(601 days)
The Thermage ThermaCool System is indicated for use in:
- Dermatologic and general surgical procedures for electro coagulation and hemostasis,
- Non-invasive treatment of periorbital wrinkles and rhytids including the upper and lower eyelids
- Non-invasive treatment of facial wrinkles and rhytids
The Thermage ThermaCool System consists of the following components:
- ThermaCool System .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) ●
- Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin ● Marking Paper
- Accessory cables and tubing
- Optional footswitch component ●
This 510(k) premarket notification is for the Thermage ThermaCool System seeking an expanded indication for the non-invasive treatment of periorbital wrinkles and rhytids, including the upper and lower eyelids. The core information requested about acceptance criteria and a study to prove performance is not explicitly present in the provided text.
The document states that the "technological characteristics of the Thermage ThermaCool System for Eyelid Indications are identical to the cleared system" and that the device is "substantially equivalent to referenced devices currently cleared for marketing in the United States."
This implies that the previous clearance (K043042) for the Thermage ThermaCool System likely established the initial acceptance criteria and associated performance studies. For this 510(k), the focus is on demonstrating safety and effectiveness for a new indication (eyelid treatment) based on the existing, already-cleared technology. The document doesn't detail a new, standalone study for this specific expanded indication with explicit acceptance criteria provided.
Therefore, many of the requested data points (sample size of test set, ground truth experts, adjudication, MRMC, standalone study, training set details) are not directly addressed for this specific 510(k).
However, I can extract what is provided and explain the implications:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or detailed performance data for the new eyelid indication are presented in this document. The submission relies on the substantial equivalence to previously cleared devices.
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (Not Explicitly Stated for this 510(k)) |
|---|---|
| (Likely related to safety and effectiveness of the previously cleared device, extended to the new indication based on substantial equivalence.) | (Based on the assertion of substantial equivalence to previously cleared devices for wrinkle and rhytid treatment.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document for the new indication.
- Data Provenance: Not specified in this document for the new indication. The submission relies on the existing clearance of the same device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in this document for the new indication.
4. Adjudication method for the test set:
Not specified in this document for the new indication.
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 unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study is mentioned or relevant to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an electrosurgical unit, not an algorithm.
7. The type of ground truth used:
Not specified for this 510(k). For a medical device like this, ground truth would typically be established through clinical outcomes, clinician assessments, or standardized photographic evaluations in a clinical trial setting. However, for a 510(k) seeking an expanded indication for an already cleared device, the ground truth for the original clearance would have been used.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/machine learning device.
Summary based on the provided text:
The Thermage ThermaCool System's 510(k) for the expanded eyelid indication does not contain a new, detailed study with explicit acceptance criteria and performance results in the provided text. Instead, it leverages the concept of substantial equivalence to existing, cleared devices (specifically, the previous clearance K043042 for the ThermaCool System itself for other wrinkle/rhytid indications).
The application asserts that the "technological characteristics... are identical to the cleared system" (for K043042). This means that the safety and effectiveness for this new indication are presumed to be similar to the already-cleared indications because the underlying technology is the same. The FDA's letter confirms that they have determined the device is substantially equivalent for the stated indications for use.
To fully understand the acceptance criteria and study proving performance, one would need to review the original 510(k) submission (K043042) for the Thermage ThermaCool System, which would have contained the detailed clinical data for its initial clearance for wrinkle and rhytid treatment. This current 510(k) is an extension of that initial clearance.
§ 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.