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Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.

Here's an analysis based on the provided document, addressing your questions about the acceptance criteria and study details for the Ivivi SofPulse device (K070541):

Summary of Device and Regulatory Context:

The Ivivi SofPulse (Models 912-M10, Roma3, and Torino II) is a shortwave diathermy medical device (now reclassified as nonthermal shortwave therapy, SWT) that applies electromagnetic energy at a radio frequency of 27.12 MHz. It's intended for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" by athermal means. This device was determined to be substantially equivalent to the predicate device, MRT (K903675).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing specific acceptance criteria (e.g., a certain sensitivity, specificity, or clinical outcome threshold) as would be seen for a novel device or a device requiring a PMA.

For devices demonstrating substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared to the predicate's established characteristics.

Therefore, the table below presents the technological characteristics of the SofPulse and its predicate, which served as the basis for determining substantial equivalence.

Study Proving Acceptance Criteria:
The document states: "Equivalence of performance of the SofPulse and MRT was demonstrated with bench testing in saline tissue equivalents and with an animal model validated for evaluation of pain and edema." This implies these studies were conducted to show that the SofPulse performs comparably to the predicate MRT device across the listed technological characteristics and intended effects on pain and edema.

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

The document explicitly mentions:

• Bench testing in saline tissue equivalents: No sample size is provided for this. These are typically in-vitro, controlled experiments.
• Animal model validated for evaluation of pain and edema: No sample size is provided for the animal study (e.g., number of animals). The document does not specify the species or country of origin for the animal model.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, animal model studies are prospective by nature.

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

The document does not suggest the use of human experts to establish "ground truth" for the test set in the way one would for diagnostic imaging. Instead, the "ground truth" for demonstrating equivalence in an animal model would likely be objective physiological measurements of pain and edema (e.g., paw swelling, behavioral responses to pain stimuli, biochemical markers). Therefore, information about experts and their qualifications in this context is not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for clinical studies where human readers or evaluators make subjective judgments that need to be reconciled. Since the studies mentioned are bench testing and an animal model, such an adjudication method would not be applicable.

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

No. The document describes bench testing and an animal model study, not an MRMC study. MRMC studies are typically performed for diagnostic devices where human reader performance is a key metric.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a therapeutic (nonthermal shortwave therapy) device, not a diagnostic algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here. The device operates independently on the patient, but its effectiveness is clinically evaluated, not algorithmically.

7. The Type of Ground Truth Used

Based on the description of the studies:

• Bench Testing: Ground truth would be based on physical measurements (e.g., RF energy deposited, duty cycle measured by instrumentation) in a controlled environment (saline tissue equivalents).
• Animal Model: Ground truth would be based on objective biological/physiological measurements of pain and edema relief (e.g., quantified reduction in swelling, validated pain scales/responses, inflammatory markers).

8. The Sample Size for the Training Set

The document does not mention a "training set." This term is typically used in the context of machine learning or AI development. The studies mentioned (bench testing, animal model) are for verification and validation of the device's performance against its predicate, not for training a model.

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

As there is no mention of a training set, this question is not applicable.

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