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Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process.

The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance.

The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.

The provided text is a 510(k) Summary for the "Air Pressure Foot Massager" (K212935). It details the device's characteristics, its intended use, and its comparison to a predicate device (K201935) to establish substantial equivalence.

However, this document does not contain the kind of information typically found in a study that describes acceptance criteria and proves a device meets them, especially from a clinical performance or AI algorithm perspective. This document focuses on demonstrating substantial equivalence to an existing predicate device based on non-clinical tests and comparisons of specifications.

Specifically, the document lacks:

• A table of acceptance criteria for performance metrics where the device's performance is reported against those criteria. The tables provided are for general device characteristics and safety comparisons, not performance against specific clinical or diagnostic thresholds.
• Details on sample size, data provenance, expert qualifications, or adjudication methods for a test set, as no clinical study or performance evaluation against ground truth is presented.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details about a training set, how its ground truth was established, or its sample size.

The document explicitly states: "No clinical study is included in this submission." This indicates that the regulatory clearance was based on non-clinical data and comparison to a predicate device, rather than a clinical performance study.

Therefore,Based on the provided document, the requested information cannot be fully provided because the submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than a clinical study evaluating specific performance criteria against a ground truth.

Here's a breakdown of why each requested point cannot be fully addressed:

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

   • The document provides a "Substantially Equivalent (SE) Comparison" table (Table 1) and a "Safety Comparison" table (Table 3). These tables compare specifications and compliance with standards between the proposed device and the predicate device. They do not list specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific quantitative measures of effectiveness) and then report the device's performance against those criteria. Instead, they demonstrate that the proposed device's characteristics are similar to or comply with the same standards as the predicate device.
   • For example, under "Pressure range," both devices are listed as "30-110mmHg," implying this is an accepted specification, but it's not a performance metric with an associated acceptance criterion.

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

   • Not applicable. No clinical test set or study involving human subjects or data is mentioned. The submission explicitly states: "No clinical study is included in this submission." Non-clinical tests were conducted to verify design specifications and compliance with safety standards (e.g., electrical safety, biocompatibility), but these do not involve a "test set" in the context of clinical or diagnostic performance evaluation.

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 test set was used, there was no need for experts to establish ground truth in this context.

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

   • Not applicable. No clinical test set requiring adjudication was used.

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 an "Air Pressure Foot Massager" and does not involve AI or human "readers" in a diagnostic or interpretive capacity. It's a physical therapy/massage device.

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

   • Not applicable. The device does not incorporate an algorithm that operates in a standalone diagnostic or interpretive capacity.

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

   • Not applicable. The "ground truth" for this submission was compliance with established medical device standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct comparison of design specifications to a legally marketed predicate device.

8. The sample size for the training set:

   • Not applicable. No training set for an AI algorithm or clinical model was used.

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

   • Not applicable. No training set was used.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on non-clinical tests (safety, biocompatibility) and a thorough comparison of technical specifications to a predicate device, which is a common pathway for devices of this type. It was not a submission requiring clinical performance data or AI algorithm validation.

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