(149 days)
high resolution ultrasound imaging
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: SKIN
The Longport™ LDSTM-1 is a proprietary, non-invasive medical device for performing ultrasound scanning of the upper layers of the dermis. It is a portable, high frequency (20 MHz) ultrasound device which captures and reproduces images of soft tissue up to 1.5 inches below the skin at a high resolution utilizing a laptop computer.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Longport™ Model LDS™-1 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Longport™ Model LDS™-1 does not explicitly state specific acceptance criteria or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device (DermaScan C® ver. 3 Cortex Technology).
Instead of performance metrics, the document highlights:
- Intended Use: "high resolution ultrasound imaging"
- Technological Characteristics Compared to Predicate Device:
- Similarities: Transducer type (focused, single element), stand-off medium (water), water reservoir retention (membrane), operating system (windows), operator control (keyboard/mouse), processor (Pentium), data format (digital), data storage (hard/floppy disk), distance measurement, split screen features, palettes (gray scale and color).
- Differences: Transducer Center Frequency (Longport 20MHz; Predicate 10, 20, 30 MHz), Scan Rate (Longport 1 scan/second; Predicate up to 6 scans/second), Safety (Longport: IEC 601-1 & EMI: EN55011, Class A; Predicate: IEC 601 & UL 544), Power Requirements, Power Consumption, Operating Temperature and Humidity.
Therefore, a table of acceptance criteria and reported device performance directly from this document cannot be created in the way typically found for algorithm performance. The basis for clearance here is substantial equivalence of technological characteristics for the stated intended use.
2. Sample size used for the test set and the data provenance
The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). Because the submission is for substantial equivalence based on technological characteristics and intended use, rather than a clinical performance study, such details are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. Given the nature of a 510(k) for an ultrasound scanner based on substantial equivalence, a formal ground truth establishment process with experts for a clinical dataset is not described.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) submission. The document focuses on the device's technical specifications and intended use in comparison to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The Longport™ Model LDS™-1 is an ultrasound imaging system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI devices was not conducted and is not applicable in this context. The device is a tool intended to be used by a human operator (human-in-the-loop).
7. The type of ground truth used
The concept of "ground truth" as typically applied to performance studies (e.g., pathology, outcomes data) is not discussed in this 510(k) because it's a submission for an imaging device based on substantial equivalence, not a clinical efficacy study requiring a definitive ground truth for diagnostic accuracy. The "truth" in this context is that the device produces "high resolution ultrasound imaging" consistent with its intended use and is technically comparable to a legally marketed predicate device.
8. The sample size for the training set
This information is not provided in the 510(k) summary. As an ultrasound imaging device, it does not involve the concept of a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary, as it's not relevant for an ultrasound imaging device that does not utilize a training set in the AI/machine learning context.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.