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It is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is for adult use only.

Blood collection tube holders is single use and sterile, it is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is sterile and to be used for assisting blood collection. The device consists of a puncture needle hub, puncture needle, rubber boot and holder. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterile. Sterilization process is validated according to EN ISO 11135. Shelf life is 5 years.

This FDA 510(k) clearance letter is for a Blood Collection Tube Holder, which is a Class II medical device. The information provided heavily focuses on the comparison to a predicate device and nonclinical (bench) testing, rather than AI-specific criteria. This document does not contain any information about an AI/ML powered device, therefore the specific requests for AI-related study details (MRMC studies, standalone algorithm performance, training set details, expert ground truth adjudication) cannot be answered from the provided text.

However, I can extract the relevant information for the device's acceptance criteria and the study that proves it meets them based on the provided document.

Device: Blood Collection Tube Holders
Device Type: Medical Device (Non-AI/ML specific, per the provided document)
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a non-AI/ML physical medical device, the "acceptance criteria" are based on compliance with established international standards and successful performance in specific physical and biological tests.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices) used for each nonclinical performance test (e.g., puncture force, tensile strength). It generally states "Performance testing was conducted."
• Data Provenance: Not explicitly stated for each test, but the manufacturer is Promisemed Hangzhou Meditech Co., Ltd. in China, implying testing was likely conducted in China or by labs serving Chinese manufacturers. The testing itself is nonclinical (bench) testing, not human data. It is inherently "prospective" in the sense that the tests were performed on newly manufactured devices for the submission.

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

• Not applicable. This device is a physical medical device (blood collection tube holder), not an AI/ML system requiring expert interpretation of medical images or data for ground truth. The "ground truth" for this device's performance is established by objective physical and chemical measurements against internationally recognized standards (ISO, ASTM) and internal engineering specifications, not human expert consensus.

4. Adjudication method for the test set

• Not applicable. As above, this is for physical device performance testing, not interpretive data requiring adjudication. Compliance is determined by meeting the specified thresholds or parameters of the relevant standards.

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 describes a physical medical device (blood collection tube holder), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective, measurable criteria defined by international standards (e.g., ISO, ASTM) and engineering specifications. Examples include specific force measurements, material properties, sterility levels, and biological reactivity thresholds. These are derived from established scientific and engineering principles for medical device safety and efficacy.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model where "training sets" are used.

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

• Not applicable. See point 8.

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