(28 days)
The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.
The NMI Control Syringes are manual control, piston type syringes consisting of a clear, calibrated, hollow barrel accommodating volumes of either 7 mL or 8 mL. As a manual control syringe, each configuration includes bilateral, external finger rings located on the proximal thumb ring, located on the piston, in tandem with the external finger rings, allows for single handed movement to create aspiration and/or expulsion of fluids.
The provided document is a 510(k) premarket notification for a medical device called the "NMI Control Syringe." It details the device's intended use, its similarities to a predicate device, and the performance testing conducted. However, the document does not describe a study involving human readers, AI, or the establishment of ground truth by clinical experts, nor does it provide an effect size for human performance improvement with AI assistance. The device is a physical syringe, not a software or AI-driven diagnostic tool.
Therefore, many of the requested categories are not applicable to this document. I will fill in the applicable information and state when a category is not applicable based only on the provided text.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "key tests" that were performed and states that the "successful results... demonstrate that the proposed NM1 Control Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, the exact quantitative acceptance criteria and the specific reported performance measurements for each test are not detailed in the provided text. The table only lists the types of tests performed.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Alignment of Nozzle on End of Barrel | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Freedom from Air Leakage past Piston | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Lubricant (Quantity) | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Piston Pull Out Force | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Barrel Finger Grips | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Freedom from Liquid Leakage past Piston | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Nozzle Conical Fitting | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Stroke Length | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Cleanliness | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Graduated Scale | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Nozzle Lumen | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Syringe Capacity | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Dead Space | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Length of Scale | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Numbering of Scale | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Zero Graduation and Fiducial Line Alignment | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Fiducial Line | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Limits for Acidity or Alkalinity | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Piston (Plunger) Forces | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Fit of piston in barrel | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Limits for Extractable Metals | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
| Piston Assembly Design | (Not specified in document) | Met pre-determined acceptance criteria (qualitative statement) |
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 for Test Set: Not specified in the provided document. The document refers to "testing" and "successful results" but does not quantify the number of devices tested.
- Data Provenance: Not specified in the provided document. The data would likely be from laboratory testing of the physical syringe components.
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. This device is a physical syringe, not a diagnostic or AI-driven system requiring expert interpretation or ground truth establishment in a clinical context. The "truth" for this device's performance would be objective measurements against engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept applies to studies where human interpreters or algorithms identify findings that require a consensus or adjudication process. For a physical device like a syringe, performance is measured against objective standards, not subject to adjudication in this manner.
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. The device is a physical NMI Control Syringe, not an AI software. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a physical NMI Control Syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for the NMI Control Syringe's performance would be derived from engineering and material standards (e.g., ISO standards, FDA guidance) and objective measurements of physical properties (e.g., freedom from leakage, dimensions, forces, material compatibility). It does not involve clinical "ground truth" like pathology or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
- Not Applicable. The device is a physical syringe, not a machine learning model. There is no concept of a "training set" for the type of testing described.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a physical device like this syringe, establishing ground truth for it is irrelevant.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.