Search Results

The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.

The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and a study proving device performance:

The provided document is a 510(k) Premarket Notification for the OmniGuide Laser System with FlexGuide™ Ultra. It aims to demonstrate substantial equivalence to previously cleared devices, not to establish new performance claims against defined acceptance criteria in the traditional sense of a clinical trial. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance metrics) is not applicable or not explicitly provided in this type of regulatory submission. The focus is on demonstrating that the modified device is as safe and effective as its predicate devices.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, explicit "acceptance criteria" against numerical performance metrics for a new claim are not presented. Instead, the acceptance is based on demonstrating that the modified device (FlexGuide™ Ultra handpiece) does not raise new issues of safety or effectiveness compared to its predicate. The "performance" reported is a qualitative assessment of similarity.

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 explicitly stated as a number of distinct "tests" or "patients." The performance testing is described as "Engineering analysis and bench testing." This implies a series of laboratory or functional tests, not a clinical trial with human subjects.
• Data Provenance: Not explicitly stated, but likely internal laboratory data from OmniGuide, Inc. (Cambridge, Massachusetts, USA). The study is retrospective in the sense that it evaluates the modified device against an existing predicate.

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)

• Number of Experts: Not applicable. Ground truth as typically established by experts (e.g., for diagnostic accuracy) is not relevant for this type of engineering and bench testing. The evaluation is against engineering specifications and functional performance.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This is not a study involving human interpretation of results requiring adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical handpiece, not an AI diagnostic tool that assists human readers.
• Effect Size of AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable in the traditional sense. The "ground truth" for the engineering and bench testing would be successful operation according to the predicate's established performance parameters and the device's design specifications. This would involve objective measurements (e.g., mechanical integrity tests, energy delivery verification) rather than human interpretation or pathology.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable.

Ask a specific question about this device

The UltraLase Flexible CO2Laser Waveguide is indicated for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, and ophthaimology, oral surgery, oto-rhino-laryngology, podiatry, gynecology and urology procedures. It is used to deliver laser energy for incision, excision, ablation, vaporization, and coagulation of soft tissues.

The UltraLase Flexible CO2Laser Waveguide can be used in open surgical procedures and endoscopic procedures.

The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The UltraLase Flexible CO2 Laser Waveguide is a laser delivery system for use in surgical procedures where a flexible delivery system would allow easier and more efficient delivery of laser energy to the targeted tissue. The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating that is highly reflective at the intended wavelength of use. A fiber optic connector is attached to the proximal end of the waveguide and the waveguide is covered with a plastic sleeve for protection. The UltraLase Flexible CO2 Laser Waveguide is supplied with a single use handpiece attached or without a handpiece so it can be used with various reusable handpieces such as the TTI Medical ACCU-Beam Fiberoptic Handpieces.

The UltraLase Flexible CO2 Laser Waveguide is designed to operate at 10.6µm and has a broad enough transmission band to accommodate any laser operating in this region.

The laser energy is coupled into the waveguide using the supplied focusing lens and travels down the waveguide by multiple bounces off the inner reflective surface, exiting to the tissue at the distal end.

The UltraLase Flexible CO2 Laser Waveguides come with either a 905 SMA connector or a 953 ST connector and are therefore can be used with any CO2 Laser that is compatible with one of these connectors. The waveguide is supplied in several diameters and lengths as shown in the following chart.

It is recommended that a purge gas system using an inert gas such as helium be used to force an inert gas through the waveguide for cooling and to keep the inner channel of the waveguide free of debris.

The waveguides delivery systems are supplied sterile for single use.

Here's an analysis of the provided text regarding the UltraLase Flexible CO2 Laser Waveguide's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It largely describes the device's technical specifications and intended uses, and then states that it was "bench tested" for transmission bandwidth and percent transmission. It does not present specific numerical acceptance criteria or detailed results from these bench tests beyond confirming they were performed. The "reported device performance" in the table above is thus an inference that the device met internal criteria for its design specifications, rather than a direct report of specific performance values against pre-defined numerical objective criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a dedicated "test set" in the context of clinical trials or specific performance verification. The performance testing mentioned ("bench tested to establish transmission bandwidth, and percent transmission") refers to laboratory/engineering testing rather than a clinical study with a distinct patient test set.

• Test Set Sample Size: Not specified for clinical or comparative studies. For bench testing, the sample size of waveguides tested is not mentioned.
• Data Provenance: The bench testing is implied to be internal to Laser Engineering (the applicant). There is no mention of country of origin for any data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for this type of device, extensive clinical data from human subjects is often not required if substantial equivalence can be demonstrated through technological characteristics and engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or not provided in the document. The submission is a 510(k) for a CO2 laser waveguide, which is a device for energy delivery. The performance testing described is engineering-focused (transmission bandwidth, percent transmission). There is no mention of a "test set" that would require expert-established ground truth in a diagnostic or interpretive context.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. As there's no mention of a clinical "test set" requiring expert interpretation or diagnosis, no adjudication method would be in play.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. The submission focuses on demonstrating substantial equivalence through technological characteristics and bench testing, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable. The UltraLase Flexible CO2 Laser Waveguide is a physical medical device (a fiber optic waveguide) used to deliver laser energy, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the described "bench testing to establish transmission bandwidth, and percent transmission," the "ground truth" would be established by physical measurements and engineering standards/specifications for laser light transmission through a fiber optic waveguide. It is not expert consensus, pathology, or outcomes data, as those are relevant for diagnostic or treatment efficacy studies.

8. The Sample Size for the Training Set

This information is not applicable or not provided. As the device is not an AI/ML algorithm or a diagnostic tool that learns from data, there is no "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable or not provided. As there is no "training set," there is no ground truth establishment for one.

Ask a specific question about this device