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510(k) Data Aggregation
(115 days)
WONJINMULSAN CO., LTD.
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.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Safety and Performance Standards: | The Model Power-Q1000 Premium has tested and meets the requirements of the following standards: |
| EN60601-1, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:91/A2:95) | Meets requirements. |
| EN60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators | Meets requirements. |
| EN60601-1-2, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility | Meets requirements. |
| Functional Equivalence to Predicate Device (WHF-324 POWER-Q1000) | The device demonstrates substantial equivalence in intended use, indications for use, contraindications, mode of compression, number of chambers, and compression applicator garments. Minor differences exist in therapy time (0-99 min vs. 0-30 min for predicate) and maximum/minimum pressure (0-240 mmHg vs. 0-300 mmHg for predicate), but these do not raise new safety or effectiveness concerns. |
| Device Specifications/Performance Characteristics: | |
| Pressure (mmHg) | 0~240 mmHg |
| Mode Selection | A, B, C, D (D1, D2, D3, D4), E selection (Initial: Mode A) |
| Interval (sec) | 0, 5, 10, 15, 20, 25, 30 sec (Initial: 0 sec) |
| Time (min) | 5~99 min (Initial: 15 min) |
| Pressure Time (mmHg) | 0 |
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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