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Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissuewith or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Medical Thulium Fiber Laser System (UroFiber 60Q) consists of a host (including a power supply, thulium fiber laser, safety conrol module, cooling module), foot switch and optical fiber (disposable use, sterilized by the user before use. Model: RL-150, RL-200, RL-272, RL-365, RL-550, RL-800, RL-1000, specification: 300) composition. Protective glasses not included.

This document pertains to the FDA 510(k) premarket notification for the Medical Thulium Fiber Laser System (UroFiber 60Q) manufactured by Rhein Laser Technologies Co., Ltd. The information provided outlines the device's characteristics and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for an AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, and how ground truth was established for the training set is not applicable and not present in the provided document.

This document describes a traditional medical device (a laser surgical instrument), and the testing described is primarily for electrical safety, electromagnetic compatibility, and biocompatibility, as well as a comparison of its technical specifications and intended use against legally marketed predicate devices.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/SaMD criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (as implied by FDA 510(k) for a device like this): Substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is demonstrated through non-clinical performance data (compliance with general and particular medical device standards) rather than clinical performance metrics or AI algorithm performance metrics.

• Reported Device Performance: The document states that "Performance data supports that the device is as safe and effective as the predicate/reference devices for its intended use." Specific performance aspects tested include:

  • Safety of Laser Products (IEC 60825-1:2014)
  • Medical Electrical Equipment (IEC 60601-1:2005+AMD1:2012+AMD2:2020)
  • Electromagnetic Disturbances (IEC 60601-1-2:2014+AMD1:2020)
  • Particular Requirements for Surgical Laser Equipment (IEC 60601-2-22:2019)
  • Biocompatibility (ISO 10993 series: Parts 10, 23, 5, 11, 4)

  Acceptance Criteria (Implied by Standards & Substantial Equivalence)	Reported Device Performance (Compliance)
  Laser Safety Compliance	Complies with IEC 60825-1:2014
  Electrical Safety & Essential Performance	Complies with IEC 60601-1:2005+AMD1:2012+AMD2:2020
  Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014+AMD1:2020
  Specific Surgical Laser Equipment Safety	Complies with IEC 60601-2-22:2019
  Biocompatibility (Skin Sensitization, Irritation, Cytotoxicity, Systemic Toxicity, Blood Interaction)	Complies with ISO 10993-10, -23, -5, -11, -4; found to be biocompatible

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable. This isn't an AI/SaMD. The "test set" in this context refers to the physical device being tested against recognized consensus standards for electrical, laser, and biological safety. The "data provenance" specifically for patient data or images (as would be relevant for AI) is not relevant for this type of device submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
* Not applicable. This is not an AI/SaMD. Ground truth, in the AI context, refers to a definitive correct answer for patient data, often established by experts. For this laser device, "ground truth" is adherence to engineering and safety standards, not a clinical assessment of data by experts in the same way.

4. Adjudication Method:
* Not applicable. No clinical data interpretation by multiple readers is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. This type of study is specifically relevant for assessing the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. No algorithm performance is being evaluated.

7. The Type of Ground Truth Used:
* Not applicable. For this laser device, the "ground truth" of its safety and effectiveness is demonstrated by its adherence to established national and international engineering, electrical, laser, and biocompatibility standards, and its substantial equivalence to legally marketed predicate devices with a history of safe use. There is no "pathology," "outcomes data," or "expert consensus" in the sense of clinical interpretations for an algorithm.

8. The Sample Size for the Training Set:
* Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:
* Not applicable. No training set exists for this device.

In summary, the provided document is a standard FDA 510(k) clearance letter and summary for a physical medical device (a laser system), not an AI/SaMD. Therefore, it does not contain the specific information requested regarding acceptance criteria and performance studies for an AI device.

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The TitanPico Laser Workstation is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the proposed device is not explicitly stated in the provided text.

However, based on the document, I can extract information related to the comparison with the predicate devices and the non-clinical tests performed to demonstrate substantial equivalence.

Here's a breakdown of the information available and what is not explicitly stated in this FDA submission:

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

The document does not explicitly define "acceptance criteria" in the sense of quantitative performance targets for the new device itself. Instead, it aims to show substantial equivalence to predicate devices by comparing technical specifications. The "reported device performance" is mainly shown through the comparison table to the predicates and the assertion that non-clinical tests met standards.

Indications for Use (TitanPico Laser Workstation):

• 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat red, yellow, and orange tattoo colors.
• 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat black, brown, green, blue, and purple tattoo colors.
• Also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

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

• The document states that no clinical tests were performed for the proposed device. The company "believes that the proposed device TitanPico Laser Workstation products does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
• Therefore, there is no explicit test set sample size or data provenance provided for the proposed device in this submission. The "test set" in this context refers to non-clinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no clinical tests were performed for the proposed device and therefore no ground truth was established by experts for a test set. Non-clinical tests typically rely on established engineering and safety standards.

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

• Not applicable, as no clinical tests or expert interpretation of results for a test set were conducted. Non-clinical tests are evaluated against predefined physical and engineering standards.

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 device is a laser workstation, not an AI-assisted diagnostic or interpretation system. No MRMC study was performed.

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

• Not applicable. This device is a hardware laser system. The "software verification and validation" mentioned refers to the device's control software, not a standalone diagnostic algorithm.

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

• For the non-clinical tests, the "ground truth" is adherence to established international and national standards for medical electrical equipment, laser safety, and biocompatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). Performance was assessed against the specifications of these standards and the equivalence to the predicate devices.
• For the clinical effectiveness implied by substantial equivalence, the ground truth would have been established through the clinical studies conducted for the predicate devices, which are not detailed in this submission.

8. The sample size for the training set

• Not applicable, as this is a hardware device and not an AI/machine learning system that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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The indications for use for the RL-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the RL-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the RL-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

Not Found

The provided FDA 510(k) clearance letter and Indications for Use document for the Artemis Diode Laser System do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The document primarily focuses on:

• Confirming the substantial equivalence of the device to legally marketed predicates.
• Listing the specific Indications for Use, which primarily involve temporary or permanent hair reduction across different skin types.
• Outlining regulatory compliance requirements (e.g., Quality System regulation, adverse event reporting).

Therefore, based solely on the provided text, it is not possible to answer your questions about the acceptance criteria, device performance study details, or ground truth establishment. This information would typically be found in the full 510(k) submission, which is not included here.

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