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The miraDry System MD4000 is indicated for use in the treatment of primary axillary hyperhidrosis plus unwanted underarm hair removal, and permanent reduction of underarm hair of all colors for Fitzpatrick skin types I - IV.

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

When used for the treatment of primary axillary hyperhidrosis, the miraDry System MD4000 may reduce underarm odor.

Device Description

The miraDry MD4000 System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat and odor glands and hair bulbs reside using a surface contact applicator. The miraDry MD4000 System consists of: the MD4000-MC Console; the MD4000-HP miraDry Handpiece; and a disposable, sterile MD4000-BT miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.

As described in K150419 and prior submissions, the miraDry MD4000 System also includes Class I components/accessories. The MD4000-TS template system is a required component for the miraDry treatment as well as the MD4000-PK priming kit and the MD4000-BT-DE demonstration bioTip. The MD4000-PK priming kit and the non-sterile "demo" bioTip are required when the system is initially set up at a user facility. Optional accessories include an armrest and disposable ice packs.

The MD4000-MC Console is a software-driven device which contains circuit boards, a microwave generator, integrated vacuum and cooling systems, and an integrated touch-screen user interface.

The non-invasive miraDry Handpiece is specifically designed to deliver microwave energy to the skin at specified frequency and power levels. The proximal end of the Handpiece has a cable bundle and a console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, which contacts the patient.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for success. Instead, it defines primary and secondary endpoints for the clinical trial and then reports the study results against these. The "acceptance criteria" are implicitly understood as achieving statistical significance for the primary endpoint.

Endpoint Category	Specific Endpoint	Acceptance Criteria (Implicit from Primary Endpoint)	Reported Device Performance	Met Criteria?
Primary Endpoint	Percentage of subjects with at least a 2-point lower odor score in the treated underarm compared to the untreated underarm (responders) when assessed 1 month after treatment.	Statistically significant (p < 0.05) proportion of subjects experiencing a 2-point difference greater than 50%.	23/35 (66%) reached this, but p=0.09, which is not statistically significant.	No
Secondary Endpoint	Statistically significant difference in % of subjects with at least a 2-point drop in underarm odor score in the treated underarm compared to the untreated underarm at 3 and 6 months.	Statistically significant (p < 0.05) proportion of subjects experiencing a 2-point difference.	3 months: 14/36 (39%); 6 months: 13/36 (36%). Not statistically significant.	No
Secondary Endpoint	Average difference in odor in the treated underarm compared to the untreated underarm at all follow-up visits.	Statistically significant average difference in odor (p < 0.05).	1 month: 2.84 (±0.73) with p < 0.0001 3 months: 1.27 (±0.74) with p = 0.0005 6 months: 1.56 (±0.56) with p < 0.0001	Yes
Additional Information	Patient-rated satisfaction (general satisfaction)	Not explicitly defined acceptance criteria.	29/35 (83%) reported being at least somewhat satisfied.	-
Additional Information	Patient-rated satisfaction (willingness to treat untreated arm for free)	Not explicitly defined acceptance criteria.	15/36 (42%) would like to undergo treatment of the untreated underarm at no cost.	-
Safety	No significant safety concerns/adverse events.	Low incidence of severe adverse events; expected post-treatment effects.	Expected post-treatment effects (edema, discomfort) reported by half; one mild infection, one pain likely due to infection (both cleared).	-
Histo-pathology	Reduction in apocrine glands and/or increase in fibrosis in treated arm.	Not explicitly defined acceptance criteria.	7/10 cases: control had more apocrine glands. 8/10 cases: treated had higher fibrosis.	-

In summary, the primary endpoint and secondary endpoint related to the percentage of responders (2-point reduction) were NOT met. However, the secondary endpoint regarding the average difference in odor was statistically significant at all time points, indicating that the treated underarm did have lower odor scores.

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

Sample Size: 40 adult subjects.
Data Provenance: Prospective, split-patient, randomized, single-center trial. The country of origin is not explicitly stated, but the FDA submission implies a US-based study or one conducted under US regulatory standards.

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

Number of Experts: 4
Qualifications of Experts: Described as "blinded, trained odor assessors." Specific professional qualifications (e.g., dermatologists, specialized clinicians) are not provided, but the term "trained" suggests they underwent a specific calibration or education process for odor assessment.

4. Adjudication Method for the Test Set

Adjudication Method: The odor scores for each underarm were obtained by "averaging the scores from the four judges." This is a form of consensus-based assessment, where individual expert scores are combined mathematically. It is not an adjudication method like "2+1" or "3+1" where a third reviewer resolves disagreements; rather, all scores are given equal weight and averaged.

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

This was not an MRMC comparative effectiveness study in the typical sense of AI vs. human readers or human readers with AI vs. without AI. The study evaluated the effectiveness of the miraDry device itself, with human odor assessors providing the "ground truth" (or assessment) of the odor.
Therefore, there is no effect size reported for how much human readers improve with AI vs. without AI assistance.

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

No, this was not a standalone algorithm performance study. The device being evaluated (miraDry System MD4000) is a physical device that treats patients. Its performance was assessed by human experts (odor assessors) and patient self-reports. There is no AI algorithm being evaluated for standalone performance in this context.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for odor assessment was established by expert consensus (average scores from four trained odor assessors) and patient self-reported odor scores and satisfaction. For the histological component, it was pathology results (blinded histopathologist review of biopsies).

8. The Sample Size for the Training Set

This document describes a clinical trial evaluating the performance of a medical device (miraDry System MD4000), not the development or training of an AI algorithm.
Therefore, there is no training set sample size mentioned, as this concept is not applicable to the study described. The miraDry system itself is not an AI device that requires a training set in this context.

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

As stated in point 8, there was no AI algorithm or associated training set in the context of this document. The miraDry device is a microwave energy device, not an AI system.

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