(85 days)
The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
The Thermage ThermaCool TC System consists of the following components:
- RF Generator .
- Coolant Control Center ●
- Coolant Canister .
- Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
- Accessory cables and tubing ●
- Optional footswitch component .
- Accessories: coupling fluid, return pad and skin marking paper .
The Handpiece Assembly and Coolant Control Center connect to the RF Generator.
Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Thermage ThermaCool TC System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit acceptance criteria (e.g., target accuracy, sensitivity, specificity, or specific performance metrics) that the Thermage ThermaCool TC System had to meet. Instead, the submission relies on the concept of substantial equivalence to predicate devices. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device has "substantially equivalent" technological characteristics and intended use to previously cleared devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Thermage ThermaCool IIA System, ThermaCool II System, ThermaCool System) in terms of: | "The technological characteristics of the Thermage ThermaCool TC System are substantially equivalent to those of the Thermage ThermaCool IIA System, ThermaCool II System, and ThermaCool System." |
| - Design | (Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim) |
| - Principle of operation | (Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim) |
| - Materials | (Not explicitly detailed, but assumed to be similar to predicate devices based on the substantial equivalence claim) |
| - Intended use (Dermatologic and General Surgical procedures for electrocoagulation and hemostasis) | "The Thermage ThermaCool TC System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis." (Matches the stated intended use) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic performance. The submission relies on establishing substantial equivalence through a comparison of technological characteristics and intended use with predicate devices. Therefore, there is no mention of a specific sample size for a test set, nor is there information about data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no described clinical study with a "test set" or diagnostic performance evaluation, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
Since no test set or diagnostic performance study is described, there is no information about an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in the provided document. The submission focuses on substantial equivalence rather than comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This device is an electrosurgical unit, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The submission focuses on the safety and effectiveness of the medical device itself through substantial equivalence.
7. The Type of Ground Truth Used
Given that this is a 510(k) submission for an electrosurgical unit based on substantial equivalence, the "ground truth" is effectively derived from the established safety and effectiveness of the predicate devices. There is no mention of pathology, outcomes data, or expert consensus in the context of demonstrating this device's performance against a specific "ground truth" for a diagnostic task.
8. The Sample Size for the Training Set
This submission is for a medical device (electrosurgical unit), not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/machine learning device, the concept of establishing "ground truth for a training set" is 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.