(89 days)
The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.
The Microline Flexible Ligating Shears system consists of the following: Microline Flexible Ligating Shears Microline Universal Power Supply Single or multiple access port device such as the TransEnterix SPIDER Single Port. The Microline Flexible Ligating Shears are designed to provide thermal ligation and division during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears consist of a sterile single patient use handpiece. The device has heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The Microline Universal Power Supply is designed to allow the surgeon control of the heating element power of the device in order to accommodate for individual patient anatomy. An instrument cord is attached to the handpiece and is plugged into the dedicated Microline Universal Power Supply. The Microline Flexible Ligating Shears are designed to be used with an Introducer such as the SPIDER Single Port Device. The Microline Flexible Ligating Shears are supplied sterile in a Tyvek/Mylar sterilization pouch on a mounting card and thermoformed tray, placed in a fiberboard carton. The device is intended to be used by a trained physician for a single patient use during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears power cable is attached to the instrument handpiece and connects to the Microline Universal Power Supply. The Universal Power Supply is supplied nonsterile for reusable use outside the sterile field. The Microline Flexible Ligating Shears incorporates Hi and Low heating modes that are used to cauterize and cut soft tissue. The heating elements in the tip are activated by a physician controlled finger switch located on the handpiece of the device. The Microline Flexible Ligating Shears is intended to provide general purpose cauterization, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.
The provided document is a 510(k) summary for a medical device, the Microline Flexible Ligating Shears. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.
The device described is a surgical instrument. The performance testing mentioned is for the physical functionality, sterilization, biocompatibility, and electrical safety of the surgical shears themselves, not for an artificial intelligence or algorithmic system that processes data or assists human interpretation.
Therefore, many of the requested criteria (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this document as it's not about an AI-powered device.
Here's an attempt to address the applicable points based on the provided text, while explicitly noting where information is not present or not relevant to an AI context:
Device Name: Microline Flexible Ligating Shears
This document describes the 510(k) clearance process for a surgical instrument, not an AI or algorithmic device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., accuracy, sensitivity, specificity of an algorithm) does not apply here. The "acceptance criteria" are related to the device's physical functionality, safety, and equivalence to predicate devices.
The "studies" conducted are verification and validation tests to ensure the device performs its intended mechanical/electrical functions and meets safety standards, rather than evaluating an algorithm's performance on a dataset.
1. A table of acceptance criteria and the reported device performance
The document focuses on establishing substantial equivalence to predicate devices, which implies that the device must meet similar performance and safety standards. Explicit quantitative "acceptance criteria" for performance metrics like "sensitivity" or "specificity" (common in AI device evaluation) are not defined in the context of this mechanical device. Instead, the "performance" demonstrated is that the device functions as intended and is safe.
| Criterion/Characteristic | Acceptance Standard (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Functionality | Simultaneous cutting and cauterization of soft tissue, cutting non-metallic sutures, general purpose cauterization, spreading, and grasping. | "The Microline Flexible Ligating Shears have been tested for functionality and they have found to perform their intended functions for minimally invasive abdominal laparoscopic procedures. Additionally, testing has proven that they perform their ligating functions." |
| System Compatibility | Compatible with the SPIDER® device. | "The device has also been tested with the SPIDER® device and pasted all required testing for system compatibility." |
| Sterilization | Sterilized to a Sterility Assurance Level (SAL) of 1x10⁻⁶ via gamma irradiation per ISO 11137-2. Sterile barrier maintains sterility for shelf life. | "The Microline Thermal Ligating Shears have been sterilized to a SAL of 1x10⁻⁶ using gamma irradiation. The gamma sterilization process was validated... Sterile barrier testing has been performed and it has been shown that the sterile barrier has the capability of maintaining sterility during the required shelf life, and that the device itself maintains its performance requirements." |
| Biocompatibility | All patient contact materials meet biocompatibility testing per ANSI/AAMI/ISO 10993-1 for an external communicating device. | "Biocompatibility testing was successfully conducted on the Microline Flexible Ligating Shears in accordance with ANSI/AAMI/ISO 10993-1... the appropriate tests were performed as described in Table A.1 in Annex A of ANSI/AAMI/ISO 10993-1." |
| Electrical Safety | Compliant with IEC 60601-1:1988 + A1:1999 + A2:1995 (general requirements for basic safety) including US, CAN National Differences. | "The Microline Flexible Ligating Shears were evaluated by an independent testing laboratory and found compliant to IEC 60601-1:1988 + A1:1999 + A2:1995 general requirements for basic safety, including all US, CAN National Differences." |
| Substantial Equivalence | No significant technological differences affecting safety and efficacy compared to predicate devices (Thermal Ligating Shears K062257, Spider Flexible Monopolar Surgical Instruments K122299). Minor design/material differences present no new safety/effectiveness issues. | Stated that "verification and validation test results are sufficient to demonstrate safety and effectiveness when compared to the predicate devices. The minor design or material differences... have been evaluated and tested and found to present no new issues of safety and effectiveness." FDA confirmed substantial equivalence. |
2. Sample sizes used for the test set and the data provenance
This document discusses physical and electrical tests performed on the device itself, not performance on a data test set for an algorithm. Therefore, "sample size" in the context of data points or images is not relevant. The "test set" would refer to the number of physical devices or components subjected to a particular test (e.g., sterilization validation might use multiple samples, but the exact number isn't specified in this summary). There's no data provenance mentioned as it's a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this physical surgical device, "ground truth" is established by engineering specifications, safety standards, and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to adjudication of discordant expert readings for AI evaluation.
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-assisted device. The document explicitly states, "clinical data was not necessary for evaluation of substantial equivalence." This means a clinical study, which an MRMC study would be, was not performed or deemed necessary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a human-operated surgical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI sense. For this device, "ground truth" for its performance is derived from:
- Engineering specifications and design: The device is designed to perform specific mechanical and electrical functions.
- International and national standards: Compliance with standards like ISO 11137-2 (sterilization), ANSI/AAMI/ISO 10993-1 (biocompatibility), and IEC 60601-1 (electrical safety).
- Functional testing: Direct observation and measurement of the device's ability to cut, cauterize, grasp, and connect to power.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the device is as safe and effective as previously cleared devices.
8. The sample size for the training set
Not applicable. There is no AI model or algorithm being "trained" for this device.
9. How the ground truth for the training set was established
Not applicable. As there's no training set for an AI model, there's no ground truth establishment process for it.
§ 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.