(86 days)
The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
The Sentient Manufacturing Laser Fiber System is a fiber optic delivery device, with the intended use of delivering laser radiation to soft tissue via contact and non-contact procedures, with any compatible laser system. The Sentient Manufacturing Laser Fibers consist of a fiber optic core, cladding, coating, laser specific compatible connector (proximal end), and optional tip configurations on the distal end (sometimes left bare). The device length can vary from 3 - 5 meters in length with core diameter sizes of 200, 400, 605, 800 and 1000 microns. The device also includes a fiber stripper, fiber cleaver, canula and hand piece to prepare and use the fibers in specific procedures. The proximal end of the fiber optic is connected to the laser system via SMA-905 or compatible connector type. This connection between the fiber and the laser system allows for the laser radiation to transmit through the fiber core and output at the distal end of the fiber optic. The fiber connector also keeps the laser centered on the fiber optic surface to ensure proper power transmission throughout the fiber optic. The fiber optic itself is multilayer; comprised of a core, cladding, and a coating. The fiber cladding and coating provide a protective laver around the core. They also have a low refractive index to keep the power confined inside of the fiber core. The distal end of the laser fiber can have multiple configurations to fit the needs of the treatment application. The most common configuration of the distal end is primarily a bare fiber, with a polished surface.
The provided text describes a 510(k) premarket notification for the Sentient Manufacturing Laser Fiber System, aiming to demonstrate its substantial equivalence to a predicate device (K200234 Quanta System Surgical Laser Fibers). This type of submission relies on comparative data rather than a detailed clinical effectiveness study with human subjects, making some of the requested information (like MRMC studies, human reader improvement, and extensive expert ground truthing) not directly applicable or reported in this document.
The acceptance criteria in this context are primarily based on demonstrating a comparable performance to the predicate device across several non-clinical parameters.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test / Acceptance Criteria | Reported Device Performance (Sentient Manufacturing Laser Fiber System) |
|---|---|
| Power Output Percentage (Comparable to Predicate) | "The Performance testing included power output percentage... The performance is nearly identical with the predicate device." Implicitly, the power output percentage was within acceptable limits compared to the predicate. |
| Long Duration Power Stability (Comparable to Predicate) | "10 individual power stability tests were done on the Predicate Device (K200234) and the Sentient Manufacturing Laser Fibers to provide a direct data comparison. A Power Fluctuation percentage was calculated." The results implicitly demonstrated comparable stability to the predicate. After 10 sterilization cycles, "re-ran the power test 10 times." and still demonstrated expected performance. |
| Tensile Strength Testing (Comparable to Predicate) | "Each fiber had 2 feet of length mounted to a folding bracket and was collapsed until the fiber core broke. Data was collected by looking at degree of bend. We discovered that each device had very similar results in the maximum bend radius due in part to having similar composition of fiber core, cladding, and coating." Implicitly, the tensile strength was comparable to the predicate. |
| Beam Profile Check (Visually Identical to Predicate) | "The distal end of the fiber was then pointed at a ceramic disk so it could be analyzed using an Infrared camera. Beam consistency and mode of the Sentient Manufacturing Laser Fibers were then visually compared to the predicate device and showed them to be as expected virtually identical." |
| Durability - Heat Testing (No Defects after 12h @ 150°C) | "Both fibers were placed into the fiber oven for a 12-hour duration at 150 degrees C and inspected for defects." Implicitly, no significant defects were detected, meeting a comparable durability standard to the predicate, or at least showing acceptable performance. The text states "none of note were detected" for sterilization durability, implying this was also true for heat testing. |
| Durability - Sterilization Durability (No Defects after 20 Autoclave Cycles) | "running each fiber optic assembly through 20 autoclave cycles and inspected for defects of which none of note were detected." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): For the performance tests:
- Power Stability: 10 individual power stability tests were performed on the Sentient Manufacturing Laser Fibers and 10 on the Predicate Device. After sterilization, the power test was re-run 10 times.
- Tensile Strength: Each fiber (Sentient and Predicate) was tested, implying at least one sample of each, likely more for robust data, but specific number not stated beyond "Each fiber".
- Beam Profile: At least one sample of each (Sentient and Predicate) was analyzed.
- Durability (Heat & Sterilization): "Both fibers" (Sentient and Predicate) were subjected to heat testing. "Each fiber optic assembly" for sterilization duration, implying at least one of each type.
- Data Provenance: The tests described are "Internal Performance Testing," meaning they were conducted by the manufacturer, Sentient Manufacturing LLC. The origin (country/location) of the testing facility is not specified, but the company is based in Park City, UT, USA. The data is prospective in the sense that these specific tests were conducted to demonstrate equivalence for this submission, rather than being collected from prior clinical use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of 510(k) submission for a laser fiber system does not typically involve expert clinical reads or establishment of ground truth by clinicians. The "ground truth" for the performance tests mentioned (power output, stability, tensile strength, beam profile, durability) is established by physical measurements and comparisons against a well-characterized predicate device. There is no mention of external experts or their qualifications in establishing the "ground truth" for these engineering and performance tests.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of clinical findings or diagnostic outputs from multiple readers. The performance data is objective (e.g., power measurements, physical characteristics, visual comparison of beam profile by technical personnel).
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
Not applicable. This is not an AI-assisted diagnostic device and therefore an MRMC study with human readers is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser fiber system), not a software algorithm. The "standalone performance" refers to the device's inherent physical and optical characteristics as measured in the performance tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Physical and Optical Measurements: For power output, power stability, tensile strength, and beam profile.
- Comparative Performance to a Legally Marketed Predicate Device: The primary "ground truth" for substantial equivalence is the demonstrated "nearly identical" or "very similar" performance compared to the K200234 Quanta System Surgical Laser Fibers. This type of submission relies on the predicate having already been deemed safe and effective.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI or machine learning algorithm. There is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable for the reason above.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.