(55 days)
The FiberLase CO2 Laser WaveGuide is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase CO2 Laser WaveGuide is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The device is limited to carbon dioxide lasers having a SMA-905 connector.
The CO2 Laser WaveGuide is a laser delivery system for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The CO2 Laser WaveGuide device is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures. The CO2 Laser WaveGuide is a hollow, semi-rigid, light-conducting tube designed to operate at wavelengths of 10.6 um and 0.6328 um. These wavelengths correspond to the output of the CO2 laser device and the helium-neon laser aiming beam, thereby allowing both laser radiations to be simultaneously and efficiently transmitted through the same channel. Laser energy entering the waveguide travels down the tube by multiple bounces off the inner reflective surface, and is delivered to the tissue at the distal end.
The CO2 Laser WaveGuide is compatible for use with any laser system that has a 905 SMA connector. The WaveGuide is supplied in several configurations with the dimensions specified in the following table:
| Core diameter [µm] | Outer diameters [µm] | Lengths [cm] |
|---|---|---|
| 300 | 700, 800 | 60, 100, 150 |
| 500 | 900, 1040 | 60, 100, 150, 200 |
| 750 | 1200, 1400 | 100, 150, 200 |
Table 1 - CO2 Laser WaveGuide Dimensions
The CO2 Laser WaveGuide is supplied with a set of eight hand pieces through which the WaveGuide may be inserted for easy handling in surgical procedures. The hand pieces are available with various features at the distal end to provide angled beam deflection with a highly polished metal surface. The WaveGuide is also provided with cleaving and cutting tools. The WaveGuide accessories are all provided as reusable tools. The CO2 Laser WaveGuide may be used with a gas purge system providing a flow of air of 2 liters per minute and a regulator pressure of 4.5 psi. The gas purge system keeps the inner channel of the waveguide free of debris. The gas purge system is not supplied with the waveguide.
The provided text describes a 510(k) premarket notification for a CO2 Laser WaveGuide and discusses performance testing. However, it does not contain the specific details required to complete all sections of your request.
Here's an analysis of the provided information:
Key Takeaways from the Document:
- Device: CO2 Laser WaveGuide (FiberLase)
- Intended Use: Ablation, vaporization, excision, incision, and coagulation of soft tissue in open, laparoscopic, and endoscopic surgical procedures.
- Predicate Device: CO2 Laser WaveGuide from Surgilase Inc. (K921671).
- Performance Testing: Bench testing was performed to establish "percent transmission" using the longest length fiber optic waveguide as the worst-case scenario.
- Substantial Equivalence: The modified device is deemed substantially equivalent to the predicate device in terms of overall design, mechanism of action, mode of operation, performance characteristics, and intended use.
Missing Information:
The document lacks critical details for many of your requested points, especially concerning specific acceptance criteria values, a detailed study report, sample sizes for test and training sets, ground truth establishment methods, and expert qualifications.
Detailed Response based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Missing from document) | Reported Device Performance |
|---|---|
| Specific quantitative criteria not stated | "Established percent transmission" |
Note: The document only states that performance testing was conducted to "establish percent transmission." It does not provide the specific acceptance criteria (e.g., "percent transmission must be > X%") nor the actual measured value of the percent transmission. Therefore, a complete comparison cannot be made from this text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "the longest length fiber optic waveguide as the worse case test scenario," implying at least one (but likely more) waveguide was tested.
- Data Provenance: The study was "bench tested," implying it was conducted in a laboratory setting. Data provenance (country of origin) and whether it was retrospective or prospective clinical data are not applicable/provided, as this was not a clinical study.
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)
This information is not applicable as the description refers to bench testing of a physical device's performance (percent transmission), not a medical imaging or diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments.
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
This information is not applicable. The device is a physical CO2 Laser WaveGuide, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this bench test was the actual physical measurement of percent transmission of the laser energy through the waveguide. This is a direct measurement of a physical characteristic of the device.
8. The sample size for the training set
This information is not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.