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The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

• Lift the eyebrow
• Lift lax submental (beneath the chin) and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions
• Improve lines and wrinkles of the décolleté
• Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms

The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

• Ensure proper coupling of the transducer to the skin
• Confirm appropriate depth of treatment such as to avoid bone

The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.

The provided FDA 510(k) clearance letter for the Ulthera System describes changes to an existing device, primarily software updates to include wireless connectivity and a new treatment planning mode (SEE.PLAN.TREAT.®). It relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria related to a new performance claim.

Therefore, the document does not contain the kind of detailed performance data and acceptance criteria that would typically be found for a device seeking clearance based on a new clinical effectiveness claim or a novel AI-driven diagnostic. The study described focuses on nonclinical performance testing to demonstrate that the minor software and hardware differences do not affect clinical functionality or performance specifications and that the device operates as intended and is as safe and effective as the predicate.

Below is an attempt to structure the information based on your request, highlighting what is present and what is absent from the provided text.

Analysis of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) clearance letter for the Ulthera System (UC-1 Control Unit PRIME Model 2.1), the device's acceptance criteria and the study proving it meets these criteria are primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, especially concerning software and minor hardware changes. The performance data presented are nonclinical and focus on safety, electrical compatibility, software validation, usability, and cybersecurity, rather than specific clinical effectiveness endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a software update and minor hardware changes to an existing device, the acceptance criteria are not presented as traditional clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, they relate to the continued safe and effective operation of the modified device.

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

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The testing reported is nonclinical.
  • For Usability Testing, it mentions "clinicians" and a "simulated use study," implying a small group of human participants, but no specific number is provided.
• Data Provenance: Not applicable as the testing is nonclinical (electrical, software, usability simulation, cybersecurity). There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This type of information (experts establishing ground truth for a clinical test set) is not relevant for the nonclinical tests performed to support this 510(k). The "ground truth" for the nonclinical tests is compliance with engineering standards and proper software operation.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for establishing clinical ground truth, typically in the context of reader studies or clinical trials, which were not detailed or the focus of this 510(k) summary for software/hardware updates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No: The document does not mention any MRMC comparative effectiveness study. The focus is on demonstrating that the device itself (with updated software) is safe and effective through nonclinical means, and that its changes do not negatively impact the clinical functionality of the predicate. There is no claim about human readers improving with or without AI assistance, as the device is a therapeutic/aesthetic system, not an AI-driven diagnostic aid for human interpretation.

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

• Not Applicable in the traditional sense: The Ulthera System is a therapeutic device with an imaging component for guidance. Its "performance" is whether it delivers focused ultrasound energy as intended and the new software features (like SEE.PLAN.TREAT.®) function correctly. It's not an algorithm producing a diagnostic output that would have a standalone performance metric like AUC, sensitivity, or specificity. The testing performed confirms the system's standalone operational integrity (electrical, software V&V, cybersecurity) rather than algorithmic diagnostic performance.

7. The Type of Ground Truth Used

• Engineering Specifications and Standard Compliance: For the nonclinical tests, the "ground truth" is adherence to established engineering specifications, international electrical safety standards (IEC 60601-1, IEC 60601-1-2), usability standards (IEC 62366-1), and FDA guidance for software and cybersecurity.
• Functional Verification: For the new software features, the ground truth is whether the features operate as designed and intended (e.g., wireless connectivity functions, SEE.PLAN.TREAT.® mode works).

8. The Sample Size for the Training Set

• Not Applicable: This document describes a 510(k) clearance for software/hardware updates to an existing device. It does not refer to the development of a new AI algorithm requiring a training set in the sense of machine learning on clinical data. The "software" in question is the operating system and treatment planning interface, not an independently learning AI model.

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

• Not Applicable: As there is no mention of a training set for an AI algorithm, this information is not provided. The development of the software features would have followed standard software development life cycle (SDLC) practices, with requirements defining the intended function.

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The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

· Lift the eyebrow

• Lift lax submental (beneath the chin) and neck tissue. which can also affect the appearance of lax tissue in the submental and neck regions

· Improve lines and wrinkles of the décolleté

The Ulthera® System, in conjunction with the Ulthera® DeepSEE® transducer, allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to:

· Ensure proper coupling of the transducer to the skin

• · Confirm appropriate depth of treatment such as to avoid bone

The Ulthera® System consists of the Ulthera® Control Unit (with system software), a handpiece with cable, and interchangeable transducers. The device produces controlled tissue coagulation below the skin surface (epidermis) within the first few millimeters of tissue (dermis) using highly focused, low-energy ultrasound deposition. The Ulthera® System directs micro-focused acoustic waves to the treatment area at desired depths without affecting or requiring a secondary action to protect the skin surface. The operator may also use the device's supplemental imaging capability to visualize the treatment area and aid in assuring full/proper skin contact of the Ulthera® System transducer to the skin in the target area.

The provided text describes a 510(k) premarket notification for the Ulthera System (UC-1 Control Unit PRIME). The submission aims to demonstrate substantial equivalence to a predicate device (Ulthera System, K180623), primarily focusing on modifications to the console.

Based on the provided text, the device is an aesthetic device (Focused Ultrasound Stimulator System for Aesthetic Use) and NOT a diagnostic device or an AI/ML-driven device that involves human readers or complex image interpretation.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not applicable or not detailed in this submission.

The "study" described is a series of non-clinical performance tests validating the modified console's functionality and safety, rather than a clinical study evaluating diagnostic accuracy or reader improvement.

Here's an attempt to address the points based on the available information, noting where information is not present due to the nature of the device and submission:

Acceptance Criteria and Device Performance for Ulthera System (UC-1 Control Unit PRIME)

The 510(k) submission primarily focuses on demonstrating that modifications to the Ulthera System's console do not significantly affect its clinical functionality or performance compared to the predicate device. The acceptance criteria are essentially that the modified device functions "as intended" and remains "as safe and effective" as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a diagnostic device with specific performance metrics like sensitivity/specificity, the "acceptance criteria" relate to engineering, software, and physical performance.

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

This is not a clinical study involving a "test set" of patient data in the typical sense for AI/ML. The "testing" involves engineering and software validation on the device itself. Therefore, concepts like "sample size" for patient data and "data provenance" (country, retrospective/prospective) are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance is established by engineering specifications, regulatory standards compliance, and direct verification of the device's physical and software functions. There are no "experts" establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of cases requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated relative to a reference standard. This device is an aesthetic treatment system, and the submission is for console modifications, not a new diagnostic algorithm.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI/ML diagnostic algorithm. The device has an "imaging mode" for visualization and user guidance (proper coupling, depth avoidance) but is fundamentally an energy delivery system for aesthetic treatment. Its performance is tied to its physical and software functions (power output, imaging capabilities, safety features), which were tested directly.

7. The Type of Ground Truth Used

The "ground truth" for the various tests were:

• Engineering specifications and design requirements: For mechanical, electrical, and acoustic performance.
• International standards (ISO, IEC, ASTM): For biocompatibility, electrical safety, EMC, usability, packaging, and transit.
• FDA Guidance: For software verification and validation, and usability/human factors.
• Predicate device's established safety and effectiveness: The ultimate "ground truth" for substantial equivalence is demonstrating that the modified device performs comparably to the legally marketed predicate.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning that would require a "training set" of data.

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

Not applicable, as there is no training set for machine learning.

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