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The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

Environments of Use: Clinics, hospital and home environments
Patient Population: Adult

The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.

The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.

The Omron Avail (Model PM601) is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the features and performance of the predicate and reference devices, as the submission aims to demonstrate substantial equivalence. The reported device performance is then compared against these.

• Product Code: Primary: NUH, Secondary: NYN, NGX (for predicate) | - Regulation: 21 CFR §882.5890
• Product Code: Primary: NUH, Secondary: NYN |
  | Indications for Use | - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household/work activities (PulseRelief, Omron Heat Pain Pro, Painmaster MCT Patch).
• Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (SmartRelief). | - Relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
• Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Tap, Shoulder, Arm or Leg mode). |
  | Environment of Use | Clinics, hospital, and home environments (Omron Heat Pain Pro); Home (PulseRelief, Painmaster MCT Patch). | Clinics, hospital and home environments. |
  | Patient Population | Adults (all comparing devices); Over 12 years of age unless under physician supervision (Painmaster MCT Patch). | Adults. |
  | Contraindications | Similar contraindications regarding pacemakers, implanted defibrillators, other implanted electronic/metallic devices (all comparing devices). Avoid placement along neck/through head for Painmaster. | Do not use if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. |
  | Power Source | Rechargeable Lithium-ion battery (PulseRelief, Omron Heat Pain Pro); 3V CR2032 lithium battery (SmartRelief); Primary battery only, one-time use (Painmaster). | Rechargeable Lithium-ion battery. |
  | Patient Leakage Current |

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The Painmaster MCT Patch is indicated for:

-temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

-temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

-symptomatic relief of chronic, intractable pain.

The Painmaster MCT Patch operates in a single non-programmable microcurrent mode, delivering a pulsed monophasic waveform that provides electrical stimulation to the body to relieve pain. The Painmaster MCT Patch consists of two electrodes mounted on adhesive material connected by a small-diameter wire. One electrode contains the control unit that includes a small circuit board, a battery, and an LED light.

The provided text is a 510(k) summary for the Painmaster MCT Patch, which is a transcutaneous electrical nerve stimulator. It states that "Additional performance testing was not required to determine the substantial equivalence of this device because the device is the same as the device previously cleared via 510(k) K090442, K130114 and MCT F5 model K013167."

Therefore, this document does not contain information about acceptance criteria or specific studies proving the device meets those criteria for the current submission (K151995). Instead, it relies on prior clearances.

However, a usability study was conducted for one of the predicate devices (K090042). While not explicitly acceptance criteria in terms of performance metrics, the "usability study" section can be interpreted as demonstrating the device meets criteria related to user comprehension and proper application.

Here's the information extracted, specifically focusing on the usability study as it's the only performance-related study mentioned for a predicate device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (presumably prospective, as it was a study conducted for a prior submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable for a usability study. The "ground truth" would be the successful completion of tasks by the users themselves.

4. Adjudication Method for the Test Set

• Not applicable as this was a usability study, not a diagnostic or comparative effectiveness study requiring adjudication. The assessment would likely be based on observers' evaluation of user behavior.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This device is a transcutaneous electrical nerve stimulator, not an algorithm-based diagnostic tool.

7. Type of Ground Truth Used

• For the usability study, the ground truth was based on observed user behavior and comprehension of the instructions for use and device application.

8. Sample Size for the Training Set

• Not applicable, as this was a usability study (for a predicate device) and clinical performance was not re-evaluated for the current submission.

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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