Search Results

The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.

Powerpress Recovery Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components.
Pneumatic Manual / Analog Pump.
Limb Sleeve or garment composes of 4 chambers
Powerpress Recovery Unit enables different treatment pressure (30 ~ 100mmHg). When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones).
After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting.
Gradient: appx 7%, example: Foot 60mmHg – Ankle 56mmHg – Calf 52mmHg - Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) – 36 sec, 2nd chamber(ankle) – 27 sec, 3rd chamber(calf) - 18 sec, 4th chamber(thigh) - 9 sec
A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Powerpress Recovery Unit." This type of document is for demonstrating substantial equivalence to a previously cleared device, not typically for proving clinical efficacy or meeting specific performance acceptance criteria through the kind of study structure you've described for an AI/ML device.

Therefore, the information you've requested regarding acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication, MRMC, standalone performance, ground truth establishment for training and test sets), is not present in this document.

Here's why and what information is available:

The FDA's 510(k) pathway (as indicated by the K202044 number) is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves:

• Comparing Indications for Use: Are they the same or very similar?
• Comparing Technological Characteristics: How does the new device work compared to the predicate? Are any differences significant enough to raise new questions of safety or effectiveness?
• Performance Testing: This usually refers to bench testing (like electrical safety, electromagnetic compatibility, usability, etc.) to ensure the device performs as intended and is safe, but typically not clinical studies designed to show therapeutic efficacy or diagnostic accuracy against a ground truth in the way you've outlined for AI/ML performance.

Specifically, regarding your questions in the context of this document:

• 1. A table of acceptance criteria and the reported device performance: This document does not contain such a table for clinical performance. It presents a "Substantial Equivalence Comparison Table" (Section K) that lists characteristics of the subject device and the predicate device to argue for equivalence. The "performance" mentioned (O. Conclusion) refers to "specifications / performance and compliance with international standards," which points to the bench testing listed in Section N.
• 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No clinical ground truth establishment is described.
• 4. Adjudication method ... for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. This type of study is common for diagnostic AI tools, but this device is a therapeutic massager.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical massager, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide related to performance and justification:

• Benchmark Testing (Section N): The device was tested against recognized standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11) and a skin sensitization test (ISO 10993). These are the "performance tests" for this type of device, focusing on safety and basic function, not clinical outcomes for aches/pains or circulation.
• Claim of Equivalence for Pressure Range (Section J): The device has a pressure range of 30-100 mmHg, while the predicate has 20-80 mmHg. To address this difference, the applicant explicitly points to other FDA-cleared devices (Recovery Pump 737R and NormaTec Pulse/Pulse Pro) which have overlapping or higher pressure ranges (20-100 mmHg and 30-110 mmHg respectively) and are also Over-The-Counter (OTC). This is their evidence that the different pressure range "raises no new questions of safety and effectiveness."
• No Clinical Testing (Section N): The document explicitly states: "Clinical: No clinical testing was performed."

In summary: The provided FDA document pertains to a physical medical device (a powered inflatable tube massager) seeking 510(k) clearance based on substantial equivalence. It does not involve AI/ML, and therefore, the detailed study design and acceptance criteria for algorithm performance you are asking about are not relevant to this specific submission and are not present in the text. The "acceptance criteria" for this device are its ability to meet electrical and usability safety standards and to demonstrate substantial equivalence to a predicate device in its intended use and technological characteristics.

Ask a specific question about this device