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The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP.

The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

Since this is not an AI/ML device, the traditional acceptance criteria and study design for such devices are not applicable.
This document is a 510(k) premarket notification for the NormaTec Pulse and NormaTec Pulse Pro, which are powered inflatable tube massagers. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.

The acceptance criteria for substantial equivalence in this context are primarily based on comparing the new device to existing predicate devices in terms of:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: The fundamental scientific technology and design principles.
• Performance: How the device functions and its capabilities.
• Safety and Effectiveness: Ensuring that any differences do not raise new questions of safety or effectiveness.

Here's an analysis based on the provided text, outlining how the device meets these criteria through comparison with predicate devices:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states:

• "No animal testing was performed"
• "No clinical testing was performed"

Therefore, there is no "test set" in the sense of patient or animal data used to establish device performance against clinical endpoints. The evaluation for substantial equivalence relied on bench testing and comparison to predicate devices rather than clinical performance data.

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 or animal testing was performed, there was no "ground truth" to be established by experts from such test sets regarding clinical outcomes. The "ground truth" for the substantial equivalence claim resides in the technical specifications, design, and performance characteristics compared to the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set 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 a physical therapy device (powered inflatable tube massager), not an AI/ML diagnostic or image reader assistance device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for proving substantial equivalence was based on:

• Technical specifications and design documents of the NormaTec Pulse and Pulse Pro.
• Technical specifications and regulatory clearances of the predicate devices (NormaTec MVP - K112890 and Figg, LLC PowerPlay model PPRT-01 - K122154).
• Bench testing results demonstrating compliance with applicable electrical safety and EMC standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the NormaTec Pulse and Pulse Pro met acceptance criteria for substantial equivalence was a comparison study against two predicate devices: NormaTec MVP (K112890) and Figg, LLC PowerPlay model PPRT-01 (K122154).

The acceptance criteria were met by demonstrating that the new device:

• Has identical indications for use and contraindications as the primary predicate NormaTec MVP (K112890).
• Utilizes identical core technology (compressor and valve system with sequential inflation).
• Has similar, or improved without raising new safety/effectiveness concerns, technological characteristics (e.g., pressure range, treatment time, controls).
• Complies with relevant, updated voluntary standards (ES 60601-1, IEC 60601-1-2, IEC 60601-1-11).
• Key differences (e.g., optional integrated battery, microprocessor control, adjustable treatment time, hip appliance, broader pressure range for hip appliance, different massage patterns) were analyzed and determined not to raise new questions of safety or effectiveness.

This evaluation was supported by bench testing to confirm the device's adherence to various controls, indicators, performance parameters, hazard mitigations, and compliance with the specified electrical and EMC standards. No animal or clinical studies were deemed necessary for this substantial equivalence determination.

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