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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 with the treatment of primary axillary hyperhidrosis, the miraDry System may reduce underarm odor.

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:

• MD4000-MC Console: O
• MD4000-HP miraDry Handpiece; and O
• MD4000-BT miraDry bioTip that snaps onto the Handpiece O

The miraDry MD4000 System also includes the following Class I components/accessories:

• MD4000-TS template system, a required component for the miraDry treatment O
• MD4000-PK priming kit; and O
• MD4000-BT-DE demonstration bioTip. O

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 of the Handpiece has a single patient use disposable, the miraDry bioTip, which contacts the underarm skin of the patient.

This document is a 510(k) summary for the miraDry System MD4000, specifically addressing a modification to the packaging of its bioTip component. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study showcasing clinical performance or an AI-based device.

Therefore, most of the requested information (acceptance criteria for device performance, sample sizes for test/training sets, expert involvement, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this document as it relates to a change in the packaging of a disposable component, not a clinical efficacy or AI performance study.

The document explicitly states: "The purpose of this Special 510(k) submission is to modify how the treatment bioTip component of the miraDry System is provided to the User. The intended use of the modified device, as described in the labeling, has not changed as a result of this modification." and "Therefore, the miraDry System MD4000 remains substantially equivalent to the predicate device currently marketed under the Federal Food, Drug and Cosmetic Act except for one characteristic: the condition of use of the bioTips."

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria for this Submission: The primary "acceptance criteria" for this Special 510(k) is demonstrating substantial equivalence to the predicate device (miraDry MD 4000 System K160141) despite the change in bioTip packaging. This is not about clinical performance metrics, but rather about safety and effectiveness remaining reasonably assured.
• Reported Device Performance (in context of this submission): The document claims that "The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance." This is the "performance" relevant to the specific change (packaging of the bioTip).
• Performance (General Indication for Use):
  • Indication: 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.
  • Definition of Permanent Hair Reduction: 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.
  • Additional Benefit: May reduce underarm odor when used for hyperhidrosis.

(As this is not a clinical study report, specific numerical performance metrics for hyperhidrosis or hair reduction are not provided in this regulatory submission for the packaging change.)

2. Sample sizes used for the test set and the data provenance:

• Not applicable. This document describes a regulatory submission for a device modification (packaging change), not a clinical trial or AI model testing. There is no "test set" in the context of clinical performance data described.
• Data Provenance (for the underlying device performance, not this submission): The original predicate device (K160141) likely involved clinical studies to establish its efficacy for hyperhidrosis and hair reduction, but details of those studies are not provided in this specific document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth establishment for a medical device's clinical efficacy is typically done through clinical trials with defined endpoints, often involving expert assessments (e.g., dermatologists for hyperhidrosis/hair reduction). However, this document pertains to a packaging change and does not detail such studies.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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:

• Not applicable. This device is an electrosurgical system, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is an electrosurgical system, not an AI or algorithm.

7. The type of ground truth used:

• Not applicable to this specific submission. For the original device's indications, ground truth would likely be clinical outcomes (e.g., sweat reduction measured objectively, hair count, patient satisfaction). For this 510(k), the "ground truth" is the predicate device's existing clearance and safety/performance profile, against which the modified device is compared for equivalence.

8. The sample size for the training set:

• Not applicable. There is no "training set" for an AI model mentioned in this document.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

Summary of what is relevant from the document regarding the modification:

• Nature of Modification: The disposable bioTips, previously provided sterile, will now be provided as clean and non-sterile for single patient use only.
• Rationale for Substantial Equivalence: The intended use, technological characteristics (device class, energy type, mode of action, product code, function, overall system structure, key components, console control mechanism, coolant usage, bioTip materials), and condition of use (single patient use, disposable) remain the same as the predicate device. The only difference is the "Treatment Condition" of the bioTip (sterile vs. clean, non-sterile).
• Risk Mitigation for the Change: Miramar Labs, Inc. utilized its established quality system and design control requirements, performing risk-based assessments including:
  • Risk assessment (including Hazard Analysis)
  • Complaints incidence and review
  • Manufacturing environment and process evaluation, including bioburden testing and monitoring trends
  • Instructions for Use
  • User interface and clinician user feedback
• Conclusion regarding safety/effectiveness of the modification: "No new risks were identified as a result of this change." and "The safety and effectiveness of the device modification are reasonably assured with no new or increased risks justifying 510(k) clearance."

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