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The surgical green laser system is intended for surgical treatment of benign prostatic hyperplasia (BPH) through photoselective vaporization of the prostate (PVP).

The surgical green laser system is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The device is a semiconductor pumped, Q-switched and double-frequency solid-state Nd:YAG green laser. The device has the following models according to different output laser powers: PVP-120, PVP-140, PVP-160 and PVP-180. It shall be used with the laser fibers cleared under K202601.

The pulse rate of the device is 10kH-18kH, and pulse width of the device is 100ns-180ns.

The surgical green laser system consists of a semiconductor-pumped controller, Laser internal circulating cooling system, electronic control system and footswitch.

The provided document is a 510(k) premarket notification for a medical device (Surgical Green Laser System) and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML powered medical device.

The document describes a traditional medical device and its comparison to a predicate device for substantial equivalence. The "Performance testing" section (page 10) refers to tests conducted on the laser system according to IEC 60825-1:2014, optical pulse and RF Wireless performance tests, electrical safety, laser safety and electromagnetic compatibility (EMC) tests (ANSI AAMI ES60601-1, IEC 60601-2-22, IEC 60601-1-2), and software verification and validation testing. These are standard engineering and safety tests for hardware and software, not clinical performance studies for an AI/ML algorithm.

Specifically, the document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the surgical green laser system and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This confirms that there are no studies related to the clinical performance of an AI-powered device, nor acceptance criteria for such a device.

Therefore, I cannot provide the requested information for an AI/ML powered medical device from this document.

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FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm-2140 mm and equipped with SMA 905 compatible connector.

FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

FLARE™ single-use surgical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The optical fiber material is fused quartz. One end of the fiber is connected to the medical laser equipment through a connector, and the other end directly outputs laser energy for laser operation. The product is sterilized by EO. It is a disposable medical device.

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the FLARE™ single-use surgical laser fiber. It details the device's characteristics, intended use, and comparison to a predicate device.

However, the document does not contain information about a study that assesses a device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop study, or a standalone algorithm performance study.

The "Performance testing" section on page 6 states: "Performance testing was conducted on FLARE™ single-use surgical laser fiber. Technical parameters about dimension, optical performance and mechanical strength were evaluated in the performance testing. In addition, the shelf life was evaluated. All of the tested parameters met the predefined acceptance criteria."

This statement refers to engineering and material performance tests (e.g., optical properties, mechanical strength, dimensions, shelf life) of the laser fiber itself, not a clinical study involving human readers or AI for diagnostic or interpretative tasks. Therefore, the detailed information requested in the prompt (acceptance criteria for a clinical study, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment for AI/diagnostic performance) is not present in this document.

In summary, the provided document does not contain the information needed to answer the prompt's specific questions regarding acceptance criteria and a study proving device performance related to diagnostic accuracy, human-in-the-loop performance, or AI algorithms. The "performance testing" described is for the physical and functional aspects of the laser fiber for its intended surgical application, not for a diagnostic or AI-assisted interpretation task.

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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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