(269 days)
The NuVue ColorMark™ Needle is intended for use when one desires the visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability.
The NuVue ColorMark™Needle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.
The NuVue ColorMark™Needle combines a hand-piece and echogenic needles like its predicates. The NuVue ColorMark™Needle is intended to allow the visualization by ultrasound of a needle- such as biopsy needle- inserted into the body. The principle is that the needle is made to vibrate at low sonic frequencies (
Because the provided text is a 510(k) summary for the NuVue ColorMark™ Needle, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with acceptance criteria and specific performance metrics. Therefore, many of the requested elements are not explicitly stated or quantifiable in the provided document.
However, I can extract the information that is present and indicate where specific details are missing based on the nature of a 510(k) submission.
Acceptance Criteria and Device Performance
The 510(k) submission does not provide explicit numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or a specific level of improved visibility) or a quantitative report of the NuVue ColorMark™ Needle's performance against such criteria. Instead, it relies on demonstrating that the device is "effective in the visualization of image of the biopsy needle, and can be easily used by the operator" and that its "imaging performance" is not lessened compared to predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated with quantifiable thresholds in the document) | Reported Device Performance (as implied or stated in the document) |
|---|---|---|
| Visibility/Imaging Performance | No explicit, quantifiable criterion provided (e.g., specific percentage increase in visualization, or a score on a scale). | "Our imaging studies show that NuVue's ColorMark™ Needle is effective in the visualization of image of the biopsy needle, and can be easily used by the operator." |
| "The changes implemented into the NuVue ColorMark™ Needle... do not lessen any imaging performance compared to the predicate devices." | ||
| "The NuVue ColorMark™Needle has improved ergonomics with similar technology and performance as its predecessor in that it presents the image of the needle as a colored line on the B-scan screen..." | ||
| "The NuVue ColorMark™ Needle is effective in the visualization of image of the biopsy needle." | ||
| Safety | No explicit, quantifiable criterion provided (e.g., specific rate of adverse events, or a threshold for tissue damage). | "A detailed analysis of the safety of NuVue's device shows no addition risk issues." |
| "In case of failure of the device, Color Doppler visualization may be lost, but the needle is still visible and can be followed by conventional techniques." | ||
| Ergonomics/Usability | No explicit, quantifiable criterion provided. | "The NuVue ColorMark™Needle has improved ergonomics..." |
| "...can be easily used by the operator." | ||
| Functionality (360° Visualization) | No explicit, quantifiable criterion provided for the degree of visualization. | "NuVue has the ability of Quadriture, which allows visualization of any of its needles in a 360 degree visualized capability, compared to the cleared ColorMark™ Visualization System, who's vibratory signal was designed in a linear responsibility..." |
Study Information
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document states "Our imaging studies show..." but does not provide details on the number of cases, patients, or images included in these studies.
- Data Provenance: Not specified. It is not mentioned whether the data was retrospective or prospective, nor the country of origin.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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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:
- MRMC Study: The document does not describe a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance. This device is not an AI-powered system; it's an interventional needle enhanced for ultrasound visualization. While it compares its performance to predicate devices (K031173 and K926351), this is not an MRMC study in the context of AI.
- Effect Size: Not applicable as no such study is described, and the device is not an AI system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a physical needle designed for human-in-the-loop interventional procedures, not a standalone algorithm. Its "effectiveness" is linked to its ability to be visualized by an operator using an ultrasound machine.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not explicitly stated. Given the nature of the device (improving visualization of a needle), the "ground truth" for imaging performance would likely be subjective expert assessment of visibility or objective measures of signal strength/contrast in an imaging study, rather than pathology or outcomes data related to the biopsy itself. However, the document only broadly refers to "imaging studies."
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is an electro-mechanical medical device, not an AI/machine learning model that requires a "training set" in the conventional sense. The "training" in its development would refer to engineering design, prototyping, and iterative testing.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for the reasons mentioned above. Development and testing would involve engineering specifications, materials science, and physical performance validations.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.