(14 days)
The Air Relax Plus Model AR-3.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment.
This submission is for the Diode Art Engineering Air Relax Plus Model AR-3.0. The Air Relax Plus Model AR-3.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates 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 device is a Class II, type BF applied part that receives power from a separately approved external IEC 60601-1 compliant power supply or optional battery pack.
The Air Relax Plus Model AR-3.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below. The hip garment is also referred to as "shorts".
The user interface is a front panel display and buttons.
The Air Relax Plus Model AR-3.0 contains an air compressor with a system control that allows the user to adjust the amount of air coming from the air compressorand going to the individual segments of the inflatable garment.
There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.
The user interface of the Air Relax Plus Model AR-3.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provides a proprietary keyed connector to the tubing which connects to the garment. The tubing connector to the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.
Pressure selection is performed by pressing pressure button multiple times. There are four pressure levels with approximate pressure levels as below:
Level 1: 60 mmHg Level 2: 100 mmHg Level 3: 140 mmHg Level 4: 170 mmHg
There are three modes (Progressive, Sequential, Full massage P, S and F) that determine the inflation sequence.
The provided text describes the 510(k) premarket notification for the Air Relax Plus Model AR-3.0, comparing it to a predicate device (Air Relax Model AR-1.0/AR-2.0, K191441) and another reference device (Rapid Reboot Compression Therapy System, K182668, inferred). The document focuses on demonstrating substantial equivalence for regulatory clearance rather than providing a detailed study proving the device meets specific acceptance criteria through clinical or performance metrics against pre-defined thresholds.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance are not applicable or not explicitly provided in this type of regulatory submission. The goal of a 510(k) is to show the new device is as safe and effective as a legally marketed predicate, not necessarily to prove absolute effectiveness against novel criteria with dedicated clinical trials.
The document primarily relies on bench testing and comparison to the predicate device's established safety and performance profile.
Here's a breakdown of the information that can be extracted, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in the context of a 510(k) for a device like this is typically demonstrated by meeting recognized standards and by showing similar performance characteristics to the predicate device. Explicit quantitative acceptance criteria with numerical targets for clinical performance are not presented. Instead, the "acceptance criterion" is implicitly demonstrating that the new device is substantially equivalent to the predicate and complies with relevant safety standards.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance (Comparative) |
|---|---|---|
| Indications for Use | Identical to predicate device for temporary relief of minor muscle aches and pains and temporary increase in circulation. | Identical: "The Air Relax Plus Model AR-3.0 is intended for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment." |
| Classification | Class II Device, IRP (21 CFR 890.5650) | Identical: Class II Device, IRP (21 CFR 890.5650) |
| OTC or Prescription | Over-The-Counter Use | Identical: OTC |
| Environment of Use | Clinics, hospital, athlete training, and home environments. | Identical: Clinics, hospital, athlete training, and home environments. |
| Compliance with Standards | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Identical: ES 60601-1, IEC 60601-1-2, IEC 60601-1-11. Bench testing confirmed compliance. |
| Mode of Operation | Sequential/Peristaltic, with options for various inflation sequences. | Identical principle: Sequential/Peristaltic. Subject device has modes "P", "S", "F", and "Target" (user selects specific chamber). Predicate has "A", "B", "C", and "Manual" (user selects specific chamber). These are described as "Identical to predicate except mode names differ." |
| Power | Safe and effective operation under specified power. | Different but acceptable: Subject device: 100~240V, 50/60Hz. Predicate: 120V, 60Hz. "Although the power rating of the subject device is different, both devices comply with ANSI/AAMI ES60601-1, so the difference does not affect safety and effectiveness." |
| Device Pressure Range | Operational pressure range for therapeutic effect. | Lower range than predicate: Subject device: 60 - 170 mmHg. Predicate: 0 - 230 mmHg. The document does not state this lower range affects safety or effectiveness given the intended use. |
| Garment Material | Safe and durable materials for patient contact. | Identical: Nylon with a Polyurethane Laminate. |
| Garment Sizes | Appropriate sizes for various body parts. | Leg Garment: Identical to predicate in size, construction, and materials. Arm Garment: Yes (Long: 13.8" x 33.5") vs. Predicate "No" / Reference "Yes" (Regular: 18" x 38", Long: 18" x 44"). Described as "Similar in size and construction. Materials are identical to K191441." Hip Garment: Yes (Large: 24.5" x 31.5") vs. Predicate "No" / Reference "Yes" (Regular: 26" x 32", Large: 26" x 35"). Described as "Similar in size and construction. Materials are identical to K191441." |
| Safety Features | User control to stop/pause therapy. | Identical: "Button at control unit allows user to stop or pause therapy session at any time." |
| Weight & Dimensions | Comparable to predicate for similar use. | Identical: Weight 1.67 kg (3.7 pounds), Dimensions 9.5" x 4.7" x 7.5". |
| Housing Materials | Durable and safe enclosure. | Identical: Molded ABS enclosure. |
| Patient Contact | Non-conductive materials. | Identical: Non-conductive garments. |
| Treatment Time | User-selectable therapy duration. | Similar but limited: Subject device: 15, 30 minutes. Reference device: 10, 20, 30 minutes with option to add 10 mins. "Similar to K182668 except time is limited to 30 minutes in subject device." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- No clinical or animal testing was performed to generate a "test set" in the traditional sense for evaluating diagnostic or predictive performance.
- Bench testing was done to verify controls, indicators, and performance, but the sample size (e.g., number of units tested, number of cycles) is not provided.
- Data Provenance: Not applicable, as no clinical/animal data was generated. Bench testing would be internal lab data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical study requiring expert ground truth for a test set.
4. Adjudication method for the test set
- Not applicable. There was no clinical study 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
- Not applicable. The device is a massager, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth in the clinical sense was required for this type of device and regulatory submission. The "ground truth" for proving substantial equivalence relies on documentation of design, materials, and bench test performance against established safety standards, and direct comparison to the predicate device.
8. The sample size for the training set
- Not applicable. No training set was used as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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).