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The Omron Heat Pain Pro is intended for:

The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.

Environments of Use: Clinics, hospital and home environments

Patient Population: Adult

The Heat Pain Pro is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat. TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.

Stimulations from the device are intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.

The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the device.

The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Heat Pain Pro device:

The provided document is a 510(k) summary for the Omron Heat Pain Pro, a Transcutaneous Electrical Nerve Stimulator (TENS) device with heat for pain relief. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed here primarily relate to demonstrating equivalence in performance and safety to the predicate device, not necessarily a pre-defined clinical efficacy target like a reduction in pain scores.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by similarity to the predicate device (Omron PM3032, K141978) and compliance with specific electrical and medical device safety standards. The reported device performance is primarily a comparison of its electrical output parameters to those of the predicate.

• Waveform: Biphasic, Rectangular (matches predicate)
• Max Output Voltage, Max Output Current across various loads
• Duration of primary phase, Pulse Duration, Frequency
• Net Charge, Max Phase Charge, Max Current Density, Max Average Power Density
• Burst Mode parameters (Pulses per burst, Bursts per second, Burst duration, Duty cycle)
• ON Time, OFF Time |
  | Material Equivalence | Patient contacting materials (PM-GELs) constructed of the same materials as the patient contacting portion of the Long Life Pads cleared in K120516. |
  | Safety and Regulatory Compliance | |
  | Compliance with AAMI / ANSI ES60601-1 | Complies (ES60601-1:2005 + A1: 2012) |
  | Compliance with IEC 60601-1-2 (EMC) | Complies (IEC 60601-1-2: 2007) |
  | Compliance with IEC 60601-1-11 (Home Healthcare) | Complies (IEC 60601-1-11: 2015) |
  | Compliance with IEC 60601-2-10 (Nerve/Muscle Stimulators) | Complies (IEC 60601-2-10: 2012) |
  | Compliance with 21 CFR 898 | Yes |
  | Patient Leakage Current within limits. | Normal Condition: 1 uA (matches predicate). Single Fault Condition: 5.52 uA max (predicate: 8.9 uA max - acceptable). |
  | Average DC current through electrodes (no pulse) at 0 uA. | 0 uA (matches predicate). |
  | Automatic No-Load Trip feature. | Yes (matches predicate). |
  | Automatic Shut Off feature. | Yes (matches predicate). |
  | Low Battery and Voltage/Current Level Indications. | Yes (matches predicate). |
  | Timer Range (30 mins vs 15 mins for predicate is a difference, but considered insignificant). | 30 minutes (Predicate: 15 minutes). The document implicitly accepts this difference as insignificant in terms of safety or effectiveness, likely due to patient safety features like automatic shut-off and user override. |
  | Drop, Vibration, and Environmental Temperature/Humidity testing. | Performed. |
  | Usability testing performed. | Performed (to address OTC use and differences vs. Rx reference device). |

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

The submission does not describe a clinical test set from a clinical study. Instead, the "test set" for the non-clinical performance evaluation appears to be the device itself subjected to a series of engineering and electrical tests. The provenance is the manufacturer's internal testing.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated on the device itself against established electrical and safety standards.
• Data Provenance: The data is from non-clinical testing performed by the manufacturer, verifying the device's electrical output characteristics and compliance with standards. It is not patient data or human subject data.

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

Not applicable. There was no clinical ground truth established for a test set of patient data, as no clinical studies were performed. The "ground truth" for the non-clinical testing was defined by industry-recognized electrical and medical device safety standards and the performance parameters of the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

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

No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was done, and no effect size for human readers with/without AI assistance is provided or applicable.

6. Standalone Performance Study

Yes, in a non-clinical sense. The device's performance was evaluated in a "standalone" fashion by subjecting it to various engineering and electrical tests as described in the "Non-Clinical Testing Summary" (e.g., testing controls, indicators, battery state, waveforms, compliance with standards like ES60601-1). This is performance of the algorithm/device itself in a lab setting, not a standalone clinical performance study on patients.

7. Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is:

• Predicate Device Performance: The electrical output and functional specifications of the legally marketed predicate device (Omron PM3032).
• Regulatory Standards: Compliance with recognized medical device safety and electrical performance standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10).
• Reference Device Performance: The basic technology and combined TENS+heat capabilities of the ezFit Digital Heating TENS (K070299) as a reference for integrating heat functionality.

8. Sample Size for the Training Set

Not applicable. There is no mention of an algorithm based on machine learning or AI that would require a training set. The device's operation is based on predefined electrical stimulation parameters and heating control.

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

Not applicable, as there was no training set for an AI/ML algorithm.

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