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The OneTouch® Delica® Plus lancets are sterile, single use devices that have been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch® Delica® Plus lancing device.

The OneTouch® Delica® Plus Lancing System consists of a non-sterile, reusable base blood lancing device that is intended for use on a single patient and is used in conjunction with a sterile, single-use lancet. The lancing device has 13 depth settings. The lancets are made available in size 30G and are packaged in boxes of 30 and 100 count.

This device is a OneTouch® Delica® Plus Lancing System, which is a blood lancing system for obtaining capillary blood samples from the fingertips. This submission is for a 510(k) premarket notification, which means it evaluates substantial equivalence to a legally marketed predicate device. Therefore, the "acceptance criteria" are demonstrating substantial equivalence through non-clinical performance testing.

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

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are the successful completion of various non-clinical performance tests to demonstrate that the device is as safe and effective as the predicate. The reported device performance is that it met the specifications for each test.

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 does not specify the exact sample sizes used for each non-clinical test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, though it would be prospective for these types of verification and validation tests.

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 information is typically not applicable to non-clinical performance testing of a lancing device. The "ground truth" here is objective measurements and adherence to established standards and specifications, not expert interpretation.

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

Not applicable to non-clinical performance testing.

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

Not applicable. This device is a blood lancing system, not an AI software. No MRMC study was performed.

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

Not applicable. This device is hardware, not an algorithm.

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

For the non-clinical performance tests, the "ground truth" refers to the established technical specifications, quality standards (e.g., ISO, ASTM), and regulatory requirements that the device must meet. The tests themselves provide objective data to verify compliance with these standards.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for this device.

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