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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.

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The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor: g) Pseudoarthrosis; h) Revision of previous surgery

The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) with nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

The provided document describes a 510(k) premarket notification for the Azure Anterior Cervical Plate System. This document is a regulatory submission for a medical device (a spinal implant), not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K130825 - Azure Anterior Cervical Plate System, SE) by removing constrained screws from the system due to a field failure mode. The performance data presented is related to mechanical testing of the spinal implant, not the performance of an AI/ML algorithm.

Therefore, I cannot populate the requested table and information as it pertains to an AI/ML device.

However, I can extract the relevant information regarding the modification to the device and the reason for the change, which led to a performance test.

Summary of Device Modification and Performance Study:

The purpose of this 510(k) submission is the removal of constrained screws from the Azure Anterior Cervical Plate System. This change was initiated because the constrained screw constructs were experiencing "total fracture of the locking mechanism" in the field.

A modified Dynamic Axial Compression test was conducted in accordance with ASTM F1717 standard to compare the performance of constrained and semi-constrained screws.

Acceptance Criteria and Reported Device Performance (for mechanical testing, not AI):

Regarding the specific questions about AI/ML studies:

1. Sample size for the test set and data provenance: N/A (Not an AI/ML device)
2. Number of experts used to establish the ground truth...: N/A (Not an AI/ML device)
3. Adjudication method: N/A (Not an AI/ML device)
4. Multi reader multi case (MRMC) comparative effectiveness study: N/A (Not an AI/ML device)
5. Standalone (i.e. algorithm only...) performance: N/A (Not an AI/ML device)
6. Type of ground truth used: N/A. The "ground truth" here is mechanical failure analysis (ASTM F1717 standard, field failure reports for constrained screws).
7. Sample size for the training set: N/A (Not an AI/ML device)
8. How the ground truth for the training set was established: N/A (Not an AI/ML device)

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The AZURE Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:

• a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
• b) Spondylolisthesis;
• c) Trauma (i.e., fracture or dislocation);
• d) Spinal stenosis;
• e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• f) Tumor;
• g) Pseudoarthrosis;
• h) Revision of previous surgery

The AZURE Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.

The provided text describes the AZURE Anterior Cervical Plate System, a medical device, and its premarket notification. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices tested) for the mechanical tests. The data provenance is non-clinical, meaning it's from laboratory testing of the device itself, not from human or animal subjects. The testing was conducted in a laboratory setting to ASTM F1717-12 standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by expert medical consensus. The performance is objectively measured against the criteria defined by ASTM F1717-12.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical mechanical testing. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth for clinical data. Here, performance is determined by objective measurements meeting predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic or assistive AI system on human reader performance for interpretation of medical images or data. The AZURE Anterior Cervical Plate System is a physical implant, not a diagnostic or AI-driven system.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. Again, this device is a physical implant, not an algorithm. The performance evaluation is based on its mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance study (mechanical testing) is the established engineering specifications and performance thresholds defined within the ASTM F1717-12 standard. The device's ability to withstand static torsion, static axial compression bending, and dynamic axial compression bending according to this standard is the objective measure of its performance.

8. The Sample Size for the Training Set

This is not applicable. Training sets are used in the development of AI algorithms. This document is for a physical medical device (an anterior cervical plate system), not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical implant.

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