(157 days)
DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.
The DENSITY consists of the following components:
•Electrosurgical Unit - Main body
•Handpiece
•6 different electrode tips
•Neutral electrode pad and neutral electrode pad cable, cleared under K201685
•Foot switch
•Power cord
This document is a 510(k) Premarket Notification for the medical device "DENSITY", an electrosurgical unit for dermatologic and general surgical procedures. It seeks substantial equivalence to a predicate device, the Thermage FLX System.
Based on the provided text, the device DENSITY is an electrosurgical cutting and coagulation device. The document does not describe an AI/ML medical device or provide information on acceptance criteria and studies related to AI/ML performance metrics such as accuracy, precision, recall, or human reader improvement with AI assistance. Instead, it focuses on demonstrating substantial equivalence based on technical characteristics and safety standards for an electrosurgical device.
Therefore, many of the requested items related to AI/ML device performance and testing (e.g., acceptance criteria for AI, sample sizes for AI test sets, expert ground truth, MRMC studies, standalone AI performance) are not applicable or cannot be extracted from this document.
However, I can extract the information pertinent to the device's substantial equivalence and non-clinical performance data.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity or specificity for a diagnostic/AI device. Instead, "acceptance" appears to be based on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and comparable technical specifications.
Here's a table summarizing the comparison with the predicate device (Thermage FLX System K170758), which serves as the basis for demonstrating equivalence in performance and safety for this type of device:
| Feature/Acceptance Criteria (Implied Comparability) | Proposed Device (DENSITY) Performance/Characteristic | Predicate Device (Thermage FLX System K170758) Performance/Characteristic |
|---|---|---|
| Indications for Use | "DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis." | "The radiofrequency-energy only delivery components of the Thermage FLX System are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis;" |
| Output Energy Type | Radio Frequency | Radio Frequency |
| User Interface | Color Touch Panel | Color Touch Panel |
| Operating Frequency | 6.78MHz | 6.78MHz |
| Max Power | 400 W | 400W |
| Electrode Tip Types | 3 types (0.25 cm², 4 cm²) | 4 types (0.25 cm², 3.0 cm², 4 cm², 16cm²) |
| Coolant Solution | Cryogen | Cryogen |
| Temperature Range | 65~75°C | 65~75°C |
| RF Time | 50 ~ 800 ms | 50 ~ 1000 ms |
| Impedance | 75 - 400 Ω | 75 - 400 Ω |
| Communication to Generator | LCD touch screen | LCD touch screen |
| Style of Electrode Tip | Monopolar, Bipolar | Monopolar |
| Number of Active Electrodes per Applicator | - I-Tip(Around eye) I, F-Tip(Face): 1ea |
- I-Tip II(Around eye), F-Tip II(Face): 2ea
- B-Tip(Body), B-Tip(Body)II: 4ea | - EYE Tip 0.25: 1ea
- TOTAL Tip 3.0: 1ea
- NEW TOTAL TIP 4.0: 1ea
- BODY TIP 16.0: 4ea |
| Coolant Control Parameters | Type of gas: 1234ze; Method of gas control: Handpiece solenoid control operation; Mouth valve specifications: 12V; Solenoid valve specifications: 1.8V 24.8 BAR | Type of gas: 1234ze; Method of gas control: Handpiece solenoid control operation; Mouth valve specifications: 12V; Solenoid valve specifications: 1.8V 24.8 BAR |
Key takeaway on performance: The document states: "There are no significant differences between DENSITY and the predicate devices (K170758) that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics." "Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing."
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: "No clinical performance testing was performed." The evaluation relies on non-clinical performance data and comparison to the predicate device's established safety and effectiveness.
- Data Provenance: Not applicable as no clinical test set data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set requiring expert ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was performed.
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 was conducted.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence is based on established technical standards and the performance of the predicate device.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
Summary of Device Acceptance (for this traditional medical device):
The acceptance of the DENSITY device for marketing is based on demonstrating substantial equivalence to an already legally marketed predicate device (Thermage FLX System K170758). This is achieved through:
- Non-clinical performance data:
- Evaluation against recognized consensus standards for electrical medical equipment such as IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-2 (high frequency surgical equipment), IEC 60601-1-6 (usability).
- Software verification and validation in accordance withIEC 62304 (moderate level of concern) and IEC 62366 (usability engineering/Human Factor Engineering).
- Biocompatibility testing documented according to ISO 10993 standards.
- Risk analysis conducted based on ISO 14971.
- Comparison of technical characteristics: As detailed in the table above, demonstrating analogous specifications (e.g., operating frequency, max power, temperature range, impedance, coolant type) to the predicate device.
The document explicitly states: "No clinical performance testing was performed." This means the device's safety and effectiveness for its intended use were demonstrated through the non-clinical testing and the comparison to a legally marketed predicate, rather than through clinical trials with human subjects.
§ 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.