in this context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies involving interpretation of data, often by multiple readers, which is not the case here.

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 section is not applicable. The device is a "lancing device," a physical tool for blood sampling. It does not involve AI or software for diagnostic interpretation, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely outside the scope of this device.

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

This section is not applicable as the device is a lancing device and does not involve any algorithm or software with standalone performance.

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

This section is not applicable. For a lancing device, the "ground truth" for its performance would be its physical properties, sterility, mechanical reliability, and safety features, which are evaluated through engineering tests and quality control, not clinical "ground truth" like pathology or outcomes data in the sense of diagnostic accuracy.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML product and does not have a "training set."

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

This section is not applicable for the same reason as point 8.

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The Accu-Chek Safe-T-Pro Plus 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 Plus 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 provided text is a 510(k) summary for a medical device called the "Accu-Chek Safe-T-Pro Plus Lancing Device." It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain any information about acceptance criteria for an AI-powered device, nor does it describe a study involving an AI algorithm.

The document specifically states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"Clinical Testing is not applicable; risk analysis confirmed risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatability section."

Therefore, I cannot provide the requested information about an AI device's acceptance criteria and study proving it meets those criteria based on this document. The device in question is a physical lancing device, not an AI software.

Ask a specific question about this device