Search Results

The Starlite 2006 will be used with the following lasers for the excision, ablation, vaporization and hemostasis of soft tissue.

Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength)

indications of use summary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths.

The StarLite will become an intergral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on.

The starLite 2065 is an "after-market" accessory for use with an existing surgical laser system. The device is used as a complete system (optical fiber and connector) The StarLite 2006 IS used as a direct replacement for the laser optical fiber supplied as original equipment or the original equipment laser optical fiber.

One of the primary considerations when using a fiber-optically delivered surgical laser system is that the fiber is capable of delivering the maximum amount of energy the laser is set for minus a small connector loss.

Most fiber based laser systems include a handpiece that clasps or grips the laser fiber on its protective jacket. For this reason the laser fiber must have an outside coating capable of protecting the inner core.

Many procedures call for the use or application of a "bare fiber" to the operative tissue; the so called "contact mode" of operation.

The StarLice is designed using industry standard connectors and optical fiber. The components of this fiber optic assembly are the same as what is currently being used on cleared existing lasers cited above. The protective outside buffer or jacket is compatible with all handpieces designed for this fiber type.

The starLite laser fiber optic is intended for use with lasers that do various surgical procedures. The StarLite is universal in nature and is intended to be used on currently FDA cleared soft tissue lasers. The StarLite assembly is designed to accommodate hard clad faser fibers including 200, 300, 400 and 600 micron diameters.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the StarLite 2006. Instead, the primary "acceptance criterion" appears to be substantial equivalence to legally marketed predicate devices, meaning it functions in the same way and uses the same materials and principles.

Therefore, the table will reflect this qualitative assessment of equivalence, rather than specific performance numbers.

Here's an analysis of the study related information, based on the provided text:

1. Sample size used for the test set and the data provenance:

   • The document does not describe a test set, a specific study with a sample size, or data provenance in the context of typical device performance evaluation (e.g., clinical trials, bench testing with a defined set of samples).
   • The focus is on demonstrating "substantial equivalence" through descriptive comparisons to predicate devices and adherence to design principles rather than empirical performance testing against a specific dataset.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no mention of a test set, ground truth, or experts establishing such ground truth.

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

   • Not applicable. No test set or adjudication method is described.

4. 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. The device is a laser optical fiber, not an AI or diagnostic imaging device. No MRMC study was performed or mentioned.

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

   • Not applicable. The device is a physical component (laser fiber), not an algorithm.

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

   • Not applicable. No ground truth is mentioned in the context of device performance evaluation. The "ground truth" for this submission is implicitly the established functionality and safety of the predicate devices and general industry standards for laser fiber optics.

7. The sample size for the training set:

   • Not applicable. The device is a physical component, not a learning algorithm or AI. There is no concept of a "training set" for this product submission.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The Lite Saber™ 2000 indications for use are for the cleared indications for the laser system to which it is attached. For example, dermatological, ENT, general surgery, GYN surgery, oral/dental, maxillofacial, orthopaedic and podiatric procedures for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

The Licesaber™ 2000 is an "after-market" accessory for use with an existing surgical laser system. The device may be used as a complete system (handpiece and tips) or just the tips may be used with an existing handpiece of the ultradent style. The LiceSaber™ 2000 is used as a direct replacement for the laser handpiece supplied as original equipment or the original equipment laser handpiece tip. The Licesaber™ 2000 is designed address the need to direct the beam in a direction other than straight through the handpiece. Further, it does so without the need for refractive or reflective contact tips. The Licesaber 2000 gently and effectively clasps the clad fiber while bending the distal bare fiber into a smooth radius. Pre-curved disposable tips channel the fiber. Precurved tips are available. The directional tips may be rotated 360 degrees. This allows the laser fiber to be directed laterally, up, down or any angle or radius in between. The tips are disposable and the handpiece is reusable.

I'm sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for the "LiteSaber™ 2000" laser accessory, primarily focusing on its substantial equivalence to a predicate device.

The document discusses:

• Device trade name, common name, and classification.
• Equivalent/comparison device.
• Device description and intended use.
• Sterilization information.
• The FDA's 510(k) clearance letter.

It does not include:

1. A table of acceptance criteria or reported device performance metrics.
2. Details on sample sizes for test sets, data provenance, or study design.
3. Information on experts, ground truth establishment, or adjudication methods for test sets.
4. Mention of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Details of a standalone (algorithm only) performance study.
6. The type of ground truth used in any study.
7. Sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Ask a specific question about this device