(42 days)
The SLT Select Fiber Delivery Systems and Contact Tips are indicated for use in General Surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic Surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems and tips to be used with any laser system meeting the following requirements:
Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector.
Fiber Delivery Systems are cleared for use for the particular indications of the laser system to which they are attached.
This device is a prescription device.
The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector.
This document, K980156, is a 510(k) summary for the SLT Select Fiber Delivery Systems and Contact Tips, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than detailed performance criteria or clinical study results as would be expected for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for AI models is not applicable or cannot be extracted from this particular document.
Here's an analysis based on the provided text, addressing the points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed performance metrics in the way a modern AI/software device submission would. The basis for approval is "substantial equivalence" to existing devices. The document states:
"Description statements were not relied on to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used. The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use."
This implies that some form of validation was conducted to show the device performed comparably to predicate devices in achieving specific "tissue effects of incision, excision, vaporization and coagulation of tissue." However, the specific criteria for these effects (e.g., depth of incision, degree of coagulation, rate of vaporization) and the results of this validation are not provided in this summary.
The "acceptance criteria" can be inferred as the device successfully demonstrating the intended tissue effects when used with compatible laser systems, comparable to how predicate devices perform these actions.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Ability to achieve precise tissue effects: incision, excision, vaporization, and coagulation. | "The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue." (The document states this as a capability rather than a measured performance against a quantitative target, implying it was demonstrated to be functionally equivalent to predicate devices.) |
| Compatibility with laser systems meeting specified requirements (wavelength, mode, numerical aperture, SMA-905 connector). | "The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905 connector." And further, "Laser must operate at a wavelength between 532 and 1064 nanometers. Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode. Laser must have a numerical apertures of 0.39 or less Laser must accept the universal SMA-905 connector." (This is a design feature enabling compatibility, implicitly demonstrating it met this criterion). |
| Safety and effectiveness comparable to legally marketed predicate devices. | "The comparison of intended use and technological features of this device to other legally marketed devices taken together with validation results indicate that this device is substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use." (This is the overarching conclusion of the 510(k) process, not a specific reported performance metric.) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device for surgical procedures, not an AI/software device that uses test sets of data for algorithm evaluation. The "validation results" mentioned are likely related to engineering testing, material compatibility, and demonstration of functional performance in controlled environments or potentially animal/benchtop models, not human data sets. The document does not provide details on the specific validation tests or the sample sizes used in them.
3. 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 "ground truth" or expert review in the context of a test set, as this is not an AI/software device being evaluated for diagnostic or predictive accuracy.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process described for this type of medical device 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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
Not applicable. As this is not an AI/software device, the concept of "ground truth" in terms of clinical outcomes or expert consensus on data is not relevant to this submission. The "validation results" would likely be based on physical measurements and observations of the fiber's ability to transmit laser energy and create the desired tissue effects.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth for this medical device.
§ 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.