(36 days)
The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
The Normatec Go is a powered, inflatable tube, calf 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. The device is to be used by people who are in good health. The device is charged from an external compliant power supply and powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec Go is a series of buttons with one small display screen, to display the treatment time. located on the control unit mounted on the calf wrap. The user interface provides for:
- . Starting and stopping the massage treatment;
- . Adjusting time and intensity (pressure) of the treatment;
In addition to the user interface on the proposed device, the device also has Bluetooth capability that allows the use of the NormaTec app to control the device. The Normatec app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience
The provided text describes a 510(k) summary for the Normatec Go device, which is an air pressure massager. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and detailed study results in the typical format of a performance study report.
However, based on the information provided, we can infer the acceptance criteria and the types of studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a specific table of quantitative acceptance criteria with numerical performance targets and reported values. Instead, it discusses "equivalent specifications of performance" and "met all acceptance criteria" when comparing to predicate devices. The primary performance characteristic highlighted with a numerical difference is the maximum pressure.
| Acceptance Criterion (Inferred) | Reported Device Performance (Normatec Go) | Comparison to Predicate (Normatec 3) | Comparison to Secondary Predicate (ST-502) |
|---|---|---|---|
| Indications for Use | "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." | Identical | Similar, with minor wording difference |
| Prescriptive Classification | OTC | Identical | Identical |
| Design, Technology, and Principle of Operation | Equivalent design and features, similar technology (Compressor and valve system that sequentially inflates cells, Bluetooth communication ability, Microprocessor) | Equivalent design and features, similar technology | Similar technology (Air pump, air pressure sensor, leg sleeves, adapter) |
| Maximum Pressure Range | 0 – 220 mm Hg | Higher (Predicate: 0 - 110 mm Hg) | Lower (Secondary Predicate: Up to 240 mm Hg) |
| Compliance with Standards | AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, ANSI C63.27-2017 | Met (Identical standards) | Met (Similar standards) |
| Performance Testing (Overall) | Met all acceptance criteria for: Software V&V, Functional Verification, Physical Features Verification, Battery Drain, Battery Charge, System Air Release, Battery Function Verification, RF Pairing Verification. | Identical tests, plus RF pairing testing | Not available |
| Patient-Contacting Materials | 200 denier nylon with a polyurethane laminate/extrusion | Identical | Different (Polyester for secondary predicate) |
| Treatment Area | Calf only | More limited (Predicate: Leg, Arm, and Hip) | Can treat foot, calf, and upper leg (or individual zones) |
| Battery Performance | Passed testing with a different, smaller battery. | Different, smaller battery (Predicate: 7.2V, 3200mAh; Normatec Go: 3.6V, 2550mAh or 3.65V, 2600mAh) | Not specified for secondary predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size for any specific test sets (e.g., number of devices tested, number of measurements). It only states that "Testing performed demonstrated that the proposed device meets defined requirements and performance claims."
The data provenance is not explicitly stated. The studies are described as "Performance Testing," "Verification and Validation activities," and "nonclinical tests," which are typically conducted in-house by the manufacturer (NormaTec Industries, LP) during product development and regulatory submission. No information about country of origin of data or retrospective/prospective nature is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document does not describe studies that require expert-established ground truth in the context of medical image interpretation or similar diagnostic applications. The testing described is primarily engineering and product performance verification.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as #3. There is no mention of human-reviewed test data 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
This section is not applicable. The Normatec Go is an air pressure massager, not an AI-powered diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to its regulatory submission as described.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm, but a physical massager with integrated software/firmware for control. The software V&V (Verification and Validation) was part of the performance testing, evaluating the algorithm's functionality within the device.
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, expert consensus) is not applicable to the performance testing described for this device. The "ground truth" for the engineering performance tests would be established by objective measurements against predefined specifications (e.g., a pressure gauge to measure output pressure, a timer to measure treatment duration, electrical tests for battery performance).
8. The Sample Size for the Training Set
This section is not applicable as this device does not utilize a "training set" in the context of machine learning or AI algorithm development. The device's software is likely based on deterministic control logic, not trained models.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as #8.
§ 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).