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DMC Medical Single-Use Polycarbonate Syringe is offered in the same configurations as the predicate. It is made from a calibrated hollow barrel, and a moveable piston with a plunger tip at the end of the piston. The piston shaft does not contact any part of the fluid path, rather the tip which attaches to the shaft and the barrel are fluid path components. Individual components are made from properly tested materials included in this submission. Additionally, there is a small amount of lubricant for moving the piston shaft smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals.

AI/ML Overview

The information provided in the document focuses on demonstrating the substantial equivalence of the DMC Medical Single-Use Polycarbonate Syringe to a predicate device (ICU Medical Single-Use Syringe) rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a typical clinical or AI/algorithm performance context.

This regulatory submission (510(k)) is for a medical device (syringe), not a software algorithm or AI model, so the "study" described is primarily non-clinical testing against recognized standards to demonstrate equivalence.

Here's an attempt to structure the available information into the requested format, with the recognition that some sections will be "N/A" or "Not Applicable" given the nature of the device and submission:

Acceptance Criteria and Device Performance for DMC Medical Single-Use Polycarbonate Syringe

The acceptance criteria for the DMC Medical Single-Use Polycarbonate Syringe are primarily based on conformity to the international standard ISO 7886-1 for sterile single-use hypodermic syringes and the biological safety standard ISO 10993-1, as well as demonstration of substantial equivalence to the predicate device, K070856.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Equivalence	Syringe Barrel: Polycarbonate	Polycarbonate
	Plunger Tip: Polyisoprene (predicate) / Elastomer (submitted)	Elastomer (considered equivalent in function)
	Lubricant: Medical Grade Oil	Medical Grade Oil
Functional Equivalence	Calibrated Barrel Volume	YES
	Sterilization Method: EtO	EtO
	Operational Characteristics: Identical to predicate device	Operations are identical to the predicate, allowing accurate fluid measurement via printed external housing in ml.
Safety & Performance Standards	Conformity to ISO 7886-1 (Sterile Single-use Hypodermic Syringes)	All syringes conform to ISO 7886-1
	Sterility Assurance Level (SAL): 10-6	SAL has been established to meet the 10-6 level
	Conformity to ISO 10993-1 (Biological evaluation of medical devices)	All syringes conform to ISO 10993-1, including minimizing residual gases.
	Pressure Testing to Failure	Tested to failure; devices meet healthcare professional needs.
Packaging	Minimizing residual gases; discourage re-use	Packaged to ensure conformity with ISO 10993-1, minimizing residual gases, and discouraging re-use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical value for a specific test set. The submission mentions "All syringes conform to..." and "DMC Medical syringes are tested to...", implying testing was performed on a representative sample to ensure compliance.
Data Provenance: The testing was "Non-clinical Testing" performed by DMC Medical Ltd. to demonstrate conformity to ISO standards and substantial equivalence. No country of origin for a clinical data set is applicable, as this is a device submission based on bench testing and material equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This submission is for a physical medical device (syringe) and relies on objective, standardized non-clinical testing (e.g., pressure testing, material analysis, sterility testing) against ISO standards, rather than expert-established ground truth from clinical interpretation.

4. Adjudication Method for the Test Set

Not Applicable. As there is no "ground truth" derived from expert consensus or interpretation, an adjudication method for such a ground truth is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for imaging or diagnostic algorithms where human readers interpret cases. This filing is for a physical syringe and does not involve human readers interpreting data.
- Effect Size of AI Improvement: Not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not an algorithm or AI device. The "standalone performance" is the inherent function and safety of the syringe itself as demonstrated through non-clinical testing.

7. The Type of Ground Truth Used

Objective Standards and Physical Testing Results: The "ground truth" for this device is its adherence to established international standards (ISO 7886-1, ISO 10993-1), material specifications, and performance characteristics (e.g., pressure resistance, accurate volume measurement) as verified through non-clinical laboratory testing. The predicate device's established safety and effectiveness also serve as a comparative ground.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires training data. The syringe components and manufacturing process are developed and refined through engineering practices, not machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. No training set or associated ground truth is relevant for this device.

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