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510(k) Data Aggregation
(53 days)
Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.
The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.
The provided document is a 510(k) Summary for a Light Based Hair Removal Device GP592. It discusses the device's substantial equivalence to a predicate device but does not include information about clinical studies with human participants to demonstrate specific acceptance criteria or device performance in terms of efficacy or safety. The document primarily focuses on nonclinical tests for safety and electromagnetic compatibility.
Therefore, requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it outlines nonclinical testing and substantial equivalence, not results from a human study demonstrating efficacy against acceptance criteria.
The document states:
- Nonclinical tests submitted:
- Safety test: IEC 60601-1: 2005+A1: 2012+A2:2020, IEC 60601-1-11: 2015
- EMC test: IEC 60601-1-2: 2020
- Reliability test: IEC 62471: 2006, IEC 60601-2-83: 2019
- Biocompatibility test: ISO 10993-5: 2009, ISO 10993-10: 2021, ISO 10993-23: 2021
- Conclusion: "None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests."
This indicates that the device met the requirements of these specific technical and safety standards, which serve as the "acceptance criteria" in this context. However, these are not performance metrics like sensitivity, specificity, or outcomes from a human clinical trial.
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(84 days)
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Diode Laser System is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (810 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The proposed Diode Laser System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free mode.
The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.
I am sorry, but the provided text does not contain information about acceptance criteria and device performance for an AI/ML device or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a Diode Laser System, which is a physical medical device, not an AI/ML software. It primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications, intended use, and non-clinical safety tests.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If an MRMC comparative effectiveness study was done and its effect size.
- If a standalone (algorithm only) performance was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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(82 days)
The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.
The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.
The model GP908D is a handheld device, consisting of a main body, power cord and adapter.
308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.
The provided text describes a 510(k) submission for a medical device, the "308nm Excimer UV-light Skin Therapy System," and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI/software algorithm efficacy.
Specifically, the document discusses:
- Device Description: A UV light therapy system for psoriasis and vitiligo.
- Technological Characteristics: Comparison of wavelength, light source, mode of operation, etc., with a predicate device.
- Nonclinical Tests: Safety (IEC 60601-1), EMC (IEC 60601-1-2), Reliability (IEC 60601-2-57), Biocompatibility (ISO 10993-5, ISO 10993-10), and Software Validation. These are primarily engineering and compliance tests, not clinical performance studies measuring treatment efficacy or algorithm accuracy.
Therefore, I cannot fulfill your request for the tables and study details as this information is not present in the provided text. The document states that "None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests." This refers to its safety and performance as a device, not its clinical effectiveness in treating patients or the performance of a diagnostics interpreting AI/software.
The provided document is a 510(k) summary for a physical medical device (an excimer UV-light system), not an AI/software as a medical device (SaMD) or an AI-assisted diagnostic system. The "software validation & verification testing" refers to the embedded control software for the device itself, not an AI intended for diagnostic or prognostic purposes, which would require the kind of clinical validation and ground truth establishment you are asking about.
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