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The Omron Heat Pain Pro Model PM311B is intended for:
The relief of pain associated with sore or aching, muscles of the lower back, arm, legs, shoulder, or foot 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.

The Heat Pain Pro (PM311B) 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 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 batterv. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
Stimulation from PM311B is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software 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 PM311B. These are the identical accessories cleared under K160115 for the Model PM311.
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.
The PM311B is identical to the PM311 cleared under 510(k) K160115, this submission is for expanded indications under product code NYN.
The PM311 and PM311B are considered - OTC devices.

The provided text is a 510(k) summary for the Omron Heat Pain Pro Model PM311B. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of AI/ML devices. Therefore, much of the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies is not applicable or available in this document.

However, I can extract information related to the device's technical specifications and how its performance is compared to predicate devices to establish substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of statistical metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" appear to be based on demonstrating that the proposed device, PM311B, is substantially equivalent to its predicate devices (PM311 and Avail) in terms of:

• Indications for Use: The PM311B's expanded indication for chronic, intractable pain and arthritis pain relief is identical to the Avail (K172079) predicate. Otherwise, its indications are identical to the PM311 (K160115).
• Design and Technology: Identical to the PM311, and equivalent to the Omron Avail.
• Performance and Specifications: Identical to the PM311, and equivalent to the Omron Avail. This is primarily demonstrated through the detailed "Output Specification Comparison" tables (pages 10-12) which show the technical parameters of the electrical stimulation.
• Patient Population: Adult (identical to predicates).
• Environment of Use: Clinics, hospital, and home environments (identical to predicates).
• Compliance with Voluntary Standards: Adherence to AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11 (identical to predicates).

Reported Device Performance (from "Output Specification Comparison" tables):
The PM311B is shown to have identical output specifications to its primary predicate, the Omron PM311 (K160115), across all tested parameters for its various modes (Tap, Knead, Rub, Arm, Lback, Leg, Foot, Joint, Shldr). These parameters include:

• Waveform (Biphasic, Rectangular shape)
• Maximum Output Voltage (@500Ω, @2kΩ, @10kΩ)
• Maximum Output Current (@500Ω, @2kΩ, @10kΩ)
• Duration of primary phase [usec]
• Pulse Duration [usec]
• Frequency [Hz]
• Net Charge (µC per pulse) (@500Ω) [µC]
• Maximum Phase Charge (@500Ω) [µC]
• Maximum Current Density (@500Ω) [mA/cm2] r.m.s.
• Maximum Average Current (average absolute value), mA
• Maximum Average Power Density (@500Ω) [W/cm²]
• Burst Mode parameters (N/A for this device)
• ON Time, OFF Time (N/A for this device)

The tables on pages 10 and 11 are identical, effectively stating that the PM311B's output is the PM311's output. The table on page 12 shows the specifications for the secondary predicate, Omron Avail (K172079), which has similar but not identical numerical values for some parameters, and also includes a "Microcurrent" mode not present in the proposed device. The "Discussion of Differences" column confirms that the proposed device, PM311B, is "Identical to predicate PM311 K160115" for almost all detailed features and electrical characteristics, except for the expanded indications for use, which are identical to the Avail.

2. Sample sized used for the test set and the data provenance

Not applicable. This device is an electrical nerve stimulator, not an AI/ML device relying on a "test set" in the context of diagnostic or prognostic model performance. The "testing" referred to is non-clinical engineering testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" establishment by experts is described as this is not an AI/ML diagnostic or prognostic system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device where adjudication of outputs would be relevant.

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. No MRMC study was conducted as this is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device with an algorithm for standalone performance. The device's "standalone" performance is its electrical output, which was tested against engineering standards and compared to predicates.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No "ground truth" of this nature is relevant for this device type within the context of the provided document. The "truth" lies in its adherence to electrical safety and performance standards and its equivalence to legally marketed devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment in that context.

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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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