FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The UroMetrics Knoll/MIDUS System is an office based Doppler ultrasound system designed to measure blood velocity in the penile cavernosal arteries. The system consists of a portable or desktop IBM compatible personal computer containing a proprietary circuit board and transducers. Blood velocity is determined by detecting the Doppler shifts of an 8 MHz ultrasound signal. Proprietary software converts this data into a useable waveform display, which is shown on the computer video display.

AI/ML Overview

This a 510(k) premarket notification for the Knoll/MIDUS System, a bi-directional vascular Doppler with spectral analysis, which was submitted in 1997. As such, the document largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a structured study to prove them, as would be expected for a more recent AI/ML-based device submission.

Therefore, much of the requested information regarding acceptance criteria, specific study design for proving those criteria, sample sizes, ground truth establishment for training and test sets, expert involvement, and MRMC studies is not explicitly available in this document.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for performance metrics of the device in the way one would see for an AI/ML device (e.g., minimum sensitivity, specificity, or F1-score). Instead, the "acceptance criteria" can be inferred to be related to demonstrating substantial equivalence to the predicate device in terms of:

Intended Use: Measurement of penile cavernosal artery velocities.
Technological Characteristics: Bi-directional vascular Doppler with spectral analysis, 8 MHz ultrasound signal.
Safety and Effectiveness: Implied by being substantially equivalent to a legally marketed device.

The document does not report specific device performance metrics (e.g., accuracy, precision) in a table format against predefined acceptance criteria for a study proving these. The entire submission acts as the "study" demonstrating substantial equivalence of the Knoll/MIDUS to the predicate device (SPECS USA, Inc. Stenodoc/EPC bi-directional vascular Doppler with spectral analysis, K946349).

Study Details (Based on available information)

Given the nature of a 1997 510(k) for a Doppler ultrasound system, the concept of "AI" and associated study methodologies (like those for AI/ML devices) are not applicable here. The device itself is a measurement tool, not an AI algorithm.

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in quantitative performance terms. The overarching "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device (SPECS USA, Inc. Stenodoc/EPC) regarding intended use, technological characteristics, and safety/effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, mean absolute error) are reported for the Knoll/MIDUS device directly against acceptance criteria. The performance is indirectly supported by its substantial equivalence to a predicate device that was already deemed safe and effective.
Sample sizes used for the test set and the data provenance: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to measure device performance against. It's a submission for a hardware-based medical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert-established ground truth is described.
Adjudication method for the test set: Not applicable. No test set adjudication is described.
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 device is not an AI product, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a hardware system for measuring blood velocity, intended for human operation and interpretation.
The type of ground truth used: Not applicable in the context of an AI study. For a traditional medical device, "ground truth" might refer to established clinical methods or physical standards to validate measurements. The submission relies on the predicate device's established safety and effectiveness.
The sample size for the training set: Not applicable. There is no AI/ML model, so no training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context for K971790:

Device: Knoll/MIDUS, a bi-directional vascular Doppler with spectral analysis.
Intended Use: Measurement of penile cavernosal artery velocities.
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to a predicate device.
Predicate Device: SPECS USA, Inc. Stenodoc/EPC bi-directional vascular Doppler with spectral analysis (K946349).
Key Information Provided: Device description, intended use, classification, and a statement of substantial equivalence by the FDA.
Missing Information (from an AI/ML perspective): No detailed performance study, no specific quantitative acceptance criteria for performance, no data on training/test sets, no expert involvement for ground truth, and no AI-specific evaluations (like MRMC or standalone algorithm performance).

The submission focuses entirely on the technical classification and equivalence to a previously cleared device, which was the standard regulatory approach for many medical devices in 1997.

Summary

Regulation Number and Section

§ 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.