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"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

"Sterile Lancet for Single Use" is a single use device indicated for capillary blood sampling. It can be used in conjunction with "Lancing Device" in home settings, or be used standalone in both home and hospital settings.

"Lancing System" consists of "Sterile Lancet for Single Use" and "Lancing Device"

"Sterile Lancet for Single Use" is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals in hospital settings or patients at home.

"Sterile Lancet for Single Use" is a disposable blood lancet intended for a single use that is comprised of a cap, a single use blade attached to a solid, non-reusable base, and it is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The needle is protected with a cap before use. The steel needle is made of stainless steel SUS304. The needle cap and needle base are made of polyethylene plastic, and are injection molded. The Sterile Lancet for Single Use is sterilized by gamma irradiation.

"Sterile Lancet for Single Use" can be used alone in either home or healthcare settings, or be used together with "Lancing Device" in home settings.

Based on different design and shape, there are three different types of "Sterile Lancet for Single Use", and also can accommodate different needle gauges.

"Lancing Device" is a multiple use, sterile, medical devices designed to be used in collecting the blood sample. The products can be used by patients and lay persons. Thev are not intended for healthcare workers because the device can not be used among different patients.

Lancing Device is a multiple use capillary blood lancet intended for use on a single patient. Before each use, a single use lancet is attached to the reusable case, and when launched, is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

After use, the single use blade ("Sterile Lancet for Single Use") is disposed of, and the lancing device is cleaned and disinfected, ready for the next use.

The lancing device has five adjustable gears (marked 1 to 5) that allow for different puncture depth.

Lancing Device is made of a needle base, spring, a launching part, return spring, launch button, a casing, and a cap. The needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components.

The provided document is a 510(k) summary for a medical device (lancing system) seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by comparing technical characteristics and performance data.

However, the request asks for details related to a study proving the device meets acceptance criteria specific to AI/Machine Learning models, including expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets.

The provided document does not contain any information about an AI/Machine Learning model. The device described is a physical lancing system for blood collection. Therefore, the requested information regarding AI/ML specific acceptance criteria and study designs (like MRMC, human-in-the-loop, or training/test set ground truth for AI) is not applicable to this submission.

The document discusses non-clinical performance testing (physical, chemical, mechanical properties, packaging integrity, sterilization validation) and biocompatibility testing, which are standard for physical medical devices. It explicitly states: "No clinical study is included in this submission." This further confirms the absence of any data related to AI/ML performance evaluation as specified in your prompt.

Therefore, I cannot populate the table or answer the specific questions about AI/ML model acceptance criteria and study design based on the provided text.

However, I can extract the information that is relevant to the device's acceptance testing as described in the document:

Acceptance Criteria and Device Performance (as per the provided 510(k) Summary for a Lancing System):

Since this is a physical medical device (lancing system) and not an AI/ML model, the "acceptance criteria" and "device performance" relate to physical, chemical, and mechanical properties, not AI metrics like sensitivity, specificity, or AUC. The document states "All tests were verified to meet acceptance criteria" without listing the specific numeric criteria or results for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a single use device indicated for capillary blood sampling.

Lianfa Safety Lancet is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals and home users. They are intended for over the counter use.

Lianfa Safety Lancet is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

The safety lancet is made up of a needle core, spring, a launching part, and a casing. The steel needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable of further use.

Based on the shape and design of the device, there are five different models: PA, PA2, APA, NPA, and TPA. Each model is offered with various gauges of needle.

This document is a 510(k) Premarket Notification for the Lianfa Safety Lancet. The provided information does not describe an AI/ML powered device, but rather a traditional medical device (a blood lancet). Therefore, many of the requested categories for AI/ML device studies (e.g., effect size of human readers with AI, ground truth for training set, adjudication methods, multi-reader multi-case studies) are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them, as much as applicable to a non-AI medical device:

Acceptance Criteria and Device Performance for Lianfa Safety Lancet

This submission is a 510(k) premarket notification for a traditional medical device, a blood lancet. As such, the concept of "AI" or "ML" powered assistance, training sets, and human reader performance with AI are not applicable. The studies described are non-clinical engineering and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are derived from a combination of general industry standards (e.g., ISO, 21 CFR regulations) and specific functional requirements for a blood lancet. The performance is reported as meeting these requirements.

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

The document does not specify the exact sample sizes used for each non-clinical bench test. It generally states that "bench testing performed verifies..." and provides the "Results" as "Meet requirement."

The data provenance is from non-clinical bench testing, presumably conducted internally or by a contracted lab for the manufacturer, Shandong Lianfa Medical Plastic Products Co. Ltd. The country of origin for the manufacturing and testing is not explicitly stated but the company is based in Zhangqiu, Jinan, Shandong Province, China. The studies are retrospective in the sense that they were completed as part of the device development and verification process before this 510(k) submission.

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

Not applicable for this type of medical device. The "ground truth" for the non-clinical tests relies on established engineering standards, material science principles, and biological evaluation protocols (e.g., ISO 10993 series). There are no human "experts" establishing a diagnostic ground truth in the way described for AI/ML devices. The "experts" involved would be technicians, engineers, and scientists conducting the tests according to the specified protocols.

4. Adjudication method for the test set

Not applicable for this type of medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and complex rules are needed to establish a "ground truth" result when there are disagreements. For non-clinical bench testing, results are typically objective measurements against a predefined specification.

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 manual blood lancet and does not incorporate AI functionality, nor does it involve human readers interpreting AI-generated output.

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. There is no algorithm.

7. The type of ground truth used

For the non-clinical and biocompatibility tests:

• Engineering Specifications / Industry Standards: For characteristics like appearance, dimension, puncture depth, puncture force, connection firmness, launch performance, and safety features. These are objective measures against predefined criteria.
• Sterility Standards: Based on a Sterility Assurance Level (SAL) of 10^-6, which is an industry standard.
• Biocompatibility Standards: Based on ISO 10993 series standards (e.g., ISO 10993-5, 10993-10, 10993-11), which define the methodologies and acceptance criteria for biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the Lianfa Safety Lancet.

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