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It is intended for capillary blood sampling.

Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.

VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.

Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.

The provided text is a 510(k) Summary for medical devices (blood lancets) and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It outlines a comparison of technical characteristics and performance testing that confirms the devices are comparable, not a study designed to establish quantitative performance against defined acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot, based on the input:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified. The document states "The bench testing performed verifies that the performance of the subject devices are substantially equivalent..." but does not provide specific sample sizes for these tests.
• Data Provenance: Not specified.

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. This is a medical device submission focused on physical and chemical performance, not diagnostic accuracy requiring expert interpretation or ground truth.

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

• Not applicable. This is not a study requiring adjudication of interpretations.

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 document pertains to blood lancets, which are physical medical devices, not AI-powered diagnostic tools.

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

• Not applicable. This document pertains to blood lancets, not algorithms.

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

• Not applicable in the context of diagnostic performance. For device characteristics, the "ground truth" would be established by physical/chemical measurement standards (e.g., ISO, ASTM standards for dimensions, sterility, biocompatibility).

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

• Not applicable. This is not an AI/algorithm-based device.

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It is intended for capillary blood sampling.

Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.

VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.

Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini--Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.

This document is a 510(k) Pre-Market Notification from the FDA regarding Promisemed Hangzhou Meditech Co., Ltd.'s blood lancet devices. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report like those typically found in clinical efficacy studies for AI/software devices.

Therefore, the information requested in your prompt related to AI/software device performance metrics (e.g., effect size of human readers with AI, standalone algorithm performance, training set details) will not be present.

However, I can extract the information relevant to the device performance verification tests that were conducted to establish substantial equivalence.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria values (e.g., minimum tensile strength, maximum penetration force) or quantitative reported device performance results. Instead, it lists the types of performance tests conducted and states that the results "verifies that the performance of the subject devices are substantially equivalent" and "met their intended use and performs as well as or better than the legally marketed predicate device."

*These tests (Locking function, Spring elasticity, Percussive function, Penetrate force) were performed for VeriFine Safety Lancet and VeriFine Mini-Safety Lancet only.

The study that "proves the device meets the acceptance criteria" is the series of bench tests summarized in Section 8 of the 510(k) Summary.

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

The document does not specify the sample size used for each of the bench tests (e.g., how many lancets were subjected to bond strength testing or corrosion resistance). It also does not explicitly state the provenance of data for these tests (e.g., whether the test materials were from a specific country of origin or if the tests were retrospective or prospective). Given these are bench tests on physical devices, the "data" would represent measurements taken from the manufactured devices.

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

This information is not applicable to the type of device and testing described. The "ground truth" for a physical medical device in bench testing is typically defined by engineering specifications, material standards, and performance characteristics (e.g., a specific bond strength in Newtons, a certain needle diameter in millimeters). Experts involved would be qualified engineers and technicians performing the tests and comparing results against established standards. However, the document does not detail their numbers or qualifications.

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

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by multiple human readers to establish a consensus ground truth. The tests described are objective, measurable physical and chemical properties of the device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which these blood lancets are not.

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

No, a standalone algorithm performance study was not done. This is not an AI/software device.

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

The "ground truth" for the performance tests conducted on these blood lancets would be based on engineering specifications, recognized international standards (e.g., ISO for biocompatibility), and performance characteristics of the predicate device. For example, "Needle Dimensions" would be compared against specified tolerances, and "Resistance to corrosion" against a defined standard. Biocompatibility was assessed against ISO standards.

8. The sample size for the training set

This information is not applicable. There is no AI algorithm being trained for this device.

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

This information is not applicable. There is no AI algorithm being trained for this device.

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