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Adjunctive treatment of musculoskeletal pain

The ActiPatch® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: ActiPatch® (K192234)
Intended Use: Adjunctive treatment of musculoskeletal pain

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a typical quantitative format for algorithm performance (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, the substantial equivalence hinges on demonstrating that the ActiPatch is "at least as safe and effective as the predicate ActiPatch (K152432)."

Therefore, the "acceptance criteria" can be inferred from the studies' primary effectiveness endpoints, which consistently aimed to show a statistically significant reduction in pain compared to a control group (either active-treatment or placebo). The device's performance is described by achieving these significant reductions.

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

The "test set" in this context refers to the clinical study populations.

• Chronic Cervical Osteoarthritis (Neck Pain) Study:
  • Sample Size: 200 intent-to-treat patients (197 completed).
  • Data Provenance: Not explicitly stated, but clinical trials are typically prospective. No country of origin is mentioned.
• Osteoarthritis of the Knee Study:
  • Sample Size: 66 intent-to-treat patients (60 completed).
  • Data Provenance: Not explicitly stated, but clinical trials are typically prospective. No country of origin is mentioned.
• Plantar Fasciitis (Heel Pain) Study:
  • Sample Size: 70 patients (all 70 completed).
  • Data Provenance: Not explicitly stated, but clinical trials are typically prospective. No country of origin is mentioned.
• Usability Testing:
  • Sample Size: 46 men and women.
  • Data Provenance: Not explicitly stated, but this would be a prospective study. No country of origin is mentioned.

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

This section is not applicable in the traditional sense for these types of clinical studies. The "ground truth" for pain reduction and adverse events is established by the patients themselves (self-reported pain scores like VAS, WOMAC) and clinical observation by study investigators/medical professionals for adverse events and objective measures.

• Experts Involved: Medical professionals (physicians, nurses, study coordinators) would have been involved in diagnosing patients, conducting the study, and recording data, but they aren't "establishing ground truth" as adjudicators in the way an AI would be validated against expert labels.
• Qualifications: Not specified for the study staff, but it's assumed they were qualified medical and research professionals appropriate for conducting clinical trials.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies where multiple readers interpret images or data. This is not applicable here because the primary endpoints (pain scores, adverse events) rely on patient self-report and clinical observation, not multi-reader interpretation.

The studies were randomized and controlled, with some being double-blinded (knee osteoarthritis and plantar fasciitis studies), which serves to mitigate bias in data collection and assessment, rather than expert adjudication of an interpretive task.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

MRMC studies are typically used to assess the change in human reader performance when assisted by an AI. The ActiPatch is a medical device, and the studies evaluated its direct effect on patients, not its impact on human reader interpretations.

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

Yes, the primary clinical studies described are standalone performance studies of the device itself.

The ActiPatch device is applied directly to the patient and delivers therapy. Its effectiveness in reducing pain (the primary outcome) is measured directly, without a human intermediary interpreting its output. The studies assess the performance of the device "algorithm" (its therapeutic mechanism) by observing patient outcomes.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Patient-reported outcomes (PROs):
  • VAS (Visual Analog Scale) pain scores: For all three pain studies.
  • WOMAC (Western Ontario and McMaster Universities Arthritis Index) scores: For the knee osteoarthritis study.
• Clinical observation/assessment: For adverse events.
• Patient understanding: For usability testing.

8. The Sample Size for the Training Set

Not applicable. The ActiPatch is a physical medical device (pulsed shortwave therapy) and not an AI/machine learning algorithm that requires a "training set" of data. Its mechanism of action is based on established physical principles, not learned patterns from data.

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

Not applicable, as there is no training set for this device.

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