(68 days)
The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications.
The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached
The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is an accessory for CO2 laser systems that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse laser systems. It consists of an adapter and a fiber assembly that propagate CO2 laser beams. The OmniGuide BeamPath CO2 Mark I Fiber Assembly is supplied sterile and is intended for single procedure use.
The provided 510(k) summary for the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System describes non-clinical performance data but explicitly states that formal clinical trials were not deemed necessary. Therefore, an acceptance criteria table and detailed information about a study proving the device meets those criteria, as typically seen with AI/ML devices, are not present.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent due to the nature of the submission (no formal clinical study for acceptance criteria):
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical study. The acceptance is based on achieving "comparable" performance to predicate devices in non-clinical tests.
- Reported Device Performance:
- "The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System performance characteristics have been evaluated through testing and analysis of laser power output and beam quality."
- "The performance of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable." (The comparison table is not included in the provided text).
- "The OmniGuide BeamPath CO2 Mark I Fiber Assembly has passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards."
- Conclusion: "The intended use and major performance parameters (energy transmission levels and beam quality) of the OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable laser power output to predicate devices | Evaluated; performance is comparable to predicate devices. |
| Comparable beam quality to predicate devices | Evaluated; performance is comparable to predicate devices. |
| Biocompatibility according to ISO 10993-1:2003 | Passed biocompatibility testing by an independent laboratory. |
| No adverse effects during compassionate use | Device performed as intended; no adverse effects noticed. |
| Similar/Equivalent energy transmission levels to predicate devices | Similar or equivalent to legally marketed devices. |
| Similar/Equivalent beam quality to predicate devices | Similar or equivalent to legally marketed devices. |
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 (Non-clinical): Not specified. The document mentions "testing and analysis of laser power output and beam quality" but does not give specific sample sizes for these tests.
- Sample Size (Clinical for Compassionate Use): Not specified. It only states "the device was used in a compassionate use per FDA permission," implying a very small, observational group, but no number is given.
- Data Provenance: Not specified for the non-clinical tests. For the compassionate use, it would be prospective, likely in the US given FDA permission, but the exact country is not stated.
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. This device is a medical accessory, not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. Evaluation was via non-clinical performance characteristics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. The device's performance stands alone in its ability to transmit laser energy, evaluated through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Non-clinical Testing: The "ground truth" was established by measured physical parameters (laser power output, beam quality) and comparison to established parameters of predicate devices and relevant industry standards (e.g., ISO 10993-1:2003 for biocompatibility).
- For Compassionate Use: The "ground truth" was clinical observation of device "performing as intended" and "no adverse effects."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.