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OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.

The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.

This document is a 510(k) premarket notification for "Single Use Blood Lancets" by Asahi Polyslider Company, Ltd. It seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly provide a table of acceptance criteria in the format of pass/fail metrics. Instead, it states that "Results confirm that the design inputs and performance specifications for the subject devices are met." and "The Single Use Blood Lancets passed all required testing in accordance with internal requirements, national standards, and international standards shown below, supporting their safety and effectiveness and substantial equivalence to the predicate device."

The tests performed and their outcomes are listed in Section 9 "Non-Clinical Performance Data":

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

The document does not specify the exact sample sizes used for each test. It broadly states that "Asahi Polyslider completed the following verification and validation activities, including non-clinical tests." and "The Single Use Blood Lancets passed all required testing...".

Data provenance: The tests were conducted to support a submission by a Japanese company (Asahi Polyslider Company, Ltd. located in Japan). The nature of the non-clinical tests (e.g., cytotoxicity, sterilization, shelf-life) suggests they are laboratory-based and likely prospective, specifically designed to evaluate the subject devices.

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 tests performed are primarily engineering and biocompatibility evaluations, which are typically performed by qualified laboratory personnel and statisticians, rather than clinical experts establishing a ground truth in the context of diagnostic performance.

4. Adjudication method for the test set

This information is not provided as it's not relevant for the type of non-clinical tests detailed (e.g., material testing, sterilization validation). Adjudication methods are typically used in clinical studies or image-based diagnostic studies to resolve discrepancies in expert interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for a mechanical blood lancet.

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

No, a standalone (algorithm only) performance study was not done. This device is a manual surgical instrument (blood lancet), not an algorithm or AI system. Its performance is entirely mechanical and physical.

7. The type of ground truth used

The "ground truth" for the non-clinical tests listed are based on:

• Established standards and specifications: e.g., ISO 10993-5 for cytotoxicity, ISO 11137-1/-2 for sterilization validation, ASTM F1980 for shelf-life, and ASTM 4169 for transportation.
• Internal requirements: "internal requirements... supporting their safety and effectiveness" (Section 9).
• Predicate device characteristics: The substantial equivalence comparison heavily relies on showing similar technological characteristics and performance to the SurgiLance® Safety Lance (K101145) and other reference devices.

For example, for cytotoxicity, the ground truth is simply whether the device material exhibits cytotoxic effects above defined thresholds in the ISO standard. For sterilization, it's achieving a specified Sterility Assurance Level (SAL).

8. The sample size for the training set

This information is not applicable as this device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

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

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