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Single use disposable syringe to inject fluids into, or retract fluids from the body

When used with the DRTS™ Laser Alignment System, the Light Saber™ Syringe will provide an accuracy of +/- 3mm from the laser path when using a 10 cm needle.

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This is a 510(k) clearance letter for the MINRAD DRTS Light Saber™ Syringe. It does not contain information about the acceptance criteria and study proving device performance as typically expected for imaging algorithm related devices.

However, based on the Indications for Use section (page 2), there is a performance claim made for the device when used with another system. I will treat this claim as an "acceptance criterion" in the absence of a detailed study report.

Here's an attempt to answer your questions based on the limited information provided in this document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in this document.
• Data Provenance: Not specified in this document.

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

• This document does not describe a study involving expert readers or ground truth establishment in the context of an AI/algorithm.

4. Adjudication method for the test set

• Not applicable as no such study is described.

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, this document does not describe an MRMC comparative effectiveness study. This is a medical device clearance for a syringe, not an AI/imaging algorithm.

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

• Not applicable, as this is for a physical medical device (syringe). The "accuracy" claim refers to its mechanical guidance capability.

7. The type of ground truth used

• The "ground truth" for the +/- 3mm accuracy claim would likely be based on physical measurements and engineering specifications, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable, as this is not an AI/algorithm device.

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

• Not applicable, as this is not an AI/algorithm device.

Summary of Limitations:

This document is a 510(k) clearance letter for a syringe, a physical medical device. It is not a study report for an imaging algorithm or AI device. Therefore, most of the questions related to AI/algorithm performance, training/test sets, expert ground truth, and comparative effectiveness studies are not applicable or cannot be answered from the provided text. The only "performance claim" mentioned is a mechanical accuracy specification for the syringe when used with a laser alignment system.

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