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WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

WIC-2008S is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

This document describes a medical device, the Compressible Limb Therapy System WIC-2008S, which is a "Powered inflatable tube massager." The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through extensive clinical trials.

Therefore, the provided text does not contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

The document focuses on:

• Device Description: It's a system that uses four-chamber garments for full legs and has variable duration, pressure, cycle time, and gradient settings.
• Intended Use: To treat conditions like primary lymphedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.
• Substantial Equivalence: The primary argument is that the WIC-2008S is substantially equivalent to a previously cleared device (WIC-2008, K102319) in terms of intended use, technological, and performance characteristics, without raising new safety or effectiveness concerns.
• Performance Characteristics (Standards Applied): Instead of reporting specific device performance against acceptance criteria, the document lists a series of national and international standards the device has conducted and applied, which are common for medical devices to ensure safety, quality, and regulatory compliance. These standards include:
  • Council Directive 93/42/EEC (Medical Devices)
  • IEC 980:2008 (Graphical symbols for use in labeling)
  • IEC 1041:2008 (Information supplied by manufacturer)
  • ISO 13485:2003 (Quality management systems)
  • ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects - General requirements)
  • ISO 14971:2007 (Application of risk management)
  • IEC 60601-1 (General requirements for safety of medical electrical equipment)
  • IEC 60601-2-10 (Particular requirements for safety of nerve and muscle stimulators)
  • IEC 60601-1-2 (Electromagnetic compatibility)

Conclusion:

Based on the provided text, it's not possible to populate the requested table or answer most of the questions, as this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria often seen for novel devices that require efficacy data.

The "performance characteristics" listed are the standards applied (bench and laboratory testing to applicable standards), not specific performance metrics like sensitivity, specificity, accuracy, or effect sizes from clinical studies. The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," which means they accepted the manufacturer's argument based on design, materials, and engineering testing to relevant safety standards, rather than new clinical outcome studies.

Therefore, the requested information (performance acceptance criteria, sample sizes, ground truth, expert qualifications, MRMC studies, etc.) is not present in the provided 510(k) summary.

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WIC-2008 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

WIC-2008 is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text from K102319 is a 510(k) summary for a medical device called "Compressible Limb Therapy System WIC-2008." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one would for a novel algorithm or diagnostic device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.

The document indicates that the device's performance was assessed through bench and laboratory testing to applicable standards and concluded that it is "as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns." This suggests performance was demonstrated against engineering and safety standards, not against clinical accuracy metrics for an AI algorithm.

Here's a breakdown of what can be extracted and what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document does not specify quantitative acceptance criteria or clinical performance metrics in the way requested for an AI/diagnostic device. The performance assessment was against regulatory and safety standards, not clinical accuracy with a "ground truth" as typically understood for AI.

The study concluded: "Compressible Limb Therapy System WIC-2008 has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 PLUS) and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of WON INDUSTRY Co Ltd. that Compressible Limb Therapy System WIC-2008 is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns."

This is a statement of equivalence based on meeting general safety and performance standards for a physical medical device, not a data-driven performance report.

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

Not Applicable. This is not a study involving a "test set" of patient data for an algorithm. It's about a physical medical device. The "testing" involved bench and laboratory testing against electrical and safety standards.

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

Not Applicable. No "ground truth" in the context of expert consensus on patient data was established, as this is not an AI or diagnostic device that interprets medical images/data.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an MRMC study. The device is a massager, not an image interpretation or diagnostic aid.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

No. This device does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used:

Not Applicable. The concept of "ground truth" in the sense of clinical diagnoses, pathology, or outcomes data is not relevant to this type of device and its substantial equivalence submission. The "ground truth" for this device's safety and effectiveness would be adherence to the cited international and electrical safety standards (e.g., IEC 60601-1).

8. The Sample Size for the Training Set:

Not Applicable. This device does not use a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See point 8.

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