Search Results

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.

Ask a specific question about this device

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:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If an MRMC comparative effectiveness study was done and its effect size.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

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.

Ask a specific question about this device

The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.

The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.

This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.

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

Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.

The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.

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

Not applicable/Not provided. This document details a 510(k) submission, which typically relies on non-clinical testing and comparison to predicate devices, rather than clinical studies with test sets in the context of diagnostic or treatment accuracy. The "test set" here refers to the units of the device itself and materials used for engineering and biocompatibility tests.

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)

Not applicable/Not provided. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not discussed. The "truth" for this submission is compliance with established device safety and performance standards and technological equivalence to predicate devices. Experts involved would be engineers, physicists, and toxicologists related to the conducted tests.

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

Not applicable/Not provided. This refers to methods for resolving discrepancies in clinical assessments, which is not relevant to this type of device submission presented here.

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/Not provided. This device is a CO2 Laser System, a surgical instrument. It is not an AI-assisted diagnostic or interpretation device that would typically involve human "readers" or MRMC studies.

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

Not applicable/Not provided. The CO2 Laser System is a surgical instrument operated by a human, not an algorithm.

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

The "ground truth" for this 510(k) submission is primarily established through:

• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, and FDA guidance for software.
• Bench performance testing: Demonstrating that the device physically delivers its intended laser energy parameters as specified.
• Comparison to predicate devices: Establishing that the technological characteristics and indications for use are substantially equivalent to devices already cleared by the FDA.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" in the context of machine learning or AI models, as this is a physical medical device. If "training set" refers to manufacturing processes or quality control, that information is not detailed here.

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

Not applicable/Not provided. As there is no "training set" for an AI or machine learning model, the establishment of ground truth in that context is not relevant.

Ask a specific question about this device

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 detachable lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from adapter via an external power.

This document, K180383, is a 510(k) summary for the "Light based hair removal device" by Shenzhen GSD Tech Co., Ltd. It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence for FDA approval.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance-based acceptance criteria for efficacy or hair reduction. The core of the submission is to demonstrate that the new device is as safe and effective as previously cleared devices.

The "acceptance criteria" in this context are interpreted as compliance with relevant regulatory standards and demonstrating similar technological and performance characteristics to the predicate device, implying similar safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and not a study with specific efficacy endpoints, there isn't a direct "acceptance criteria" table in terms of clinical performance metrics (e.g., % hair reduction). Instead, the performance shown is in relation to safety and regulatory compliance.

2. Sample Size Used for the Test Set and Data Provenance

• No human clinical study data is presented for efficacy. The studies described are engineering/laboratory tests (biocompatibility, electrical safety, eye safety, software validation).
• Therefore, there is no "test set" in the context of human subjects, nor data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. As no human clinical efficacy study is described, there is no "ground truth" established by experts in that context. The "ground truth" for the engineering tests would be the established international standards themselves, and the expertise lies with the testing laboratories performing the assessments.

4. Adjudication Method for the Test Set

• Not applicable. There is no human clinical test set requiring adjudication in the document.

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 light-based hair removal device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was done or mentioned.

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

• Not applicable. This is not an algorithmic device in the sense of AI. The software validation is for the device's operational software, not for an AI algorithm.

7. The Type of Ground Truth Used

• For the engineering tests, the "ground truth" is the established and recognized international standards (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). Compliance with these standards indicates safety and performance.

8. The Sample Size for the Training Set

• Not applicable. There is no machine learning or AI component mentioned that would require a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

In summary:

This 510(k) submission demonstrates the substantial equivalence of the "Light based hair removal device" by showing that it meets recognized safety and performance standards through engineering and biocompatibility testing, and that its technological characteristics are similar to those of predicate devices. It does not include clinical efficacy studies with human subjects or AI performance evaluations.

Ask a specific question about this device