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droplet® personal lancets are sterile, single-use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.

droplet® personal lancet is made of steel needle placed inside the plastic body lancet with plastic protective cap.

The lancet remains sterile until the cap is removed. There are two versions of droplet® personal lancets which differ in the needle diameter: 28G and 30G. These two versions differ in lancet body color. The version 28G is available in pink and blue colors, and version 30G is available in violet version.

The provided FDA 510(k) Clearance Letter for droplet® personal lancets outlines the device's technical characteristics and studies performed. However, it does not contain detailed acceptance criteria tables, specific performance metrics, sample sizes, or information typically associated with AI/software-based medical devices (such as clinical study design, ground truth establishment, expert adjudication, or MRMC studies).

The document states: "Clinical data is not required." and focuses on non-clinical performance data for physical device characteristics and compatibility.

Therefore, the following response is based solely on the information available in the provided text, and will highlight what is present while explicitly stating what information is not provided as per the request.

Acceptance Criteria and Study Proving Device Meets Criteria for droplet® personal lancets

The droplet® personal lancets are mechanical medical devices (blood lancets) and as such, the acceptance criteria and study data relate to physical and functional attributes rather than diagnostic or analytical performance metrics typical of AI/software devices. The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests performed and states that "All tests were passed and met the predefined acceptance criteria." However, it does not provide a specific table of these "predefined acceptance criteria" or the quantitative reported performance values. It lists the categories of tests conducted.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests.

• Data Provenance: The tests were conducted internally by HTL-Strefa S.A.'s quality control and presumably in their home country (Poland), as indicated by the company's address. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. The droplet® personal lancets are physical medical devices, and their performance evaluation relies on engineering, material science, and functional testing, not expert interpretation of outputs like in AI/imaging devices. Ground truth for properties like sharpness or needle protrusion would be established via metrology and physical testing methods, not human expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus ground truth in clinical evaluations, particularly for subjective assessments or borderline cases, which is not relevant to the described non-clinical testing of a lancet.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC study was not conducted and is not applicable. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, typically within imaging or pathology. The droplet® personal lancets are standalone devices used for blood sampling, not for diagnostic interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm was not conducted and is not applicable. This device does not involve an algorithm. The reported non-clinical performance data represents the "standalone" performance of the physical device on its own against specified criteria.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be based on:

• Manufacturer's Predefined Product Specifications: For physical attributes like color, aesthetics, needle presence, orientation, sharpness, and length.
• Engineering/Functional Test Standards: For compatibility with lancing devices (e.g., proper fit, function, retraction).
• International Standards: For biocompatibility (ISO 10993-1) and sterilization (SAL).
• Simulated Environmental Conditions: For transport tests.

It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product and does not involve AI/machine learning, therefore, there is no "training set."

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

This information is not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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