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The Nipro Disposable Syringe is intended to inject fluids into or withdraw fluids out of the body.

The NIPRO Disposable syringe is a piston syringe consisting of graduated barrel, plunger rod, gasket and nozzle tip cap. Its function is mechanical and it is intended to inject fluids into or withdraw fluids out of the body. The syringe is sterile, single to only, non-toxic, non-pyrogenic and sterilized by Gamma radiation.

The provided text describes a 510(k) summary for the NIPRO® Disposable Syringe. It outlines the device's purpose, materials, and intended use, and states that non-clinical tests were submitted to demonstrate substantial equivalence to a predicate device (K944355). However, the document does not contain specific acceptance criteria, reported device performance metrics, or details of a study that explicitly proves the device meets such criteria.

The submission focuses on establishing substantial equivalence based on what the device is and that it performs similarly to a predicate, rather than providing quantitative performance data against defined thresholds.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics cannot be extracted from this document, as they are not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

Acceptance Criteria and Study to Prove Device Meets Criteria

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

• Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on demonstrating "substantial equivalence" to a predicate device (NIPRO® Disposable Syringe K944355). This implies that the 'acceptance criteria' are implicitly tied to performing similarly to the predicate in terms of "intended use, materials of construction, labeling, and overall performance characteristics," but no specific quantitative thresholds are given.

• Reported Device Performance: Not explicitly detailed with quantitative metrics. The document states:

  "Biocompatibility data, performance testing and comparison testing with the predicate are included in this submission and demonstrate substantial equivalence."
  "The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® Disposable Syringe Gamblegical characteristics device and is a from and ff device and is safe and effective when used as intended."

  This indicates that performance testing was done, but the results (e.g., specific measurements, values) are not reported in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This question is not applicable as the device is a simple mechanical piston syringe, and the "ground truth" concept (e.g., for diagnostic accuracy) does not apply in the same way it would for an AI/diagnostic device. Performance testing likely involved engineering and quality control assessments against recognized standards or internal specifications, rather than expert-derived ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication method for the test set

• Not applicable for this type of device and submission.

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

• Not applicable. This is not an AI/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used

• Given the device is a piston syringe, "ground truth" would likely be established through engineering specifications, material standards, and functional performance benchmarks (e.g., fluid delivery accuracy, plunger force, seal integrity, sterility, non-pyrogenicity, non-toxicity). The document mentions "Biocompatibility data" and "performance testing," which would relate to these types of ground truths, but specific methods are not detailed.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses training sets.

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

• Not applicable.

Summary of available information:

The provided 510(k) summary for the NIPRO® Disposable Syringe (Gamma) confirms that:

• The device is a piston syringe for injecting or withdrawing fluids.
• It is sterile, single-use, non-toxic, non-pyrogenic, and sterilized by Gamma radiation.
• The applicant performed "Biocompatibility data, performance testing and comparison testing with the predicate" (NIPRO® Disposable Syringe K944355) to demonstrate substantial equivalence.
• The conclusion is that the device is "safe and effective when used as intended."

However, the detailed quantitative results of these tests, specific acceptance criteria (beyond "substantial equivalence"), sample sizes, and methodologies for establishing ground truth (in the context of advanced diagnostic or AI systems) are not present in this document. This level of detail is typically found in the full submission, not in the publicly available 510(k) summary.

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The Disposable Hypodermic Syringes with or without Needle are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described are: luer lock, slip-tip, eccentric, and catheter tip. Syringes will be packaged with and without needles. Various sizes are described including: 1, 3, 5, 10, 20, 30, and 60 milliliters.

The provided text describes a 510(k) premarket notification for "NIPRO Disposable Syringe with or without needle." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal study design for a novel device. Therefore, much of the requested information (sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission and is not present in the provided text.

The core of this submission is a comparison of technical characteristics and performance to legally marketed predicate devices, with the goal of showing they are "substantially equivalent."

Here's the information that can be extracted or derived from the provided text, with explanations where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Not Applicable. The document describes performance tests to demonstrate substantial equivalence to voluntary standards, but it does not detail a specific "test set" or study in the manner requested (e.g., a clinical trial or a performance study with a distinct sample size of patients/cases). The "performance tests" are likely internal engineering and quality testing to ensure the device meets specified manufacturing and product standards rather than a clinical performance study.
• Data Provenance: Not specified, but likely refers to internal testing data generated by Nipro Medical Corporation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This type of information is relevant for studies where expert consensus or interpretation is used to establish "ground truth" (e.g., in diagnostic devices). For a disposable medical device like a syringe, "ground truth" typically relates to its physical and functional performance meeting established engineering and safety standards, rather than expert interpretation of data.

4. Adjudication Method

• Not Applicable. As no expert review or "ground truth" adjudication process in the requested sense is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is typically done for diagnostic imaging devices or algorithms where human readers are making interpretations. It is not relevant for a disposable hypodermic syringe.

6. Standalone (Algorithm Only) Performance Study

• No. Syringes are mechanical devices; there is no embedded algorithm. "Standalone performance" here refers to the device's physical function. The document states that "Performance tests demonstrated that the devices are substantially equivalent and meet voluntary standards for syringes," which implies standalone testing of the device's physical properties and function. However, no specific metrics or study details are provided beyond this general statement.

7. Type of Ground Truth Used

• For the performance tests mentioned, the "ground truth" would be established by engineering specifications, recognized voluntary standards (e.g., ISO standards for syringes), and relevant regulatory requirements for physical and mechanical performance (e.g., plunger force, leak-tightness, sterility, material compatibility). The document states the device "meet voluntary standards for syringes," implying these standards serve as the "ground truth" for performance.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not part of a disposable syringe. Device validation for manufacturing would involve process validation and testing of production lots, rather than a "training set."

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

• Not Applicable. See point 8.

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The Nipro Disposable Syringes are intended for use to inject fluids into or withdraw fluids from the body.

The subject devices can be classified as piston syringes as described in 21 CFR 880.5860. Among the syringe types described here are: flat-head; circular irrigation syringes; and, screw nozzle syringes. Various sizes are described including: 1, 2, 2.5, 3, 5, 10, 20, 30, 50, and 100 milliliters.

The provided text describes a 510(k) premarket notification for Nipro Disposable Syringes (K030683). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the information required to populate the table and answer the study-related questions is not present in the provided text. The document states that "Performance tests demonstrated that the devices are substantially equivalent," but it does not elaborate on these tests, their acceptance criteria, or the specific results.

Here's why the information is missing based on the nature of the document:

• 510(k) Summary: A 510(k) summary (or statement, as this appears to be part of) primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technical characteristics and showing that any differences do not raise new questions of safety or effectiveness.
• Performance Tests Mentioned but Not Detailed: While "Performance tests demonstrated that the devices are substantially equivalent" is stated, the summary does not include the specifics of these tests, such as the actual criteria, methodologies, or outcomes. These details would typically be in a more comprehensive testing report submitted to the FDA, but not necessarily in the publicly available summary.
• Device Type: The device is a "Piston Syringe, Hypodermic, Single Lumen Syringe" and is classified as Class II. For such straightforward, well-understood devices, the "performance tests" likely refer to standard engineering and biocompatibility tests (e.g., sterilization validation, material strength, leakage, plunger force) that confirm it performs as expected for its intended use, rather than complex clinical studies involving human readers or AI algorithms.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics because this information is not included in the 510(k) summary.

If this were a submission for a sophisticated AI/ML-based device, the content would be vastly different and would include detailed clinical validation studies addressing these points.

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