(65 days)
The Normatec Elite 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 Elite is a powered inflatable tube massager. 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 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 charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery.
The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for:
- Starting and stopping the massage treatment; .
- . Adjusting time and intensity (pressure) of the treatment;
- Selection of the zone to boost the pressure .
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 Elite. The document details the device's characteristics and compares it to a predicate device (Normatec 3). However, it does not contain the specific acceptance criteria or the full study details to prove the device meets these criteria in the way you've requested.
The document states:
- "Performance testing demonstrated that the proposed device met its acceptance criteria." (Page 11)
- "Discussion - The test results are similar to the predicate and within pre-defined acceptance criteria." (Page 11)
Despite these statements, the document does not explicitly list the quantitative acceptance criteria for performance (e.g., specific pressure ranges, circulation increase percentages, muscle ache relief metrics) nor does it provide a detailed study that proves these criteria were met. It mentions "Testing of all controls," "Testing of all indicators," "Testing of battery state indicators," "Testing of performance," and "Testing of hazard mitigations" as types of bench testing performed, but no specific results or methodologies are shared.
Therefore, for your request, I can only provide the information that is present in the document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document states that performance testing met acceptance criteria, but it does not list the specific quantitative acceptance criteria or the reported device performance details (e.g., what specific values were achieved for pressure, time, etc., against defined thresholds). It only broadly mentions general areas of testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: The document mentions "Performance testing" and "Bench testing" but does not specify any sample sizes for a test set or the provenance of any data used for testing (e.g., patient data, country of origin, retrospective or prospective). This device is a massager, and the testing described appears to be bench testing for device functionality rather than clinical studies on human subjects with specific sample sizes.
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)
- Cannot be provided: This information is not present. The document focuses on the engineering and regulatory comparison of the device to a predicate, not on a study involving human experts establishing ground truth for a diagnostic or interpretive task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: This information is not present in the document.
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
- Cannot be provided: This information is not present. The device is a powered inflatable tube massager, not a diagnostic imaging device typically requiring MRMC studies. There is no mention of AI assistance in relation to human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided: While the device uses a "Microprocessor" and "Bluetooth communication ability" to control inflation sequences, the document does not describe "standalone algorithm performance" in the context of diagnostic AI or a human-in-the-loop comparison. The "performance testing" mentioned is for the device's operational functionality (controls, indicators, battery, hazard mitigations).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable to the descriptions of testing in this document. The testing described is functional verification against pre-defined engineering and safety specifications, not "ground truth" derived from clinical outcomes or expert labels.
8. The sample size for the training set
- Cannot be provided: The document does not describe any machine learning/AI models that would require a "training set" in the conventional sense. The "Microprocessor Control" mentioned refers to the device's embedded firmware, not a trainable AI model with a distinct training set.
9. How the ground truth for the training set was established
- Cannot be provided: As no training set is described, this information is not applicable.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).