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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 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-905connector.

·Laser must operate at a wavelength between 532 and 1064 nm.

• Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.

• · Laser must have a numerical aperture of 0.35 or less.
  · Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.

Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.

During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.

The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.

The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a non-AI medical device (SLT Select Fiber Delivery System and Contact Tips).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details for an AI device from the provided text.

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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.

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.

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