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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 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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