(174 days)
The CONMED ALTRUS® Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired.
The CONMED Altrus Thermal Tissue Fusion system consists of the following:
- CONMED Altrus Thermal Tissue Fusion Energy Source .
- CONMED Altrus Thermal Tissue Fusion Handpiece. .
The CONMED Altrus Thermal Tissue Fusion system employs focused thermal energy and pressure to simultaneously seal and/or seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the ConMed Altrus products can reduce the potential of unintended thermal injury.
The energy source uses an LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows for the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature, by means of simple resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal) The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software.
The CONMED Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication to and from the handpiece.
The CONMED Altrus Thermal Tissue Fusion System is a medical device that uses focused thermal energy and pressure to seal and/or divide tissue, aiming to reduce the potential for unintended thermal injury compared to traditional electrosurgical methods.
Here's an analysis of the provided information regarding its acceptance criteria and the study that proves it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) premarket notification summary, does not explicitly list quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence implies that the new device is as safe and effective as a legally marketed device.
Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the predicate devices. The document states:
| Implicit Acceptance Criterion (based on Predicate) | Reported Device Performance (CONMED Altrus) |
|---|---|
| Function as intended (tissue sealing/division) | "Preclinical laboratory and performance testing were performed to ensure the devices functioned as intended..." |
| Meet design specifications | "...and met design specifications." |
| Substantially equivalent or better than predicate devices in function, construction, intended use, and indications for use | "Sufficient data was obtained to demonstrate the CONMED Altrus Thermal Tissue Fusion System was substantially equivalent to or better than the predicate devices." |
| "The data provide demonstrates the CONMED Altrus Thermal Tissue Fusion system is substantially equivalent to the identified predicate devices in function, construction, intended use, and indications for use." | |
| Compliance with applicable ISO 60601 Standards | "The CONMED Altrus Thermal Tissue Fusion System complies with all the applicable ISO 60601 Standards..." |
| Biocompatibility of patient/clinician contacting surfaces | "...as well as being wholly composed of biocompatible materials for all patient or clinician contacting surfaces." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Preclinical laboratory and performance testing were performed." However, it does not provide specific details about the sample sizes used for these tests, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full testing reports that accompany a 510(k) submission, but is not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth for any testing. Given that the testing mentioned is "preclinical laboratory and performance testing," it is likely that engineering and clinical experts were involved in designing and evaluating the tests, but this is not explicitly stated.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Since the testing mentioned is "preclinical laboratory and performance testing" rather than human clinical trials involving subjective interpretation, a formal adjudication process (like 2+1 or 3+1 for image reviews) would not typically be applicable or described in this type of submission summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was done or is mentioned. The CONMED Altrus system is a surgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human reader performance with AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The CONMED Altrus Thermal Tissue Fusion System is a physical medical device (energy source and handpiece) used directly by a surgeon. It is not an algorithm that operates standalone. Therefore, a standalone algorithm-only performance test is not applicable and was not performed. The performance is inherently "human-in-the-loop" as a surgeon manipulates the device.
7. The Type of Ground Truth Used
Based on the description of "preclinical laboratory and performance testing," the ground truth would likely be established through:
- Direct observation and measurement of physical outcomes: e.g., tensile strength of sealed vessels, burst pressure, time to seal, charring, tissue division efficacy, and temperature profiles.
- Engineering specifications and standards: Confirming the device operates within defined parameters (e.g., power output, temperature control, mechanical force).
- Comparative results against predicate devices: Demonstrating similar or superior performance to existing, legally marketed devices.
Pathology or outcomes data are not explicitly mentioned in this summary but could be part of comprehensive preclinical testing to assess tissue effects.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI algorithms. Since the CONMED Altrus Thermal Tissue Fusion System is a hardware device with associated software controlling its operation, but not an AI/ML device in the modern sense, the term "training set" for algorithm development is not applicable or mentioned in this summary. The software parameters are likely determined through engineering design, testing, and optimization rather than an iterative machine learning training process.
9. How the Ground Truth for the Training Set Was Established
As "training set" for an AI/ML algorithm is not applicable, the question of how its ground truth was established is also not relevant to this device. The "ground truth" for the device's design and operating parameters would be established through engineering principles, benchtop testing, and preclinical studies to ensure safety and effectiveness.
§ 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.