(17 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 .
- 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 .
The provided text is a 510(k) Safety Summary for the Thermage ThermaCool System. It focuses on demonstrating substantial equivalence to a predicate device, particularly for the Skin Marking Paper accessory, and does not contain information about specific acceptance criteria, detailed study designs, or performance metrics in the way modern medical device submissions typically do for efficacy.
Therefore, I cannot provide the requested information in full detail. Here's a breakdown of what can and cannot be extracted from the provided text, based on the categories requested:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The submission relies on "substantial equivalence" to the predicate device. This means the acceptance criterion is that the new device (Thermage ThermaCool Skin Marking Paper) is as safe and effective as the predicate device (Skin Marking Paper from K032088).
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, clinical outcomes) are reported for the Skin Marking Paper. The statement "The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device" is the primary "performance" statement, referring to its design, principle of operation, materials, and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided. The submission focuses on the substantial equivalence of the Skin Marking Paper as an accessory, not a detailed clinical study with a test set of data.
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)
- Not applicable/not provided. No test set requiring expert ground truth establishment is mentioned for the Thermage ThermaCool Skin Marking Paper.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided.
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 predates widespread AI in medical devices, and the submission is for an electrosurgical unit accessory (skin marking paper), not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not provided for the Skin Marking Paper. The "ground truth" for this 510(k) submission is the regulatory clearance and performance of the predicate device to which it is compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The provided document is a 510(k) premarket notification for the Thermage ThermaCool System, specifically highlighting the Skin Marking Paper accessory. The study proving the device meets acceptance criteria is essentially a substantial equivalence comparison to a legally marketed predicate device (Skin Marking Paper, K032088).
Here's what we can infer:
| Information Category | Details from Text |
|---|---|
| Acceptance Criteria | Implicit: Substantial equivalence to the predicate device (Skin Marking Paper, K032088) in terms of safety and effectiveness, based on design, principle of operation, materials, and intended use. No specific quantitative performance metrics are listed as acceptance criteria. |
| Reported Device Performance | "The technological characteristics of the Thermage ThermaCool Skin Marking Paper are substantially equivalent to those of the predicate device." This is the core performance statement, implying that its function and safety are comparable to the previously cleared device. No quantitative performance data, clinical efficacy/safety rates, or specific measurements are provided in this summary. |
| Sample Size (Test Set) & Data Provenance | Not specified, as this is a substantial equivalence claim for an accessory, not a detailed clinical trial. |
| Number & Qualifications of Experts for Ground Truth | Not applicable. |
| Adjudication Method for Test Set | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study (Algorithm Only) | No. |
| Type of Ground Truth Used | The "ground truth" implicitly references the regulatory clearance and established safety/effectiveness profile of the predicate device. |
| Sample Size (Training Set) | Not applicable. |
| How Ground Truth for Training Set was Established | Not applicable. |
§ 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.