(79 days)
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.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).