(44 days)
The SureGuide CO2 Laser Beam Delivery System is intended for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
Refer to the laser system Directions for Use manual for specific indications for Use.
The SureGuide CO2 Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, otorhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue.
The specific SureGuide CO2 Laser Beam Delivery System indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
The SureGuide CO2 Laser Beam Delivery System is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover.
The SureGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories.
The laser adapter design is derived from the Medical Optics laser system flexible cable assembly interface adapter and has a section designed to fit the Luxar LX-20 mast interface. Beam alignment and focus optics are built into the interface adapter to allow correction of inherent beam alignment variations between laser systems and provides optimization of laser beam coupling into the SureGuide.
The provided text describes the acceptance criteria and the study conducted for the SureGuide CO2 Laser Beam Delivery System.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Laser power loss comparable to similar cleared devices. | "The SureGuide performance characteristics have been evaluated through testing and analysis of laser power loss... compared to similar devices cleared for marketing in the past. The performance of the SureGuide is comparable." |
| Beam quality from the guide comparable to similar cleared devices. | "...and beam quality from the guide when the laser is energized, compared to similar devices cleared for marketing in the past. The performance of the SureGuide is comparable." |
| Predicted energy transmission levels meet established criteria. | "The predicted energy transmission levels... meet criteria established through evaluation of the SureGuide on various commercially available medical CO2 laser systems." |
| Beam quality meets established criteria when evaluated on various commercially available laser systems. | "...and beam quality meet criteria established through evaluation of the SureGuide on various commercially available medical CO2 laser systems." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the "test set." It mentions "testing and analysis of laser power loss and beam quality" and "evaluation of the SureGuide on various commercially available medical CO2 laser systems." This suggests a laboratory or engineering testing environment rather than a clinical study with patient data.
The data provenance is industrial/engineering testing of the device itself with various commercially available medical CO2 laser systems. It is not a retrospective or prospective clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set in the context of clinical interpretation or diagnosis. The "ground truth" here seems to be defined by established engineering parameters for laser power loss, beam quality, and energy transmission, likely set by internal company standards or industry benchmarks for CO2 laser systems.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-reviewed test set or any adjudication method. The evaluation appears to be based on objective physical measurements and comparisons to predicate devices' performance characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a component of a laser delivery system, not an AI or diagnostic tool that assists human readers.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance
Yes, the testing described appears to be a standalone performance evaluation of the device itself (the SureGuide CO2 Laser Beam Delivery System) without human intervention in its operation or interpretation of its output. The device's performance characteristics (power loss, beam quality, energy transmission) were measured directly.
7. Type of Ground Truth Used
The ground truth used is based on engineering and performance specifications for laser power loss, beam quality, and energy transmission, which are then compared to "criteria established" (presumably from industry standards or performance of predicate devices).
8. Sample Size for the Training Set
Not applicable. The document describes non-clinical performance testing of a physical device, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.