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It is intended for capillary blood sampling.

The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use. The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The "acceptance criteria" are generally implied to be compliance with relevant international standards and FDA guidance, as well as performance comparable to the predicate device. Specific numerical acceptance criteria are not explicitly stated for all tests, but rather the outcome of "met the requirements" or "complies with."

2. Sample Size Used for the Test Set and Data Provenance:

• Simulated Clinical Use: 600 device samples.
• Biocompatibility and Bench Tests: Specific sample sizes for individual tests are not detailed beyond "the lancet" or "the proposed device."
• Data Provenance: The document does not specify the country of origin of the data for these studies. The studies are non-clinical (laboratory/bench) and simulated clinical use, not clinical trials on human subjects. They are prospective tests conducted for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not applicable. This submission describes a medical device (Lancet) and its performance under various non-clinical and simulated clinical conditions. The "ground truth" for these tests relates to objective measurements, standard compliance, and device functionality, not expert interpretation of clinical data. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective measurements and compliance assessments (e.g., dimensions, force, cytotoxicity), there is no mention or need for an adjudication method like 2+1 or 3+1. The results are directly measured against predefined standards or specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases. This document pertains to a blood lancet, and no such study was conducted or is relevant for its substantial equivalence claim.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a manual blood lancet, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Objective Test Results and Compliance with International Standards/Guidance: The "ground truth" for the performance tests consists of objective measurements (e.g., dimension records, force measurements, chemical analysis results) and direct compliance with the requirements outlined in recognized international standards (ISO 7864, ISO 9626, ISO 10993 series, ISO 23908, ASTM F756-17, ASTM D4169-16, USP , USP-NF, USP-NF) and FDA guidance documents.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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