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The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.

The device is intended to be used by professionals and individuals.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Disposable Safety Lancet". It does not describe an AI/ML device or its acceptance criteria and study. Therefore, I cannot generate the requested information based on the provided text.

Here's why the request cannot be fulfilled:

No AI/ML Device: The document is about a "Disposable Safety Lancet," a physical medical device used for drawing capillary blood samples. It does not mention any artificial intelligence or machine learning components.
No Acceptance Criteria for AI/ML: Since it's not an AI/ML device, there are no acceptance criteria related to its performance in tasks like image interpretation, prediction, or classification. The document outlines bench testing for physical characteristics (e.g., appearance, dimensions, needle sharpness, safety).
No "Ground Truth," "Experts," or "Training Set": These terms are specific to the evaluation of AI/ML models. A physical medical device does not have a "ground truth" in the same sense, nor does it require experts to establish a ground truth or a training set for an algorithm.

If you intended to provide a different document describing an AI/ML medical device, please provide that text.

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K Number

K222090

Device Name

Safety Lancet

Manufacturer

Ningbo Medsun Medical Co., Ltd.

Date Cleared

2022-09-30

(77 days)

Product Code

FMK

Regulation Number

878.4850

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K192666,K101145

Intended Use

Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Device Description

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.

AI/ML Overview

The provided document is a 510(k) summary for the "Safety Lancet" device, which makes an equivalence claim to previously cleared predicate devices. Since this is an equivalence claim, the studies described are primarily non-clinical bench testing to demonstrate that the subject device performs as safely and effectively as the predicate devices. It does not contain information about clinical studies with human participants.

Therefore, many of the requested fields related to clinical efficacy studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this 510(k) summary. These types of studies are typically conducted for new technologies or to demonstrate clinical efficacy, which is not the primary purpose of a 510(k) submission based on substantial equivalence.

Here's the information extracted from the document based on the request:

1. Table of acceptance criteria and the reported device performance:

The document lists performance tests conducted but does not explicitly state "acceptance criteria" and "reported device performance" in a direct side-by-side format with quantitative measures for each criterion. Instead, it states that the performance data were "provided in support of the substantial equivalence determination" and that "The test results show that the product had well sharps injury prevention feature." This implies that the device met the internal (or external standard-based) acceptance criteria for each test.

Test Item	Implied Acceptance Standard/Goal	Reported Device Performance
Biocompatibility Testing	Compliance with ISO 10993 series standards, demonstrating no adverse biological reactions.	Met requirements. "The biocompatibility evaluation items of proposed device were completed for each model and each sterilization method (Co-60 and e-beam) individually. The testing included the following tests: In vitro cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen." The document also notes that the subject device's biocompatibility testing was "more strict" than Predicate Device A.
Dimension	To meet specified dimensions and potentially ISO 9626:2016 for needles.	Met requirements. "Dimension/gauge of the needles all meet the requirements ISO 9626:2016."
Appearance	To meet visual inspection standards (e.g., no defects, damage).	Met requirements. (Implied, as it's listed as a conducted test without issues).
Needle-tip	To meet specified characteristics (e.g., sharpness, integrity).	Met requirements. (Implied, as it's listed as a conducted test without issues).
Trigger force	To be within a functional range for intended use.	Met requirements. (Implied, as it's listed as a conducted test without issues).
Corrosion resistance feature	To prevent corrosion during shelf life and use.	Met requirements. (Implied, as it's listed as a conducted test without issues).
Retractable	To ensure the needle retracts automatically after puncture.	Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the design description).
Penetration Depth	To meet specified penetration depths for different models/gauges.	Met requirements. The range for the subject device (1.2mm to 2.8mm) is noted as "the same as the penetration depth of predicate device A." Specific depths for various models are listed in the comparison table.
Challenge Safe Mode-Resistance	To ensure the sharps injury prevention feature functions correctly, resisting attempts to expose the needle after use.	Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test).
Challenge Safe Mode-Needle Tip Exposed	To ensure the needle tip remains shielded after use.	Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test).
Anti-activation test (Model XH and XA)	To ensure the device does not activate accidentally.	Met requirements. (Implied, as it's listed as a conducted test without issues).
Self-destruct performance test	To ensure the device cannot be reused after initial activation.	Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the automatic inactivation mechanism description).
Sterility	To achieve a Sterility Assurance Level (SAL) of 10^-6.	Met requirements. "Sterilization SAL:10-6" with Irradiation Sterilization (Co-60 or e-beam).
pH and total heavy metal content, Cd content	To meet safety standards for leachable substances.	Met requirements. (Implied, as it's listed as a conducted test without issues).
Bacterial Endotoxins	To ensure endotoxin levels are below specified limits.	Met requirements. (Implied, as it's listed as a conducted test without issues).
Clinical simulated use testing for sharps injury protection	Compliance with ISO 23908:2011 and FDA Guidance for Medical Devices with Sharps Injury Prevention Features. To demonstrate prevention of sharps injuries.	Met requirements. "we have completed the test of clinical simulated use testing for sharps injury protection for each model. The test results show that the product had well sharps injury prevention feature."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is typically provided in detailed test reports, not in a 510(k) summary. The document does not specify exact sample sizes for each bench test. The studies were non-clinical bench tests. The country of origin for the studies is not explicitly stated, but the manufacturer is Ningbo Medsun Medical Co., Ltd. in China.

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)

Not applicable, as this was a non-clinical bench study for a physical medical device (safety lancet), not an AI/software device requiring expert interpretation for ground truth.

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

Not applicable, as this was a non-clinical bench study.

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, as this was a non-clinical bench study for a physical medical device.

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

Not applicable, as this was a non-clinical bench study for a physical medical device.

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

The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, internal specifications) for mechanical function, material properties, sterility, and biocompatibility. For example, ISO 9626:2016 for needle dimensions or ISO 10993 series for biocompatibility.

8. The sample size for the training set

Not applicable, as this was a non-clinical bench study for a physical medical device, not an AI/software device that requires a training set.

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

Not applicable, as this was a non-clinical bench study for a physical medical device.

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