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The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostatic hyperplasia (BPH).

The single-use sterile medical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. The optical fiber material is fused quartz, and its core diameter is 760 µm. One end of the optical fiber is a special connector, which can be connected to the medical laser surgery system. The output structure of the other end of the optical fiber can be divided into side-firing type and front-firing type: W760SF-30, B760SF-30, G760SF-30 and P760SF-30 are side-firing types, W760F-30, B760FF-30, G760FF-30 and P760FF-30 are front-firing types.

The product is sterilized by EO. It is a disposable medical device.

The provided document is a 510(k) premarket notification for a medical device: a "Single-use sterile medical laser fiber." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving a specific level of clinical performance against pre-defined acceptance criteria in the manner of a novel AI/ML device.

Therefore, the information typically requested for AI/ML device studies (such as specific performance metrics, sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment) is not present in this document. The document focuses on showing substantial equivalence through comparison of technical specifications, intended use, and non-clinical testing (biocompatibility and general performance testing to ensure the device meets its own specifications).

Here's what can be extracted from the document regarding acceptance criteria and performance, as well as the types of studies performed:

1. A table of acceptance criteria and the reported device performance

The document mentions "predefined acceptance criteria" for performance testing, but the specific acceptance criteria and the detailed reported device performance values are not explicitly listed in a table format in the provided text.

However, the following specifications are given for the device, and the document states that performance testing confirmed these were met:

The document states: "All of the tested parameters met the predefined acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Performance testing" and "Biocompatibility testing" but does not detail the sample sizes for these tests or the data provenance. These are likely engineering and material tests, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided. This device is a physical medical instrument (laser fiber), not an AI/ML algorithm that requires expert labeling for ground truth. Technical specifications are likely verified by engineers or lab technicians using calibrated equipment.

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

This information is not applicable/provided. Adjudication methods are relevant for subjective interpretations of data, typically in AI/ML or clinical imaging studies. The tests mentioned are objective performance and biocompatibility assessments.

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

This information is not applicable/provided. This is a physical medical device, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies are not relevant to its 510(k) submission.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm.

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

This information is not applicable/provided in the context of clinical ground truth. For the performance and biocompatibility tests, "ground truth" would be established by standard engineering and chemical/biological testing methodologies that define material properties, optical performance, and biological safety. The document implies that industry standards (e.g., ISO 10993-1:2018 for biocompatibility) and internal test protocols were used to define and verify these "truths."

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, this is not an AI/ML system.

Summary of Device Performance Study as Described in the Document:

The document describes non-clinical testing to support the substantial equivalence determination. These tests include:

• Biocompatibility testing: Conducted according to ISO 10993-1:2018. This included tests for Cytotoxicity, Sensitization, Irritation, and Systemic toxicity. The document states these tests were performed and implies they met acceptance criteria (though specific results are not provided).
• Performance testing: This involved evaluating "technical parameters about dimension, optical performance and mechanical strength." Additionally, "shelf life was evaluated." The document explicitly states: "All of the tested parameters met the predefined acceptance criteria."

The "study" in this context is a series of engineering and laboratory tests to confirm the physical and biological characteristics of the laser fiber, not a clinical study involving patients or AI model validation. The purpose is to demonstrate that the device performs according to its specifications and is safe for its intended use, thereby showing substantial equivalence to a predicate device.

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