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High resolution ultrasound imaging for wounds, superficial musculoskeletal diagnosis and assessment, plastic/reconstructive surgery planning and assessment, dematological assessment and diagnosis, and aesthetic application

The Episcan I-200 has been developed to examine the human skin and the first few centimeters of underlying soft tissue using ultrasound of center frequency 20 MHz. The system displays the information obtained in the form of brightness or B-scans, which are presented either color-coded or grayscale images. These images can be stored on magnetic media, printed or transferred electronically for archive or analysis. Physically, the system consists of two main components: the hand-held ultrasound probe and the portable instrument/computer body with its monitor and keyboard. Operation of the Episcan I-200 is similar to that of most medical diagnostic ultrasound systems in clinical use today. The near real-time imaging of the scanner allows you to view the scanner's screen as you reposition the probe and alter the scanner's parameters. The image can be saved to a disk, printed, forwarded via a network or modem to a remote location or discarded. The Episcan I-200 contains enhancements or new features including short cut menus; adjust and move measurements and annotations; copy and paste measurements and annotations, tidy and repair databases, and new analysis functions.

This FDA 510(k) premarket notification (K062571) describes the Longport Episcan I-200 ultrasound system. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses for various transducers. It does not present a study with acceptance criteria and reported device performance data in the way typically seen for AI/ML device submissions. Instead, it's a traditional 510(k) for an ultrasound imaging system.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document as it does not contain a performance study against specific acceptance criteria.

However, I can extract information related to the device's intended use and the transducers.

Here's a breakdown of the available information relevant to your request, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance for a study. This is a premarket notification for a medical device (an ultrasound system), which typically focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a clinical performance study with predefined acceptance criteria for a specific diagnostic task.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided document. The document describes a medical imaging device (ultrasound system) and its intended uses, but it does not detail any specific clinical performance studies that involved a "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available in the provided document. As there is no described performance study with a test set, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As there is no described performance study with a test set, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

This information is not available in the provided document. This type of study is common for evaluating AI/ML systems' impact on human reader performance, but this submission is for a traditional ultrasound device and does not describe such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available in the provided document. The Episcan I-200 is an ultrasound imaging system operated by a clinician ("human-in-the-loop"). The document does not describe an "algorithm only" or standalone performance study in the context of AI/ML.

7. The Type of Ground Truth Used

This information is not available in the provided document. Since no specific performance study is detailed, no ground truth method is described. The device inherently generates images for clinical assessment, where clinicians interpret the images without a pre-established "ground truth" provided by an algorithm.

8. The Sample Size for the Training Set

This information is not available in the provided document. This device is an imaging system and not described as an AI/ML device that would undergo a training phase on a dataset.

9. How the Ground Truth for the Training Set was Established

This information is not available in the provided document. As there is no mention of a training set, there is no method described for establishing ground truth for it.

Summary of Available Information from the Provided Text:

The provided document (K062571) is a 510(k) premarket notification for the Longport Episcan I-200 Ultrasound System. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Device Description:
The Episcan I-200 is an ultrasound system with a center frequency of 20 MHz, designed to examine human skin and the first few centimeters of underlying soft tissue. It produces brightness (B-scans) images in color-coded or grayscale, which can be stored, printed, or transferred. It consists of a hand-held ultrasound probe and a portable instrument/computer body with a monitor and keyboard. Its operation is similar to other medical diagnostic ultrasound systems, offering near real-time imaging. Enhancements include shortcut menus, adjustable measurements and annotations, and new analysis functions.

Intended Use (across various transducers):
"High resolution ultrasound imaging for wounds, superficial musculoskeletal diagnosis and assessment, plastic/reconstructive surgery planning and assessment, dematological assessment and diagnosis, and aesthetic application."

More specific indications for various transducer models (e.g., 1030-20, 0931-12, 0931-10, 0931-07, 1248-07, 1248-10, 1248-12) include:

• Superficial Musculo-skeletal (indicated as 'N' for New Indication for some transducers)
• Skin and underlying soft tissue
• Wound management and assessment
• Detection and assessment of pressure ulcers, detection of deep tissue injury, burn depth assessment, differentiation of edema from lymphedema
• Clinical Dermatology, skin lesion assessment, aesthetics

Substantial Equivalence:
The device is deemed substantially equivalent based on similar technological characteristics to predicate devices (Longport LDS-1, Hudson 2020/2040/2060, Diasus P75LHF, Cortex DermaScan C). Similar characteristics include transducer center frequency, scanning mode, scan field/length, transducer stand-off medium, water reservoir retention, Windows Operating System, operator control, data format, data storage, distance measurement, split screen features, palettes, safety, power requirement, power consumption, and operating temperature/humidity. Differences noted are transducer type and scan rate.

This submission is a regulatory filing for marketing clearance, not a clinical study report with performance metrics against acceptance criteria.

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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.

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