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The radiofrequency energy delivery components of the Thermage CPT System and Accessories are indicated for use in:

• · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• · Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
• · Non-invasive treatment of wrinkles and rhytids.

The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT System and Accessories are indicated for use in:

• · Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
• · Non-invasive treatment of periorbital wrinkles and rhytids:
• · Non-invasive treatment of wrinkles and rhytids;
• · Temporary improvement in the appearance of cellulite;
• Relief of minor muscle aches and pains;
• · Relief of muscle spasms;
• · Temporary improvement of local circulation (i.e., blood circulation).

The Thermage CPT System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. The Thermage CPT System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs radio frequency tuning to provide radio frequency energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.

The provided text describes a Special 510(k) submission for the Thermage CPT System and Accessories, demonstrating its substantial equivalence to a predicate device. This submission focuses on modifications to an existing device rather than a new AI/ML device, so it doesn't contain all the information requested about AI model performance.

Here's what can be extracted and inferred from the document regarding acceptance criteria and testing:

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

The document lists "Summary of Testing" with "Requirement" as the acceptance criteria and "Results" as the reported performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The treatment tip design shall be capable of delivering up to the maximum REP count, and shall be verified or validated to show with 90% confidence that the tips will do so with a minimum of 90% reliability." This implies that a sample of treatment tips was tested to determine their reliability in delivering REP counts. However, the exact sample size or the provenance of the data (e.g., how many tips were tested, if they were from a specific country, or if the testing was prospective) is not explicitly stated in this document. The testing appears to be centered on the physical and functional aspects of the device and its accessories, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The testing described appears to be engineering verification/validation, not human expert evaluation of clinical data.

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

Not applicable, as the testing described is not clinical adjudication.

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 is not an AI/ML device and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML device. The testing described is for the device's physical and functional integrity.

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

The "ground truth" for the tests described is based on engineering specifications and performance requirements (e.g., maximum REP count delivery, snap fit, fluid barrier, dielectric strength, burst pressure). It's essentially "meets design specifications."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. This is not an AI/ML device.

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The radiofrequency-energy only delivery components of the Thermage CPT® System and Accessories are indicated for use in:

• Dermatologic and General Surgical procedures for electrocoagulation and hemostasis:
• Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
• Non-invasive treatment of wrinkles and rhytids.
  The simultaneous application of radiofrequency energy and skin vibration by the Thermage CPT® System and Accessories in indicated for use in:
• Dermatologic and General Surgical procedures for electrocoagulation and hemostasis;
• Non-invasive treatment of periorbital wrinkles and rhytids;
• Non-invasive treatment of wrinkles and rhytids;
• Temporary improvement in the appearance of cellulite;
• Relief of minor muscle aches and pains;
• Relief of muscle spasms;
• Temporary improvement of local circulation (i.e., blood circulation).

The Thermage CPT System delivers monopolar radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis. Cleared for commercial distribution under K090580, the Thermage CPT System delivers a maximum power of 500W of energy from the disposable tip to the patient. The Handpiece delivers output energy and cooling while also offering user-selectable vibration in the vertical dimension for mechanical manipulation of tissue. Vibration is active only during each treatment cycle while the 3cm² treatment tip is in contact with the skin. Vibration is not active when either the activation switch is released, when the treatment tip is not in contact with the skin, or when the 0.25cm2 eye tip is used. Single-use, disposable Treatment Tips are attached to the Handpiece that comes in contact with the patient during the treatment procedure. The Treatment Tip is classified as a direct skin contact device of limited duration (

This 510(k) summary describes a modification to an existing device, the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to "clean" and non-sterile for single patient use. It is not a study to prove acceptance criteria for a new device's performance, but rather a demonstration of substantial equivalence for a modified existing device.

Therefore, many of the requested categories for a new device's study and acceptance criteria (e.g., specific performance metrics, sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) are not applicable in this context.

Here's an adaptation of your requested format based on the provided 510(k) summary:

Thermage CPT® System (TG-2B) Modification Acceptance Criteria and Justification of Equivalence

The document describes a modification to the Thermage CPT System (TG-2B), specifically changing the treatment tips from sterile to non-sterile ("clean") for single patient use. The acceptance criteria for this modification revolve around demonstrating that this change does not introduce new risks and that the modified device remains substantially equivalent to the cleared predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance

1. Risk documents review: FMEA's and Hazard Analysis conducted.
2. Complaints incidence and review: No issues identified related to this change.
3. Manufacturing environment and process evaluation, including bioburden monitoring trends: This evaluation confirmed the suitability of the "clean" non-sterile state for single-patient use.
4. Design Control Conformance: Declared conformance to design controls (21 CFR 820).
5. Elimination of Cross-Contamination Risk: The "single patient use" and disposable nature of the tips eliminates the risk of cross-contamination between patients, rendering the non-sterile condition inconsequential in this aspect. |
   | Performance/Effectiveness: Maintain substantial equivalence in intended use and technological characteristics to the predicate device. | Demonstrated by:
6. Comparative Table Analysis: The provided tables show that all key technological characteristics (e.g., energy type, frequency, max RF power, treatment type, handpiece and electrode features, and indications for use) of the modified device are identical or substantially similar to the predicate Thermage CPT System and other predicate devices.
7. Indications for Use: The indications for use for the modified device are identical to those of the predicate Thermage CPT System. The only difference in "Treatment Tip Condition" (non-sterile vs. sterile) and "Condition of Use" (Disposable Single Patient Use Only vs. Reusable Multiple Patient Use* for some predicates) is explicitly addressed by the single-use nature of the modified tips. |

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

This was not a clinical study with a "test set" as would be typically understood for evaluating device performance metrics. Rather, it was a regulatory submission demonstrating substantial equivalence for a manufacturing change.

• Sample Size: Not applicable in the context of a "test set" for performance evaluation. The "data" considered included risk assessments, manufacturing evaluations, and historical complaint data for the predicate device.
• Data Provenance: The data provenance is internal to Solta Medical, Inc., consisting of various internal analyses related to design control, manufacturing processes, and risk management. It is retrospective in the sense of reviewing existing safety and manufacturing data. Country of origin is the USA (manufacturer is Solta Medical, Inc., in Hayward, CA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This submission focused on regulatory compliance and risk management for a product modification, not on establishing a "ground truth" for a performance study dataset. The "experts" would be the internal regulatory, quality, and engineering teams at Solta Medical, Inc. responsible for design controls and risk assessments.

4. Adjudication Method for the Test Set

Not applicable. No "test set" or adjudication method was used for performance measurement. The evaluation was a regulatory assessment based on documented evidence.

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

No. An MRMC study is typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance. This device is an electrosurgical unit used for aesthetic and surgical procedures, and the submission concerns a change in tip sterility, making an MRMC study irrelevant.

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

No. This device is a treatment system that requires human operation. It does not involve an "algorithm only" component in the sense of artificial intelligence. The submission focuses on the safety and equivalence of a physical component modification.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the existing predicate Thermage CPT System (K090580) and the demonstration that the modification does not alter this "ground truth" or introduce new unacceptable risks. This is based on regulatory standards, risk management principles, and product performance history.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm for this type of device modification submission.

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

Not applicable, as no training set was used.

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