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Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.

The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.

The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.

There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.

The proposed device is provided sterilized.

The provided text describes a 510(k) submission for a Blood Transfusion Set, and thus there is no information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device.

Specifically:

• No acceptance criteria or device performance table is provided. The document states that "Laboratory testing was conducted to validate and verify that Blood Transfusion Set met all design specifications and was substantially equivalent to the predicate device," but it does not specify what those design specifications or acceptance criteria were, nor does it report specific performance metrics.
• No information on sample size for test sets or data provenance is available. No clinical or performance study details are included in this summary.
• No information on experts for ground truth or adjudication methods is available. There is no mention of a ground truth in the context of this device's submission, as it relates to a physical device rather than an AI or diagnostic algorithm.
• No MRMC comparative effectiveness study or standalone algorithm performance study was mentioned. These types of studies are typically relevant for AI/ML-based diagnostic devices, which is not the case here.
• The type of ground truth used is not applicable/not mentioned. For a physical device like a blood transfusion set, "ground truth" would not be established in the same way as for a diagnostic algorithm. The validation would likely involve engineering and biocompatibility testing against predefined standards.
• No information on training set sample size or how ground truth was established for a training set is available. This is not relevant for the type of device described.

In summary, the provided document is a 510(k) summary for a Blood Transfusion Set, focusing on its description, intended use, and substantial equivalence to a predicate device, rather than detailed performance studies or AI-specific validation criteria.

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To Administer Blood to the patient's vascular system.
To administer Blood and Blood Derivatives into a patient's vascular system

The PENTATRASFU™ Blood Transfusion Sets are Single Use, Non-toxic, Sterile, Non-Pyrogenic devices used to administer Blood to a patient's vascular system through a Needle or Catheter inserted into a vein.

The provided document describes the PENTATRASFU™ Blood Transfusion Sets and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML device. Therefore, the information required for this request (AI/ML acceptance criteria, study details, expert involvement, etc.) is not present in the provided text.

However, I can extract the information related to the performance testing and compliance with standards as described for this medical device.

Here's the information as best as can be extracted from the provided text, focusing on the performance criteria and testing mentioned for the PENTATRASFU™ Blood Transfusion Sets:

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

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 not provided in the document. The document refers to "Performance Testing" but does not specify sample sizes or data provenance.

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)

This information is not provided in the document. The testing mentioned refers to compliance with a standard (ISO 1135-4) and biocompatibility, which typically involve laboratory testing, not expert-adjudicated ground truth as would be relevant for an AI/ML device.

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

This information is not applicable/not provided. The assessment of this medical device is based on compliance with recognized standards and laboratory testing, not a human reader adjudication process.

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

This information is not applicable/not provided. This device is a blood transfusion set, not an AI/ML-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

This information is not applicable/not provided. This device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is established through compliance with recognized international standards (ISO 1135-4 for performance, ISO 10993 for biocompatibility) and direct physical/material testing, rather than clinical outcomes or expert consensus on diagnostic interpretations.

8. The sample size for the training set

This information is not applicable/not provided. This device is a physical product and does not have a "training set" in the context of AI/ML.

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

This information is not applicable/not provided. This device is a physical product and does not have a "training set" or "ground truth" in the context of AI/ML.

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For the delivery of blood or blood related solutions by or on the order of a physician or other licensed practitioner.

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device performance as requested. The text consists of an FDA 510(k) clearance letter for the "Protos Blood Transfusion Set" and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not detail performance studies, acceptance criteria, or any of the specific points you've asked for regarding AI/algorithm performance.

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