(203 days)
The Lagis Endoscopic Instruments are designed for use in a variety of surgical procedures to facilitate grasping, dissecting, and transecting of tissues.
The Lagis Endoscopic Instruments is a sterile, single use device having an insulated shaft with a diameter of 4.5-5.0 mm for use in 6mm and larger size trocar. The shaft can be rotated through the actions of a roller knob. A pair of plastic handles manipulates closing or opening of the tip scissors or graspers. An electrical connector allows for connection of the instrument to a generator for electrosurgical applications.
The provided 510(k) summary describes a new medical device, Lagis Endoscopic Instruments, and its substantial equivalence to predicate devices. However, it does not contain the level of detail regarding acceptance criteria and study particulars that is typically found in a clinical study for AI/software-based medical devices.
The document describes a physical medical instrument (electrosurgical instruments), not an AI or software-based device. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML devices (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) are not applicable or not provided in the context of this device.
Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent differences for a hardware device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Test results demonstrated acceptable results with respect to predicate devices." The performance evaluation focused on mechanical and electrical characteristics.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Unit Packaging Integrity | Acceptable results |
| Functional Characteristics | Acceptable results (e.g., jaw/scissor movement) |
| Performance Characteristics | Acceptable results (e.g., tip rotation, shaft sturdiness) |
| Electrical Safety | Acceptable results (e.g., shaft dielectric strength, monopolar connection capability) |
| Grasping Force | Acceptable results (in respect to predicate devices) |
| Cutting Capability | Acceptable results (in respect to predicate devices) |
| Biocompatibility | Satisfactorily tested for cytotoxicity, sensitization, intracutaneous reactivity and systematic toxicity per ISO 10993 and US FDA G-95 requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the bench tests. It broadly mentions "Performance bench tests were carried out." The "data provenance" in this context refers to the origin of the test results, which are from internal bench tests conducted by the manufacturer, Lagis Enterprise Co. Ltd. This is a retrospective evaluation against established engineering and safety standards, rather than prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device and study. Bench tests for electrosurgical instruments typically involve engineering and quality control personnel following defined test protocols and specifications, not clinical experts establishing "ground truth" in the way it's done for diagnostic AI. The "ground truth" here is adherence to engineering specifications and safety standards.
4. Adjudication Method for the Test Set
This question is not applicable. The performance tests are objective measurements against specifications (e.g., torque, force, electrical resistance), not subjective assessments requiring adjudication by multiple readers.
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
This question is not applicable. This is a hardware medical device, not an AI or software-based diagnostic or assistive system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on engineering specifications, established safety standards (e.g., ISO 10993 for biocompatibility), and comparison to the performance characteristics of predicate devices. For example, a "grasping force" test would have an engineering specification for the minimum/maximum force the jaws should exert, which serves as the ground truth.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical device, and the concept of a "training set" is not relevant to its development or pre-market notification process.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this type of device.
§ 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.