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The LaserTouchOne™(OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

The LaserTouchOne™ (LTO) device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy (LLLT) is delivered with a single diode laser of

Here's the breakdown of the acceptance criteria and study information for the LaserTouchOne™ (OTC) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the LaserTouchOne™ (OTC)'s performance. Instead, it refers to prior studies and demonstrates the device's usability for over-the-counter use.

The key performance indicators are implied:

• Symptomatic relief of chronic, intractable pain.
• Adjunctive treatment of post-surgical and post-traumatic acute pain.
• Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

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

• Sample Size for Test Set: The text does not specify the exact sample size for either of the two studies mentioned.
• Data Provenance:
  • The first study (mentioned in K083822, for prescription use) was a "randomized, controlled clinical trial," implying prospective data collection.
  • The second study (for OTC use) was "conducted at a clinical research site," also implying prospective data collection.
  • The country of origin is not specified, but given the FDA submission, it is likely the United States or a country with clinical trial standards recognized by the FDA.

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

The text does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the test set. This type of detail is more common for imaging or diagnostic devices where expert interpretation is a primary measure. For a pain relief device, the "ground truth" is typically patient-reported pain scores or clinical assessments by treating physicians.

4. Adjudication Method for the Test Set

The text does not specify an adjudication method. For clinical trials of pain relief devices, adjudication usually involves blinded assessments by investigators or independent committees, but the specific process is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

• The text does not describe an MRMC study in the context of human readers improving with AI vs. without AI assistance. This concept is not applicable as the LaserTouchOne™ is a physical device for pain therapy, not an AI-driven diagnostic or imaging tool requiring human interpretation comparison.
• The first study was a "randomized, controlled clinical trial in which the LTO performed favorably compared to predicate TENS and LLLT devices." This is a comparative effectiveness study, but not an MRMC study in the typical sense of evaluating human reader performance with AI. The effect size is simply stated as "performed favorably" without specific metrics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

The concept of a "standalone algorithm" is not applicable to this device. The LaserTouchOne™ is a physical device that is used by a human (the patient or user) to deliver therapy. Its performance is inherently linked to its direct application.

7. The Type of Ground Truth Used

The ground truth for this type of device (pain relief) would typically be based on patient-reported outcomes (e.g., pain scores, quality of life metrics) and potentially clinical assessments by healthcare professionals. The text does not explicitly detail the specific metrics used but refers to "symptomatic relief" and performance compared to predicate devices, implying these types of clinical endpoints were assessed.

8. The Sample Size for the Training Set

The text does not provide information on the sample size for a training set. This is because the device is not an AI/machine learning model that typically requires a distinct "training set." The clinical trials served as the basis for demonstrating efficacy and safety.

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

As this is not an AI/machine learning device, the concept of a "training set" and its "ground truth establishment" in that context is not applicable. The efficacy and safety of the device were established through the clinical trial(s) involving patient outcomes and comparisons to predicate devices.

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