(107 days)
The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis.
Note: The miraDry System is not indicated for treating hyperhidrosis related to other body areas or generalized hyperhidrosis.
The miraDry System is a microwave device designed to heat tissue located at the dermal- hypodermal interface where the sweat glands reside using a surface contact applicator. The miraDry System consists of: the DTS3000 Console: the miraDry Handpiece; and a disposable, sterile miraDry bioTip that snaps onto the Handpiece to provide a sterile protective cover.
The DTS3000 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 console connector that supplies the energy and cooling to the Handpiece. The distal end has a sterile, disposable barrier, the miraDry bioTip, that contacts the patient.
Here's a breakdown of the acceptance criteria and the study details for the miraDry System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for treating primary axillary hyperhidrosis. | Adverse events were generally mild in severity. All but one (persistent hyperhidrosis on the face) resolved. |
| Efficacy: Device effectively reduces sweat in primary axillary hyperhidrosis. | A statistically significant difference in sweat reduction efficacy was demonstrated between treated subjects and sham-treated subjects. |
| Biocompatibility: Patient-contacting materials are biocompatible. | Patient-contacting materials have been demonstrated to be biocompatible. |
| Conformance to Standards: Conforms to applicable electrical and medical device safety standards. | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-2-6. |
| Equivalence to Predicate Device: Thermal zones created are similar to the predicate device. | Animal testing demonstrated that thermal zones created with the predicate device were similar to those created with the miraDry System. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 120 subjects with primary axillary hyperhidrosis.
- Treated subjects (n=81)
- Sham-treated subjects (n=39)
- Data Provenance: The document does not explicitly state the country of origin. The study was a "randomized, blinded study," which generally indicates a prospective design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on specific experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The study was a comparison between the device treatment and a sham treatment, not a comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The clinical study evaluated the device's performance (efficacy and safety) as a standalone treatment against a sham control, without human intervention in the device's core treatment mechanism beyond its operation by a clinician.
7. Type of Ground Truth Used
The ground truth for the test set was based on sweat reduction efficacy as the primary endpoint. While not explicitly stated as "expert consensus," the measurement of sweat reduction would typically involve standardized clinical assessment methods to objectively quantify sweat output.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or AI. The miraDry system is described as a microwave device, not a machine learning algorithm that requires a training set. The "training" here refers to the device's design and engineering. However, the animal testing and conformance to standards could be seen as part of the "development" or "validation" phase before clinical human trials.
9. How the Ground Truth for the Training Set Was Established
As the miraDry system is a physical device, not an AI algorithm, the concept of a "training set" and "ground truth for the training set" as it applies to AI is not directly relevant. The "ground truth" for the device's design and development (which could be loosely analogous to a training phase) was established through:
- Product and animal testing: To ensure conformance to product specifications and equivalence to the predicate device.
- Animal testing: Specifically demonstrated that thermal zones created were similar to the predicate device.
- Conformance to international electrical and medical device standards.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.