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LF-400 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.

LF400 is the pressurization system helping to relieve the symptom of lymphedema and prevent aggravation of symptoms by applying the air pressure to limbs. LF400 comprises 4-step sleeves which move the body fluids through the limbs by evenly applying pressure to the limbs. The basic set of Air Compression Therapy System consists of the main body, which includes the air pump that generates air pressure and control panel, air hose that transfers air pressure and cutoff sleeve (cuff) for leg and its accessories include overlapping sleeve (cuff) for leg, cutoff sleeve (cuff) for arm, overlapping sleeve (cuff) for arm, cutoff sleeve (cuff) for waist and pants sleeve (cuff). The device consists of 4 parts-PCB, control panel, air pump (AC motor pump) and distributor (solenoid).

The provided text describes a 510(k) premarket notification for the LF-400 Compressible Limb Therapy System, which is a medical device for treating various lymphedema and edema conditions. The document focuses on demonstrating substantial equivalence to a predicate device, the LX7 (V7), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them in the way clinical trials or AI performance evaluations usually do.

Based on the nature of this 510(k) submission, the "acceptance criteria" discussed are primarily related to safety, electrical performance, biocompatibility, and software validation, rather than clinical efficacy metrics like sensitivity or specificity. The "reported device performance" refers to the results of these technical tests, which found the device to be satisfactory and substantially equivalent to the predicate.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of clinical data (e.g., patient cases). The performance data cited are from technical tests (biocompatibility, electrical safety, EMC, software). These types of tests typically use specific numbers of samples of the device components or the device itself, rather than a "sample size" of patients or data from medical records. The text does not specify the exact number of units or materials tested for these engineering and materials assessments.

Regarding data provenance:

• The submitter, DaeSung Maref Co., Ltd., is located in the Republic of Korea.
• The standards (ISO, IEC, FDA guidance) are international and US-based.
• The tests are implied to be conducted as part of the device development and regulatory submission process, which would typically be prospective for these types of technical evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of performance data presented. The "ground truth" for technical standards is the standard itself, and the performance is measured against objective criteria within that standard by qualified test engineers/labs, not by a panel of medical experts establishing consensus on patient-specific data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used for expert review of clinical results or imaging data, which are not part of this document's performance section.

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

This is not applicable. The LF-400 is a physical medical device (compressible limb therapy system), not an AI/imaging diagnostic tool that involves "human readers" or AI assistance in interpretation.

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

This is not applicable as the device is not an AI algorithm. Its software validation ensures its control functions operate correctly, but it does not perform diagnostic interpretation or AI-driven decision-making in a "standalone" algorithmic sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance data, the "ground truth" is adherence to established international and national standards (ISO, IEC) for biocompatibility, electrical safety, EMC, and FDA guidance for software. These standards define the acceptable parameters and test methodologies.

8. The sample size for the training set

This is not applicable. This device does not use machine learning or AI that would require a "training set" of data. The software components are for control and user interface, verified through traditional software validation methods.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

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The device is indicated 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 injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Power Q1000 Premium 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. Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs.

The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance validation study for an AI/ML device.

Instead, this is a 510(k) summary for a Compressible Limb Therapy System (Power-Q1000 Premium), which is a physical medical device (a pneumatic pressure treatment system, essentially a massager). The acceptance criteria and "study" described here pertain to demonstrating substantial equivalence to a predicate device, primarily by showing compliance with recognized electrical safety and electromagnetic compatibility standards, and by comparing its technical specifications and intended use to the predicate.

Therefore, the requested information elements related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or available in this document.

Here's the information that can be extracted from the provided text, reframed to fit the request where possible, and noting where information is not relevant or available:

1. Table of acceptance criteria and the reported device performance

For this type of device (physical medical device, not an AI/ML diagnostic system), "acceptance criteria" primarily relate to compliance with recognized safety and performance standards for electrical medical equipment, and demonstrating comparable specifications to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a physical medical device and not an AI/ML system requiring a clinical test set with patient data. The "testing" referred to is laboratory testing for compliance with electrical and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the context of an AI/ML system's diagnostic performance, is not relevant here. The ground truth for this device's safety and performance is established by its adherence to internationally recognized electrical safety and medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML devices.

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

This information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which doesn't apply to this physical therapeutic device.

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

This information is not applicable, as it refers to an algorithm's performance, not a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's "performance" is its successful demonstration of compliance with the specified international safety and performance standards (EN60601-1, EN60601-2-10, EN60601-1-2). This is established through standard laboratory testing protocols defined by those standards.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML system that utilizes a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this physical medical device.

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WHF-324 (POWER-Q1000 PLUS) 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.

WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration.pressure, cvcle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text describes a 510(k) premarket notification for a medical device, the "Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS))". This notification seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the document does not contain details about specific acceptance criteria, a standalone study proving the device meets those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on establishing substantial equivalence based on intended use, technological characteristics, and performance characteristics (though these are broadly stated as adherence to international standards rather than specific device performance metrics).

Therefore, I cannot provide the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop study results. The document primarily highlights compliance with general medical device standards.

However, I can extract the information that is present regarding the device's regulatory pathway and the nature of the submitted evidence:

Here's a breakdown of what the document does provide in relation to your questions, and where it lacks the requested information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as specific performance thresholds for the device itself (e.g., pressure accuracy within X mmHg, cycle time deviation within Y seconds). The document establishes "substantial equivalence" as the primary acceptance criterion for regulatory clearance.
• Reported Device Performance: Not reported in terms of specific, quantifiable device performance metrics (e.g., pressure output, cycle duration, gradient range, accuracy). Instead, the document states: "WONJIN MULSAN Co., Ltd. that Compressible Limb Therapy System (WHF-324 (POWER-Q1000 PLUS)) has conducted and applied by standard of..." followed by a list of general medical device and quality management standards (e.g., Council Directive 93/42/EEC, IEC 60601-1, ISO 13485:2003, ISO 14971:2007). This indicates that the device's performance is deemed acceptable because it complies with these recognized standards for safety, quality, and electrical compatibility, rather than through specific performance tests against proprietary acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The document does not describe a "test set" for performance evaluation in the way you might expect for an AI or diagnostic device. The evaluation is based on demonstrating compliance with standards and substantial equivalence to a predicate device, not on clinical performance data from a specific patient cohort. The mention of "bench as well as laboratory testing to applicable standards" suggests internal engineering and safety tests, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As no clinical "test set" is described for performance evaluation, there is no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set.

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. This device is a "Powered Inflatable Tube Massager," not an AI diagnostic or assistive device for human readers. It has no AI component, and thus no MRMC study would be relevant.

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

• Not Applicable. This device is hardware for physical therapy; it does not involve algorithms or human-in-the-loop performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No clinical ground truth is discussed in relation to device performance. The "ground truth" for regulatory clearance is the established predicate device and compliance with international safety and performance standards.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning or AI, and therefore has no "training set."

9. How the ground truth for the training set was established

• Not Applicable. No training set.

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