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Safety lancet is intended for capillary blood sampling.

The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.

The provided text is a 510(k) summary for the Medifun Safety Lancet (MSL1 series). It details the device's characteristics, its comparison to a predicate device, and the performance data that supports its substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Physical/Mechanical/Chemical Tests: Not explicitly stated for each individual test. The text generally states "Non-clinical tests were performed on the proposed device."
• Sample Size for Simulated Clinical Use: 500 device samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given no specific patient data is mentioned, these are likely laboratory-based tests.

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

This information is not provided in the document. For these types of non-clinical, performance-based tests for a lancet, "experts" in the traditional sense (e.g., radiologists for image interpretation) are not typically involved in establishing ground truth. The ground truth for these tests is defined by the physical/mechanical/chemical properties and standards outlined in the acceptance criteria. The tests are conducted by trained technicians or engineers following standard operating procedures.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where agreement among multiple human readers is required to establish a ground truth for a diagnostic device. For physical performance tests of a lancet, the results are objectively measured against predefined specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic devices (especially those involving image interpretation or AI assistance) to compare performance with and without AI. The Medifun Safety Lancet is a mechanical device for blood sampling, not a diagnostic device requiring human interpretation of results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the device is a physical medical device (safety lancet), not a software algorithm or AI.

7. The Type of Ground Truth Used:

The ground truth for most of the listed tests is based on predefined engineering specifications, international standards (e.g., ISO 9626 Annex A for Acidity/Alkalinity, which implies a standardized method for determining "truth"), and regulatory guidance (e.g., FDA Guidance for simulated clinical use). For the biocompatibility tests, the ground truth is established by the absence of adverse biological reactions according to standardized test protocols.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence.

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

This information is not applicable as the device is a physical medical device and does not utilize a training set.

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Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.

This 510(k) summary is for a lancing device, which is a mechanical device used to obtain blood samples. The document focuses on showing substantial equivalence to existing predicate devices, primarily through non-clinical bench testing. It does not involve AI or human-in-the-loop performance studies. Therefore, many of the requested categories related to such studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily non-clinical bench testing. Therefore, details about sample size (e.g., number of devices tested for mechanical properties) and data provenance (country of origin, retrospective/prospective) for these bench tests are not provided in this summary.

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

This is not applicable as the studies were non-clinical bench tests; there was no "test set" requiring expert ground truth in the clinical sense.

4. Adjudication method for the test set

This is not applicable for the same reasons as point 3.

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 is not applicable. The device is a mechanical lancing device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a mechanical lancing device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the criteria defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and the device's own internal specifications for functional performance. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for a mechanical lancing device as there are no algorithms being trained.

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

This is not applicable for the same reasons as point 8.

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