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The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use 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® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge.

The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers 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.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle.

The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing 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 provided text describes a 510(k) premarket notification for a medical device (Unistik® 3, Unistik® 3 Value, and Abbott SF sterile single-use safety lancets), not an AI/ML powered device. As such, information regarding AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, or training set details are not applicable and are not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with relevant standards for a traditional medical device (blood lancets).

Below is the information regarding the acceptance criteria and study as presented in the document for the non-AI medical device.

1. Table of acceptance criteria and the reported device performance

Additionally, the document states: "All additional performance tests met the acceptance criteria."

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

The document does not specify the exact sample sizes used for each of the bench tests mentioned. The "data provenance" (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated, but the tests were conducted as part of the design verification for the devices by the manufacturer, Owen Mumford Ltd (United Kingdom). These would be considered prospective design verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical medical device (lancet), not an AI/ML diagnostic system requiring expert-established ground truth for a test set. The acceptance criteria are based on internal test specifications and engineering requirements.

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

This question is not applicable for a physical medical device where performance is evaluated through objective bench tests against technical specifications.

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 question is not applicable as the device is a physical medical device (lancet) and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable as the device is a physical medical device (lancet) and does not involve an algorithm.

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

For the bench tests, the "ground truth" or reference against which the device performance was measured were the internal test specifications. These specifications define the expected performance parameters (e.g., integrity, firing protocol, cap removal torque, needle penetration depth, environmental resilience, drop test). Biocompatibility was assessed against ISO 10993-1, and sterility against ISO 11137 with a Sterility Assurance Level (SAL) of 10^-6.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" in the AI/ML context.

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

This question is not applicable as the device is a physical medical device (lancet) and does not involve a "training set" or "ground truth" for training purposes.

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