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510(k) Data Aggregation
(121 days)
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 reasured at 6. 9 and 12 months after the completion of a treatment regime.
The miraDry System MD4000 is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the axillary sweat glands and hair bulbs reside using a surface contact applicator. The miraDry System MD4000 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 K131162, the miraDry System MD4000 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. The MD4000-PK priming kit is 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.
Here's an analysis of the acceptance criteria and study detailed in the provided document, restructured to address your specific points:
The document describes the Miramar Labs miraDry System MD4000, which has an expanded indication for underarm hair removal in addition to primary axillary hyperhidrosis treatment. The information below focuses on the hair removal aspect.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Hair Reduction) |
|---|---|
| Primary Endpoint: >30% reduction (baseline to 3 months, measured by hair counts) in >50% of subjects. | 88.1% (37/42) of subjects showed >30% hair reduction at 3 months (lower 95% CL: 76.6%). This met the criterion. |
| Secondary Endpoint: >30% reduction (comparing baseline to 12 months photos) to make a claim for permanent axillary hair reduction. | 95.5% (42/44) of subjects showed >30% hair reduction at 12 months (lower 95% CL: 86.4%). This met the criterion. |
| Average Reduction: | |
| - 3 months: 66% (± 30%) | |
| - 6 months: 72% (± 29%) | |
| - 9 months: 75% (± 28%) | |
| - 12 months: 75% (± 27%) | |
| Side-by-side axilla review: | |
| - 3 months: 74% of pairs had at least 26-50% reduction | |
| - 6 months: 78% of pairs had at least 26-50% reduction | |
| - 9 months: 78% of pairs had at least 26-50% reduction | |
| - 12 months: 89% of pairs had at least 26-50% reduction | |
| Patient satisfaction with hair reduction (rating "very satisfied" or "somewhat satisfied"): | |
| - 3 months: 81% | |
| - 6 months: 70% | |
| - 9 months: 68% | |
| - 12 months: 70% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 56 subjects were enrolled.
- For the primary endpoint (3-month hair count): 42 subjects were assessable.
- For the secondary endpoint (12-month hair count): 44 subjects were assessable.
- Data Provenance: The study was conducted at three private dermatology clinics in the United States. It was a prospective clinical trial, initiated in September 2012.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states that an "independent physician reviewer" conducted a blinded comparison of baseline to follow-up full-axilla photos to score hair reduction.
- The specific number of independent physician reviewers is not explicitly stated (e.g., "an independent physician reviewer" could imply one, or a panel reviewed by one lead).
- The qualifications of the independent physician reviewer(s) are not detailed beyond "physician."
4. Adjudication Method for the Test Set
- The document primarily mentions a "blinded comparison of baseline to follow-up full-axilla photos by an independent physician reviewer," implying a single reviewer's assessment for photo-based evaluation.
- For hair counts, the method of counting and potential adjudication is not explicitly described. Given it's a quantitative measure, it might rely on standardized methods rather than expert adjudication in the same way image review would.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done.
- This study evaluates the device's direct performance in hair reduction, not the influence of AI on human reader performance. The device itself is the treatment, not an AI diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, this was a standalone performance study of the device/treatment itself. The device, the miraDry System MD4000, is a therapeutic device that physically reduces hair. The study assesses the effectiveness of this physical treatment in a clinical setting, without any AI algorithm involved in the treatment delivery or primary assessment.
- The "performance" described is the direct clinical outcome from using the miraDry system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established using a combination of:
- Quantitative Measurement: Hair counts (primary method).
- Expert Review: Blinded comparison of baseline and follow-up photos by an independent physician reviewer.
- Patient-Reported Outcomes: Subject assessment of overall satisfaction, odor rating, and sweat ratings (though sweat and odor are related to the hyperhidrosis indication, they were collected).
- Clinical Observation: Assessment of adverse events.
8. The Sample Size for the Training Set
- The document describes a clinical trial (performance study) for the expanded indication. It does not mention a "training set" in the context of an AI algorithm or a machine learning model.
- Therefore, N/A (Not Applicable) as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- N/A (Not Applicable) as there was no training set mentioned in the context of an AI/ML device.
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