(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular (CWD)
The Nicolet VersaLab is a DC rechargeable battery / DC powered device. The Nicolet VersaLab employs fixed [not adjustable] CW Doppler power levels that are pre-set at a limit below the maximum allowable of 720mw/cm²; therefore, the ALARA condition is always met. There are hardware levels controlling the power as well as redundant software controls.
The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical performance study for an AI/ML medical device. Instead, the document is a 510(k) clearance letter from the FDA for the Nicolet VersaLab, a diagnostic ultrasound system.
The "acceptance criteria" here are related to regulatory compliance and safety limits, particularly concerning ultrasound power levels, rather than performance metrics like sensitivity or specificity for a diagnostic output. The "study" mentioned is the manufacturer's assurance that the device adheres to these safety limits and substantially equivalent to predicate devices.
Here's the breakdown of what can be extracted from the provided text, framed against your requested categories, acknowledging that much of the information you've asked for (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies) is not applicable or present in this type of regulatory document for an ultrasound device without AI/ML components.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Criterion | Reported Device Performance |
|---|---|---|
| Instrument Safety (Acoustic Output) | Ultrasound signals emitted at power levels below FDA recommended maximum exposure limits. | - Reported Performance: Fixed (not adjustable) CW Doppler power levels are pre-set at a limit below the maximum allowable of 720 mW/cm². |
- Evidence: Hardware and redundant software controls are in place to ensure power levels are always met, adhering to the ALARA (As Low As Reasonably Achievable) principle.
- Additional Requirement: Post-clearance special report required for acoustic output measurements based on production line devices (as per Appendix G of FDA guidance). This report is a condition for the substantial equivalence. |
| Clinical Classification & Intended Use | Regulatory Class II / 21 CFR 892.1540 (Diagnostic ultrasonic transducer), 21 CFR 870.2880 (Ultrasound imaging system). | - Reported Performance: The device is deemed substantially equivalent for the indications for use stated in the enclosure (primarily Peripheral Vascular, Continuous Wave Doppler). - Evidence: Formal FDA 510(k) clearance (K010521) for the Nicolet VersaLab with 4 MHz (CWD) and 8 MHz (CWD) transducers. |
| Manufacturing & Quality System Compliance | Compliance with Good Manufacturing Practice (GMP) / Quality System Regulation (QSR) for Medical Devices (21 CFR Part 820). | - Reported Performance: Substantial equivalence determination assumes compliance with GMP. - Evidence: FDA states they will verify such assumptions through periodic QS inspections. |
| Labeling Requirements | Adherence to specific labeling regulations (21 CFR Part 801 and 809.10). | - Reported Performance: Implicitly expected for marketing; no direct performance metric here. - Evidence: FDA advises contacting the Office of Compliance for specific advice on labeling regulations. |
2. Sample Size for the Test Set and Data Provenance
This document specifies a medical device (ultrasound system), not an AI/ML algorithm that processes data. Therefore, the concept of a "test set" with a sample size for evaluating an algorithm's performance against ground truth is not applicable in this 510(k) submission.
The "data" referred to in this context would be engineering data confirming acoustic output, electrical safety, biocompatibility (if applicable), and comparison to predicate devices, rather than a clinical dataset for diagnostic performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is primarily regulatory compliance with safety standards and substantial equivalence to existing devices, which is evaluated by the FDA based on the manufacturer's submissions and internal expertise.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication by experts.
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 Nicolet VersaLab is a diagnostic ultrasound device from 2001, not an AI-powered diagnostic system. No AI assistance or MRMC study is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm but a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Regulatory Standards: Compliance with FDA regulations (e.g., 21 CFR parts related to medical devices, GMP).
- Engineering Specifications: Acoustic output measurements meeting established safety limits (e.g., 720 mW/cm²).
- Substantial Equivalence: Comparison to legally marketed predicate devices, demonstrating that the new device is as safe and effective as a device already on the market.
- Safety Data: General understanding of ultrasound safety based on organizations like the American Institute of Ultrasound in Medicine ("No confirmed biological effects...").
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set or AI/ML model is involved.
In summary: The provided document is a regulatory clearance for a diagnostic ultrasound device, focusing on its safety (particularly acoustic output) and substantial equivalence to previously cleared devices. It does not describe a clinical performance study involving diagnostic accuracy metrics or AI/ML algorithm evaluation, which would typically involve the types of acceptance criteria and study details you've outlined in your request.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in 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.