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The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

The Normatec 3 is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are 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 also be powered by an internal IEC 62133-2 compliant lithium-ion battery.

The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for:

• Starting and stopping the massage treatment; .
• Adjusting time and intensity (pressure) of the treatment; .
• Selection of Attachment in use (Leg, Arm, Hip); .
• . Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected

In addition to the user interface on the devices the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

This document is a 510(k) Premarket Notification from the FDA for a medical device called Normatec 3. It compares the Normatec 3 to a predicate device (NormaTec Pulse 2.0 and Pulse Pro 2.0, K183169) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific performance metrics and their corresponding reported device performance values. Instead, it asserts substantial equivalence based on a comparison of characteristics between the proposed device (Normatec 3) and the predicate device (NormaTec Pulse 2.0 / Pulse Pro 2.0).

The "acceptance criteria" are implicitly met by demonstrating that the Normatec 3 is substantially equivalent to the predicate device across various aspects. The "reported device performance" is essentially the demonstrated equivalence to the predicate's performance and compliance with relevant standards.

Here's a summary derived from the provided text:

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

The document does not specify a numerical sample size for a test set that would typically be used in a clinical study to evaluate device performance against specific clinical acceptance criteria.

The evaluation for the Normatec 3's substantial equivalence appears to rely primarily on non-clinical testing to demonstrate compliance with standards and equivalence to the predicate device. The text states:

• "Verification and Validation activities required that establish the performance, functionality, and reliability characteristics of the Normatec 3 with respect to the predicate were performed."
• "Testing performed demonstrated that the proposed device meets defined requirements and performance claims."
• "The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as the predicate device..."

This suggests engineering and bench testing rather than human subject testing to generate a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here as a distinct clinical test set is not described.

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

This information is not applicable/not provided. The assessment for the Normatec 3 is based on engineering and performance comparisons, and compliance with standards, rather than expert-adjudicated clinical data to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable/not provided for the same reasons as point #3. There is no mention of a human-reviewed "test set" requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers interpret medical images or data. The Normatec 3 is a physical therapy device (powered inflatable tube massager) and does not involve human readers interpreting medical cases. Furthermore, it is not an AI-assisted device in the context typically seen in MRMC studies.

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

A standalone performance study in the context of an algorithm's diagnostic accuracy is not applicable and was not done. The Normatec 3 is a physical device, and while it has software/firmware and Bluetooth control, its core function is physical massage, not algorithmic diagnosis or interpretation. The "algorithm" here controls the physical inflation/deflation cycle.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology for cancer detection, expert consensus on imaging findings) is not directly applicable in this submission.

Instead, the "ground truth" for the device's performance is implicitly established by:

• Compliance with recognized voluntary standards (e.g., IEC 60601 series for electrical medical equipment safety).
• Engineering specifications and measurements demonstrating the device performs within expected physical parameters (e.g., pressure range, cycle type).
• Equivalence to the legally marketed predicate device, implying that if the predicate is safe and effective, and the new device is substantially equivalent, then it also meets safety and effectiveness criteria.

8. The sample size for the training set

This information is not applicable/not provided. The Normatec 3 is a physical device with embedded software; it is not primarily an AI/machine learning model that undergoes "training" on a dataset in the typical sense. Its control logic is programmed, not learned via large data sets.

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

This information is not applicable/not provided for the same reasons as point #8. There is no mention of a traditional "training set" or "ground truth" establishment for training in this 510(k) submission.

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