(78 days)
The Cyber Tm 150W and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery.and Arthroscopy
The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed. The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01pm wavelength with power adjustable from 5 to 150W. An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600pm) and bare fibers (200, 365, 400, 550, 600, 800 and 1000um) are available for both laser source. The emergency red push button , the key-switch and the operation status led are housed in the front part of the system. The footswitch connector is housed in the back side of the system. A metal door closes the lower rack. On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chiller outlet grids cooling . The device is controlled by a touch-screen PC mounted on an orientable arm.
The Quanta System Cyber Tm 150W is a surgical laser instrument intended for various surgical procedures. The submission states that the device is substantially equivalent to predicate devices, focusing on the performance similarities between the 150W model and a 120W predicate.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for performance; instead, it relies on demonstrating substantial equivalence to a predicate device (Cyber Surgical Laser Family K090962) through comparative animal testing. The performance is assessed by comparing the effects of a 150W laser to a 120W laser on animal tissue.
| Acceptance Criteria (Implied) | Reported Device Performance (Cyber Tm 150W vs. 120W predicate) |
|---|---|
| Similar lateral coagulation width and axial coagulation depth | "lateral coagulation width and axial coagulation depth do not show any significant difference – therefore the remaining tissue is affected in the same amount" |
| Similar depth of ablation crater at higher velocities | "depth of the ablation crater: no significant differences when velocities of 5 and 10mm/s were used" |
| Acceptable ablation depth at lower velocities | "a significant increase of ablation depth at 1mm/s at 150W compared to 120W" (This suggests a different performance at 1mm/s, which the FDA presumably deemed acceptable given the overall substantial equivalence finding.) |
| Similar carbonization of tissue | "carbonisation of Tm:YAG laser power occurred at 150W in the same manner as could be observed at 120W" |
| Safe and effective as predicate devices for intended uses | "Quanta System Cyber Tm 150W is as safe and effective as the predicate devices. The Cyber Tm 150W has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device." |
| No new issues of safety or effectiveness from technological differences | "The minor technological differences between the Cyber Tm 150W and its predicate devices raise no new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states that "Animal tests were performed." It does not specify the number of animals or the quantity of tissue samples used in these tests.
- Data Provenance: The tests were performed on "animal tissue." The country of origin of the data is not specified, but the submitter is Quanta System SpA in Italy. The tests appear to be prospective studies conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not detail the number or qualifications of experts involved in establishing the "ground truth" for the animal tissue studies. The assessment of "significant difference" in coagulation, ablation depth, and carbonization would typically be done by qualified researchers or pathologists, but specifics are not provided.
4. Adjudication method for the test set
The document does not describe the specific adjudication method used for the animal tissue study results. The determination of "significant difference" would imply statistical analysis and potentially expert consensus, but no details are given.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to a standalone evaluation of an algorithm. This device is a physical surgical laser, not an algorithm. Therefore, a standalone algorithm performance study was not performed.
7. The type of ground truth used
The "ground truth" for the animal tissue study was based on direct observation and measurement of the physical effects of the laser on the tissue (lateral coagulation width, axial coagulation depth, depth of ablation crater, carbonization). This would typically involve microscopic and macroscopic pathological examination of the treated tissues.
8. The sample size for the training set
This device is a physical medical device, not a machine learning or AI model that requires a "training set." Therefore, there is no training set in this context.
9. How the ground truth for the training set was established
As there is no training set for this device, how its ground truth was established is not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.