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510(k) Data Aggregation
(13 days)
The OmniGuide's Highland 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 surgical procedures related to gynecology, otorhinolaryngology, neurosurgery, gastroenterology, and pulmonary surgery for surgical and aesthetic applications. The indications for use for which the device is used are also dependant upon the cleared indications for use of the laser system and the laser system accessories to which it is attached.
The Highland Beam Delivery System is the CO2 laser beam delivery system that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse CO2 laser. It consists of a laser adapter with a fiber cable and optical fiber handpiece that propagate CO2 laser beam, cooling devices for fiber cable and movable cart that houses all system components.
The optical fiber handpiece consists of optical fiber integrated with a handpiece. It is supplied sterile and is intended for single procedure use. The laser adapter and fiber cable are re-usable devices that transmit CO2 laser radiation from the laser to the fiber assembly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Highland Beam Delivery System:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a CO2 laser beam delivery system. The primary acceptance criteria relate to its ability to effectively transmit and deliver a CO2 laser beam for surgical purposes, comparable to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance - General | Comparable to predicate devices in: | "The performance of the Highland Beam Delivery System and related parameters of predicate devices (as specified in comparison table) are comparable." |
| - Laser power output | Evaluated through bench testing | |
| - Beam quality | Evaluated through bench testing | |
| - Energy transmission levels | "similar or equivalent to same characteristics of above mentioned legally marketed devices." | |
| - Interaction with human tissue | "does not present any differences in the delivery, quality and / or control of laser beam and does not change the interaction between the laser beam and human tissue." | |
| Safety - Biocompatibility | Biocompatibility of materials | "The materials of optical fiber handpiece have passed biocompatibility testing as performed by an independent laboratory in accordance with ISO 10993-1:2003 Standards." |
| Safety - Standards Compliance | Compliance with relevant standards | "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 IEC 60601-1 and 2" |
| Reliability/Convenience | Improvements in device reliability and convenience | "improvements in the device reliability and convenience for use, introduced by utilization of actively cooled fiber cable and better controlled cooling methods for fiber." |
| Intended Use | Maintains intended use as incision, excision, ablation, vaporization and coagulation of soft tissues. | "The intended use... of the Highland Beam Delivery System are similar or equivalent to same characteristics of above mentioned legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical study with patients. The performance data is primarily based on bench testing and analysis. The document does not specify a "sample size" of devices tested, but rather refers to the evaluation of performance characteristics.
- Data Provenance: The data is from non-clinical performance data (bench testing and analysis). The document does not indicate a country of origin for this specific testing, other than stating it was performed by an "independent laboratory" for biocompatibility. The regulatory submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on non-clinical bench testing rather than human expert interpretation of data or images to establish ground truth for a test set. The validation is against established engineering and safety standards, and comparison to predicate devices, rather than expert consensus on medical findings.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in this submission.
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, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (a CO2 laser beam delivery system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no concept of human readers improving with or without AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance evaluation was a standalone (algorithm/device-only) non-clinical evaluation via bench testing. The device's ability to deliver a laser beam and its safety characteristics were assessed directly, without a human operator's performance being part of the primary test metrics.
7. The Type of Ground Truth Used
The ground truth used for this device involves:
- Engineering specifications and regulatory standards: Compliance with FDA Guidance on Medical Lasers and IEC 60601-1 and 2, and ISO 10993-1:2003 for biocompatibility.
- Performance characteristics of legally marketed predicate devices: The "ground truth" for performance (power output, beam quality, energy transmission) is established by the known and accepted performance of the referenced predicate CO2 laser beam delivery systems.
8. The Sample Size for the Training Set
Not applicable. As a medical device that is not an algorithm requiring machine learning, there is no "training set" in the context of AI. The development of the device would involve engineering design and iterative testing, but not a labeled data set for training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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