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POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).

POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body. Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.

The provided document is a 510(k) summary for the "Compressible Limb and Circulation Therapy System, Model POWER-Q2300". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Based on the information provided in this 510(k) summary, the device under review is a physical medical device (a massager) aiming for "temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation". It is NOT an AI/ML-enabled diagnostic or therapeutic device. Therefore, many of the typical acceptance criteria and study components requested in the prompt (such as accuracy metrics for an AI model, ground truth establishment by experts, MRMC studies, training/test set sample sizes for AI, etc.) are not applicable to this type of device.

The "study that proves the device meets the acceptance criteria" for a physical device like this primarily involves non-clinical performance testing to ensure it adheres to recognized standards for safety and essential performance, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an attempt to answer the prompt based only on the provided document, highlighting which aspects are applicable and which are not:

Acceptance Criteria and Device Performance for POWER-Q2300

As this is a physical medical device and not an AI/ML model, the acceptance criteria are based on meeting recognized medical electrical equipment standards and demonstrating comparable performance to a predicate device for its intended physical function.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable in the context of AI/ML testing. For this physical device, "testing" refers to non-clinical laboratory verification against engineering standards. The document states: "Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed." It does not specify sample sizes for these tests, as they would typically involve engineering samples tested to specific physical and electrical standards, not a "test set" of patient data.

Data provenance: Not applicable. There is no patient data or clinical data used for regulatory submission, as explicitly stated: "No clinical testing was performed."

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Not Applicable. As there was no clinical testing performed and no AI/ML component, there was no need for expert ground truth establishment using patient data.

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

Not Applicable. This is relevant for clinical studies or AI algorithm validation with uncertain ground truth. For this physical device, regulatory clearance relied on non-clinical engineering tests and comparison to a predicate device.

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 physical massager, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant.

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

Not Applicable. There is no AI algorithm to evaluate in standalone mode.

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

Not Applicable for clinical ground truth. The "ground truth" for this device's performance validation is its adherence to recognized engineering standards (IEC, ANSI/AAMI) for electrical safety, EMC, usability, and specific physical performance parameters (pressure accuracy, seam strength, fail mode). There is no "patient-specific" ground truth required for this type of device clearance by FDA.

8. The sample size for the training set

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

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

Not Applicable. As there is no AI model or training set, there is no ground truth establishment for a training set.

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POWER RECOVERY is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).

Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.

The provided text describes a 510(k) premarket notification for the "Compressible Limb and Circulation Therapy System, Model POWER RECOVERY" and its comparison to a predicate device, the "Rapid Reboot Compression Therapy System."

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. It does not present a table of specific acceptance criteria (e.g., minimum sensitivity/specificity thresholds) or quantitative performance metrics typically seen in studies evaluating the diagnostic or predictive accuracy of a device.

Instead, the "acceptance criteria" here are implicitly related to meeting safety and performance standards for a powered inflatable tube massager and having indications for use and technological features that are substantially equivalent to a legally marketed predicate device.

The device has been tested and met the requirements of these standards. |
| Indications for Use | Indications for use must be substantially equivalent to the predicate device. | POWER RECOVERY: "intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
Predicate Device: "indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment."

Reported as "Identical." |
| Technological Characteristics | Key technological characteristics (operation mode, pressure range, cuffs, etc.) should not raise new questions of safety or effectiveness compared to the predicate. | Operation Mode: 5 modes (SEQUENTIAL, ADDITION, MASSAGE) vs. 2 (Sequential, Peristaltic). Massage mode of subject device is a combination of SEQUENTIAL and Addition modes, which are similar to predicate modes.
Pressure Range: 60-150 mmHg vs. 0-200 mmHg. Subject device has a smaller pressure range.
Number of Inflatable Appliance Segments: 6 or less for leg/arm, 5 or less for hip vs. 4. Subject device has more segments.
Sleeve and Chamber: Leg: 6-chambers, Arm: 6-chambers, Hip: 5-chambers vs. Leg: 4-chambers, Arm: 4-chambers, Hip: 4-chambers. Subject device has more chambers.
Power Source(s): 15 VDC via IEC 60601-1 compliant power supply (100-240 VAC input), Optional integrated rechargeable battery vs. 110VAC, 60Hz. Minor difference.
Weight: 2 kg including battery vs. 2.63 kg (5.8 pounds). Minor difference.
Dimensions: 114 x 141 x 245 mm vs. 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5"). Minor difference.
Treatment Time: User can select 10, 20, and 30 minutes vs. User determines therapy time, choose from 10, 20, or 30 minute session time, with option to add additional 10 minutes. Reported as "Identical."
Anatomical site: Identical.
Prescriptive or OTC: Identical (OTC).
Environment of Use: Identical. |

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical testing was performed." Therefore, there is no test set in the sense of a clinical trial or a dataset of patient cases. The evaluation relies entirely on non-clinical testing for standards compliance and a comparison of technical specifications to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as no clinical testing or test set involving expert ground truth existed.

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

Not applicable as no clinical testing or test set involving expert ground truth existed.

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. The device is a physical therapeutic device (powered inflatable tube massager), not an AI-based diagnostic or imaging interpretation system. No MRMC study was conducted.

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

Not applicable. The device is a physical therapeutic device, not an algorithm, and does not operate in a standalone algorithmic capacity as would be understood in the context of AI or diagnostic software.

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

Not applicable. For this type of device (a massager), ground truth related to diagnostic accuracy is irrelevant. The "ground truth" for its safety and claimed physiological effects (e.g., temporary increase in blood circulation) would typically come from well-controlled clinical studies demonstrating these effects, but the document states "No clinical testing was performed." Instead, compliance with safety and performance standards and substantial equivalence to a predicate device with established safety and efficacy (for its limited indications) forms the basis of its clearance.

8. The sample size for the training set

Not applicable. The device is a physical therapeutic device, not a machine learning model, so there is no "training set."

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

Not applicable for the reason stated above.

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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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The WHF-314 (POWER Q1000) device 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, Post immobilization 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, cycle time and gradient setting Power unit features visual operation status and fault indicators

The provided 510(k) summary for the WONJIN MULSAN Co., Ltd. WHF-314 (POWER Q1000) device does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a submission for substantial equivalence to a predicate device, focusing on regulatory information, intended use, device description, and a comparison with the predicate. There is no mention of a performance study, clinical trial, or any data presented to establish device performance against predefined acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and comparison to existing devices, rather than presenting new performance data. The section "Performance Characteristics (If/when applicable)" explicitly states "See the Exhibits," but these exhibits are not included in the provided text.

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