(17 days)
The OmniGuide Zero Flow ZF-T WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy.
The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.
The OmniGuide Zero Flow ZF-T WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T wave guide fiber is supplied sterile and is intended for single procedure use.
The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.
Here's an analysis of the provided text regarding the OmniGuide Zero Flow ZF-T WaveGuide Fiber, focusing on acceptance criteria and study information.
It's important to note that this 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/machine learning devices. The information provided is for a traditional medical device (a fiber for CO2 laser systems) and therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, training set details) are simply not applicable or not present.
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
The OmniGuide Zero Flow ZF-T WaveGuide Fiber is an accessory for CO2 laser systems. Its acceptance criteria are primarily related to its physical performance characteristics, specifically its ability to transmit CO2 laser energy effectively and maintain beam quality, demonstrating substantial equivalence to predicate devices. The study conducted was non-clinical in nature.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Laser Power Output: Comparable to predicate devices. | Evaluated through testing and analysis; deemed comparable to predicate devices. |
| Beam Quality: Comparable to predicate devices. | Evaluated through testing and analysis; deemed comparable to predicate devices. |
| Safety and Effectiveness: No new issues raised compared to predicate devices. | Evaluation and testing completed did not raise any new issues of safety and effectiveness. |
| Intended Use: Similar to predicate devices. | Intended use is similar/equivalent to legally marketed predicate devices. |
| Technological Characteristics: Similar to predicate devices. | Device uses similar technology as predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. This was a non-clinical, bench-top performance study, not a clinical trial with human subjects. Thus, "test set" in the context of clinical data or AI systems is not applicable.
- Data Provenance: Not applicable. The data is from laboratory testing of the device itself, not from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (laser fiber performance) is established through technical specifications and physical measurements, not expert consensus interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to the reconciliation of expert opinions on clinical data, which was not part of this submission.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is a key component, which is not the case for this laser fiber.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical instrument for laser delivery, not an algorithm or an AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is based on engineering specifications and direct physical measurements of laser power output and beam quality. This aligns with the "non-clinical performance data" described.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
§ 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.