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The SG LANSET I, SG LANCETS and SOFT LANCETS are indicated to obtain a capillary blood sample from the side of a fingertip for testing utilizing small amounts of blood.

The SG LANSET I, SG LANCETS and SOFT LANCETS are a single use, sterilized by gamma radiation, which is a pointed piece of surgical steel encased in plastic, used to puncture the skin on one's finger to get a blood sample. The SG LANSET I, SG LANCETS and SOFT LANCETS can be used anytime and anywhere to obtain a blood sample form diabetic patients to measure their blood sugar level. A cap is included to protect the needle from becoming contaminated with dust, etc. The cap completely seals the needle making it impossible for any foreign material to come in contact with the needle. This ensures safe storage and easy portability.

The lancing device used with most blood lancets, offers an adjustable tip with variety depth settings for quick, comfortable and easy blood sampling.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the requested details (table, sample size, experts, etc.).

The provided document is a 510(k) summary for a medical device (blood lancets). While it discusses substantial equivalence to predicate devices and lists types of performance tests (Dimension, Inner-Outer surface, Draw test, Biocompatibility, Sterilization, Shelf-Life), it does not provide specific acceptance criteria or detailed results of these tests. For example, it states "Dimension: Pass" but doesn't specify what the dimensional requirements were. It also explicitly states, "This 510(k) does not include data from clinical tests."

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or multi-reader studies, as that information is not present in the provided text.

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