(217 days)
A device intended to temporarily relieve minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health.
This product is an Intermittent Pneumatic Compression system to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.
The provided document is a 510(k) summary for the LX9max device, which is a powered inflatable tube massager. The document aims to demonstrate that the LX9max is substantially equivalent to a legally marketed predicate device (Rapid Reboot Compression Therapy System) and a reference device (Rapid Reboot REGEN+).
Here's an analysis of the acceptance criteria and the study as requested:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics or thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This typically involves showing that the new device has similar indications for use, technological characteristics, and safety and effectiveness profiles as the cleared predicate.
The table provided (Table 1: Comparison of Proposed Device to Predicate / Reference Devices) compares various characteristics:
| Characteristic | Proposed Device (LX9max) | Predicate Device (Rapid Reboot Compression Therapy System) | Reference Device (Rapid Reboot REGEN+) |
|---|---|---|---|
| Indications For Use | A device intended to temporarily relieve minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. | Same as proposed device, with added "simulates kneading and stroking of tissues by using an inflatable garment." | Same as predicate device. |
| Intended Use environment | Home environments (Indoor environments) | Clinics, hospital, athlete training, and home environments. | Clinics, hospital, athlete training, and home environments. |
| OTC or Rx only | OTC | OTC | OTC |
| Accessories | Leg sleeves, Arm sleeve, Center body sleeve | Leg sleeve, Arm sleeve, Hip sleeve | Leg sleeve, Arm sleeve, Hip sleeve |
| Power Source | 100-127V~, 50/60Hz | 110 V, 60Hz | 110 V, 60Hz |
| Time | 5-90 min | 10,20,30 min | 1-179 minutes |
| Pressure | 10-180mmHg ± 20 mmHg | 0-200 mmHg | 0-200 mmHg |
| Number of chamber | 4 | 4 | 4 |
The "reported device performance" for the LX9max is implicitly that it meets the safety and effectiveness standards of the predicate devices because its technological characteristics are similar, and any differences (pressure range, time range, sleeve type) do not raise new questions of safety or effectiveness. The justification for these minor differences is presented on page 7.
The document also states that the LX9max complies with several voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment (listed on page 8). These standards serve as technical acceptance criteria for safety.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Testing was not required to demonstrate the substantial equivalence of the LX9max to its predicate / reference device." (page 8).
Therefore, there
- was no clinical test set used for this submission to prove substantial equivalence.
- no observational data provenance (country, retrospective/prospective) is applicable.
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 testing was performed for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed for substantial equivalence.
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 (massager), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as no clinical testing was performed. The basis for substantial equivalence relies on comparison of technical characteristics and compliance with safety standards.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).