(66 days)
The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue.
The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.
The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips.
The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide.
The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System.
The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips.
The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon.
The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.
The provided text describes a 510(k) premarket notification for the Clinicon Universal WaveGuide Handpiece and Fiber Tips. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance metrics, is not available in the provided text.
Here's an analysis of why the requested information cannot be found and what is present in the document:
1. A table of acceptance criteria and the reported device performance:
- Not Available: The submission is for a medical device (CO2 Laser Powered Surgical Instrument), not an AI/ML diagnostic or predictive device. The FDA 510(k) process for such devices typically focuses on comparing the new device's technological characteristics, intended use, and safety/effectiveness to a legally marketed predicate device. This usually doesn't involve defining specific performance metrics (like sensitivity, specificity, AUC) and comparing them against pre-defined acceptance criteria in a quantitative table.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Available: Since no formal performance study with a test set (in the context of AI/ML) is described, these details are not present. The submission focuses on substantial equivalence through design and material comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable/Not Available: This refers to the establishment of ground truth for a diagnostic or predictive algorithm. As this is a surgical instrument, such expert-driven ground truth establishment for a test set is irrelevant and not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Available: Similar to the above, adjudication methods are used to resolve discrepancies in expert-labeled ground truth for diagnostic studies. This is not relevant to a surgical instrument.
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/Not Available: MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is a surgical tool, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available: This refers to standalone AI algorithm performance. This device is a physical surgical instrument.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable/Not Available: The concept of "ground truth" as used in AI/ML performance validation does not apply to this surgical device. The "truth" in this context would be aspects like material properties, laser energy delivery capabilities, and sterility, which are assessed through engineering tests and regulatory compliance rather than "ground truth" derived from expert consensus or pathology data.
8. The sample size for the training set:
- Not Applicable/Not Available: No training set, in the AI/ML sense, is involved.
9. How the ground truth for the training set was established:
- Not Applicable/Not Available: No training set or ground truth establishment for it is relevant here.
What the document does describe (relevant to substantial equivalence):
The document provides information comparing the new device to existing predicate devices, focusing on:
- Intended Use: The device is intended to deliver carbon dioxide laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue, similar to the predicate devices.
- Technological Characteristics:
- Design Features: Descriptions of two handpiece designs (1.5mm and 2.5mm O.D. fiber tips), collet component, nozzle and tip lock collet, FSMA connector. Description of fiber tips (rigid/flexible, various lengths, curvature, Teflon contact probe tip cover), disposable nature, colored polyethylene depth gauge and sterilizer indicator.
Conclusion:
This 510(k) submission is for a conventional surgical instrument and relies on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety/performance profiles, rather than presenting a statistical performance study against explicit acceptance criteria in the manner requested for an AI/ML 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.