Search Results

Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

Azure consists of main body, articulated arm, handpiece, foot switch, power cord, protective glasses. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD manipulated by simple hand touch, which facilitates operation of the equipment at user's convenience. The laser output is released by the foot switch. This laser operation device uses CO2 medium based wave of 10.6 micrometers.

The provided text describes a 510(k) premarket notification for a medical device called "Azure," a laser surgical instrument. The document focuses on demonstrating the substantial equivalence of the Azure device to a legally marketed predicate device (Finexel, K213557), and as such, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for the novel aspects of the device's performance.

Instead, the document details physical and technical characteristics and compliance with recognized standards. Since no new clinical claims are being made that would necessitate a clinical study to establish acceptance criteria, the document states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies for a novel feature. The device is being cleared based on its substantial equivalence to an existing device, implying that its performance is expected to be comparable to the predicate for its stated indications for use.

Here's a summary of the information available based on the provided text, focusing on how the device does meet criteria for regulatory clearance, even if not in the way a study for novel performance claims would typically describe:

The Azure device is a Laser Surgical Instrument (Product Code: GEX, Regulation Number: 21 CFR 878.4810, Class II). Its stated Indications for Use are: "Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry."

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the context of a performance study demonstrating novel capabilities. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device. The performance data provided are related to technical specifications and safety standards.

2. Sample size used for the test set and the data provenance:

• Test set for non-clinical testing: Not specified as a "sample size" in the context of clinical trials. The testing refers to engineering and safety compliance tests on the device itself.
• Data provenance: The non-clinical testing was performed for this 510(k) Notification by DAESHIN ENTERPRISE CO., Ltd. in South Korea (company address in Seoul, Republic of Korea). It is internal testing to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The document describes non-clinical engineering and safety tests, not studies requiring expert-adjudicated ground truth.

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

• Not applicable. The document describes non-clinical engineering and safety tests.

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:

• No. This is a laser surgical instrument, not an AI-assisted diagnostic or imaging interpretation device. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is not a standalone algorithm. It is a physical medical device.

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

• Not applicable. "Ground truth" in the sense of clinical accuracy is not established for this type of device in this 510(k). The "truth" for safety and performance is based on compliance with harmonized standards.

8. The sample size for the training set:

• Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device