(15 days)
The OmniGuide Mark III 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 Beam Path CO2 Mark III WaveGuide Fiber is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.
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 assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.
The provided text describes the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber, but it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.
Instead, it states that:
- Clinical Performance Data: "Formal clinical trials were not deemed necessary as the device is using the same technology and intended use as predicate device."
- Non-clinical Performance Data: "The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber performance characteristics have been evaluated through testing and analysis of laser power output and beam quality. This type of testing complies with the respective section of the FDA Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995) and is similar to the predicate device tests. The performance of OmniGuide Beam Path CO2 Mark III WaveGuide Fiber and related parameters of predicate device are comparable."
- Conclusion: "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide Beam Path CO2 Mark III WaveGuide Fiber are similar or equivalent to the characteristics of above mentioned legally marketed device."
Based on this, I cannot fill out the requested table or provide details about a study proving specific acceptance criteria. The device's approval appears to be based on substantial equivalence to a predicate device (K050541), rather than meeting predefined acceptance criteria through a specific study with a test set, ground truth, or expert review.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's an attempt to answer the questions based only on the provided information, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from study) | Reported Device Performance (from study) |
|---|---|
| Not specified. | "laser power output and beam quality" |
| Not specified. | "energy transmission levels" |
| Not specified. | "beam quality" |
| Not specified. | Performance is "similar or equivalent to the characteristics of above mentioned legally marketed device." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. The document states "Formal clinical trials were not deemed necessary." Non-clinical testing focused on device characteristics and comparability to a predicate.
- Data provenance: Not applicable/Not provided in the context of a "test set" for a clinical study. The non-clinical data would be laboratory-generated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical "test set" requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical "test set" requiring adjudication is mentioned.
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. This is a medical device (CO2 laser fiber), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided, as no clinical study with a "ground truth" is described. The performance evaluation was primarily non-clinical, comparing technical specifications to a predicate.
8. The sample size for the training set
- Not applicable/Not provided. No machine learning training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No machine learning training set or ground truth establishment is mentioned.
§ 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.