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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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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.

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.

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.

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.

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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 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

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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The miraDry System is indicated for use in the treatment of primary axillary hyperhidrosis. Note: The miraDry System is not indicated for use in the treatment of 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 axillary sweat glands reside using a surface contact applicator. The miraDry 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 K103014, the miraDry System also includes Class I components/accessories. The MD4000-TS template system is a reguired 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. The technological characteristics and the principles of operation for the MD4000 miraDry System are the same as the predicate miraDry System.

This 510(k) summary describes a modified version of the miraDry System, which is a microwave device for treating primary axillary hyperhidrosis. The submission (K131162) concerns the substantial equivalence of the modified device to a predicate device (K103014).

Based on the provided text, the submission focuses on demonstrating that the modified miraDry System is substantially equivalent to its predicate, rather than presenting a study that establishes new acceptance criteria or proves the device meets entirely new performance metrics. The core argument for substantial equivalence is that the modifications do not raise new questions of safety or effectiveness.

Therefore, the structure of the acceptance criteria and study proving it are presented as conformance to existing standards and equivalence to the predicate.

Here's a breakdown of the information as requested, though some categories may not be directly applicable due to the nature of a substantial equivalence submission for device modification:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards Conformance)

Study Details Demonstrating Substantial Equivalence

The provided text describes the rationale and testing performed to demonstrate substantial equivalence for a modification to an already cleared device, rather than a de novo clinical study proving the primary efficacy of the miraDry system itself.

1. Sample size used for the test set and the data provenance:

   • The document mentions "bench testing and pre-clinical testing" for the modifications. However, specific sample sizes for these tests are not provided within this 510(k) summary.
   • Data provenance: Not explicitly stated, but the testing would typically be conducted by the manufacturer, Miramar Labs, Inc. The nature of the testing (bench and pre-clinical) suggests laboratory/engineering data rather than human clinical trial data for direct performance comparison in patients.

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

   • Not applicable in the context of this 510(k) summary. "Ground truth" in the clinical sense (e.g., disease diagnosis) is not established by a panel of experts for this substantial equivalence submission. The "truth" here is the conformance to engineering standards and equivalence to the predicate, which is evaluated by the submitter and FDA.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes. The testing described here is focused on engineering and functional performance.

4. 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, an MRMC study was not done. This device is an electrosurgical cutting and coagulation device (microwave therapy for hyperhidrosis), not an AI-based diagnostic imaging tool that would typically undergo MRMC studies.

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

   • Not applicable. This device is a physical system that requires human operation. The concept of "standalone algorithm" does not apply to this type of medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the "bench testing and pre-clinical testing" conducted for the modifications, the 'ground truth' would be defined by engineering specifications, design requirements, and established performance parameters of the predicate device. These would be used to verify that the modified device performs as expected and similarly to the original. For the safety standards, the 'ground truth' is compliance with the requirements outlined in the cited IEC standards.

7. The sample size for the training set:

   • Not applicable. This device does not employ machine learning or AI algorithms that require a "training set" in the conventional sense.

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

   • Not applicable. (See point 7).

Summary of the Study for this 510(k):

The core "study" for K131162 is a technical and risk assessment to demonstrate substantial equivalence of a modified miraDry System to its predicate (K103014). This involved:

• Comparison of Indications for Use: Showing identity to the predicate.
• Comparison of Technological Characteristics: Demonstrating they are the same as the predicate.
• Bench Testing and Pre-clinical Testing: Performed to ensure the modified aspects (e.g., new materials for durability, functional changes) continue to conform to product specifications and maintain equivalence to the predicate. This testing addressed potential risks associated with the modifications.
• Conformance to International Electrotechnical Commission (IEC) Standards: The device was tested and found to conform to multiple IEC 60601 series standards related to general safety, electromagnetic compatibility, usability, and specific requirements for microwave therapy equipment.

The conclusion drawn from these activities is that the device "is substantially equivalent to the predicate device... The indications for use and technological characteristics are equivalent; therefore, the miraDry System is substantially equivalent to the predicate device."

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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

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.

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The DTS G2 System is indicated for use for coagulation of soft tissue.

The DTS G2 System is designed to interact-using a surface contact applicator. The system consists of an applicator; external microwave generator with integrated vacuum pump; and a cooling fluid pump and tubing. The desired power and delivery time are set manually by the operator. The generator contains electric circuits, circuit boards, and integrated control panel. The major components of the generator are cooling fans, power supply, integrated vacuum pump, microwave module and the front panel/control board assembly. The applicator is a specifically designed to deliver microwave energy at the frequency and power levels that the generator outputs. The proximal end of the applicator has a microwave connector that fits onto the generator and allows the energy to be delivered to the applicator. The distal end has a sterile, disposable applicator head that contacts the patient.

The provided 510(k) summary for the DTS G2 System is for a Class II medical device, specifically an electrosurgical cutting and coagulation device. The information provided in the document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed studies demonstrating performance against specific acceptance criteria for a diagnostic AI/ML device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI/ML performance, ground truth, expert consensus, and reader studies) are not applicable to this submission.

Here's a breakdown of the available information and why other fields are N/A:

Acceptance Criteria and Reported Device Performance

Study Details for this Device

Given the nature of this 510(k) submission (a medical device for tissue coagulation, not an AI/ML diagnostic) and the provided text:

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

   • Sample Size: Not specified for performance testing.
   • Data Provenance: "Product and animal testing was conducted." No country of origin is specified. This was likely prospective bench and animal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. This is a non-AI device; ground truth for performance was likely based on physical measurements and observations during product and animal testing, not expert interpretation.

4. Adjudication method for the test set: N/A. Not relevant for this type of device testing.

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: N/A. This is not an AI/ML diagnostic device requiring a reader study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, not an algorithm. Performance involves the device's physical interaction, not an algorithm's standalone output.

7. The type of ground truth used: For the product and animal testing, the ground truth would have been established through direct observation, physiological measurements, and possibly histological examination in animal models to confirm "coagulation of soft tissue" and device function according to specifications. Pathology data would be relevant for animal testing outcomes.

8. The sample size for the training set: N/A. This device does not use an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: N/A. No training set is applicable.

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