Search Results

The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation supplied with the laser system being used with the LaserGuard™ system.

The product submitted herein is, in fact, the predicate device fitted with a LaserGuard™ device as an accessory. The basic device is a wave guide for laser light sources and will transmit light between 532 and 2100 nanometer wavelengths. The cladding of the fibers is either doped silica or a polymer. The outer buffer material is either Nylon or Tefzel.

The LASERGUARD™ accessory included with the submitted product is an electronic device that will detect heat generated as a result of the fiber overheating anywhere along the light path and will disengage the foot switch of the laser thereby putting the laser in standby mode. The LASERGUARD™ will also indicate by an audible alarm and a light that the fiber has overheated.

Both the predicate device and the submitted products are capable of delivering laser radiation from a laser instrument to the surgical site with minimal loss. Both deliver wavelengths from 532 to 2100 nanometers as, for example, is generated by Ho:YAG or Nd:YAG lasers. The laser energy is emitted through a flat, orbed or conical tip located at the distal end of the fiber. Both the predicate and submitted products are offered in a range of core sizes from 145 to 940 micrometer silica cores and are from 2.5 to 5.0 meters in length. The products are supplied in sterile and non-sterile as well as single-use and re-usable versions.

Here's an analysis of the acceptance criteria and study information provided for the "Optical Integrity General Shaped Fiber with LaserGuard™" device, based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative numerical acceptance criteria in a pass/fail format with defined thresholds. Instead, it describes performance expectations and the results of bench testing.

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

• Sample Size: The document does not specify a numerical sample size (e.g., number of fibers tested, number of simulated breaks). It only mentions "Bench testing."
• Data Provenance: The data is described as "Bench testing," indicating it was conducted in a controlled laboratory environment. The country of origin is not explicitly stated, but the submission is from Optical Integrity, Inc. in Panama City Beach, Florida, USA, implying the testing likely occurred in the USA or under their supervision. The study appears to be prospective in the sense that the testing was designed and executed to evaluate the new device's performance.

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

This information is not provided in the document. The testing described is bench testing of the device's physical and functional performance, not an evaluation requiring human expert interpretation of clinical data where a ground truth would typically be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. The described study focuses on the technical function of a physical device.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the standalone performance of the device and its equivalence to a predicate device in terms of energy delivery, and the added safety features of the LaserGuard™ accessory. It does not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone study (bench testing) was performed. The described study evaluates the device (including the LaserGuard™ accessory as an electronic device) in isolation. It verifies its ability to:

• Deliver energy comparably to the predicate device.
• Automatically detect and respond to fiber breaks (shut down laser, alarm, indicator light).
• Automatically detect and respond to thermal runaway events.

There is no "human-in-the-loop" aspect to the performance evaluation described, as the LaserGuard™'s primary function is described as automatic. The surgeon's role is to "determine what course of action to take" after the system has already alerted them.

7. The Type of Ground Truth Used

The "ground truth" for this engineering-focused bench test would be the expected functional behavior of the device based on its design specifications. For example:

• For Energy Delivery: The ground truth is that the undamaged fiber with LaserGuard™ should transmit the same energy as the undamaged fiber without it. This would be measured directly using calibrated power meters.
• For Laser Shutdown on Break: The ground truth is that the laser must shut down when a fiber break is induced. This is a direct observation of the device's response.
• For Alarms/Lights: The ground truth is that the audible alarm and indicator light must activate in response to a detected event. This is a direct observation.

In essence, the ground truth is derived from the engineering design specifications and the known physics of laser light transmission and thermal detection, rather than from expert consensus on clinical findings or pathology.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical device with an electronic accessory (LaserGuard™). It is not an AI/ML algorithm that requires a training set in the conventional sense.

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

This information is not applicable and not provided, as the device is not an AI/ML algorithm requiring a training set.

Ask a specific question about this device