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The syringe is intended to inject or withdraw fluids from the body.

The Monoject 60mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and an attached gasket. It is available in three nozzle types: Luer lock, luer slip and catheter tip. The barrel is made from polypropylene and is designed with clear graduation for easy use. The luer barrel nozzle has an ISO 594 compliant male luer tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 30 devices, and the master case contains 12 inner boxes. This syringe is sterilized by gamma irradiation.

The provided text describes a 510(k) summary for a medical device, specifically the Monoject 60mL Syringe. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study with acceptance criteria and a detailed report of how a device meets those criteria in the context of an AI-powered system or a study involving human readers.

Therefore, most of the requested information (points 1, 2, 3, 4, 5, 6, 7, 8, 9) is not applicable or cannot be extracted from the given text because:

• This is a traditional medical device (syringe), not an AI/ML-powered device. The 510(k) summary details performance tests for a physical product (syringe), not an algorithm's performance.
• The document focuses on non-clinical performance testing for safety and effectiveness, not clinical trials with human subjects or AI-assisted performance.
• The concept of "ground truth," "experts," "adjudication," "training set," and "test set" as typically understood in the context of AI/ML or comparative effectiveness studies of diagnostic algorithms is not relevant here. The "ground truth" for a syringe is its physical specifications and functionality.

However, I can extract information related to the performance testing and conclusions based on the provided text, aligning with the spirit of "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific type of device.

Acceptance Criteria and Device Performance (Interpreted for a Syringe Device)

The "acceptance criteria" for the Monoject 60mL Syringe are implicitly defined by the successful completion of the non-clinical performance tests, proving the device is safe and effective and comparable to predicate devices. The "reported device performance" is that it met these test requirements.

Here's a breakdown of the specific points related to the provided 510(k) summary, acknowledging the context of a traditional medical device:

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

   • See the table above. The acceptance criteria are implicitly met by successful completion of the listed non-clinical tests, and the reported performance is that these tests were passed, leading to the conclusion of safety, effectiveness, and substantial equivalence.

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

   • Sample Size: The document does not specify the exact sample size for each performance test. It only states that "Performance testing was conducted."
   • Data Provenance: Not specified. This typically refers to the testing done by the manufacturer (Nipro Medical Corporation) or a contracted lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these terms are less relevant in the context of physical product performance testing for regulatory submission.

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. For a physical device like a syringe, "ground truth" is established by adherence to engineering standards, material specifications, and performance requirements. There are no "experts" in the sense of medical reviewers establishing ground truth for diagnostic accuracy, as this is not a diagnostic device. The tests themselves, conducted by qualified engineers/technicians following standardized protocols, serve as the verification.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical trials or expert reviews, especially for diagnostic outputs. For objective performance tests of a physical device, the outcome is measured by instrumentation against defined limits, not adjudicated by human consensus.

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 is not an AI-powered device, nor is it a diagnostic device that involves human "readers." Therefore, an MRMC study is completely irrelevant here.

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

   • No. This is a physical medical device (syringe), 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 objective, defined by established engineering and performance standards for syringes (e.g., ISO 594 compliance, specified limits for force, leakage, etc.) and the material properties required for biocompatibility.

8. The sample size for the training set:

   • Not applicable. This term relates to machine learning (AI), which is not involved in the development or testing presented for this syringe.

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

   • Not applicable. As above, this is an AI/ML concept and does not apply to this traditional medical device submission.

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