(145 days)
The LL TENS 160A and LL TENS 160B are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
LL TENS 160A and LL TENS 160B are handheld battery powered TENS devices for pain relief intended for over-the-counter use. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's (user's) skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
LL TENS 160A and LL TENS 160B has two output channels and four preset programs. The program mode is displayed on LCD. The user can adjust the output intensity by 14 steps.
LL TENS 160A and LL TENS 160B have same hardware, software and mechanical structure. The difference is that LL TENS 160A's LCD display is placed on the bottom of keys while LL TENS 160B's LCD display is on the top of keys.
Since the device is battery powered, there is no connection to AC mains supply.
This document is a 510(k) Summary for the LL TENS 160A and LL TENS 160B devices, which are Transcutaneous Electrical Nerve Stimulators (T.E.N.S.) intended for over-the-counter use. The purpose of the document is to demonstrate substantial equivalence to a legally marketed predicate device, "Pain Buddy" (K102051).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define "acceptance criteria" as pass/fail thresholds for clinical performance metrics in the way a diagnostic AI device might. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical characteristics and safety parameters against established standards.
The "acceptance criteria" implicitly revolve around ensuring the new device's electrical stimulation parameters, safety features, and usability are within acceptable limits as defined by relevant IEC standards and are comparable to or safer than the predicate device.
| Characteristic | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (LL TENS 160A/160B) | Met Criteria? |
|---|---|---|---|
| Indications for Use | Same as predicate: Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. | Same as predicate. | Yes |
| Patient Population | Adult | Adult | Yes |
| Prescription/OTC | OTC | OTC | Yes |
| Environment of Use | Clinics, hospital, and home environment | Clinics, hospital, and home environment | Yes |
| Maximum Phase Charge (500 Ω) | Less than safety limit (not explicitly stated, but inferred from conclusion statement) | 18.1 µC | Yes (stated as "less than the limit of the safety standard") |
| Maximum Average Current (500 Ω) | Below 10 mA | 0.9 mA | Yes (stated as "below the 10mA limit") |
| Maximum Average Power Density (500 Ω) | Less than 0.25 W/cm² | 0.0025 W/cm² | Yes (stated as "less than 0.25W/cm²") |
| Electrical Safety | Compliance with IEC 60601-1:2005 + A1:2012 | Not explicitly detailed, but implied by adherence to standards. | Yes (stated as "The relevant standards including..." followed by a list of IEC standards) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007 | Not explicitly detailed, but implied by adherence to standards. | Yes |
| Home Healthcare Environment Safety | Compliance with IEC 60601-1-11:2010 | Not explicitly detailed, but implied by adherence to standards. | Yes |
| Usability | Device can be used correctly and safely by users. | Usability study performed and showed users were able to use the device correctly and safely. | Yes |
| Overall Safety & Effectiveness | Differences from predicate device do not raise new questions of safety and effectiveness. | Concluded that differences do not raise questions on safety and effectiveness, and the device is as safe as the predicate. | Yes |
Note: The document focuses on demonstrating equivalency rather than specific performance metrics against pre-defined, numerical acceptance criteria for clinical efficacy, as this is a 510(k) for a TENS device, not an AI diagnostic. The electrical parameters are compared to the predicate, with the overarching "acceptance" being that any differences do not impact safety or effectiveness beyond what is accepted for similar devices.
2. Sample Size Used for the Test Set and Data Provenance
For the usability study, the document states "A usability study has been performed," but it does not specify the sample size of participants in the test set.
- Data Provenance: Not explicitly stated, meaning no information on country of origin or if it was retrospective or prospective. Given the nature of a usability study, it would typically be prospective, involving human participants performing tasks with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the usability study, the document does not mention the number of experts used to establish ground truth (e.g., assessing correct usage or safety issues), nor does it specify their qualifications. Typically, usability studies would involve human factors engineers or independent evaluators, but this is not detailed here.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the usability study.
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
No, an MRMC comparative effectiveness study was not done. This document pertains to Transcutaneous Electrical Nerve Stimulators (TENS devices), which are physical medical devices for pain relief, not AI software or diagnostic imaging devices that would typically involve human readers (e.g., radiologists) or AI assistance. The concept of "AI vs. without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is not an AI device. The "device" in question is a hardware TENS unit. The document mentions "software uses same mechanism as Pain Buddy," but this refers to the embedded firmware controlling the TENS unit, not a standalone algorithm in the AI sense.
7. The type of ground truth used
For the usability study, the "ground truth" would be the observed ability of users to operate the device correctly and safely, likely assessed against predefined operational requirements and safety criteria. This would be qualitative and quantitative data gathered during the usability testing sessions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The device is a TENS unit.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, there is no training set for this type of device.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).