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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

Regarding the AI/ML specific questions (2-9), the document explicitly states information that makes them not applicable: "No clinical study is included in this submission." and the device is not an AI/ML product.

However, to address the prompt for completeness based on the absence of AI/ML, I will state "Not Applicable" for these points.

2. Sample sized used for the test set and the data provenance: Not Applicable (No AI/ML model, tests are bench testing on physical units)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable (No AI/ML model; ground truth for physical device testing is based on engineering specifications and laboratory measurements)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable (No AI/ML model; testing is primarily objective bench testing)

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 (No AI/ML model)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Applicable (No AI/ML model)

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, ground truth for performance is established by engineering specifications, relevant ISO standards, and established laboratory measurement techniques.

8. The sample size for the training set: Not Applicable (No AI/ML model)

9. How the ground truth for the training set was established: Not Applicable (No AI/ML model)

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