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Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate kneading and stroking of tissues by using an inflatable garment.

Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health. The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.

The provided text describes a 510(k) premarket notification for a medical device, the "Leg and Foot Air Wave Pressure Therapy Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness. Therefore, the information provided does not include a detailed study with acceptance criteria and reported device performance in the way a clinical trial for a new therapeutic device would.

However, based on the non-clinical testing section and the comparison to predicate devices, we can infer the types of acceptance criteria that would have been used for the safety and performance evaluations.

Here's an attempt to structure the information according to your requested points, making inferences where the exact details are not explicitly stated in the provided documents:

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

Since this is a 510(k) submission, the "performance" is demonstrated by adherence to recognized standards and comparison to a predicate device, rather than specific clinical outcome metrics. The acceptance criteria for such a device are typically compliance with safety and performance standards.

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

• Sample Size for Test Set: Not explicitly stated for specific non-clinical tests. These validations typically involve a set number of units for various environmental, electrical, and mechanical stress tests, which can vary depending on the standard. For the Usability Study, the sample size is also not specified, but such studies usually involve a small, representative group of users.
• Data Provenance: The testing was "evaluated the safety and performance by lab bench testing" and included a "Usability Study." This indicates prospective, controlled testing. The submission is from China (manufacturer: ZHANGZHOU EASEPAL INNOVATION CO., LTD. in Fujian, China; correspondent: Guangzhou KEDA Biological Technology Co., Ltd in Guangzhou, China). Therefore, the testing likely occurred in China or at certified labs engaged by the manufacturer.

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)

• For the technical standards (electrical safety, EMC, etc.), the "ground truth" is established by the standard itself, and expert judgment is applied in performing and interpreting the tests according to the standard. The document does not specify the number or specific qualifications of experts involved in conducting these tests or reviewing the results for the submission. The presumption is that qualified engineers and technicians performed these analyses.
• For the Usability Study, the "ground truth" would be the observed user interactions and feedback. The number and qualifications of evaluators (human factors experts) are not specified.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or symptoms where there is subjective assessment by multiple readers. This device is a physical therapy device with non-clinical testing for safety and performance against objective standards. Therefore, such adjudication methods would not be applicable or described in this type of submission. The compliance to standards is generally verifiable through a single, qualified test.

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

No MRMC comparative effectiveness study was done. This device is a physical therapy device (a powered inflatable tube massager) intended for direct user application for temporary relief of minor muscle aches and pains and increased circulation. It does not involve "human readers" or AI assistance in the interpretation of medical data, so this type of study is not relevant. The document explicitly states: "Clinical testing is not necessary for the subject device."

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

This question is not applicable. The device is a physical therapy device, not an AI algorithm. Its performance is inherent to its mechanical and electrical function as controlled by an internal microprocessor, not through a standalone AI algorithm.

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

The "ground truth" for this device's evaluation is primarily:

• Compliance with recognized international and national safety and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2).
• Demonstrated functional parameters (e.g., pressure range, cycle times, inflation rates) that are comparable to legally marketed predicate devices, implying similar therapeutic effect without requiring new clinical outcome data.
• Validation of software according to FDA guidance.
• Usability testing to ensure the device can be used safely and effectively by its intended lay operators.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML algorithm that requires a "training set." It's a hardware device with an embedded microprocessor and software for control.

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

This question is not applicable, as there is no "training set" for this device.

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