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The Nipro Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests.

The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has an outer diameter of 0.90 mm and a back end length of 20 mm to 24 mm. The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests. The luer adaptor is used to connect to a blood collection needle that has a female luer taper for use. As such, this product has a hub with a male luer taper. The product is a sterilized single-use product. The materials used for the components include stainless steel SUS 304 (SS), synthetic rubber, and polypropylene (PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.

This document (K992729) is a 510(k) premarket notification for a medical device called the "Nipro Luer Adaptor." It describes the device's intended use and claims substantial equivalence to a predicate device.

Based on the provided text, the document does not contain a study design, acceptance criteria, or performance data for the Nipro Luer Adaptor.

Instead, it's a submission to the FDA for a new device, arguing its similarity to an already approved device (the Exel International Luer Adaptor K861152A). The key statement that dictates the type of "proof" offered is:

"The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical."

This means the acceptance criteria and "study" described are implicitly met by virtue of the Nipro Luer Adaptor being identical to a device already deemed safe and effective by the FDA. There is no independent performance evaluation described for the Nipro Luer Adaptor itself, as its substantial equivalence is based on its direct identity to the predicate device.

Therefore, I cannot fill out the requested table or answer most of the questions because the document explicitly states the two devices are identical.

Here's what can be inferred or stated from the document:

• Acceptance Criteria: Implicitly, the Nipro Luer Adaptor must meet all the technical characteristics and performance standards of the predicate device, the Exel International Luer Adaptor (K861152A). These criteria are not explicitly listed but are assumed to have been met by the predicate device when it was cleared.
• Study Proving Acceptance Criteria: The "study" is the assertion of technical identity between the Nipro Luer Adaptor and the legally marketed predicate device, Exel International Luer Adaptor (K861152A). By stating they are "exactly the same devices" and "all technical characteristics are identical," the Nipro Medical Corporation is arguing that no new performance study is needed for the Nipro device specifically.

Table of Acceptance Criteria and Reported Device Performance (Based on the document's assertion of identity):

Answers to Specific Questions (Based on available information in K992729):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable / Not provided. No specific test set or data provenance is mentioned as the approval relies on substantial equivalence by identity to a predicate device, not on new performance data for the Nipro Luer Adaptor.
2. 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 / Not provided. Ground truth establishment for a test set is not described, as there is no independent performance testing reported.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable / Not provided. No adjudication method for a test set is mentioned.
4. 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 is for a physical medical device (luer adaptor), not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable / Not provided. Since no new performance studies are presented for the Nipro device, no ground truth types are described. The "ground truth" for its safety and effectiveness is implicitly derived from the prior clearance of the identical predicate device.
7. The sample size for the training set: Not applicable / Not provided. No training set is mentioned as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable / Not provided. No training set ground truth establishment is mentioned.

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