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The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.

The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism. Unistik® Touch safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes. The Unistik® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows: Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm The Unistik® Touch contact-activated safety lancets are intended for prescription and over-the-counter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female. right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime. Unistik® Touch contact-activated safety lancets are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use. The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded. The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.

The Unistik® Touch Single-Use Safety Lancets were evaluated through a series of non-clinical performance studies, primarily bench testing and a simulated clinical use study.

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Simulated Clinical Use Study: 500 device samples were used.
• Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective, beyond stating it was a "simulated clinical use study."

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 studies described are non-clinical, primarily bench testing, and a simulated clinical use study. The performance criteria are objective measurements against established standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set:

• This information is not applicable and not provided. The studies involved objective measurements against predefined acceptance criteria rather than subjective expert adjudication.

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, an MRMC comparative effectiveness study was not done. This device is a blood lancet, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's inherent functional performance without human interaction regarding its analytical functions (e.g., accurate puncture depth, safety mechanism activation). This was assessed through the various bench tests.

7. The type of ground truth used:

• The ground truth for the bench testing was based on objective, verifiable measurements and physical characteristics outlined in the acceptance criteria (e.g., freedom from burrs, adherence to dimensions, pH values, metal content, puncture depth measurements, force to activate safety features).
• For the simulated clinical use study, the ground truth was based on demonstrating that the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA Guidance and ISO 23908.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

• Not applicable. As noted above, this is a physical medical device and does not involve a training set for an AI/ML algorithm.

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